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The STERRAD™ Chemical Indicator (CI) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:

• · STERRAD™ 100S Sterilization System
• · STERRAD NXTM Sterilization System
  o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
• · STERRAD™ 100NX Sterilization System
  o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology o ULTRA GITM Cycle with Integrated ALLClear Technology

STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 11140-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:
· STERRAD™ 100S Sterilization System
· STERRAD NXTM Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology

• · STERRAD™ 100NX Sterilization System
  o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology o ULTRA GI™ Cycle with Integrated ALLClear™ Technology
  The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed loads.

The STERRAD VELOCITY™ Biological Indicator (BI)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:

• . STERRAD™ 100NX Sterilization System
  o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
  o ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only).
• . STERRAD NX™ Sterilization System
  o (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
  · STERRAD™ 100S Sterilization System

The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (BI) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ 100NX Sterilization System with ALLClear™ Technology.

The STERRAD™ Chemical Indicator (Cl) Strip consists of chemically reactive ink, a clear overcoat ink, a yellow comparator bar, and black ink for copy printed on a strip of white styrene. This device is a through-put process indicator to be used with ASP's STERRAD™ Sterilization Systems. The STERRAD Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. When in the presence of hydrogen peroxide, the indicator will change from red to yellow as indicated by the comparator bar to indicate that the load has been exposed to hydrogen peroxide.

The STERRAD™ SEALSURE™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD™ Sterilization Systems that utilize hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. The Chemical Indicator Tape reacts with hydrogen peroxide as it is introduced into the sterilization chamber. The chemical reaction between the indicator ink and the hydrogen peroxide causes the dye of the indicator ink on the diagonal STERRAD logos and the chemical indicator square on the tape to change color, indicating that the load has been exposed to hydrogen peroxide.

The STERRAD VELOCITY Biological Indicator (BI) is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and/or periodic testing in STERRAD Sterilization Systems.

The assembled ULTRA GI PCD is composed of a vial that encapsulates the STERRAD VELOCITY Biological Indicator (BI). The vial creates a stronger resistance to the ULTRA GI Cycle. At the end of the Bl is removed from the vial and used in conjunction with the STERRAD VELOCITY Reader (software version 1139260417 or newer) to verify the effectiveness of the ULTRA GI PCD Vial is only used for the ULTRA GI Cycle in STERRAD 100NX Sterilizers.

The provided document describes the acceptance criteria and the studies conducted for several sterilization process indicators and related devices (Chemical Indicator Strip, Chemical Indicator Tape, Biological Indicator, Biological Indicator Reader, and Process Challenge Device Vial). The studies aim to demonstrate the substantial equivalence of these devices to their legally marketed predicates, particularly with the inclusion of the new ULTRA GI Cycle.

Here's a breakdown of the requested information for each device where available:

1. STERRAD™ Chemical Indicator (CI) Strip (14100)

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and data provenance:

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and qualifications:

• Not applicable for these types of physical/chemical indicators. Ground truth is based on physical/chemical properties and adherence to ISO standards.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective chemical reactions and physical changes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not applicable for chemical indicators.

6. If a standalone study (algorithm only without human-in-the-loop performance) was done:

• Yes, the studies described are standalone performance tests of the chemical indicator strip itself.

7. Type of ground truth used:

• Objective physical/chemical change (color change due to hydrogen peroxide exposure) validated against ISO 11140-1:2014 Type 1 requirements.

8. Sample size for the training set:

• Not applicable. These are physical/chemical indicators, not AI/ML devices with training sets.

9. How the ground truth for the training set was established:

• Not applicable.

2. STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape (14202NL)

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and data provenance:

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and qualifications:

• Not applicable for these types of physical/chemical indicators. Ground truth is based on physical/chemical properties and adherence to ISO standards.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective chemical reactions and physical changes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not applicable for chemical indicators.

6. If a standalone study (algorithm only without human-in-the-loop performance) was done:

• Yes, the studies described are standalone performance tests of the chemical indicator tape itself.

7. Type of ground truth used:

• Objective physical/chemical change (color change due to hydrogen peroxide exposure) and physical properties (adhesion strength) validated against ISO 11140-1:2014 Type 1 requirements.

8. Sample size for the training set:

• Not applicable. These are physical/chemical indicators, not AI/ML devices with training sets.

9. How the ground truth for the training set was established:

• Not applicable.

3. STERRAD VELOCITY™ Biological Indicator (BI) and STERRAD VELOCITY™ Reader (43210, 43210-30, 43220)

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and data provenance:

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and qualifications:

• Not applicable. Ground truth for biological indicators is based on microbiological growth/no growth and fluorescence detection, which are objective measures.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective microbiological and fluorescence readings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not applicable for biological indicators and their readers.

6. If a standalone study (algorithm only without human-in-the-loop performance) was done:

• Yes, the studies described are for the standalone performance of the biological indicator and the reader. The reader's "algorithm" interprets the fluorescence, but it's not described as an AI/ML system requiring typical training/test sets.

7. Type of ground truth used:

• Microbiological growth (absence or presence of Geobacillus stearothermophilus ATCC 7953) and fluorescence detection, which correlates to enzymatic activity of the organism.

8. Sample size for the training set:

• Not applicable. While the reader processes data, it's not described as an AI/ML system with a separate training set.

9. How the ground truth for the training set was established:

• Not applicable.

4. ULTRA GI™ Process Challenge Device (PCD) Vial (43400)

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and data provenance:

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and qualifications:

• Not applicable. Ground truth for PCDs is based on the resistance they provide to the sterilization process, measured using biological indicator growth/no growth and fluorescence detection.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective microbiological and fluorescence readings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not applicable for PCDs.

6. If a standalone study (algorithm only without human-in-the-loop performance) was done:

• Yes, the studies described are for the standalone performance of the PCD vial in conjunction with the biological indicator and reader.

7. Type of ground truth used:

• Microbiological growth (absence or presence of Geobacillus stearothermophilus) and fluorescence detection, demonstrating the designed resistance to the sterilization process.

8. Sample size for the training set:

• Not applicable.

9. How the ground truth for the training set was established:

• Not applicable.

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The Velocity Alpha™ Drill System is indicated for trepanating, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and bone replacement materials.
Applications: Cutting, removing, shaping and sawing hard and soft tissue, bone, and bone replacement materials.
Areas of use: Neurosurgery and spinal surgery.

