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The ETHICON™ Total Energy System is intended to supply energy to surgical devices.
The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.

The subject device, The ETHICON™ Total Energy System, is an electrosurgical generator that integrates Advanced Energy (Advanced Bipolar and Ultrasonic) and Core Monopolar and Bipolar energy modalities into one system, the Ethicon Total Energy System. The subject device consists of two modules: the Communications Module (ETHCM and ETHUSC) and the Energy Module (ETHEM). Atop the Energy Module is the Communications Module and the User Screen. The Communications Module contains the power button and speakers, connects to the User Screen, distributes power to the system, and provides external interfaces for other connectivity to external devices including Ethernet and USB. One or two Energy Modules can be connected to the Communications Module. When two Energy Modules are connected, each Energy Module can independently power any of the energy modalities. This feature allows for simultaneous use of two surgical instruments in one system to support complex surgical procedures where two surgeons are operating on a patient at the same time. The User Screen features a touch-operable graphical user interface (GUI) for system settings adjustment, user profile management, and alarm troubleshooting. The ETHICON™ Total Energy System accessories include a cart for system transport, footswitches (single, double, round), and an output verification key. The cart provides a mobile platform with adjustable shelves and accessory storage. Additionally, the cart has custom features to create stability for the system including cut-outs on the top shelf for holding the rubber feet of a second module layers. Casters provide 360° mobility with locking tabs that lock to prevent unwanted cart movement. Footswitches may be used to control power delivery to connected instruments, enabling surgeons to activate the energy output hands-free. The different footswitches can be used for various energy modalities and instruments. Up to four footswitches can be connected to the Communications Module of the Ethicon Total Energy System at the same time. The footswitches are assigned to the desired instrument port via the User Screen GUI. Output Verification is a service mode of the system used to periodically confirm that the power outputs of each energy modality are within the required specifications. The Energy Output Verification Key is used by biomed/hospital facility servicing personnel to complete this process for annual maintenance on the Energy Module, with on-screen guidance to assist in this process. The ETHICON™ Total Energy System is compatible with Ethicon HARMONIC™, Ethicon ENSEAL™, and Ethicon MEGADYNE™ monopolar and bipolar instruments.

The provided FDA 510(k) summary for "The ETHICON™ Total Energy System" does not contain the specific details regarding acceptance criteria and the comprehensive study results typically found in a full scientific report.

However, based on the information provided, I can infer the general nature of the acceptance criteria and the studies performed, and explain what is missing from a complete answer regarding detailed acceptance criteria and proof of meeting them:

General Conclusion from the Document:
The FDA 510(k) summary states, "The subject device showed either equivalent or improved performance compared to the predicate devices and met all functional requirements of its features. It successfully met the acceptance criteria for bench testing, animal studies, usability, and electrical testing, demonstrating no new safety or effectiveness issues compared to the predicate."

This indicates that acceptance criteria were established and met for various aspects, but the specific, quantifiable criteria and the detailed results proving they were met are not explicitly listed in the provided text.

Here's an attempt to answer your request based on the available information, highlighting what is present and what is absent:

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

Missing Information: The document states that the device "met the acceptance criteria for bench testing, animal studies, usability, and electrical testing" and "demonstrated equivalent output, stability, and thermal spread control" compared to predicates. However, specific quantitative acceptance criteria and their corresponding reported device performance values are not provided in this 510(k) summary. For example, it doesn't state "Acceptance Criterion: Vessel burst pressure > X mmHg, Reported Performance: Y mmHg."

To illustrate what would be in such a table, based on the mentioned tests:

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The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The 4x reprocessed Monarch Bronchoscope. MBR-000211-B. (hereafter referred to as "Proposed Device") is similar to the 2x reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Predicate Device").

The Original Monarch Bronchoscope. MBR-000211-A. (hereafter referred to as "Co-Predicate Device") cleared under K193534 is identical to the 2x reprocessed Monarch Bronchoscope ("Predicate Device"), cleared under K203614.

Both device designs are controlled by Auris Health, Inc., throughout their total product lifecycle.

