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The Reprocessed DECANAV™ Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, in the Coronary Sinus. In addition, the Reprocessed DECANAV™ Catheter is used with compatible Carto® 3 EP Navigation Systems to provide catheter tip location information.

The Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. In addition, the Reprocessed WEBSTER® Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and coronary sinus.

The Reprocessed DECANAV™ Catheter is a sterile, single patient use device designed to be used with the CARTO® 3 EP Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The Reprocessed DECANAV™ Catheter has a single proximal electrode that can be used for unipolar recording signals. The Reprocessed DECANAV™ Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in curve types D and F. Pushing the thumb knob forward causes the catheter tip to bend (curve); when the knob is pulled back, the tip straightens. The plane of the curved tip can be rotated during use. The Reprocessed DECANAV™ Catheter interfaces with standard recording equipment and CARTO® 3 EP Navigation System equipment via interface cables with the appropriate connectors.

The Reprocessed WEBSTER® Duo-Decapolar Catheter (DDP) is a sterile, single patient use device designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording. Tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumb knob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.

The provided text describes the 510(k) summary for reprocessed electrophysiology catheters, which are medical devices, not AI/ML-enabled software. Therefore, the questions related to AI/ML device performance, such as sample size for test sets (data provenance), number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, and training set information (sample size, ground truth establishment), are not applicable to this document.

The document discusses acceptance criteria and device performance in the context of demonstrating substantial equivalence for reprocessed medical devices to their predicate devices.

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

The document lists several tests performed to demonstrate appropriate functional characteristics and substantial equivalence to predicate devices. It states that "Performance testing shows the Reprocessed DECANAV™ and Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheters perform as originally intended." and "Results demonstrated substantial equivalence to the predicate devices."

Specific acceptance criteria (e.g., numerical thresholds for compliance) are not explicitly detailed in this summary. However, the types of tests conducted serve as the basis for determining if the reprocessed devices meet acceptable performance comparable to the original predicate devices.

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

The document states: "Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics." It does not specify the exact sample size for each test or the total test set.

• Data provenance: Not explicitly stated, but the testing was conducted by Sterilmed, Inc. or its contractors in the context of their reprocessing efforts. This would be considered internal data from the reprocessing process. The data is retrospective in the sense that it evaluates the reprocessed devices after manufacturing, but the tests themselves are prospective studies on those samples.

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

This question is not applicable. The device is a reprocessed electrophysiology catheter. Performance is assessed through engineering and biocompatibility tests against established specifications and comparison to the original (OEM) device, not through expert human review of interpretative data like medical images.

4. Adjudication method for the test set

This question is not applicable, as the performance evaluation relies on objective engineering and biological test results, not expert human interpretation or adjudication.

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

This question is not applicable. MRMC studies are typically used to evaluate the diagnostic accuracy of imaging systems or AI algorithms by comparing performance with and without an AI assist. This document is for a reprocessed medical device.

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

This question is not applicable. This is not an AI/ML-enabled device.

7. The type of ground truth used

The "ground truth" for the performance of these reprocessed catheters is established by:

• Engineering specifications and performance characteristics of the original equipment manufacturer (OEM) predicate devices. The reprocessed devices are tested to ensure they meet these specifications.
• Compliance with recognized standards for medical device reprocessing, safety, and performance (e.g., ISO 10993 for biocompatibility, ASTM standards for packaging and shelf-life, and internal functional performance criteria designed to mimic intended use).
• Visual inspection for physical integrity.

Essentially, the ground truth is the performance and safety profile of the new, original predicate device.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML-enabled device, so there is no training set in the context of machine learning.

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

This question is not applicable, as there is no training set for an AI/ML algorithm.

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The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3.x.

The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the CARTO® 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 Fr guiding sheath. This deflectable catheter consists of multiple 3 Fr spines on the distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO® 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the CARTO® 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.

The provided text describes the 510(k) summary for the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter. This document outlines the device's characteristics and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are implicitly derived from demonstrating substantial equivalence to the predicate device, the original PENTARAY® NAV eco High-Density Mapping Catheter (Biosense Webster K123837). The tests performed cover various functional, safety, and manufacturing aspects to ensure the reprocessed device performs as intended and is safe for use.