The Velocity Alpha™ Highspeed Surgical Drill System is an electric AC powered surgical motor drill system for rapid cutting, sawing, drilling and manipulation of soft tissue and bone.
The Subject Device has several components, such as an electric motor hand piece connected to and driven by an AC-powered control unit, a foot control unit (wired or wireless (Bluetooth)) and several adapters and nosepiece attachments, e.g. straight & angled nosepiece attachments, craniotome attachments, speed reducer attachments and sawing attachments.
The device has an optional irrigation pump that can supply irrigation through sterile tubing. Speed is variable from 1.000 RPM up to 80.000 RPM in order to adjust the speed to the surgeon's requirements. The direction of rotation can be pre-selected to the left and to the right.

The provided text describes the "Velocity Alpha Highspeed Surgical Drill System" and presents a summary of its substantial equivalence to a predicate device, including performance data. However, it does not contain a typical study design with acceptance criteria and results in the format implied by your request for "device performance" in relation to specific clinical outcomes or diagnostic accuracy.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance (510(k)). The "Performance data testing" section refers to engineering and functional tests rather than clinical studies or those involving expert review of diagnostic output.

Here's an analysis of the provided information based on your requested headings:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify a "test set" in the context of clinical data, diagnostic images, or patient-specific results. The performance data presented are for the device itself (e.g., motor speed, temperature, electrical safety). Therefore, there is no information on sample size or data provenance in that regard.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The "ground truth" for the engineering performance tests (motor speed, temperature, etc.) would be established by technical specifications and validated measurement equipment, not by clinical experts.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as the tests performed are technical and do not involve subjective interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document does not describe any studies comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a surgical drill system, not an AI algorithm or diagnostic tool. The performance tests are for the physical device's operation.

7. The Type of Ground Truth Used

The ground truth for the performance data testing was based on technical specifications and established international standards (e.g., IEC 60601-1, IEC 60601-1-2) which define acceptable limits for motor speed, torque, temperature, noise, electrical safety, and electromagnetic compatibility.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical/electrical surgical system and does not utilize a "training set" in the AI/machine learning sense.

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as above.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The document describes a series of engineering and functional performance tests conducted on the Velocity Alpha Highspeed Surgical Drill System. These tests evaluated various technical aspects of the device, including:

• Motor speed and torque analysis: To confirm the motor performs within its specified range.
• Temperature analysis: To ensure the motor temperature remains within safe and specified limits during activity.
• Lifetime testing: To verify the system's durability and functionality over its expected operational lifespan.
• Noise level analysis: To confirm the noise generated by the device does not exceed specified limits.
• Electrical Safety testing: Conducted to ensure compliance with IEC 60601-1:2005, a standard for medical electrical equipment safety.
• Electromagnetic Compatibility (EMC) testing: Conducted to ensure compliance with IEC 60601-1-2:2014, a standard for EMC of medical electrical equipment.
• Wireless Foot Control testing: Included software verification/validation (IEC 62304:2006), EMC (IEC 60601-1-2:2007), and Electrical Safety (IEC 60601-1-1:2005) tests.
• Software Validation: Met requirements according to IEC 62304:2006.
• Biocompatibility testing: Performed on patient-contacting components (attachments/nosepieces) to meet ISO 10993 and EN ISO 10993-1 requirements.

Conclusion of the study: All tests "Passed," indicating that the device met its specified technical and safety acceptance criteria, demonstrating its substantial equivalence to the predicate device (Aesculap ELAN 4 Electro Motor System) based on technological characteristics, functionality, and intended use, without negative effects on safety or effectiveness. The document explicitly states "No clinical data is required for this device classification submission."

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EnSite™ Velocity™ Cardiac Mapping System: The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. When used with the EnSite™ Array™ Catheter, the EnSite™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with an EnSite™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

EnSite Precision Cardiac Mapping System: The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™M Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

EnSite Verismo Segmentation Tool: The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.

EnSite Derexi Module: When used with EnSite Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™M System / WorkMate Claris™ System for synchronizing and display of patient information.

EnSite Courier Module: When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.

EnSite Fusion Registration Module: EnSite Fusion is indicated for registering the EnSite Navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.

EnSite Contact Force Module: When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite AutoMap Module: When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user AutoMark Module When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in realtime.

AutoMark Module: When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.

The EnSiteTM VelocityTM Cardiac Mapping System / EnSite PrecisionTM Cardiac Mapping System is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber. The EnSiteTM VelocityTM Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies. An EP study involves the introduction of one or more electrode catheters into the heart to record its electrical activity. These catheters connect to the EnSiteTM VelocityTM Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSiteTM VelocityTM Cardiac Mapping System is designed for use in the EP laboratory in conjunction with other equipment. The EnSite VelocityTM Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing. The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier. The system operates using impedance only or impedance plus magnetics based upon its configuration. The EnSite™ Velocity™ Cardiac Mapping System base software only collects impedance data. Adding EnSite Precision™ software to the base software allows the system to receive both magnetic data from the MediGuide™ Technology System or the EnSite Precision™ Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to the base software) together make up the EnSite Precision™ Cardiac Mapping System. The EnSite Precision™ software interfaces to the MediGuide Technology System or the EnSite Precision™ Module to collect magnetic position and orientation information. The EnSite Precision™ software uses the magnetic data for magnetic field scaling (NavX SE), shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling adjusts the dimensions of the navigation field based on both the positon and orientation of magnetic sensors and the electrodes on Sensor Enabled™ (SE) tools, optimizing the appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a potential shift based on a correlation of magnetic and impedance locations when using any Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point of the respiration cycle using magnetic data to determine respiration phase. The EnSite Precision™ Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field Frame, and EnSite Precision™ Patient Reference Sensors.

The provided document does not contain information regarding the acceptance criteria or a study proving the device meets those criteria for an AI/ML-driven medical device.

The document is a 510(k) premarket notification for the Abbott EnSite Velocity Cardiac Mapping System and EnSite Precision Cardiac Mapping System. This device is described as a cardiac mapping and navigation system, used to display the 3D position of electrophysiology catheters and cardiac electrical activity.

The "Non-Clinical Testing Summary" section (pages 7-8) details various types of performance and safety tests conducted, such as:

• Packaging tests (Visual Inspection, Bubble Leak Test, Pouch Seal Strength)
• Shelf Life tests (Electrode Gel Adhesion, Electrode Impedance & Capacitance, Impedance Stability, Electrode Temperature & Current Dispersion)
• Cable Pullout
• Electrode Identification
• Design Validation (Nominal Design Verification, Impedance Tests, Electrical Safety, Adhesion Testing)
• Risk Management

However, these are standard engineering and product validation tests for medical devices, focusing on the physical and electrical performance of the system and its components. There is no mention of:

• Any AI/ML components within the device for which acceptance criteria would typically involve performance metrics like sensitivity, specificity, accuracy, or other clinically relevant measures derived from a test set.
• A "study that proves the device meets the acceptance criteria" in the context of an AI/ML product's clinical performance against ground truth.
• Specific quantitative acceptance criteria for algorithm-driven performance.
• Details about a test set, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
• Information on training sets or how ground truth for a training set was established.