The Monarch Bronchoscope is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that is either discarded or returned to Auris for reprocessing after clinical use. The original singleuse Monarch Bronchoscope was cleared for one clinical use under K193534. The reprocessed single-use (rSUD) Monarch Bronchoscope was cleared for two (2) clinical uses under K203614. This premarket notification intends to gain market clearance for a reprocessed single-use (rSUD) Monarch Bronchoscope that can be reprocessed up to three (3) times, for a total of four (4) clinical uses.

Identical to the Predicate Device, the Reprocessed Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the Predicate Device.

The provided text describes the regulatory clearance of a reprocessed medical device, the Monarch Bronchoscope, and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria for a diagnostic algorithm, nor does it detail a study that proves a device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity).

The document is a 510(k) premarket notification letter from the FDA, confirming clearance for the "4x reprocessed Monarch Bronchoscope" (meaning it can be reprocessed up to three times for a total of four clinical uses). The performance testing described focuses on the physical and functional integrity of the reprocessed device, not on diagnostic accuracy of an algorithm or an AI component.

Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, type of ground truth) are not applicable or cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not relevant to diagnostic algorithm validation:

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

The document provides a list of performance tests conducted for the reprocessed bronchoscope, with "Pass" as the result, indicating that the device met internal design specifications and applicable standards for safe and effective reprocessing. These are functional and safety-related criteria for the physical device, not diagnostic performance metrics.

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 performance tests refer to "worst case device conditioning" but do not specify the number of devices or clinical cases used in these tests. The data provenance is not mentioned.

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 to the type of device and testing described. The document pertains to the reprocessing of a physical bronchoscope, not a diagnostic algorithm requiring expert ground truth for image interpretation or diagnosis.

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

This information is not applicable to the type of device and testing described. Adjudication methods are typically relevant for human-in-the-loop or diagnostic studies, which are not detailed 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 to the type of device and testing described. The document does not mention an AI component or any MRMC studies.

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

This information is not applicable to the type of device and testing described. The Monarch Bronchoscope is a physical device; there is no mention of a standalone algorithm.

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

This information is not applicable in the context of diagnostic performance. For the safety and functional tests performed, the "ground truth" would be the established engineering and biological standards and specifications the device aims to meet (e.g., sterility, electrical safety, cleaning effectiveness).

8. The sample size for the training set

This information is not provided and is not applicable as there is no mention of an algorithm or machine learning model being developed or trained.

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

This information is not applicable as there is no mention of algorithmic training or ground truth for such a purpose.

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The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Proposed Device") is identical to the Original Monarch Bronchoscope, MBR-000211-A, (hereafter referred to as "Predicate Device"), which is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that can be reprocessed up to one (1) time.

The Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the predicate Monarch Platform bronchoscope.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document implies the acceptance criteria through the description of the tests and the "Pass" results. Specific numerical or qualitative thresholds for "Pass" are not detailed in the provided text.

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

The document does not explicitly state the numerical sample size used for the test set for each performance test. It mentions "worst case device conditioning" for several tests, implying that specific devices were subjected to these conditions.

Regarding data provenance:

• Country of Origin: Not specified in the provided text.
• Retrospective or Prospective: Not explicitly stated. Given the nature of performance testing for reprocessing validation, it would typically involve prospective testing of reprocessed devices.

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

This information is not provided in the given text. The tests described are primarily engineering and safety validation tests (cleaning, functional, electrical, biocompatibility, sterilization) rather than clinical studies requiring expert interpretation of results to establish ground truth in a diagnostic context.

4. Adjudication Method for the Test Set:

This information is not provided in the given text. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where disagreement needs resolution. The described tests are objective performance tests which would not typically involve such adjudication.

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 conducted or described in the provided document. The submission focuses on demonstrating the safety and effectiveness of a reprocessed bronchoscope compared to its original form, primarily through laboratory and performance testing, not direct comparative clinical effectiveness with human readers.

