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Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps are intended to be used during GI procedures for endoscopic tissue sample acquisition.

Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract.

Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.

Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by Clear Medical to Clear Medical protocol Number 40003. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. Clear Medical is a "third party reprocessor" and reprocesses used, single-use medical devices. Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps. CMI intends to reprocess used disposable hot and cold biopsy forceps manufactured by Micovasive. CMI reprocessed biopsy forceps are disposable unless reprocessed again by Clear Medical, Inc.

This document is a 510(k) summary for Reprocessed Used Disposable Biopsy Forceps by Clear Medical, Inc. It mainly focuses on the substantial equivalence of the reprocessed devices to new predicate devices. It does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria in the way a clinical study would for efficacy/performance claims.

Here's an analysis based on the provided text, focusing on what can be extracted or inferred about acceptance criteria directly related to the reprocessing and substantial equivalence, rather than a clinical performance study.

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

Based on the nature of this 510(k) submission, "performance" here refers to the ability of the reprocessed device to meet the functional and safety characteristics of the original device after reprocessing, demonstrating substantial equivalence. The document doesn't provide a table of precise quantitative acceptance criteria with reported numerical performance values from a study. However, it implicitly states the requirement for the reprocessed device to perform equivalently to the new predicate device.

The acceptance criteria for "reprocessed" devices, as stated by Clear Medical, are defined by the FDA's Compliance Policy Guide #7124.16 related to "reusable - by Clear Medical" devices:

• Ability to withstand necessary cleaning and sterilization processes.
• Physical characteristics or quality of the device will not be adversely affected.
• The device remains safe and effective for its intended use.

The document states that Clear Medical believes these conditions are met, and the FDA's 510(k) clearance implies that the provided data (though not detailed here) was sufficient to demonstrate this belief as valid for substantial equivalence.

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

The document does not specify the sample size, data provenance, or study design (retrospective/prospective) for any specific testing related to establishing substantial equivalence. The submission is for "Reprocessed Used Disposable Biopsy Forceps," indicating that the "test set" would be reprocessed devices. The original disposable biopsy forceps were manufactured by Microvasive.

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)

This 510(k) summary does not mention the use of experts to establish a "ground truth" in the context of a clinical performance study. The primary focus is on the substantial equivalence of the reprocessed device to the predicate device, which would typically involve engineering and sterilization validation rather than expert clinical assessment of patient outcomes for a test set.

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

Not applicable, as a clinical test set requiring adjudication by experts is not described in this document.

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 document pertains to the reprocessing of medical devices (biopsy forceps), not an AI-assisted diagnostic tool or a study involving human readers.

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

Not applicable. This document pertains to the reprocessing of medical devices (biopsy forceps), not an algorithm.

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

For this type of device, the "ground truth" for substantial equivalence would likely revolve around:

• Functional equivalence: Demonstrating that the reprocessed device performs the biopsy function (e.g., tissue sample acquisition) comparably to new devices. This might involve mechanical testing, tissue grip tests, cutting performance.
• Sterility: Proving that the device is sterile after reprocessing.
• Material integrity: Ensuring the device materials do not degrade and no toxic residues remain after reprocessing. This would involve chemical analysis, material compatibility testing, and biocompatibility.
• Biocompatibility: Demonstrating that the reprocessed materials are still biocompatible.

The document does not provide details on which specific "ground truth" methods were employed, but these are typical for reprocessing validations.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an algorithm based on machine learning.

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

Not applicable, as there is no training set for an algorithm.

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