The "EnSite Verismo Segmentation Tool," "EnSite AutoMap Module," and "AutoMark Module" are mentioned as optional expansion modules, with "EnSite Verismo" generating 3D models from DICOM images and "AutoMap" automatically collecting mapping points based on user criteria, and "AutoMark" displaying lesion marks based on user parameters and other system data. While these modules involve some level of automation or processing, the document does not treat them as AI/ML systems requiring a specific clinical validation study against diagnostic ground truth. The testing mentioned appears to be functional and safety testing, not statistical performance validation of an AI model's output.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided document. The device in this submission does not appear to be an AI/ML device in the context of the detailed AI/ML performance validation questions.

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STERRAD VELOCITY® Biological Indicator/Process Challenge Device, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD Sterilization Systems:

• · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear® Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear® Technology
• · STERRAD® 100S

The STERRAD VELOCITY Biological Indicator (BI) /Process Challenge Device (PCD) is a selfcontained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRAD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2ºC.

The STERRAD VELOCITY BI/PCD can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple) if used for frequent monitoring purposes. When using this method, the biological indicator must be cultured in an incubator at 55-60°C for 5 to 7 days to get a final visual result.

The STERRAD VELOCITY BI/PCD consists of a glass fiber disc containing a minimum of 1 x 100 Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow with some red/orange/brown dots when exposed to hydrogen peroxide.

The STERRAD VELOCITY BI/PCD has the same a-glucosidase enzyme system for the fundamental scientific technology as the predicate device cleared under K182404. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4-methylumbelliferyl (4-MU) moieties of 4methylumbelliferyl a-D-glucopyranoside (α-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of a-MUG.

The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth, the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI/PCD and is used to distinguish between the positive and negative responses.

The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI/PCD to obtain the final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric assay method to detect the enzyme activity from the BI and the fluorescence emitted from the BI is converted into a voltage. This voltage reading is then used by the fluorescence algorithm in the Reader to determine the final fluorescence result.

There are eight individual BI incubation wells in the STERRAD VELOCITY Reader. Its heater system is designed to maintain the biological indicators at 57 ± 2℃ to promote the outgrowth of the indicator organisms. Each well contains an ultraviolet light source that excites fluorescence in the growth medium, and a photodetector to detect that fluorescence.

The STERRAD VELOCITY Reader features a touch screen for an effective user interface. Directly under each well is a well number illuminated by a well status indicator light. Three colors (white, green, and red) and two states (off and solid line) are used for the indicator light on the touch screen to show the status of the BI processing. The Reader has a thermoplastic exterior which makes it easy to clean and maintain. A built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy.

The STERRAD VELOCITY Reader of the subject device has the same hardware and uses same fundamental scientific technology as the predicate device cleared under K182404. Only the algorithm for fluorescence reading has been modified in the subject device to reduce the fluorescence readout time from 30 minutes to 15 minutes.

Here's a breakdown of the acceptance criteria and study information for the STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes for the test sets in each study. It mentions that:

• For "Hydrogen Peroxide Dose Response and Sterilization Verification," "Design evaluation and Performance Qualification for Periodic Testing," "Verification of Reduced Incubation Time," and "Verification of BI Holding Time," the device's performance was evaluated by reanalyzing fluorescence results and data collected from previously submitted studies using the modified algorithm. No additional sterilization cycles were performed for these specific re-evaluations. This suggests the data provenance is retrospective, using previously gathered data.
• The original provenance of the data used for the reanalysis (e.g., country of origin) is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The studies primarily involve analytical testing against established biological and chemical indicators, rather than expert interpretation of medical images or other data requiring clinical expertise.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are based on analytical measurements (fluorescence readings, growth/no growth, chemical indicator changes) and adherence to set criteria. There is no mention of a human adjudication process for interpreting results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is a biological indicator system used for monitoring sterilization, not a diagnostic AI system that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are essentially standalone performance evaluations of the STERRAD VELOCITY BI/PCD and Reader. The modified algorithm's ability to accurately read and interpret the biological indicator's fluorescence (without human intervention in the interpretation process) is the core of the verification. The reader automatically determines and displays the result ("Positive" or "Negative").

7. The type of Ground Truth Used:

The ground truth used in these studies is primarily biological/chemical reference standards and established scientific principles:

• Biological model: For periodic testing, the BI's resistance is compared to a "biological model," which represents the most difficult item routinely processed.
• Sterile BIs (growth and fluorescence): The "growth" outcome of the Geobacillus stearothermophilus spores (or lack thereof) after incubation, and the corresponding fluorescence, serve as the biological ground truth for assessing sterilization effectiveness.
• Chemical indicator changes: The color change of the chemical indicator (from red/pink to yellow/orange/brown dots) provides a chemical ground truth for exposure to hydrogen peroxide.
• 7-day incubation spore growth results: For verifying reduced incubation time, the rapid fluorescence results are compared against the longer, traditional 7-day visual assessment of spore growth, which is a well-established method for confirming biological indicator results.

8. The Sample Size for the Training Set:

This information is not provided. Given that the modification was an update to an existing algorithm based on reanalysis of previous data, and the device is a biological indicator reader rather than a deep learning AI, a distinct "training set" in the context of machine learning might not be applicable or explicitly documented in this way. The algorithm's development would have likely involved extensive testing and refinement, but the specific size or methodology for a formal "training set" is not detailed here.

9. How the Ground Truth for the Training Set was Established:

As with the training set size, the specific methodology for establishing ground truth for any potential "training set" for algorithm development is not detailed. However, it can be inferred that the ground truth would have been established through controlled experiments involving the exposure of biological indicators to varying levels of hydrogen peroxide and subsequent traditional incubation and growth assessment (e.g., the 7-day incubation method mentioned). The previous K182404 submission would have contained details on the initial algorithm's development and associated ground truth.

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The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD Sterilization Systems:

• · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear™ Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
  · STERRAD® 100S

The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2ºC.
The STERRAD VELOCITY BI can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple) if used for frequent monitoring purposes. When using this method, the biological indicator must be cultured in an incubator at 55-60℃ for 5 to 7 days to get a final visual result.
The STERRAD VELOCITY BI consists of a glass fiber disc containing a minimum of 1 x 100 Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow or yellow with some red/orange/brown dots when exposed to hydrogen peroxide.
The STERRAD VELOCITY BI has the same α-glucosidase enzyme system for the fundamental scientific technology as the predicate device cleared under K170039. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4-methylumbelliferyl (4-MU) moieties of 4-methylumbelliferyl a-D-glucopyranoside (α-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of a-MUG.
The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth. the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI and is used to distinguish between the positive and negative responses.