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

This question is not applicable to the device described. The Monarch Bronchoscope is a physical medical device, specifically a reprocessed bronchoscope, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance tests described (cleaning, functional, electrical, biocompatibility, sterilization) are evaluations of the hardware itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests is established by:

• Engineering Specifications/Design Requirements: Functional and system compatibility tests verify performance against the original design.
• International Standards: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-18 for electrical safety and EMC, ISO 10993-1:2018 for biocompatibility, and ISO 11135:2018 for sterilization.
• Validated Processes: For cleaning and sterilization, the ground truth is established by the successful validation of the reprocessing protocol itself, ensuring devices meet specified cleanliness and sterility levels (e.g., SAL of 10-6).

8. The Sample Size for the Training Set:

This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm.

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Milagro Interference Screw (5x12, 6x12, 7x15, 8x15)

The MILAGRO BR Interference Screws are designed to attach soft tissues to bone in Orthopedic surgical procedures for the following indications:

Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair

Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair

Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation)

Milagro Advance Interference Screw (7x23, 8x23, 9x23)

The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Additionally, the 7, 8 and 9mm x 23mm screws are indicated for: medial and lateral ligament repart, medial patellofemoral ligament reconstruction (femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

The proposed devices are interference screws used for attachment of soft tissue to bone in Orthopedic surgeries. The proposed devices are cannulated, threaded interference screws, made of absorbable Biocryl® Rapide™ (composite of β-TCP and PLGA copolymer). The devices are provided as sterile (EtO), and are for single patient use only.

There is no accessory accompanied with the devices. Manual Orthopedic instruments such as tap and driver are used for screw insertion. Instruments are classified as LXH: Orthopedic Manual Surgical Instruments, Class I Exempt device, regulated per 21 CFR 888.4540. No new instrumentation is developed for the purpose of this submission.

This document is a 510(k) Premarket Notification from the FDA regarding the Milagro / Milagro Advance Interference Screw. It focuses on establishing substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with specific acceptance criteria related to accuracy or performance metrics.

Therefore, the requested information components related to acceptance criteria, ground truth, expert adjudication, and comparative effectiveness studies typical for AI/CAD devices are not applicable in this context. The device is a bone fixation appliance, not an AI or diagnostic device.

Here's a breakdown of the available information based on your request, highlighting why certain sections are not applicable:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Not explicitly defined in terms of numerical performance thresholds as this is a medical implant seeking substantial equivalence, not a diagnostic or AI device with performance metrics like sensitivity/specificity. The implicit "acceptance criterion" is demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness for the stated indications for use.
   • Reported Device Performance:
     | Performance Metric | Reported Performance |
     | :----------------- | :------------------- |
     | Fixation Strength | Demonstrated substantial equivalence to the predicate device. |

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

   • Sample Size: Not specified in the provided document. The study was "bench-top mechanical testing," implying lab-based material or device samples, not patient data.
   • Data Provenance: Not applicable. This was a physical bench-top test, not a study involving human 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):

   • Not applicable. The ground truth for mechanical testing is typically established by engineering standards and measurement accuracy, not expert consensus as in diagnostic imaging.

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

   • Not applicable. This is not a human-readable diagnostic test; it's mechanical performance assessment.

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 a medical implant, not an AI or diagnostic tool that would involve human readers.

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

   • Not applicable. This is a medical implant, not an algorithm.

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

   • The "ground truth" for the mechanical testing would be defined by engineering standards and measured physical properties (e.g., force required for failure, displacement under load) obtained through controlled laboratory experiments. It's not clinical data like pathology or outcomes.

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 above, this is not an AI device.

Summary of the Study:

The study conducted was bench-top mechanical testing to assess the fixation strength of the Milagro / Milagro Advance Interference Screw. The primary goal was to demonstrate that its fixation performance was substantially equivalent to that of the predicate device (Bioraptor Knotless Anchor and BioTenodesis Interference Screw). The document explicitly states: "The data demonstrated substantial equivalence of fixation performance." There were no changes to the material, packaging system, or sterilization, further supporting the substantial equivalence claim.

