(243 days)
The Thyrosampler® Kurtaran Frass is indicated for ultrasound guided fine needle aspiration of soft thyroid nodules that are about 1 cm or greater in diameter, located up to depth of 4 cm from the skin.
Not Found
I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, as the document you provided is an FDA 510(k) clearance letter. This letter primarily certifies that the Thyrosampler® Kurtaran Frass device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
The provided document does not contain information on:
- Acceptance criteria: Specific performance metrics or thresholds the device must meet.
- Device performance data: Results from any studies demonstrating the device's efficacy or safety.
- Sample sizes, data provenance, expert qualifications, or adjudication methods related to specific performance studies.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Ground truth types or details on training set data.
The letter focuses on regulatory approval based on "substantial equivalence" to a predicate device, as opposed to detailed clinical study results demonstrating performance against specific acceptance criteria.
§ 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.