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The reprocessed ViewFlex™ Xtra ICE catheter is in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

The Reprocessed ViewFlex™ Xtra ICE catheter is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use.
The Reprocessed ViewFlex™ Xtra ICE catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction.

The provided text describes the regulatory clearance for a reprocessed medical device, specifically the Reprocessed ViewFlex™ Xtra ICE Catheter (K190478). This document primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical performance and safety tests. It does not pertain to an AI/ML-driven device or a study involving human readers or efficacy in diagnosing conditions. Therefore, many of the requested categories in the prompt are not applicable.

Here's an analysis based on the information available:

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

The document details various tests performed to ensure the reprocessed device is substantially equivalent to the original predicate device. The "acceptance criteria" are implied to be that the reprocessed device performs "as originally intended" and meets the same functional and safety characteristics as the new, original (OEM) device.

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

The document does not specify exact sample sizes for each particular test (e.g., number of catheters tested for electrical leakage). It refers to "representative samples of reprocessed devices" for functional testing. The data provenance is implied to be from internal lab testing conducted by Sterilmed, Inc. No information on country of origin or retrospective/prospective nature of the testing is provided beyond it being part of the 510(k) submission process for a reprocessed device.

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)

This is not applicable. The study described is a non-clinical, bench-top engineering and biocompatibility study comparing a reprocessed device to a new device, not a diagnostic study requiring expert interpretation of medical images or data. Therefore, there is no "ground truth" established by medical experts for a test set in the context of diagnostic accuracy.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies to resolve discrepancies in expert interpretation. This document describes physical, chemical, and functional engineering tests.

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

This is not applicable. The device is an intracardiac ultrasound catheter for visualization, not an AI-driven diagnostic tool that assists human readers. No MRMC study was performed.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" in this context is the performance and safety specifications of the original (OEM) predicate device (ViewFlex™ Xtra ICE Catheter, K133853). The reprocessed device is tested to ensure it meets these established technical specifications and performance characteristics, demonstrating "substantial equivalence" rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

This is not applicable. There is no AI/ML algorithm that requires a training set. The study involves reprocessed physical devices.

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

This is not applicable. There is no AI/ML algorithm or training set.

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The Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

The Reprocessed Harmonic FOCUS Shears + Adaptive Tissue Technology is a sterile, single-patient use surgical instrument consisting of a soft grip scissor handle housing assembly with two hand controls (MIN for minimum power level and MAX for maximum power level). The instrument's working length is 9 cm in length with a 16 mm active blade length. The instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.

The provided text describes the regulatory clearance for a reprocessed medical device, specifically the "Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology." It details the device's indications for use, its characteristics, and the non-clinical tests performed to demonstrate its substantial equivalence to an original predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" with quantitative targets and reported performance in the format typically seen for AI device studies (e.g., sensitivity, specificity thresholds). Instead, for this reprocessed surgical instrument, the acceptance criteria are implicitly defined by demonstrating that the reprocessed device performs as "originally intended" and is "substantially equivalent" to the original predicate device through a series of functional, safety, and sterilization tests.

From the "Summary of Non-Clinical Tests Conducted" section, the performance tests conducted include:

The overall conclusion states: "Performance testing shows the Harmonic FOCUS Shears + Adaptive Tissue Technology performs as originally intended." and "Results demonstrated substantial equivalence to the predicate devices with respect to safety and effectiveness."

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

The document does not specify the exact sample sizes used for each performance test. It mentions "Reprocessed devices were tested" and "Each device and accessory are marked and tracked through the reprocessing cycle." The testing appears to be conducted on samples of the reprocessed devices. The provenance is not explicitly stated in terms of country of origin of data or whether it was retrospective or prospective. It is implied to be prospective testing of reprocessed devices manufactured by SterilMed.

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)

This is a physical medical device, not an AI or imaging device that requires expert interpretation for ground truth. Therefore, the concept of "experts" establishing ground truth in this context is not applicable. The performance is assessed through objective engineering and biological tests, not human interpretation of data.

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

Not applicable, as this is objective performance testing of a physical device, not an interpretative task requiring adjudication.

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. This is not an AI or imaging device, and there is no human reader component. The study compares the performance of the reprocessed device against its original predicate device.