The provided text describes the acceptance criteria and a study proving the device meets the acceptance criteria for the STERRAD VELOCITY™ Biological Indicator.

Here's a breakdown of the requested information:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the device, as outlined by the "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, Section 10, Test Pack, issued on October 4, 2007," appears to be that the resistance of the subject device must be greater than or equal to the biological models for all claimed STERRAD Cycles. Additionally, all fluorescence-negative results during testing must be obtained in triplicate runs.

• Performance Study in STERRAD 100NX (STANDARD and FLEX Cycles, with/without ALLClear Technology): Pass
• Performance Study in STERRAD 100NX (EXPRESS Cycle, with/without ALLClear Technology): Pass
• Performance Study in STERRAD 100NX (DUO Cycle): Pass
• Performance Study in STERRAD NX (STANDARD and ADVANCED Cycles, with/without ALLClear Technology): Pass
• Performance Study in STERRAD 100S Cycle: Pass |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states that "all fluorescence-negative results were obtained in triplicate runs." This implies that for each performance study listed, testing was conducted in triplicate. The exact number of biological indicators (BIs) or runs per condition is not explicitly stated beyond "triplicate runs."
• Data Provenance: The data is from non-clinical performance testing conducted by Advanced Sterilization Products (ASP). There is no explicit mention of the country of origin of the data, but given ASP is based in Irvine, California, it's highly likely the testing was conducted in the United States. The study is inherently prospective as it involves new performance testing of the device for expanded indications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a biological indicator, the ground truth is typically established by the growth or non-growth of the microbial spores after exposure to a sterilization process, which is an objective measurement. It does not typically involve expert interpretation in the same way as, for example, reading medical images.

4. Adjudication Method for the Test Set

This information is not applicable in the context of biological indicator testing as described. The results (fluorescence-negative or positive, and spore growth/non-growth) are objective measurements based on the device's functionality and the viability of the spores. It does not involve human interpretation that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The STERRAD VELOCITY™ Biological Indicator is a standalone device for monitoring sterilization processes and its performance is assessed directly, not in conjunction with human interpretation in an MRMC setting.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance study described is essentially a standalone (algorithm only) performance evaluation of the STERRAD VELOCITY™ Biological Indicator. The device, in conjunction with the STERRAD VELOCITY Reader, determines a "positive or negative result" based on the detected fluorescent signal, which is determined using an "algorithm developed for the STERRAD VELOCITY BI." The results presented ("Pass" or "Fail" for the performance studies and the resistance being "greater than" the biological model, and "fluorescence-negative results were obtained in triplicate runs") are indicative of the algorithm's direct performance in identifying effective sterilization.

7. The Type of Ground Truth Used

The ground truth for the biological indicator testing is based on the viability (growth or non-growth) of the Geobacillus stearothermophilus (ATCC 7953) spores after exposure to sterilization cycles, as well as the expected D-value (decimal reduction time) and and absence of growth in fully processed units. This is a biological/microbiological ground truth, directly tied to the primary function of a biological indicator. The "fluorescence-negative" result detected by the reader is directly correlated to the inactivation of spores. The document also mentions the optional visual pH-based color change result after 5-7 days of culture, which further confirms spore viability (or lack thereof).

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This device is a biochemical indicator with an enzymatic detection system, rather than a machine learning or AI model that typically requires a large training dataset for learning patterns from data. The "algorithm developed for the STERRAD VELOCITY BI" likely refers to a pre-defined threshold or logic based on the biochemical reaction, rather than a machine-learned algorithm.

9. How the Ground Truth for the Training Set Was Established

As no specific "training set" in the context of machine learning is indicated, the method of establishing ground truth for a training set is not applicable as described in the document. The foundational principles for the device's operation (α-glucosidase enzyme system, spore viability detection) are based on established microbiological and biochemical science. The development of the algorithm would have relied on understanding the relationship between enzyme activity, fluorescence, and spore inactivation, established through scientific studies and threshold determination rather than a traditional machine learning training process with a distinct training set.

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EnSite™ Velocity™ Cardiac Mapping System v5.2:
The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies have been indicated.
When used with EnSite™ Array Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping system alone.
Or
When used with the EnSite™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

EnSite Precision™ Cardiac Mapping System v2.2:
The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

EnSite™ Verismo™ Segmentation Tool:
The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT. MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.

EnSite™ Derexi™ Module:
When used with EnSite Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information.

EnSite™ Courier™ Module:
When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.

EnSite™ Fusion™ Registration Module:
EnSite Fusion is indicated for registering the EnSite Navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.

EnSite™ Contact Force Module:
When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ AutoMap Module:
When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.

AutoMark Module:
When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.

The EnSite™ Velocity™ Cardiac Mapping System with software version 5.2 / EnSite Precision™ Cardiac Mapping System with software version 2.2 is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.

The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies. An EP study involves the introduction of one or more electrode catheters into the heart to record its electrical activity. These catheters connect to the EnSite™ Velocity™ Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSite™ Velocity™ Cardiac Mapping System v5.2 is designed for use in the EP laboratory in conjunction with other equipment.

The EnSite Velocity™ Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing.

The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multi-electrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier.

The system operates using impedance only or impedance plus magnetics based upon its configuration. The EnSite™ Velocity™ Cardiac Mapping System base software only collects impedance data. Adding EnSite Precision™ software to the base software allows the system to receive both magnetic data from the MediGuide™ Technology System or the EnSite Precision™ Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to the base software) together make up the EnSite Precision™ Cardiac Mapping System.

The EnSite Precision™ software interfaces to the MediGuide Technology System or the EnSite Precision™ Module to collect magnetic position and orientation information. The EnSite Precision™ software uses the magnetic data for magnetic field scaling (NavX SE), shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling adjusts the dimensions of the navigation field based on both the position and orientation of magnetic sensors and the electrodes on Sensor Enabled™ (SE) tools, optimizing the appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a potential shift based on a correlation of magnetic and impedance locations when using any Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point of the respiration cycle using magnetic data to determine respiration phase.

The EnSite Precision™ Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field Frame, and EnSite Precision™ Patient Reference Sensors.

