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The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.

The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.

The provided text is a 510(k) summary for the Espiner Tissue Retrieval System. This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and performance metrics typically associated with AI/ML medical devices.

Therefore, many of the requested categories based on AI/ML device studies are not applicable to this document.

Here's a breakdown based on the information available:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics, but the overarching criterion is "substantial equivalence" to the predicate device.
• Reported Device Performance:
  • Technological Characteristics: "A comparative review...found that the technological characteristics, performance and principle of operation were substantially equivalent (identical)."
  • Performance/Physical Data: "Bench testing demonstrated that the safety and effectiveness of the TFT Espiner Tissue Retrieval System is equivalent (identical) to the predicate devices."
  • Safety and Effectiveness: "indicated no adverse indications or results. It is our determination that the Espiner Tissue Retrieval System is safe, effective and performs within its design specifications and is substantially equivalent (identical) to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This submission relies on substantial equivalence and bench testing, not a clinical test set with human or patient data in the context of an AI/ML study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No ground truth established by experts for a test set in the context of an AI/ML study.

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

• Not applicable. No test set adjudication in the context of an AI/ML study.

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 an AI/ML device, and no MRMC study was performed.

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

• Not applicable. This is not an AI/ML algorithm.

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

• Not applicable in the context of AI/ML ground truth. The "ground truth" here is the established safety and effectiveness of the predicate device, which was deemed identical through comparative review and bench testing.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Summary of the Study:

The "study" presented in this 510(k) is a substantial equivalence assessment. It's not a clinical trial or an AI/ML performance study. The core of the evidence is:

• Predicate Device: The Espiner Tissue Retrieval System identifies its own prior version (K982073) as the predicate device. Espiner Medical Ltd. states they are the "original manufacturer of the product family that is currently approved."
• Comparison: A side-by-side comparison table (Page 3) highlights that the new device has identical properties (manufacturer, trade name, 510(k) number - for predicate, product code, common name, classification, intended use) to the predicate device, with the exception of the 510(k) number itself.
• Bench Testing: The submission states that "Bench testing demonstrated that the safety and effectiveness of the TFT Espiner Tissue Retrieval System is equivalent (identical) to the predicate devices." The specifics of this bench testing (e.g., types of tests, number of units tested, precise parameters measured) are not detailed in this summary document but would have been part of the full 510(k) submission.
• Conclusion: The manufacturer concludes that the new device is "substantially equivalent (identical)" to the predicate device in its technological characteristics, performance, principle of operation, safety, and effectiveness.

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