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

Not applicable, as this is a physical surgical instrument, not an algorithm. The "standalone performance" in this context refers to the device's functional integrity and safety.

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

The "ground truth" for this device's reprocessed performance is established by:

• Predicate Device Performance: The original HARMONIC FOCUS® Shears + Adaptive Tissue Technology (Ethicon K133314) serves as the benchmark for expected performance.
• Accepted Standards: Compliance with various international and national standards (e.g., ISO 10993-7, ISO 10993-1, IEC 60601, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-07) for sterilization, biocompatibility, packaging, and electrical safety.
• Engineering Specifications: The device's original design specifications for grasping force, seal burst, tissue adhesion, jaw pad life, removal force, thermal spread, and transection time.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The Sterilmed Reprocessed HARMONIC ACE®+ 7 Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

The Sterilmed Reprocessed HARMONIC ACE+7 Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch. The two models are identical to each other in materials, form, fit and function except for the length of the shafts which are 23cm and 36 cm.

This document describes the validation of reprocessed HARMONIC ACE®+ 7 Shears with Advanced Hemostasis, demonstrating their substantial equivalence to the original equipment manufacturer (OEM) predicate device. Given that the provided text is a 510(k) summary for a reprocessed medical device (surgical shears), the acceptance criteria and study design are focused on demonstrating that the reprocessed device performs as safely and effectively as the original device. This is a non-clinical submission, thus the information regarding AI/human reader studies, expert consensus on images, etc., is not applicable here.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a reprocessed device are fundamentally centered on demonstrating that it performs equivalently to the new, original device in terms of safety and functional effectiveness. The performance of the reprocessed device is compared against the OEM predicate device. Specific quantitative acceptance criteria or threshold values are not explicitly listed in this summary, but the general principle is that the reprocessed device "performs as originally intended" and is "substantially equivalent" to the predicate.

Study Details

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

• Sample Size: The document states that "representative samples of reprocessed devices were tested," and for functional testing, "all products produced" undergo visual and validated functional testing. However, specific numerical sample sizes for each test (e.g., how many devices were tested for vein seal burst, or fatigue testing) are not provided in this summary.
• Data Provenance: The testing was conducted by Sterilmed, Inc., a reprocessor based in Plymouth, MN, and Maple Grove, MN, USA. The data is from prospective bench testing and validation studies of their reprocessed devices. It is not human clinical data.

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):

This information is not applicable as this is a submission for reprocessed surgical shears based on non-clinical, bench testing, and engineering validation, not an AI or imaging-based device. No "experts" in the sense of medical professionals interpreting images were used to establish ground truth for the device's functional performance. Ground truth was established through validated engineering and laboratory test methods, often comparing performance against the OEM predicate.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving multiple human readers interpreting data, typically in diagnostic imaging. For a reprocessed surgical device, the "adjudication" is inherent in the robust, validated test methods and comparison to established predicate performance. If a test failed, it would need to be investigated and resolved, but there isn't a "reader-based" adjudication process.

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:

This is not applicable. MRMC studies are specific to diagnostic imaging devices, often involving AI, where human readers evaluate cases. This submission is for reprocessed surgical shears, which do not involve human readers for diagnostic interpretation.

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

This is not applicable. This device is a mechanical/ultrasonic surgical instrument, not an algorithm.

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

The "ground truth" for this device's performance is established by:

• Engineering specifications and performance characteristics of the OEM predicate device (Ethicon HARMONIC ACE®+7 Shears with Advanced Hemostasis, K132612).
• Validated industry standards and test methods (e.g., ISO 10993, ASTM standards for packaging, electrical safety).
• Successful functional performance benchmarks (e.g., vein/artery seal burst pressure, thermal spread, grasping force), which show the device "performs as originally intended."
  In essence, the ground truth is that the reprocessed device must meet or exceed the safety and functional performance of the new, original device.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device; there is no "training set" in the computational sense. The "training" for the manufacturing process involves process validation and quality control measures to ensure consistent reprocessing.

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

This is not applicable for the same reason as point 8. The "ground truth" for the overall manufacturing and reprocessing process is established through rigorous validation of cleaning, sterilization, packaging, and functional testing protocols to ensure the device is consistently reprocessed to meet its intended performance specifications.