Expansion Module Device Description
The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the following optional expansion software modules:

1. EnSite™ Verismo™ Segmentation Tool - an optional expansion module used in generating 3D models from CT, MR or rotational angiography DICOM image data and displaying images on the EnSite™ Velocity™ Cardiac Mapping System. The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.
2. EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMate™ Recording System to support the exchange of mapping point data and patient setup information between the two systems.
3. EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansion module that allows the EnSite™ Velocity™ Cardiac Mapping System to communicate with the hospital PACS (Picture Archiving and Communication System) server for the purposes of storing and retrieving patient data in DICOM format.
4. EnSite™ Fusion™ Registration Module - an optional expansion module that provides non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model. The module is used with the EnSite™ NavX™ Navigation and Visualization Technology Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D models created from digital images from CT and MRI data can be imported onto the EnSite™ Velocity™ System.
5. EnSite™ Contact Force Module - an optional expansion module that provides the display of information from the TactiSys Quartz System. The EnSite Velocity System's EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
6. EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
7. AutoMark Module - module allows the user to set parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation. The user set parameters is based on data from Ensite™ Contact Force Module, the Ampere Generator, and the WorkMate Claris™ System which is displayed on the AutoMark Module as lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark are defined by the user.

Based on the provided FDA 510(k) submission summary for the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2 (K183128), here's an analysis regarding acceptance criteria and the study proving the device meets them:

Crucial Observation: This 510(k) summary is for a Special 510(k) submission. A Special 510(k) is used for modifications to a legally marketed device where the modification does not affect the device's fundamental scientific technology or lead to a new intended use. As stated in the document:

"The proposed labeling modifications to the subject device pertain to warnings only. The labeling modifications include removal of the black box warning from the cover of the Instructions for Use as well as the addition of a warning in the warnings section of the Instructions for Use. There are no new or increased risks that result from the proposed modifications presented within the submission, and the changes do not raise any new questions of safety and effectiveness in regards to the subject device."

"No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission."

This means that the submission does not contain new performance data or a new study proving the device meets specific acceptance criteria for functionality or clinical impact. Instead, it relies on the predicate device's existing performance, as the changes are limited to labeling and deemed not to affect safety or effectiveness.

Therefore, many of the details typically associated with studies proving device performance against acceptance criteria (like sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and detailed ground truth establishment for new data) are not applicable to this specific Special 510(k) submission.

Addressing your points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for labeling changes only, there are no explicit new "acceptance criteria" for device performance in this document, nor new "reported device performance" data from new studies. The device's performance is implicitly accepted as equivalent to the predicate device.

If we were to infer "acceptance criteria" from the premise of a Special 510(k), it would be that the modified device must perform no worse than the predicate and introduce no new risks.

2. Sample sizes used for the test set and the data provenance

• Sample Size: Not applicable. No new test set data was used or generated for this Special 510(k) submission, as stated: "No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission."
• Data Provenance: Not applicable for new performance data. The device relies on the established performance of its predicate, EnSite™ Velocity™ Cardiac Mapping System v5.2 (K182644) and EnSite™ Precision™ Cardiac Mapping System v2.2 (K182644). The provenance of data for the predicate would be detailed in its original 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No new test set requiring expert ground truth was created for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No new test set requiring adjudication was created for this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. The device (EnSite Velocity/Precision Cardiac Mapping System) is a "Programmable Diagnostic Computer" primarily for displaying catheter position and cardiac electrical activity. It's not described as an AI-powered diagnostic device in the context of assisting human readers with interpretation (e.g., radiology AI). Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to the information provided for this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable for this Special 510(k) for reasons similar to point 5. The device's function is to display mapping information, not to provide an automated diagnosis that would be evaluated in a standalone manner without human oversight.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable for new data in this submission. The "ground truth" for catheter mapping systems typically relates to the accuracy of position sensing and electrical signal display, which would have been established during the development and clearance of the predicate devices. This might involve phantom studies, in-vitro testing, and potentially clinical correlation, but this specific document does not detail new ground truth establishment.

8. The sample size for the training set

• Not applicable. The document does not describe any machine learning or AI components that would require a "training set" in the conventional sense for image or signal interpretation. The system is a diagnostic computer that processes and displays data, not an AI model that learns from large datasets.

9. How the ground truth for the training set was established

• Not applicable, as there is no mention of a training set for an AI/ML model.

Ask a specific question about this device

EnSite™ Velocity™ Cardiac Mapping System v5.2:
The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated.
When used with EnSite™ Array Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arthythmias that may be difficult to identify using conventional mapping system alone.
Or
When used with the EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

EnSite Precision™ Cardiac Mapping System v2.2:
The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

EnSite™ Verismo™ Segmentation Tool:
The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT. MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.

EnSite™ Derexi™ Module:
When used with EnSite Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information.

EnSite™ Courier™ Module:
When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.

EnSite™ Fusion™ Registration Module:
EnSite Fusion is indicated for registering the EnSite Navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.

EnSite™ Contact Force Module:
When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ AutoMap Module:
When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.

AutoMark Module:
When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.

The EnSite™ Velocity™ Cardiac Mapping System with software version 5.2 / EnSite Precision™ Cardiac Mapping System with software version 2.2 is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.
The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies. An EP study involves the introduction of one or more electrode catheters into the heart to record its electrical activity. These catheters connect to the EnSite™ Velocity™ Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSite™ Velocity™ Cardiac Mapping System v5.2 is designed for use in the EP laboratory in conjunction with other equipment.
The EnSite Velocity™ Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing.
The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier.
The system operates using impedance only or impedance plus magnetics based upon its configuration. The EnSite™ Velocity™ Cardiac Mapping System base software only collects impedance data. Adding EnSite Precision™ software to the base software allows the system to receive both magnetic data from the MediGuide™ Technology System or the EnSite Precision™ Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to the base software) together make up the EnSite Precision™ Cardiac Mapping System.
The EnSite Precision™ software interfaces to the MediGuide Technology System or the EnSite Precision™ M Module to collect magnetic position and orientation information. The EnSite Precision™ software uses the magnetic data for magnetic field scaling (NavX SE), shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling adjusts the dimensions of the navigation field based on both the positon and orientation of magnetic sensors and the electrodes on Sensor Enabled™ (SE) tools, optimizing the appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a potential shift based on a correlation of magnetic and impedance locations when using any Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point of the respiration cycle using magnetic data to determine respiration phase.
The EnSite Precision™ Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field Frame, and EnSite Precision™ Patient Reference Sensors.

