(25 days)
The Avitus® 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 connect to a vacuum source. 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 and bone marrow from the cutting tip and into the bone reservoir inside the handle. The Cap has a filter feature that prevents material from escaping the handle into the suction system by utilizing a physical sieve. After harvesting, the bone graft can be retrieved from the handle. The proposed device includes a Filter Insert accessory that can assist the user to scoop the bone out from within the Handle after harvesting.
This document is a 510(k) Pre-Market Notification from the FDA regarding the Avitus® Bone Harvester with Filter Insert - 5mm. It is a clearance letter and a summary, not a detailed study report. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving device performance is not present in this document.
However, based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance. It only mentions that "These tests concluded that the proposed device will perform in a manner that exceeds anticipated clinical loads and are therefore, substantially equivalent to the predicate Avitus® Bone Harvester - 8mm device (K152474)." This implies the acceptance criterion was "demonstrating performance that exceeds anticipated clinical loads" and "substantially equivalent to the predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance exceeds anticipated clinical loads | Device performs in a manner that exceeds anticipated clinical loads. |
| Substantially equivalent to the predicate device (K152474) | Demonstrated substantial equivalence based on non-clinical testing results. |
| No reports or records in the FDA MDR Database (for predicate) | Predicate device has no records or reports in the FDA MDR Database. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the non-clinical tests (Clinical Load Evaluation, Worst Case Failure of Cutting Tip Breakage, Benchtop Verification Test). It does not provide information on data provenance (country of origin, retrospective/prospective) for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text. The non-clinical tests described are benchtop tests, not human interpretation studies, so "ground truth" in the context of expert consensus is not applicable here.
4. Adjudication method for the test set
This information is not available in the provided text. The tests performed are engineering/benchtop evaluations, not studies requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was performed or mentioned. The device is a manual surgical instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a manual surgical instrument.
7. The type of ground truth used
For the non-clinical tests mentioned, the "ground truth" would be established by engineering specifications, material properties, and mechanical testing standards. For example, the "Clinical Load Evaluation" would likely involve testing under defined load conditions to see if the device meets or exceeds specified strength or durability requirements.
8. The sample size for the training set
This is not applicable as the device is a manual surgical instrument and not an AI/algorithm-based system requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
Summary of the Study Mentioned:
The document refers to "Non-Clinical Testing" which included:
- Clinical Load Evaluation: Tested the device's ability to withstand anticipated loads.
- Worst Case Failure of Cutting Tip Breakage: Evaluated the device's resilience under extreme conditions.
- Benchtop Verification Test: General verification tests performed in a laboratory setting.
These tests were performed to demonstrate that the proposed device, the Avitus® Bone Harvester with Filter Insert - 5mm, is substantially equivalent to the predicate device (Avitus® Bone Harvester - 8mm, K152474) and performs in a manner that exceeds anticipated clinical loads. No clinical testing, multi-reader studies, or AI-specific evaluations were performed. The materials used in the proposed device were confirmed to be biocompatible, being identical to the materials in the predicate 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.