(73 days)
The Smith & Nephew BIOSURE SYNC Tibial Fixation Device is indicated for use in combination with BIOSURE PK Screws for fixation of soft tissue to bone during cruciate ligament reconstruction.
The Smith & Nephew BIOSURE SYNC Tibial Fixation Device is an intra-tunnel device used to secure soft tissue grafts to bone during cruciate ligament reconstruction procedures. The fixation device is a polymer implant for use with BIOSURE PK Screws (25 mm length). The device is provided sterile, for single use only.
This document is a 510(k) Summary of Safety and Effectiveness Information for the Smith & Nephew BIOSURE™ SYNC Tibial Fixation Device. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. As such, it focuses on comparing the new device to existing ones rather than presenting a comprehensive study of its performance against specific acceptance criteria in the manner one might find for a software or AI device.
Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (tibial fixation device) and not a software/AI-driven one. There is no mention of acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, nor any study details regarding test sets, ground truth, expert review, or multi-reader studies.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in Intended Use and Fundamental Scientific Technology to predicates (BIOSURE® PK Screw, GTS Sleeve, Intrafix) | Performance testing demonstrates that the insertion and fixation properties of the BIOSURE SYNC Tibial Fixation Device are substantially equivalent to the predicate devices. |
| Safe and effective as currently marketed predicate devices | Performance testing demonstrates that the proposed devices are as safe and as effective as currently marketed predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document describes a physical medical device and its substantial equivalence to predicate devices, not a software or AI model undergoing testing with a specific dataset. There is no mention of a "test set" in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. As per point 2, there is no test set or ground truth in the context of a diagnostic AI device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For this physical device, "ground truth" would refer to established biomechanical properties and clinical performance of predicate devices. The study focuses on demonstrating that the new device's insertion and fixation properties are comparable.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a learning-based algorithm or AI.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.