Expansion Module Device Description:

1. EnSite™ Verismo™ Segmentation Tool - an optional expansion module used in generating 3D models from CT, MR or rotational angiography DICOM image data and displaying images on the EnSite™ Velocity™ Cardiac Mapping System. The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.
2. EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMate™ Recording System to support the exchange of mapping point data and patient setup information between the two systems.
3. EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansion module that allows the EnSite™ Velocity™ Cardiac Mapping System to communicate with the hospital PACS (Picture Archiving and Communication System) server for the purposes of storing and retrieving patient data in DICOM format.
4. EnSite™ Fusion™ Registration Module - an optional expansion module that provides non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model. The module is used with the EnSite™ NavX™ Navigation and Visualization Technology Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D models created from digital images from CT and MRI data can be imported onto the EnSite™ Velocity™ System.
5. EnSite™ Contact Force Module - an optional expansion module that provides the display of information from the TactiSys Quartz System. The EnSite Velocity System's EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
6. EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
7. AutoMark Module - module allows the user to set parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation. The user set parameters is based on data from Ensite™ Contact Force Module, the Ampere Generator, and the WorkMate Claris™ System which is displayed on the AutoMark Module as lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark are defined by the user.

The provided document does not contain information about a study that proves a device meets acceptance criteria for an AI/ML-based medical device. Instead, it is a 510(k) clearance letter for the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2, which are described as programmable diagnostic computer systems. These systems are used for catheter navigation and mapping in electrophysiology studies.

The document discusses validation activities for functional testing related to hardware and software modifications, as well as verification testing against industry standards. However, it does not detail a clinical study with acceptance criteria and performance metrics typically associated with proving the effectiveness of an AI/ML diagnostic tool, such as sensitivity, specificity, accuracy, or human-AI comparative performance.

Therefore, I cannot extract the requested information to fill in the table and describe the study as it pertains to AI/ML device performance. The testing described largely relates to electrical safety, electromagnetic compatibility, basic system function, system-level accuracy, and software/hardware verification after proposed modifications.

To answer your request, if this were an AI/ML device, the study would typically involve:

1. A table of acceptance criteria and the reported device performance: This would list specific thresholds for metrics like sensitivity, specificity, AUC, or agreement rates, and the actual performance achieved by the AI device.
2. Sample size used for the test set and data provenance: Details on the number of medical images/cases in the test set, their origin (e.g., specific hospitals, geographical regions), and whether the data was collected retrospectively or prospectively.
3. Number of experts used to establish the ground truth and qualifications: How many, and what level of experience (e.g., board-certified radiologists with X years of experience in the specific domain), defined the true labels for the test data.
4. Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert review).
5. MRMC comparative effectiveness study: If human readers were involved, how their performance changed with and without AI assistance (e.g., increase in true positives, decrease in false negatives).
6. Standalone performance: The performance of the algorithm without any human intervention.
7. Type of ground truth: Whether ground truth was established by expert consensus, biopsy/pathology results, clinical follow-up data, or other definitive methods.
8. Sample size for the training set: The number of cases used to train the AI model.
9. How the ground truth for the training set was established: Similar to the test set, how the true labels for the training data were determined.

The provided document, while comprehensive for a 510(k) submission for a non-AI/ML device, does not contain these specific details.

Ask a specific question about this device

The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated.
When used with EnSite Array Catheter, the EnSite Velocity Cardiac Mapping System is intended to be used in the right atrium of patients with complex arthythmias that may be difficult to identify using conventional mapping system alone.
Or
When used with the EnSite Velocity Surface Electrode Kit, the EnSite Velocity Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart

EnSite Precision Cardiac Mapping System v2.2:
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

EnSite™ Verismo™ Segmentation Tool: The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.

EnSite™ Derexi™ Module: When used with EnSite Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information.

EnSite™ Courier™ Module: When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.

EnSite™ Fusion™ Registration Module: EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.

EnSite™ Contact Force Module: When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ AutoMap Module: When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.

EnSite™ AutoMark Module: When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.

The EnSite™ Velocity™ Cardiac Mapping System with software version 5.2 / EnSite Precision™ Cardiac Mapping System with software version 2.2 is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.

The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies. An EP study involves the introduction of one or more electrode catheters into the heart to record its electrical activity. These catheters connect to the EnSite™ Velocity™ Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSite™ Velocity™ Cardiac Mapping System v5.2 is designed for use in the EP laboratory in conjunction with other equipment.

The EnSite Velocity™ Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing. The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier. The system operates using impedance only or impedance plus magnetics based upon its configuration. The EnSite™ Velocity™ Cardiac Mapping System base software only collects impedance data. Adding EnSite Precision™ software to the base software allows the system to receive both magnetic data from the MediGuide™ Technology System or the EnSite Precision™ Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to the base software) together make up the EnSite Precision™ Cardiac Mapping System. The EnSite Precision™ software interfaces to the MediGuide Technology System or the EnSite Precision™ M Module to collect magnetic position and orientation information. The EnSite Precision™ software uses the magnetic data for magnetic field scaling (NavX SE), shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling adjusts the dimensions of the navigation field based on both the positon and orientation of magnetic sensors and the electrodes on Sensor Enabled™ (SE) tools, optimizing the appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a potential shift based on a correlation of magnetic and impedance locations when using any Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point of the respiration cycle using magnetic data to determine respiration phase. The EnSite Precision™ Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field Frame, and EnSite Precision™ Patient Reference Sensors.

The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the following optional expansion software modules:

1. EnSite™ Verismo™ Segmentation Tool - an optional expansion module used in generating 3D models from CT, MR or rotational angiography DICOM image data and displaying images on the EnSite™ Velocity™ Cardiac Mapping System. The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.
2. EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMate™ Recording System to support the exchange of mapping point data and patient setup information between the two systems.
3. EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansion module that allows the EnSite™ Velocity™ Cardiac Mapping System to communicate with the hospital PACS (Picture Archiving and Communication System) server for the purposes of storing and retrieving patient data in DICOM format.
4. EnSite™ Fusion™ Registration Module - an optional expansion module that provides non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model. The module is used with the EnSite™ NavX™ Navigation and Visualization Technology Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D models created from digital images from CT and MRI data can be imported onto the EnSite™ Velocity™ System.
5. EnSite™ Contact Force Module - an optional expansion module that provides the display of information from the TactiSys Quartz System. The EnSite Velocity System's EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
6. EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
7. AutoMark Module - module allows the user to set parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation. The user set parameters is based on data from Ensite™ Contact Force Module, the Ampere Generator, and the WorkMate Claris™ System which is displayed on the AutoMark Module as lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark are defined by the user.

This document describes the regulatory submission (K172396) for the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2. The submission is a Traditional 510(k) and focuses on minor software updates and support for a new catheter. The key takeaway regarding acceptance criteria and study data is that this submission primarily relies on non-clinical software verification and validation, performance testing, and preclinical animal studies, rather than large-scale clinical trials involving human experts for ground truth establishment.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

The document states that "Design verification activities for functional testing were performed with their respective acceptance criteria to ensure that the software modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, specific numerical acceptance criteria and reported device performance values are not explicitly detailed in the provided text. The general statement indicates that all criteria were met.

