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The GENICON Specimen Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.

The Genicon Specimen Retrieval Bag System is comprised of a flexible plastic bag and deployment mechanism. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment the bag with the use of the biasing arms. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

I am sorry, but the provided text from the FDA 510(k) document for the GENICON Specimen Retrieval Bag (GeniStrong) does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria in the format requested.

The document is a general FDA clearance letter and a 510(k) Summary. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a performance study with quantitative acceptance criteria and results.

Specifically, the document states:

• "There were no clinical trials performed on the GENICON Specimen Retrieval Bag (GeniStrong)." This immediately tells us there's no clinical performance data to report in the context of human reader studies, ground truth establishment, or multi-reader multi-case studies.
• The "Nonclinical Tests" section describes bench testing for various mechanical properties (introduction forces, seam strengths, puncture forces, fluid permeability, transparency, open and closure forces, re-deployment tests). However, it does not provide specific acceptance criteria values (e.g., "seam strength must be >X Newtons") or the precise numerical results obtained for each test. It generally states that "The tests show that after multiple deployments there are no concerns of safety or effectiveness of the device after multiple uses" and that "The critical performance features of the device passed all minimum acceptance currently applied to the product." This is a qualitative summary, not quantitative data.

Therefore, I cannot populate the table or answer the specific questions regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training data, as this information is simply not present in the provided text.

The document indicates "Bench Testing and Clinical Evaluation performed" for the predicate device, but for the GENICON Specimen Retrieval Bag (GeniStrong), it explicitly states "There were no clinical trials performed." The focus is on demonstrating equivalence through material composition, design, and non-clinical bench testing.

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The GENICON Single-Use Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.

The GENICON Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessible opening, a push-pull rod with thumb ring handle, finger rings, string and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim. A string with a closure suture facilitates closure of the specimen bag after the specimen has been collected. This device is packaged and sterlized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

The provided document is a 510(k) summary for the GENICON Specimen Retrieval Bag. It details the device's description, indications for use, and a statement about nonclinical tests supporting substantial equivalence to predicate devices. However, it does not contain the specific acceptance criteria or a detailed study report that proves the device meets those criteria, as typically found in a clinical trial or performance study report. The document mentions "Bench Testing and Clinical Evaluation performed (ref. TR-12022-A and CLEV-032-A)," but the details of these tests are not provided in this regulatory submission.

Therefore, for aspects requiring detailed study information, the answer will reflect that the information is "Not Available in the provided text."

Here's an attempt to answer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly list quantitative acceptance criteria or detailed device performance metrics from a study. It only states that "Successful results support a determination of substantial equivalence" for general operation, seal strength peel, and puncture resistance. Without access to TR-12022-A and CLEV-032-A, specific criteria and performance values cannot be extracted.

2. Sample Size for the Test Set and Data Provenance

• Sample size used for the test set: Not available in the provided text. The document mentions "Bench Testing and Clinical Evaluation," but no sample sizes are given for either.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not available in the provided text.

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

• Number of experts: Not available in the provided text.
• Qualifications of those experts: Not available in the provided text.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication method: Not available in the provided text.

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

• MRMC comparative effectiveness study: Not applicable. This device is a physical specimen retrieval bag, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

• Standalone performance study: Not applicable. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of ground truth: Not available in the provided text. For bench testing, ground truth would likely be established by objective physical measurements according to specified test methods. For clinical evaluation, it would typically relate to the device's ability to safely and effectively retrieve specimens in a surgical setting, which could involve surgical observations, successful specimen retrieval without complications, and potentially pathology results of retrieved specimens. However, the document does not specify.

8. The Sample Size for the Training Set

• Sample size for the training set: Not applicable/Not available. This device is a physical specimen retrieval bag, and the concept of a "training set" is usually associated with machine learning algorithms, which is not applicable here. Even if a design verification/validation process involved iterative testing, the term "training set" as used in AI contexts does not apply.

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

• How the ground truth for the training set was established: Not applicable/Not available, as the concept of a "training set" for a physical device is not relevant in the context of this summary.

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