(51 days)
The Arthrex DynaNite Nitinol Staples are indicated for:
- . Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- . Fixation of proximal tibial metaphysis osteotomy.
- . Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
- . Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extend to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomies.
The provided text describes the 510(k) premarket notification for the "Arthrex DynaNite Nitinol Staples." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the performance of an AI/ML powered device.
Therefore, the information required to answer your questions about acceptance criteria, study design for AI/ML performance, sample sizes, expert ground truth establishment, MRMC studies, and standalone algorithm performance is not present in the provided text. The document outlines performance testing related to the physical and material properties of the staples (e.g., pull-out strength, bend fatigue, biocompatibility, MRI compatibility), not the performance of a diagnostic AI.
Here's why each of your requested points cannot be addressed with the provided text:
- A table of acceptance criteria and the reported device performance: The document states that testing was "conducted to demonstrate that the Arthrex DynaNite Nitinol Staples perform statistically equivalent to the devices cleared under K142292, K993714 and K172052." Specific numerical acceptance criteria and reported performance values beyond "statistically equivalent" are not provided. These are mechanical and material performance criteria, not related to AI.
- Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing mechanical, chemical, and biocompatibility tests, not a dataset for an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is about correct diagnoses or classifications, which is not relevant to testing medical staples.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Pertains to expert consensus for AI ground truth.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a study design for evaluating the impact of AI on human reader performance, not relevant for a surgical staple.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. There is no algorithm mentioned.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would be its physical properties meeting standards.
- The sample size for the training set: Not applicable. There is no AI model mentioned.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) submission for a physical medical device (surgical staples), not an AI/ML software as a medical device. Therefore, the questions related to AI/ML device performance and study design are not addressed.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.