The device is a "Programmable Diagnostic Computer" for cardiac mapping. The performance is assessed based on:

• Catheter compatibility
• Catheter impact
• Functional testing
• EnGuide stability
• System accuracy
• Effective installation and continued intended use of the software version
• Overall clinically acceptable performance (from preclinical animal studies)

Since the document does not provide a table with specific numerical acceptance criteria and performance metrics, it's not possible to create one. The general acceptance criterion is that the software updates and new catheter support do not adversely affect the safety or effectiveness and meet established performance specifications.

Study Details

Given the nature of this submission (minor software update to an existing device, supporting a new catheter), the studies are primarily non-clinical.

1. A table of acceptance criteria and the reported device performance:

   • As mentioned above, specific numerical acceptance criteria and performance data are not provided in this document. The submission states that all testing performed met the established performance specifications.

2. Sample sized used for the test set and the data provenance:

   • Test Set (Non-Clinical): The document refers to "software verification and validation," "performance testing on the bench," and "preclinical animal studies."
     • Software Verification/Validation & Performance Testing: The exact sample sizes (e.g., number of test cases, number of bench tests) are not specified.
     • Preclinical Animal Studies: The sample size (number of animals) is not specified.
   • Data Provenance: The studies were conducted as part of the regulatory submission process for St. Jude Medical (now Abbott). The location of the testing is not specified, but it would typically be conducted at the manufacturer's facilities or a contract research organization. The studies are prospective as they were conducted to support this specific regulatory submission for the updated device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For non-clinical software and performance testing, "ground truth" is typically established by comparing the device's output against known, pre-defined correct behaviors or physical measurements using validated reference standards. This does not involve "experts" in the sense of clinicians interpreting patient data.
   • For the preclinical animal studies, the "ground truth" would be established by the animal study protocols, surgical procedures, and direct physiological measurements, assessed by veterinary and scientific personnel involved in the study. The number and qualifications of such experts are not specified in the document. This is not a human-in-the-loop clinical study requiring expert readers for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Given that this is primarily non-clinical testing (software verification, bench testing, animal studies), traditional clinical adjudication methods (like 2+1 reader consensus for image interpretation) are not applicable and not mentioned. Results would be evaluated against engineering specifications and veterinary assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. The document describes updates to a cardiac mapping system, which is a diagnostic tool, but not an AI-assisted diagnostic imaging system in the sense that would typically require an MRMC study to show human reader improvement. The updates are to the system's core mapping and navigation capabilities, and its interoperability, not directly to an AI component for image interpretation requiring human reader evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The software updates and new catheter support were evaluated for their standalone performance (e.g., software verification, bench testing to ensure system accuracy and stability, and animal studies to confirm proper function). The "algorithm only" performance would be part of the "functional testing" and "system accuracy" mentioned. Specific standalone performance metrics or studies are not detailed beyond the general statements that testing met specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For software verification and bench testing: The ground truth is based on engineering specifications, expected software behavior, physical measurements from laboratory equipment, and established hardware/software interface standards.
   • For preclinical animal studies: Ground truth is established through direct physiological data collection, procedural observations, and possibly post-mortem analysis in the animal models, as per the study protocol.
   • There is no mention of "expert consensus," "pathology," or "outcomes data" from human subjects for establishing ground truth in this particular submission.

8. The sample size for the training set:

   • The document does not mention a training set in the context of machine learning or AI models. This submission is for updates to a pre-existing cardiac mapping system, not the initial development or a significant AI component that would require a distinct "training set." The testing described is verification and validation of software changes and new hardware compatibility.

9. How the ground truth for the training set was established:

   • Since no training set for a machine learning/AI model is mentioned, this question is not applicable to the information provided.

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Velocity is a software package that provides the physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume rendering, registration, and fusion of medical images as an aid during use by diagnostic radiology, radiation therapy planning and other medical specialties. Velocity is not intended for mammography.

Velocity is a software application providing relevant tools for Radiotherapy professionals to use while creating treatment plans. The Velocity device is a Picture Archiving and Communication System (medical imaging software). Velocity provides medical image processing designed to facilitate the oncology or other clinical specialty work flow by allowing the comparison of medical imaging data from different modalities, points in time, and / or scanning protocols. The product provides users with the means to display, co-register and analyze medical images from multiple modalities including PET, SPECT, CT, RT Dose and MR; draw Regions of Interest (ROI), calculate and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other values within those regions; and import / export results to/from commercially available radiation treatment planning systems and PACS devices. Co-registration includes deformable registration technology that can be applied to DICOM data including diagnostic and planning image volumes, structures, dose, and automatic anatomical atlas-based segmentation tools. Velocity is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.

The provided document is a 510(k) Premarket Notification for the "Velocity" software. It focuses on demonstrating substantial equivalence to a predicate device ("Velocity AI – K081076") and does not contain detailed information about specific acceptance criteria, test set sizes, expert qualifications, or comparative effectiveness studies typically associated with proving a device meets strict performance benchmarks via a clinical study with AI components.

However, based on the information provided, we can infer some aspects and highlight what is explicitly stated:

Key Takeaways from the Document:

• Device Type: Velocity is a "Picture Archiving and Communication System (Medical Imaging Software)" designed for display, annotation, volume rendering, registration, and fusion of medical images for diagnostic radiology, radiation therapy planning, and other medical specialties.
• Predicate Device Approach: The submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device (Velocity AI – K081076) and a secondary predicate for a specific feature (MIM Y90 Dosimetry - K172218).
• No Clinical Tests: The document explicitly states: "No clinical tests have been included in this pre-market submission." This immediately tells us that the detailed performance studies often associated with AI/ML model validation (e.g., MRMC studies, standalone performance with robust ground truth) were not part of this submission for the core functionality.
• Software Verification & Validation (V&V): The primary performance data cited is "Software Verification and Validation Testing," indicating a focus on functional correctness, reliability, and safety of the software rather than a direct clinical performance evaluation. The software was considered a "major" level of concern.
• Ground Truth: Given no clinical tests, there's no mention of how ground truth for a test set was established using expert consensus, pathology, or outcomes data for clinical performance metrics. The ground truth for V&V would be tied to software requirements and specifications.
• AI/ML Context: While "AI" is in the predicate device name ("Velocity AI"), the listed functionalities of "Velocity" (display, annotation, volume rendering, registration, fusion) are standard PACS and image processing features. The "deformable registration technology" and "automatic anatomical atlas-based segmentation tools" could be considered AI/ML elements, but the document does not detail specific performance studies of these elements with clinical ground truth.