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The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/ interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.

The ELITECROSS™ Support Catheter is a single-use, 5F sheath-compatible sterile catheter designed to provide additional support to the distal portion of ancillary diagnostic/interventional devices, including the FRONTRUNNER® XP CTO Catheter, as well as to deliver saline or contrast medium. After crossing the occlusion with the ancillary device, the ELITECROSS™ may be used to facilitate placing a guide wire across the occlusion.

The ELITECROSS™ Support Catheter device is a single lumen torqueable tube containing a full-length PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating on the distal 40 cm of the catheter body. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The ELITECROSS™ Support Catheter will be available in various configurations and several lengths. The ELITECROSS™ Support Catheter is provided sterile (by EO) and intended for single use only.

This document is a 510(k) Pre-market Notification for the ELITECROSS Support Catheter. It seeks to demonstrate substantial equivalence to a predicate device, the Cordis Micro Guide Catheter ELITE. Therefore, the information provided focuses on the substantial equivalence and performance testing compared to the predicate, rather than a standalone study proving the device meets de novo acceptance criteria for an AI/ML device.

Because this is a submission for a medical device (catheter) and not an AI/ML device, the typical acceptance criteria and study design elements you've requested for AI/ML performance (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable in the context of this document.

Instead, the "acceptance criteria" for a medical device like this are generally related to its functional performance, physical dimensions, material properties, and biological safety, demonstrating that it performs as intended and is as safe and effective as a legally marketed predicate device.

Here's how to interpret the provided information in relation to your request, keeping in mind the device type:

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

Based on the document, the "acceptance criteria" are implied by the performance characteristics tested, demonstrating equivalence to the predicate and ensuring the device functions as intended. The reported performance is that the device "meets applicable performance requirements" and "continues to meet all previous performance specifications" of the predicate.

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

• Sample Size: Not specified in the provided document. For physical device testing, sample sizes are typically determined by statistical methods or industry standards but are not usually detailed in this summary section of a 510(k).
• Data Provenance: Not specified nor is it typically relevant for this type of physical device performance testing. The tests are benchtop, laboratory evaluations.

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

• Not Applicable. This is not an AI/ML device where expert consensus on interpretations or diagnoses would be required for ground truth. Ground truth for a catheter involves objective physical and functional measurements (e.g., burst pressure, flow rate, dimensions).

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

• Not Applicable. As above, this is for AI/ML interpretative tasks, not for physical device performance validation.

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 a physical medical device (catheter), not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant here.

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

• Not Applicable. This is a physical medical device. There is no algorithm or "standalone" performance in the AI/ML sense.

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

• Objective Technical Measurements: The "ground truth" for this type of device testing consists of objective, quantifiable measurements of physical properties and performance characteristics (e.g., dimensions, burst pressure, flow rates, compatibility with other devices). These are typically verified against engineering specifications and industry standards.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

• Not Applicable. No training set is involved.

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The OUTBACK Elite Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The OUTBACK Elite Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.

The OUTBACK® Elite Re-Entry Catheter is a single-use device designed to facilitate placement and positioning of guidewires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The OUTBACK® Elite Re-Entry Catheter is supplied sterile and is available in two useable lengths.

The provided document is a 510(k) summary for the OUTBACK Elite Re-Entry Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment, which are typical for studies validating AI/software-driven medical devices, is not available in this document.

However, I can extract the information provided about device performance testing:

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 results in a quantitative manner as would be expected for an AI study. Instead, it states that "Design verification and validation testing demonstrate that the catheter continues to meet all previous performance specifications and that none of the critical clinical performance parameters have changed." and "The OUTBACK® Elite Re-Entry Catheter continues to meet all previous performance specifications and none of the critical clinical performance parameters have changed."

The performance data listed are primarily related to physical, chemical, and biological properties of the catheter, not diagnostic accuracy or clinical outcomes as would be relevant for devices with AI components. The types of testing performed, and the general statement of conformity, are:

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 as the study described is a device verification and validation study, not a clinical study involving a test set of 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/provided as the study did not involve establishing ground truth from expert interpretation of a test set.