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The Reprocessed 3D Diagnostic Ultrasound eco Catheters are indicated for intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible Carto® 3 EP Navigation Systems (version 2.3 and higher) the reprocessed 3D Diagnostic Ultrasound eco Catheters provide location information.

Sterilmed Reprocessed 3D Diagnostic Ultrasound eco Catheters are specially designed catheters that provide two-dimensional imaging using an ultrasound transducer and three-dimensional location sensor. They are IntraCardiac Echo (ICE) Catheters with acoustic array and magnetic location sensor equivalent to the currently cleared SoundStar eco 8F G Ultrasound Catheter, and SoundStar eco 8F Ultrasound Catheters 510(k) K140318. The magnetic location sensor (providing location information to the CARTO® 3 EP Navigation System) and an ultrasound transducer (acquiring real time ultrasound images) are embedded in the catheter tip. The Reprocessed 3D Diagnostic Ultrasound Catheters, when connected to the corresponding Ultrasound Systems, will provide real-time integration of the ultrasound images with CARTO® 3 electromagnetic acquired maps.

The document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of reprocessed 3D Diagnostic Ultrasound eco Catheters to new (OEM) devices.

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 size for each individual test within the "Verification Testing" or "Summary of Non-Clinical Tests Conducted" sections. It refers to "representative samples of reprocessed devices" for functional characteristics testing. Other tests like "100% in-process inspected" indicate testing of every reprocessed device during manufacturing.

Data Provenance: The data is generated internally by Sterilmed, Inc. as part of their reprocessing validation. It is retrospective in the sense that it evaluates the performance of reprocessed devices after the reprocessing procedure has been applied. The country of origin of the data is the USA (Maple Grove, MN).

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

This section is not applicable as the described tests are primarily physical, electrical, chemical, and functional performance benchmarks against defined standards and specifications, rather than a clinical study requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" here is the established performance parameters of the original (OEM) device and relevant industry standards.

4. Adjudication Method for the Test Set:

This is not applicable as the tests performed are objective, quantitative measurements against predefined pass/fail criteria, not subjective assessments requiring adjudication.

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:

This is not applicable. The document describes the validation of reprocessed medical devices (catheters), not an AI algorithm or a study involving human readers.

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

This is not applicable. The document describes the validation of reprocessed medical devices (catheters), not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on:

• Performance specifications of the original (OEM) devices: The reprocessed devices are compared to the performance characteristics of the Biosense Webster SoundStar eco 8F and eco 8F G Ultrasound Catheters (K140318).
• Industry Standards: Compliance with various ISO, ASTM, USP, and IEC standards (e.g., ISO 11135, USP , ISO 10993-1, ISO 10993-7, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-99, IEC 60601-1:2005 A1:2012, IEC 61161:2013).
• Internal Specifications: Criteria established by Sterilmed, Inc. for functional performance, cleaning, and sterilization.

8. The Sample Size for the Training Set:

This is not applicable. The document describes the validation of reprocessed medical devices, not a machine learning model that would require a training set. The "process validation testing" for cleaning and sterilization procedures are internal validation processes, not machine learning training.

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

This is not applicable, as there is no training set mentioned in the context of machine learning. The "ground truth" for the processes mentioned (cleaning, sterilization) is established through rigorous scientific testing and adherence to recognized industry standards to ensure the reprocessed devices meet safety and efficacy requirements.

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The Reprocessed Harmonic Shears with Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

The Reprocessed Harmonic Shears with Adaptive Tissue Technology are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate and transect soft tissue with a single instrument. The devices are hand-actuated with shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch. The device includes a torque wrench as an accessory piece (the torque wrench is designed to ensure that the hand piece is properly secured to the device.

The provided text describes the 510(k) summary for Sterilmed's Reprocessed Harmonic Shears with Adaptive Tissue Technology. It details various tests conducted to demonstrate substantial equivalence to the predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "Performance testing shows the reprocessed Harmonic Shears with Adaptive Tissue Technology to perform as originally intended" and "Results demonstrated substantial equivalence to the predicate devices with respect to safety and effectiveness."

