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The Applied Medical Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Applied medical specimen Retrieval System is a disposable receptacle used to collect and extract tissue, organs and calculi during laparoscopic procedures. It consists of a flexible polymer bag and an introducer structure that fits through a trocar port. Extracorporeal activation of the introducer handle ejects the flexible bag which automatically opens in preparation for receipt of the specimen. The device is constructed of various polymers and stainless steel. It is packaged in a Tyvek/Mylar peel pouch and a product shelf pack. The shelf pack will be sterilized using gamma irradiation per AAMI/ISO guidelines. Sterility Assurance Level will be 10°.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Applied Medical Specimen Retrieval System (K100959):

Overall Assessment:

The provided document is a 510(k) summary for a medical device. For this type of submission, the "acceptance criteria" are not typically presented as quantitative performance metrics that the device must meet to be considered "accepted." Instead, the key acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device. This substantial equivalence is primarily shown through a comparison of technological characteristics and, crucially, through non-clinical testing that confirms the new device's safety and effectiveness compared to the predicate.

The "study" described is not a typical clinical trial or a performance study that generates specific statistical metrics like sensitivity, specificity, or accuracy that would be used to meet predefined quantitative acceptance criteria. Instead, it's a comparative non-clinical testing program designed to show that the new device performs similarly to the predicate.

Acceptance Criteria and Reported Device Performance

Additional Information on the Testing ("Study")

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the numerical sample size (e.g., number of test specimens, number of devices tested) for the functionality, robustness, and bag strength tests. It only refers to "test methods" and "test results."
   • Data Provenance: The testing was conducted by Applied Medical. It is non-clinical/bench testing, not involving human subjects. The country of origin of the data is not specified but assumed to be the United States, given the company's location and FDA submission. It is by definition a prospective test of the newly manufactured device.

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

   • Not applicable. This was a non-clinical, bench testing study. "Ground truth" in the clinical sense (e.g., expert diagnosis) is not relevant here. The ground truth for performance was established by engineering specifications and comparative testing against the predicate device.

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

   • Not applicable. As a non-clinical bench test, there was no expert adjudication process for establishing a "ground truth" outcome. Test results were likely directly measured against predetermined engineering criteria or predicate device performance.

4. 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 device is a specimen retrieval system, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was conducted or relevant.

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

   • Not applicable. This is a physical medical device, not a software algorithm.

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

   • For the non-clinical testing, the "ground truth" was established by:
     • Engineering specifications and design requirements: For functionality, robustness, and bag strength.
     • Predicate device performance: The "ground truth" for acceptable performance was essentially defined by the performance characteristics of the legally marketed predicate device (K060051), as the goal was to demonstrate substantial equivalence.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this device. This is a physical medical device, not a machine learning model.

8. How the ground truth for the training set was established:

   • Not applicable. As no training set was used.

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