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

This information is not applicable/provided.

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/provided. The device is a physical catheter, not an AI or software-driven diagnostic tool that would typically undergo an MRMC study.

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

This information is not applicable/provided. This device is a physical medical device, not an algorithm.

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

This information is not applicable/provided. For the physical and performance tests, the "ground truth" would be established by validated test methods and specifications, not by expert consensus or pathology on patient data.

8. The sample size for the training set

This information is not applicable/provided. This is a physical device, not an AI model, and therefore does not have a training set in the AI sense.

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

This information is not applicable/provided.

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The Micro Guide Catheter ELITE accessory is to be used with the Frontrumer® CTO Catheter. The Frontrumer® CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

The Micro Guide Catheter ELITE is a 6F sheath compatible catheter designed to navigate and place guidewires in the peripheral vasculature and to provide additional support for the Frontrunner® CTO Catheter. The Frontrunner® CTO Catheter is indicated to facilitate the intraluminal placement of conventional guidewires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Micro Guide Catheter ELITE is a single lumen torqueable tube containing a PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The Micro Guide Catheter ELITE is available in various configurations and several lengths. The Micro Guide Catheter ELITE is provided sterile (by EO) and is intended for single use only.

The provided document is a 510(k) summary for the Micro Guide Catheter ELITE. It outlines the device description, intended use, and comparison to a predicate device, along with performance data. However, it does not explicitly present acceptance criteria in a table format with reported device performance for specific clinical or diagnostic metrics as one would expect for an AI/ML powered device.

Instead, the document details various types of performance tests conducted to demonstrate substantial equivalence to a predicate device. For the purpose of answering your request, I will interpret "acceptance criteria" as the successful completion and meeting of specifications for each listed performance test, and "reported device performance" as the documented successful outcome of these tests.

It's important to note that this device is a physical medical device (catheter), not an AI/ML-powered diagnostic tool. Therefore, many of your specific questions regarding AI/ML study design (ground truth, expert consensus, MRMC studies, training sets, etc.) are not applicable in this context.

Here's an attempt to structure the information based on your request, with a focus on how the provided document does address performance and testing, and explicitly stating where information requested for AI/ML devices is not present or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Animal Study: Two animals were used. Within each animal, four devices were evaluated (2 test articles, 2 control articles). This gives a total of 4 uses of the test device (Micro Guide Catheter ELITE) across two animals.
  • Other Testing (Biocompatibility, Dimensional, Functional, Packaging/Sterilization): The document does not specify the exact number of units or samples used for each of these in vitro/bench tests. It mentions "finished and sterilized catheters" for biocompatibility.
• Data Provenance:
  • Animal Study: Prospective, conducted in a porcine model. The country of origin is not specified but it was a GLP (Good Laboratory Practice) study.
  • Biocompatibility & Other Tests: Likely lab-based (in vitro/bench) testing of manufactured devices. Provenance (country of origin) not specified. These were not human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This is a physical medical device, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is determined by physical measurements, chemical analyses, and biological responses in animal models.

4. Adjudication Method for the Test Set

• Not applicable. There was no expert adjudication in the context of diagnostic interpretation. For the animal study, evaluation was done by the study investigators.

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

• No. This type of study is relevant for diagnostic devices, especially those using AI, to assess reader performance. It does not apply to a physical catheter.

6. Standalone (Algorithm Only) Performance Study

• No. This applies to AI/ML algorithms, not physical medical devices.

7. Type of Ground Truth Used

• Physical/Chemical Measurements and Biological Observations:
  • For biocompatibility: Adherence to ISO standards and observed biological responses (cytotoxicity, hemolysis, etc.).
  • For dimensional/functional: Engineering specifications and measurements.
  • For packaging/sterilization: Measured levels of contaminants or residuals against safety limits.
  • For animal study: Direct observation of device performance (radiopacity, rotation, advancement, retraction) and gross pathological evaluation of tissues for damage.