The types of tests performed, which imply the areas where performance was assessed, are listed under "Summary of Non-Clinical Tests Conducted" and "Functional and Safety Testing." These tests aimed to demonstrate that the reprocessed devices perform as well as the original predicate devices.

• Electrical Safety
• Device Functionality
• Vessel Seal Burst (Static and Burst Pressure)
• Vessel Seal Thermal Spread
• Drop
• Fluid Ingress
• Pad Retention
• Pad Failure
• Clamp Force |
  | Biocompatibility (meeting ISO 10993-1 for short duration contact with blood) | Passed tests for:
• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous Reactivity
• Acute Systemic Toxicity
• Hemocompatability
• Chemical Pyrogens
• Hemolysis
• Immune Response |

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

The document mentions "Representative samples of reprocessed devices were tested" for functional characteristics. However, specific sample sizes for each test are not provided in this summary.

The data provenance is from non-clinical tests conducted by Sterilmed, Inc., a reprocessing company. This is an in-house prospective testing of their reprocessed devices. The country of origin is implicitly the USA where Sterilmed is located and where the FDA regulatory submission was made.

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

This type of information is not applicable to this document. The "ground truth" for this device (a reprocessed surgical instrument) is established by objective engineering and safety standards (e.g., sterilization parameters, mechanical performance, biocompatibility) rather than expert interpretation of data like images or patient outcomes. The performance is compared against the original (predicate) device.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective measurements against engineering standards and comparison to a predicate device, not on subjective assessments requiring adjudication among experts.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument, not an AI-powered diagnostic or assistive technology that would involve human readers or AI.

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

This question is not applicable as the device is a reprocessed surgical instrument and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on defined engineering specifications, performance standards, regulatory requirements (e.g., ISO for biocompatibility and residuals), and the performance characteristics of the legally marketed predicate device. The goal is to demonstrate that the reprocessed device performs identically or equivalently to the new/original device.

8. The Sample Size for the Training Set

This question is not applicable. This is a reprocessed medical device, not an AI or machine learning algorithm that requires a "training set."

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

This question is not applicable for the same reason as above.

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The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. stimulation and recording only. The catheters are designed to obtain electrograms in the atrial regions of the heart.

The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters with navigation (Nav) capabilities provide location information when used with compatible Carto® 3 EP Navigation Systems. (These catheters are not compatible with Carto® 3 EP Navigation Systems prior to version 2.3.)

The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are designed to facilitate electrophysiological mapping of the atria of the heart. They are deployed in the right or left atrium through an 8F guiding sheath. These deflectable catheters consist of a circular spine on the distal tip with platinum/iridium electrodes that can be used for stimulation and recording.

Models designated as NAV are compatible with the Carto® 3 EP Navigation System.

The provided text is a 510(k) summary for reprocessed medical devices, specifically electrophysiology catheters. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than proving novel efficacy through clinical studies of an AI algorithm. Therefore, many of the requested elements for AI device performance studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and details on training sets) are not applicable or extractable from this document.

The document primarily outlines non-clinical testing to ensure the reprocessed devices maintain their original functionality and safety.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present or not applicable:

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

The document does not provide a specific table of quantitative acceptance criteria with corresponding reported performance values in the way one would for an AI algorithm's diagnostic metrics. Instead, it refers to validation of functional performance, cleaning, sterilization, biocompatibility, and packaging. The "reported device performance" is a general statement that the reprocessed devices "perform as originally intended."

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

This information is not provided in the document. The document refers to "Representative samples" but does not specify the number of samples used for any of the non-clinical tests. The tests are benchtop, laboratory-based tests of the reprocessed physical device, not clinical studies involving patient data.

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)

This information is not applicable/not provided. Ground truth in the context of expert review for AI algorithms is not relevant here. The "ground truth" for these tests would be established by validated test methods and reference standards for the physical and chemical properties of the device (e.g., sterility, material strength).

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

This information is not applicable/not provided. Adjudication methods are typically used in clinical studies or expert review for diagnostic tasks, neither of which are described here.

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

This information is not applicable/not provided. This document describes the reprocessing of physical medical devices, not an AI algorithm. Therefore, no MRMC study or AI assistance is mentioned or relevant.

