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The Tissue Removal System is indicated for the contained removal of tissue, including contained manual tissue sectioning, during minimally invasive surgical procedures.

The Tissue Removal System is comprised of the Tissue Removal Pouch cleared under K150781 and an additional accessory Sectioning Device. It is provided sterile, and is for single patient use.

The Tissue Removal Pouch of the Tissue Removal System includes a bag with a single large opening held open by a thin, opening ring. During laparoscopic surgery, the bag is placed within the peritoneal space via an existing port site. Tissue that has been resected is placed within the bag for isolation, containment and removal from the patient. The bag opening is exteriorized. Two halves of the Tissue Removal Pouch flip ring are attached to each other and to the bag is rolled around the flip ring by inverting the flip ring, in order to draw the resected tissue toward the port site.

The resected tissue is then removed en bloc (for smaller specimens), or by first dividing the specimen using the accessory Sectioning Device. The Sectioning Device is comprised of a blunt wire, a flexible passer and a handle with a blunt hook. The passer is used to encircle the specimen with the wire. The handle includes a blunt hook that can be used to aid in the advancement of the passer. The specimen is divided by the manual application of a back and forth motion to the wire. Use of the accessory Sectioning Device permits division of the specimen while maintaining the containment effectiveness of the Tissue Removal Pouch

Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured according to your request:

Unfortunately, the provided document does not contain information related to an AI/ML device. The document is a 510(k) premarket notification for a medical device called "Tissue Removal System," which is a physical device used in surgery to contain and remove tissue.

Therefore, many of your requested points, such as AI-related performance metrics, sample sizes for training or test sets for an algorithm, expert adjudication, or MRMC studies, are not applicable to this document.

However, I can extract the information that is present regarding the non-clinical testing performed for this physical device.

Description of Acceptance Criteria and Supporting Study for the Tissue Removal System

The document describes non-clinical testing performed to demonstrate the safety and effectiveness of the "Tissue Removal System," particularly focusing on the integrity and containment capabilities of the Tissue Removal Pouch when used with its accessory Sectioning Device.

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

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 for Test Set: The document does not specify the sample sizes (e.g., number of pouches, sectioning devices, or test repetitions) used for any of the non-clinical tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, though non-clinical tests are inherently prospective laboratory studies.

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

• Not Applicable. This document describes non-clinical engineering and material integrity tests on a physical device, not an AI/ML diagnostic system requiring expert interpretation or ground truth establishment in the traditional sense. The "ground truth" here is the physical performance of the device against predefined engineering standards (e.g., no leaks, no punctures, no tears).

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

• Not Applicable. As above, this is not an interpretive diagnostic study requiring adjudication. The outcomes are objective measurements of physical integrity (e.g., presence/absence of bubbles, dye penetration, tears, punctures).

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 a study involving human readers or AI assistance.

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

• Not Applicable. This document pertains to a physical medical device, not an algorithm.

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

• The "ground truth" in this context refers to the objective performance of the physical device as measured by specific non-clinical test methods. For example, for "Bubble Leak" testing, the ground truth for failure would be the observation of bubbles, and for "Dye Penetration," it would be the observation of dye. These are direct physical observations, not interpretive diagnoses.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML model.

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

• Not Applicable. There is no "training set."

Summary of Device and Testing Context:

The Tissue Removal System is a physical device for containing and removing tissue during minimally invasive surgery. Its key innovation over a predicate device is the inclusion of an accessory Sectioning Device that uses a blunt wire for dividing specimens, in contrast to predicate devices that might require sharp instruments.

The non-clinical tests aim to prove that this new Sectioning Device does not compromise the primary function of the Tissue Removal Pouch, which is to maintain containment and integrity. The tests specifically assessed physical characteristics such as leak prevention, puncture resistance, and tear resistance under various conditions, including simulated and extreme use. The "conclusions" state that the device is "as safe and effective as, and performs as well as, or better than, the legally marketed predicate device" based on these non-clinical tests.

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