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

The GENICON EZee Retrieval is comprised of a flexible plastic bag with a large, easily accessible opening, an actuation rod with thumb ring handle, finger rings, string and closure suture, and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim, and the size of the specimen bag is 4" x 5" with a volume of 230ml. A string with a closure suture facilitates closure of the specimen bag after the specimen had been collected. This device is disposable device packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial or a performance study with specific metrics and statistical analysis. Instead, it describes a substantial equivalence determination based on non-clinical bench testing.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the GENICON EZee Retrieval (K180579) indicates that there are "no FDA performance standards for these products." Therefore, the acceptance criteria are based on internal performance studies and bench testing to demonstrate the device performs as intended and is substantially equivalent to a predicate device (GENICON EZEE Retrieval [K162059]).

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

• Test Set Sample Size: Not explicitly stated. The text mentions "the sample pouch" in reference to the leak inspection, suggesting a small number of units were tested, but no specific count is given.
• Data Provenance: The testing was conducted internally by Genicon. The text does not specify the country of origin of data or whether it was retrospective or prospective, but it implies prospective bench testing.

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

• Number of Experts: Two, "our Chief Technical Officer and Design Engineers."
• Qualifications: "Chief Technical Officer and Design Engineers." Specific years of experience or specialized certifications are not provided, but their titles suggest expertise in medical device design and engineering.

4. Adjudication Method for the Test Set

Not applicable. The "experts" (CTO and Design Engineers) appear to have directly conducted and/or reviewed the performance studies and bench testing results. There is no mention of a separate adjudication process for subjective assessments, as the tests described (force, strength, leaks) are objective measurements.

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 done. The device is a physical retrieval bag for laparoscopic procedures, not an AI or imaging diagnostic tool that would typically undergo such a study.

6. If a Standalone Performance Study Was Done

Yes, a "standalone" performance evaluation in the form of bench testing was done. This testing assessed the device's physical properties and performance characteristics (Deployment Force, Seam Strength, Puncture Force, and performance after simulating multiple specimen captures) independent of human interaction beyond operating the test equipment.

7. Type of Ground Truth Used

The "ground truth" for the bench testing was based on engineering specifications and direct observation of physical properties. For example, seam strength would be compared against a defined engineering requirement or industry standard for adequate strength, and leak inspection relied on visual confirmation of no water egress.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" for the algorithm.

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

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

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

The GENICON EZEE Retrieval is comprised of a flexible plastic bag with a large, easily accessible opening, an actuation rod with thumb ring handle, finger rings, string and closure suture, and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim, and the size of the specimen bag is 4" x 5" with a volume of 230ml. A string with a closure suture facilitates closure of the specimen bag after the specimen had been collected. This device is disposable device packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

This document describes the regulatory submission for the "GENICON EZEE Retrieval" device, a specimen retrieval bag for laparoscopic procedures. The provided text outlines the device's technical specifications and a summary of testing conducted to demonstrate substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested categories related to AI/ML device evaluation (like sample size, ground truth, experts, MRMC studies, standalone performance, and training set details) are not applicable to this document.

Here's the information that can be extracted or inferred from the provided text regarding the GENICON EZEE Retrieval device:

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

The document does not explicitly state numerical acceptance criteria in the typical sense of AI/ML performance metrics (e.g., sensitivity, specificity). Instead, it refers to "performance studies and bench testing" for specific physical attributes. The "reported device performance" is broadly stated as showing substantial equivalence to predicate devices based on these tests.

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

The document does not specify sample sizes for the "performance studies and bench testing." Data provenance information (country of origin, retrospective/prospective) is not provided as these are not a clinical study involving patients or data.

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

Not applicable in the context of an AI/ML device. For the physical performance tests, the evaluation was conducted by the device manufacturer's internal team: "our Chief Technical Officer, Design Engineers, and Chief Medical Officer." Their specific qualifications beyond their titles are not detailed.

4. Adjudication method for the test set

Not applicable as this is not a study requiring adjudication of expert interpretations.

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 MRMC study was done, as this is a medical device (a specimen retrieval bag) and not an AI/ML product.

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

Not applicable, as this is not an AI/ML algorithm.

7. The type of ground truth used

For the specific performance characteristics (Deployment Force, Seam Strength, Puncture Force), the "ground truth" would be the measured physical properties of the device under test conditions. Biocompatibility and sterilization compliance are based on adherence to ISO standards.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Ask a specific question about this device