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

This information is not applicable/not provided. This document describes the reprocessing of physical medical devices, not an AI algorithm.

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

This information is not applicable/not provided in the context of AI studies. For the functional and safety testing of the reprocessed catheters, the "ground truth" is based on established industry standards and validated test methodologies for medical device performance, sterility, biocompatibility, and integrity.

8. The sample size for the training set

This information is not applicable/not provided. This document does not describe an AI algorithm that requires a training set.

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

This information is not applicable/not provided. This document does not describe an AI algorithm that requires a training set.

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The reprocessed steerable introducer devices are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The reprocessed steerable introducer consists of a steerable sheath and plastic dilator, which is indicated for introducing various cardiovascular catheters including the left side of the heart through the interatrial septum. The device is always delivered over a guidewire. The steerable introducer device enters through the right femoral vein and is guided into the right atrium of the heart. A knob on the introducer handle dictates the amount and direction of curl at the distal tip of the sheath. The shaft of the introducer is filled with radiopaque material so the device can be seen using fluoroscopy. A guidewire pokes through the septum into the left atrium and a tapered dilator enlarges the hole. The dilator is then removed allowing the introduction of a catheter.

The device is an 8.5F asymmetrical bi-directional steerable introducer with a varying amount of curl (small, medium or large) at the distal tip and a useable length of 61 or 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect the large curl 90 degrees in the counterclockwise direction and 180 degrees in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

The provided document is a 510(k) premarket notification letter from the FDA to Sterilmed, Inc. for a Reprocessed Steerable Introducer. This document is not a study report that includes details about acceptance criteria and device performance in the context of an AI/ML medical device.

The content focuses on demonstrating substantial equivalence of the reprocessed device to legally marketed predicate devices, rather than on the performance of a novel AI/ML algorithm. Therefore, many of the requested details about acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this document.

However, I can extract the information that is relevant to the device's functional and safety performance, as established for its substantial equivalence claim, even though it doesn't involve AI.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing intended to show that the reprocessed device performs similarly to the new predicate device. While specific numerical acceptance criteria values are not explicitly listed in the submission summary, the intent is that the reprocessed device meets the functional and safety standards expected of the original, new device.

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

• Test Set Sample Size: The document does not specify the exact sample size for each performance test. It mentions that "the device was tested" and "functional testing has shown."
• Data Provenance: The testing was conducted by Sterilmed, Inc. as part of their premarket notification submission to the FDA. The nature of this document suggests the data is prospective for the reprocessed device, generated specifically for this submission to demonstrate substantial equivalence. The country of origin of the data is implied to be the USA (Plymouth, MN, where Sterilmed is located).

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

• This information is not applicable as this submission relates to a reprocessed medical device and its physical/functional characteristics, not an AI/ML algorithm requiring expert ground truth for classification or prediction. The "ground truth" here is the performance of the new, predicate device and established engineering/biocompatibility standards.

4. Adjudication method for the test set:

• Not applicable. There is no expert adjudication process described, as the evaluation is based on objective measurements against engineering specifications and regulatory standards for device performance.

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. This document is about a physical medical device (steerable introducer), not an AI/ML system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or described.

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

• Not applicable. This document is about a physical medical device, not an AI/ML algorithm.

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

• The "ground truth" for the reprocessed device is its ability to meet the established performance specifications and safety profiles of the original, new predicate devices (St. Jude Agilis™ NxT Steerable Introducers, K061363 and K081645), as well as relevant international standards (e.g., ISO 10993-1 for biocompatibility) and regulatory requirements. This is an engineering and materials science-based ground truth, not an expert consensus or pathology-based one.

8. The sample size for the training set:

• Not applicable. This document is about a reprocessed physical device, not an AI/ML system that utilizes a training set.

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

• Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

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The reprocessed vessel sealer/dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the iaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

Indications for use include general open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The reprocessed vessel sealer/dividers can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

The reprocessed vessel sealer is a sterile, hand-held bipolar RF electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during general surgical procedures (as indicated), laparoscopic or open, using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws without having to latch the lever, which includes a clicking mechanism that indicates to the user that the jaws are in the grasping zone, a button (switch) to activate the LigaSureTM mode by closing the handle against the button (switch) for vessel sealing, and a trigger to actuate an independent cutting blade.

