(53 days)
The Avitus(TM) Bone Harvester is intended to harvest cancellous bone and marrow.
The proposed device is a manual surgical instrument that cuts cancellous bone by manual actuation of the cutting tip. The cap contains a barbed nozzle that connects to standard sized suction tubing (tube with an ID of 6-10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressure between 150 mmHg. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone marrow from the cutting tip and into the bone reservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bone graft can be retrieved from the handle.
I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document is an FDA 510(k) premarket notification letter for the Avitus™ Bone Harvester, detailing its substantial equivalence to a predicate device and its intended use. It mentions non-clinical testing for load evaluation and tip breakage, and biocompatibility testing, but it does not provide specific acceptance criteria values or detailed study results with the requested parameters.
Therefore, I cannot fulfill your request for the table of acceptance criteria, detailed study information, sample sizes, ground truth establishment, or multi-reader multi-case study results.
§ 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.