(56 days)
The Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set is intended for vertebral body access, biopsy and infusion during a vertebroplasty procedure.
The Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set consists of a cannula with an accompanying inner stylet and an obturator. The device may include an additional inner biopsy needle and obturator. The cannula is available in several sizes (11, 13 or 15 gauge) and lengths (10 or 15 cm) with various cannula/stylet tip configurations. The additional inner biopsy needle is available in two sizes (14 or 16 gauge) and lengths (17.1 or 22.1 cm) with a trephine tip and functions coaxially with the cannula once the stylet is removed. A plastic, non-radiopaque needle holder is also available to aid with needle placement.
The provided document does not contain information related to software or AI/ML-driven medical devices. Therefore, it is impossible to extract the requested details such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document discusses a physical medical device, the "Osteo-Site Bone Biopsy Needle and the Osteo-Site Bone Biopsy Needle Set," and its substantial equivalence to a predicate device. The performance data presented refers to mechanical and biocompatibility testing of this physical device.
Therefore, I cannot fulfill the request for information on acceptance criteria and study details relevant to AI/ML device performance based on the provided text.
§ 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.