This document describes the regulatory clearance for reprocessed vessel sealers (device name: Reprocessed Vessel Sealers, models LF1737 and LF1723) which are electrosurgical instruments. The submission aims to demonstrate substantial equivalence to predicate devices (Covidien LigaSure™ 5 mm, Maryland Jaw Sealer/Dividers, K133338).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way one might expect for an AI/CADe device. Instead, the acceptance criteria are implicitly defined by a series of non-clinical tests designed to demonstrate that the reprocessed devices perform as intended and are safe and effective, similar to the original predicate devices. The reported device performance is generally stated as achieving compliance with these tests.

However, based on the "Summary of Non-Clinical Tests Conducted" section, we can infer the following:

Overall Conclusion: "Performance testing shows the reprocessed vessel sealers to perform as originally intended." and "Sterilmed concludes that the reprocessed vessel sealers are safe, effective, and substantially equivalent to the predicate devices..."

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

The document mentions that "Representative samples of reprocessed devices were tested" for various functional and safety characteristics. However, specific sample sizes (e.g., number of devices, number of seals, number of tests for each parameter) for each test are not provided.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be bench and laboratory testing performed by the manufacturer/reprocessor (Sterilmed, Inc., located in Minnesota, USA). The nature of these tests (cleaning, sterilization, packaging, functional performance, biocompatibility) indicates they are prospective tests performed on manufactured devices, not retrospective data analysis from clinical cases.

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)

This section is not applicable as the device is a reprocessed surgical instrument, not an AI/CADe device or diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., burst pressure thresholds, sterility levels, biocompatibility profiles) and comparison to the performance of the original device.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human readers or AI outputs. The tests described are objective engineering and laboratory tests where the outcome is determined by adherence to a predefined standard or measurement, not by expert consensus or adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance, especially for AI-assisted image interpretation. The device in question is a reprocessed surgical instrument, and its performance is evaluated through bench testing and safety assessments, not through human reader interpretation.

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

This section is not applicable. The device is not an algorithm or AI system. It is a physical medical instrument. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

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

The "ground truth" for this device's performance is based on objective engineering standards, validated laboratory testing protocols, and comparison to the established performance of the original, new device. For example:

• Sterility: Absence of microorganisms, verified by sterilization indicators and microbial testing.
• Ethylene Oxide Residuals: Concentrations below a specified limit (ISO 10993-7).
• Mechanical Functionality: Ability to open, close, grasp, seal, and cut within specified force ranges and dimensions, often compared to the original device's specifications.
• Vessel Seal Burst Strength: Ability to withstand a certain pressure without leaking (e.g., specified kPa or mmHg).
• Electrical Safety: Compliance with electrical safety standards (e.g., leakage current, insulation).
• Biocompatibility: Absence of adverse biological reactions (cytotoxicity, irritation, etc.) validated through in vitro and in vivo tests.

Essentially, the ground truth is established by meeting predefined scientific and engineering thresholds that demonstrate the device is safe and performs identically or equivalently to the original device.

8. The sample size for the training set

This section is not applicable. The device is a physical reprocessed medical instrument, not an AI model. Therefore, there is no "training set" in the context of machine learning. The "training" for the reprocessing procedures involves process validation and adherence to established protocols for cleaning, sterilization, and functional testing.

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

This section is not applicable as there is no "training set" in the machine learning sense. However, if one were to loosely interpret "training set" as the data that informed the reprocessing procedures and quality checks, then the "ground truth" for establishing these procedures would be derived from:

• Regulatory standards: Follow FDA guidelines and relevant international standards (e.g., ISO for sterilization, biocompatibility).
• Manufacturer's specifications: Understanding the original device's design, materials, and performance requirements.
• Scientific and engineering principles: Applying established methods for cleaning, disinfection, sterilization, and material compatibility.
• Validation studies: Performing rigorous studies to prove that the reprocessing methods consistently achieve the desired outcomes (e.g., sterility, functionality).

The "ground truth" in this context is the successful demonstration that the reprocessed device can consistently meet the same safety and performance characteristics as the new, original device.

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