(89 days)
This device is to be used for soft tissue biopsy.
Quick-Cut® Automatic Biopsy System
This document is a 510(k) clearance letter from the FDA for a medical device called the "Quick-Cut® Automatic Biopsy System." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
Unfortunately, this document does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself, which is a much more extensive document presented to the FDA for review, rather than in the final clearance letter. The clearance letter is a summary of the FDA's decision based on its review of that submission.
Therefore, I cannot provide the requested table and study details based solely on the provided text.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance
- Not present. The document does not define any specific performance metrics or acceptance criteria for the device, nor does it report any performance data.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. The document makes no mention of test sets, sample sizes, or data provenance.
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 present. The document does not discuss ground truth establishment or the involvement of experts in that process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. The document does not describe any adjudication methods.
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 present. The document is for a biopsy system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance would not be applicable or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. This device is a biopsy system, a physical tool, not an algorithm. Standalone performance for an algorithm is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not present. The document does not describe how ground truth was established for any studies. For a biopsy system, the de facto "ground truth" for its performance would typically be the quality of tissue samples obtained and their subsequent pathological analysis, but this is not discussed in the provided text.
8. The sample size for the training set
- Not present. This device is a biopsy system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not present. Not applicable for this type of device.
What the document does state:
- Device Name: Quick-Cut® Automatic Biopsy System
- Indications for Use: This device is to be used for soft tissue biopsy.
- Regulatory Class: II
- Product Code: KNW
- Regulatory Decision: Substantially equivalent to devices marketed prior to May 28, 1976. This means the FDA found that the device is as safe and effective as a legally marketed predicate device, and thus does not require a full Premarket Approval (PMA) submission. Substantial equivalence is determined by comparing the new device to a predicate device regarding intended use, technological characteristics, and performance data if needed to demonstrate equivalence. The details of that comparison are what's missing here.
§ 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.