(90 days)
This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow.
A disposable single use Biopsy Needle. The product consist of a 304 stainless steel cannula and 302 stainless steel stylet. The cannula is inserted molded into an ABS hub that provide a grip for manipulation of the Needle. Inside of the cannula is a stylet made by 302 stainless steel, inserted molded into an ABS hub. An additional patented stylet is provided to be used for trapping the sample in the cannula. An extracting 302 stainless steel wire with safety grip. The protective cover of cannula is made of polypropilene.
The provided document is a 510(k) summary for a medical device (TrapSystem® Set Bone Marrow Biopsy Needle) and does not contain information on acceptance criteria, device performance studies, or details relevant to artificial intelligence/machine learning (AI/ML) device performance.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is for a conventional medical device (a biopsy needle) seeking substantial equivalence and does not involve AI/ML components or associated performance studies as typically found in submissions for AI/ML-powered devices.
§ 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.