8. Sample Size for the Training Set

• Not applicable. This device does not involve an AI/ML algorithm that requires a training set. The device design and testing are based on engineering principles and preclinical evaluations.

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

• Not applicable. As there is no AI/ML training set, there is no ground truth related to it.

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The Healix Ti Anchor is intended for:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
• Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Hip: Capsular Repair, Acetabular Labral Repair

The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. The Healix Ti Anchors are manufactured of Titanium material. Permacord suture is non-absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device, nor does it provide specific numerical performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device through various non-clinical tests.

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

The document mentions "Verification activities were performed on the implant and / or its predicates. Testing assessment includes pull out testing." However, it does not provide any details regarding the sample size used for these tests, nor the data provenance (country of origin, retrospective or prospective). Given the nature of a 510(k) summary, these granular details are often found in the full submission, not the publicly available summary.

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 device in question is a medical implant (suture anchor), not an AI or diagnostic device that requires expert review for ground truth establishment. The "ground truth" for this device would be its physical and mechanical performance characteristics.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

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 as the device is a medical implant, not an AI or diagnostic tool that would involve human readers.

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

This is not applicable as the device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering and mechanical testing data, primarily "pull out testing" to demonstrate its fixation strength in bone. It also relies on the established performance and safety record of its predicate devices.

8. The Sample Size for the Training Set

This is not applicable as the device is hardware (medical implant) and not an AI algorithm that would require a training set.

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

This is not applicable as the device is hardware and does not have a training set or associated ground truth in the context of machine learning.

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The VAPR® ARCTIC™ Suction Electrode for use with the VAPR VUE® RF System is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the hip.

The VAPR® ARCTIC™ Electrode is a single use, one-piece bipolar suction articulating electrode for use in arthroscopic surgery of the hip. The electrode has a hand-controlled articulating tip to improve access and suction capabilities. This will enhance the efficiency of the electrode and extend the utility of the system by assisting in the removal of bubbles and debris created during activation within the operating site.

The ARCTIC Electrode has been designed to facilitate access and control the delivery of RF energy to the joint space. The plug of the ARCTIC Electrode is designed to fit the VAPR VUE® generator socket only. It has an internal identification capacitor code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be run only off the VAPR VUE electrosurgical generator at pre-determined default settings specific for the device.

The provided text describes a 510(k) premarket notification for the VAPR® ARCTIC™ Suction Electrode. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, detailed study design, and AI performance is not explicitly available in the provided text.

However, I can extract information about the types of tests performed to ensure safety and performance, which can be seen as meeting product specifications and user needs.

Here's a breakdown of the available information:

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

The document does not provide a specific table of quantitative acceptance criteria and their corresponding reported performance values. Instead, it lists various verification and validation tests performed to ensure the device meets its specifications and user needs. The conclusion states that the "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use."

Here's a summary of the types of tests conducted:

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 the sample size for individual tests, nor does it provide details about data provenance (e.g., country of origin, retrospective/prospective nature). The tests appear to be laboratory or bench-top tests of the device components and functionality.

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. The device is an electrosurgical tool, and its performance is evaluated against engineering specifications and functional requirements, not through expert-labeled diagnostic data. Therefore, there's no "ground truth" in the clinical imaging or diagnostic sense being established by experts for a test set in this context.

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

This is not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of data (e.g., medical images). This document describes device performance and safety testing, not diagnostic 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

This is not applicable. The VAPR® ARCTIC™ Suction Electrode is an electrosurgical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness metrics are not relevant to this submission.

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

This is not applicable. As stated above, this device is a surgical instrument, not an algorithm, and the concept of "standalone" performance for an algorithm is not relevant here.

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, industry standards (listed in Table 2), and functional requirements for surgical tools. This includes measurements of physical properties (e.g., articulation angle, tensile strength), electrical properties, biological compatibility, and demonstration of proper function (e.g., activation, suction flow, non-clogging). It does not involve clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm that requires a training set.

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

This is not applicable. This device is not an AI algorithm that requires a training set or ground truth establishment for a training set.

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