Based on the available text, here's an attempt to answer your questions. Please note that many answers will state that the information is "Not provided" or "Not applicable" due to the nature of this 510(k) submission, which did not include clinical performance studies.

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding reported device performance metrics in the way a clinical study typically would (e.g., sensitivity, specificity, F1-score for an AI component). The performance data cited is:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. As "No clinical tests have been included," there isn't a "test set" in the context of clinical performance evaluation using patient data for AI validation. The V&V would use internal test cases.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Since no clinical tests were performed for the submission, there is no mention of external experts establishing ground truth for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical tests were performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. The document explicitly states: "No clinical tests have been included in this pre-market submission." Therefore, an MRMC comparative effectiveness study was not performed or submitted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not specified in a clinical performance context. While the software operates "as a stand-alone application," this refers to its deployment rather than a standalone algorithmic performance study against clinical ground truth. The V&V process would have involved testing the algorithm's functional performance against specified requirements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For Software Verification and Validation: The ground truth would be defined by the software requirements and specifications (e.g., expected output for given input, correctness of calculations, proper display of images). This is a technical ground truth, not a clinical one derived from patient outcomes or expert consensus on a diagnosis.
• For Clinical Performance: Not applicable, as no clinical tests were performed.

8. The sample size for the training set

• Not specified. The document does not describe the development or training of any AI/ML components beyond mentioning "deformable registration technology" and "automatic anatomical atlas-based segmentation tools." No information is provided regarding the training data or its size.

9. How the ground truth for the training set was established

• Not specified. As there is no information on a specific training set or the development process for embedded AI/ML features, how any training ground truth was established is not detailed.

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The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring STERRAD Sterilization Systems: · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear™ Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
· STERRAD® 100S

The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator (BI), used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃.
The STERRAD VELOCITY BI can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple). When using this method, the biological indicator must be cultured in an incubator at 55-60°C for 5 to 7 days to get a final visual result.
The STERRAD VELOCITY BI consists of a glass fiber disc containing a minimum of 1 x 10° Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow with some red/orange/brown dots when exposed to hydrogen peroxide.
The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI to obtain the final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric enzymatic assay method to detect the enzyme activity from the BI and the fluorescence emitted from the BI is converted into a voltage. This voltage reading is then used by the fluorescence algorithm in the Reader to determine the final fluorescence result.
There are eight individual BI incubation wells in the STERRAD VELOCITY Reader. Its heater system is designed to maintain the biological indicators at 57 ± 2℃ to promote the outgrowth of the indicator organisms. Each well contains an ultraviolet light source that excites fluorescence in the growth medium, and a photodetector to detect that fluorescence.
The STERRAD VELOCITY Reader features a touch screen for an effective user interface. Directly under each well is a well number illuminated by a well status indicator light. Three colors (white, green, and red) and two states (off and solid line) are used for the indicator light on the touch screen to show the status of the BI processing. The Reader has a thermoplastic exterior which makes it easy to clean and maintain. A built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy.
The STERRAD VELOCITY BI and Reader have intended capability for "ecosystem" connectivity and integration. This system is intended to allow communication among STERRAD Sterilizers with ALLClear™ Technology.

Here's a breakdown of the acceptance criteria and study information for the STERRAD VELOCITY™ Biological Indicator and Reader based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes (number of biological indicators or test runs) used for each individual performance test (e.g., D-value determination, RIT study, performance in various sterilizers). However, it implies that the testing was rigorous enough to satisfy the requirements of ISO 11138-1:2006 and FDA guidance.

The data provenance is retrospective, as these are non-clinical lab performance tests conducted by the manufacturer for regulatory submission. The country of origin of the data is not specified, but the manufacturer is Advanced Sterilization Products (ASP), located in Irvine, California, USA, suggesting the studies were likely conducted in the US or in facilities compliant with US standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

This information is not provided in the document. The "ground truth" for the biological indicator's performance is established by scientific methods for spore viability, resistance characteristics (D-value), enzyme activity, and growth inhibition, rather than expert interpretation of results. For electrical safety and EMC, the ground truth is established by adherence to recognized national and international standards by accredited testing bodies.

4. Adjudication Method for the Test Set

This information is not applicable/provided for these types of non-clinical laboratory performance studies. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of medical images/data, where discrepancies between readers need to be resolved. The "results" of these tests (e.g., Pass/Fail, numerical measurements) are objectively determined by the methodology described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and the AI's assistance to human readers is evaluated. The STERRAD VELOCITY™ Biological Indicator and Reader is a system for objectively monitoring sterilization processes, not a diagnostic tool requiring human interpretation for its primary function.

6. Standalone Performance

Yes, a standalone (algorithm only) performance was done. The entire suite of "Non-Clinical Data" presented details the performance of the STERRAD VELOCITY™ Biological Indicator and Reader system independently. The Reader's algorithm determines the final fluorescence result without human-in-the-loop interpretation for its primary function of determining BI positivity/negativity within 30 minutes. The BI's performance (spore population, D-value, RIT, etc.) is also evaluated systematically.

7. Type of Ground Truth Used

The ground truth used for the scientific performance testing of the Biological Indicator is based on objective scientific measurements and established microbiological and sterilization standards. This includes:

• Microbiological assays: For spore population determination, growth inhibition, and characterization of Geobacillus stearothermophilus.
• Sterilization kinetics: For D-value determination (using Holcomb-Spearman-Karber Procedure (HSKP) and Survivor Curve method as per ISO 11138-1).
• Enzymatic activity measurements: Fluorescence detection and its correlation to spore outgrowth.
• Physical and Chemical Testing: For chemical indicator functionality and real-time shelf life studies.
• Compliance with recognized standards: For electrical safety (e.g., IEC/EN 61010-1) and EMC (e.g., FCC Part 15, Subpart B).

8. Sample Size for the Training Set

The document does not contain information about a "training set" in the context of machine learning. The STERRAD VELOCITY™ Biological Indicator and Reader is not described as an AI/machine learning device that requires a training set in the conventional sense. Its "algorithm" is for fluorescence detection and conversion of voltage readings to positive/negative results, based on established biological and enzymatic principles, not necessarily learned from a large dataset. If there was any internal calibration or parameter setting, the details are not provided.

9. How the Ground Truth for the Training Set Was Established

As there is no explicit mention of a "training set" for an AI/machine learning model as understood in typical AI device submissions, this information is not applicable and not provided in the document. The device's operational parameters and decision thresholds would have been established through a combination of scientific principles, engineering design, and empirical testing against known positive and negative controls.

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