(29 days)
The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.
The TriTis Absorbable Tibial Reconstruction System consists of a three piece implant designed to provide soft tissue fixation for tibial anterior cruciate ligament (ACL) reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secure the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray. The modifications made to the device that are the subject of this submission are: Add a new, 12 mm diameter graft cleat implant size, and a new, 12 mm Dilator instrument. All other device features and instruments remain unchanged.
The device discussed in the provided text is Scandius TriTis™ Absorbable Tibial Reconstruction System, which is a mechanical device, not an AI/ML powered device. As such, several categories from the request (2, 3, 4, 5, 6, 7, 8, and 9) are not applicable as they relate to AI/ML device performance and study design.
Here's the information extracted from the provided text, focusing on the mechanical aspects and the relevant performance data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design integrity maintained (Simulated use) | Confirmed |
| Design integrity maintained (System strength) | Confirmed |
2. Sample size used for the test set and the data provenance
Not applicable for a mechanical device; no "test set" in the context of data for AI/ML. The performance data was generated through "Simulated use test" and "System strength test," which are bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for a mechanical device; no "ground truth" in this context.
4. Adjudication method for the test set
Not applicable for a mechanical device; no "adjudication method" in this context.
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 for a mechanical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a mechanical device.
7. The type of ground truth used
Not applicable for a mechanical device. The "ground truth" for a mechanical device is its physical properties and functionality as determined by engineering tests.
8. The sample size for the training set
Not applicable for a mechanical device; no "training set."
9. How the ground truth for the training set was established
Not applicable for a mechanical device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided 510(k) summary for the Scandius TriTis™ Absorbable Tibial Reconstruction System indicates that the device's modifications (adding a new 12 mm diameter graft cleat implant size and a new 12 mm Dilator instrument) were assessed through bench testing.
Specifically, the "Performance Data" section states that the following tests were conducted to support the substantial equivalence determination:
- Simulated use test: This test was performed to confirm that the design integrity of the device is maintained.
- System strength test: This test was conducted to also confirm that the design integrity of the device is maintained.
The results of these tests indicated that the design integrity of the device was "maintained" for both simulated use and system strength. The 510(k) clearance by the FDA implies that these performance data were sufficient to demonstrate that the minor technological differences introduced by the modifications "do not raise any new questions of safety and effectiveness" compared to the predicate device. This confirms the device meets the stated acceptance criteria, which revolve around maintaining design integrity under simulated use and strength conditions.
§ 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.