(295 days)
The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination. These forceps are advanced to the site for sampling via the operating channel of an endoscope.
The device consists of a proximal handle which is connected, via a coil, spring or rod mechanism, to the biopsy jaws at the distal tip. The biopsy forceps range from 100 to 240cm in length and 1.8-3.3mm in diameter. The jaws range from 1.8 to 3.3mm in diameter. The jaws of the forceps may or may not have serrated edges, a fenestration, needle, or distal biting tooth.
The provided document is a 510(k) summary for SterilMed's Reprocessed Cold Biopsy Forceps. This submission is for a reprocessed medical device, not a novel AI/software-as-a-medical-device (SaMD) or diagnostic device that relies on algorithms for analysis or detection. Therefore, many of the typical questions regarding acceptance criteria and study design for AI-based devices are not applicable.
This document describes the functional and safety testing to demonstrate that the reprocessed devices perform equivalently to their original manufactured counterparts and predicate devices.
Here's an analysis based on the information provided, specifically addressing the questions where applicable, and noting where information is not present given the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document states that "Reprocessed Cold Biopsy Forceps underwent bench testing to demonstrate appropriate functional characteristics." It also mentions "Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced."
However, specific numerical acceptance criteria (e.g., tensile strength, bite completeness, cleanliness levels) and quantitative performance results are not detailed in this summary. The conclusion broadly states that the reprocessed forceps are "substantially equivalent" based on "similarities in functional design, materials, indications for use and methods of construction."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "Representative samples" were used for bench testing. It does not specify the exact sample size for the functional and safety testing. Given it's a medical device reprocessing submission, the "data provenance" would refer to the testing results of the reprocessed devices themselves, rather than clinical data from human subjects. The testing described is prospective in nature as it's performed on reprocessed devices to validate the process. There is no mention of country of origin of the data beyond the submitter's location (Minneapolis, MN, USA).
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 question is not applicable to this submission. The "ground truth" for the performance of a reprocessed biopsy forceps would be its ability to safely and effectively retrieve tissue samples, as demonstrated through functional and safety testing. There are no "experts" establishing ground truth in the sense of image interpretation or medical diagnosis as would be relevant for an AI/diagnostic device. The "ground truth" is typically defined by engineering specifications and performance benchmarks compared to new devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert review processes for diagnostic devices to resolve discrepancies in interpretations. For functional bench testing of a reprocessed mechanical device, direct physical measurements and observations are used, not expert adjudication of 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
This question is not applicable as this is a submission for a reprocessed medical device, not an AI/SaMD. There are no human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical biopsy forceps; it does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for the functional and safety testing would be adherence to established engineering specifications and performance characteristics of new, equivalent devices, as well as the sterility and cleanliness standards required for a reprocessed device. This relies on benchmarking against predicate devices and validated manufacturing/reprocessing specifications, rather than expert consensus on medical images or pathology.
8. The sample size for the training set
This question is not applicable as this is not an AI/machine learning device. There is no "training set."
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/machine learning device. There is no "training set" or ground truth establishment as it would apply to AI.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.