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The Anchor™ Tissue Retrieval System™ by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy.

The Anchor™ Tissue Retrieval System™ by CONMED is a sterile, disposable, retrieval pouch for use with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy. The Anchor™ Tissue Retrieval System™ by CONMED consists of a rip stop nylon with polyurethane laminate pouch and two stainless steel arms attached to internal pusher rod, which is connected to a handle at the end distal to the patient. Around the internal pusher rod is the introducer with handle. The introducer handle incorporates a spring-loaded button and a stop mechanism is built into the pusher rod. There is a braided drawstring which enters the introducer with the pusher rod and loops through the rip stop nylon pouch with polyurethane laminate.

The provided text describes a 510(k) premarket notification for the Anchor™ Tissue Retrieval System™ by CONMED. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a new device's performance.

Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth methodologies) is not explicitly detailed in the provided text, as these are typically part of a full study report or design validation documentation, not a 510(k) summary.

However, I can extract the available information.

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Design verification activities demonstrate the device meets design specifications" and lists the types of tests conducted. It does not provide specific numerical acceptance criteria or the reported performance values for each criterion. It only states that the results were "acceptable."

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

The document states: "Design validation activities consisted of simulated use in a cadaver model."

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: Cadaver model (simulated use). Country of origin is not specified, but the submission is to the U.S. FDA, implying U.S. standards or studies. It is a prospective simulation study.

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

The document mentions "Users performance including insertion, multiple assessed device deployments, device/specimen removal, clarity of instructions for use and overall reliability and quality of the device."

• Number of Experts: Not explicitly stated. The term "Users" suggests multiple individuals participated.
• Qualifications of Experts: Not explicitly stated. However, given the context of a surgical device and "user performance," it is highly probable these "users" were surgeons or other medical professionals with relevant experience in laparoscopic hysterectomy.

4. Adjudication Method for the Test Set

Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, this type of study is not described. The device is a tissue retrieval system, not an AI diagnostic tool that would typically involve a multi-reader study.

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

Not applicable. This is a medical device (a tissue retrieval system), not an algorithm or AI.

7. The Type of Ground Truth Used

For the simulated use in the cadaver model, the "ground truth" was likely subjective user assessment of performance, reliability, and clarity of instructions, potentially with objective measures of device functionality during the simulation (e.g., successful deployment, retrieval without tearing). It is based on expert assessment/observation in a simulated environment.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set. The "design verification activities" and "design validation activities" constitute the testing phases for the device.

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 Anchor Tissue retrieval system by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

The Anchor Tissue Retrieval System™ by CONMED is a sterile, disposable retrieval pouch for use with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. The Anchor Tissue Retrieval System™ by CONMED consists of a rip stop nylon pouch, two stainless steel arms attached to internal pusher rod connected to a handle at the distal end to the patient. Around the internal pusher rod is the introducer and handle. The introducer handle incorporates a spring loaded button and stop mechanism is built into the pusher rod. There is a braided drawstring which enters the introducer with the pusher rod and loops through the rip stop nylon pouch.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" with a particular sample size from a patient population, nor does it mention data provenance in terms of country of origin or retrospective/prospective nature. The studies conducted were primarily targeted performance and design verification/validation testing.

• Sample Size for performance testing: The document mentions "bench and simulated use testing" and "redeployment verification testing." It doesn't specify the exact number of devices or trials for these tests.
• Data Provenance: The studies are "non-clinical bench and simulated use testing," implying laboratory-based testing rather than patient data.

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 document. The testing described is primarily engineering and performance-based validation rather than clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described does not involve a process of adjudication by experts for a test set.

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

An MRMC comparative effectiveness study was not conducted. This device is a surgical tissue retrieval system, not an AI-powered diagnostic tool, so such a study would not be relevant.

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 physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

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

• Design Specifications: The device is tested against its established design specifications.
• Performance Standards (Industry/Regulatory): Compliance with relevant ISO standards (e.g., ISO 11607-1:2006 for packaging, ISO 11135:2014 for sterilization, ISO 10993-1:2009 & ISO 10993-7:2008 for biocompatibility).
• User Needs: Demonstrated conformance to user needs and intended use from design validation.
• Substantial Equivalence to Predicate: Performance is compared to a legally marketed predicate device (K091930) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this traditional medical device. This term is typically used for machine learning or AI models.

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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