(147 days)
This instrument has been designed to be used with an Olympus ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
The subject device is a Single Use Aspiration Needle NA-U200H to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
The subject device consists of a handle section, needle section, and sheath section. When users use the device, the syringe needs to be attached to the subject device. The subject device is used to obtain an acceptable specimen. The lesion is punctured by the Needle equipped at the distal end of the subject device and aspirated by the syringe. Subsequently, the tissue of the lesion in the needle is taken out by feeding air from the syringe or pushing the tissue with the stylet for sampling.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter and a 510(k) summary for the "Single Use Aspiration Needle NA-U200H".
While it states that "Performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended," and that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007," it does not provide specific details on:
- A table of acceptance criteria and reported device performance (with specific metrics and values).
- Sample sizes used for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
- Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
- Type of ground truth used.
- Sample size for the training set (again, not applicable to a physical device in the context of AI).
- How ground truth for the training set was established.
This document focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices, rather than detailed performance study results with specific acceptance criteria that would be typical for an AI/software device.
§ 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.