(77 days)
The Scandius TriTis ACL Reconstruction System is intended for use for fixation of ligament and tendon grafts in cruciate ligament reconstructions of the knee.
The TriTis Tibial ACL Reconstruction System consists of a three piece implant designed to fixation soft tissue for tibial ACL reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secures 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 provided text describes the 510(k) summary for the Scandius TriTis Tibial ACL Reconstruction System. However, it does not contain the detailed information required to fully answer your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.
Here's what can be extracted and what is missing based on your questions:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical ultimate failure strength | Bench testing demonstrates that any minor technological differences do not raise any new questions of safety and effectiveness. |
| Other specific criteria (e.g., specific strength values, fatigue life, material compatibility, biocompatibility) | Not provided in the document. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing is described simply as "Bench testing," implying laboratory-based mechanical tests rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a mechanical implant, and the performance data provided is mechanical bench testing, not clinical data requiring expert review for ground truth.
4. Adjudication method for the test set:
- Not applicable. As the performance data is mechanical bench testing, there would be no adjudication method in the context of expert review or clinical outcomes.
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:
- No. This is a medical device (ACL reconstruction system), not an AI/imaging diagnostic device. An MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This question is relevant for AI algorithms. The device discussed is a physical implant.
7. The type of ground truth used:
- For the mechanical ultimate failure strength, the "ground truth" would be the measured mechanical properties of the device under specific test conditions, and comparison to predefined engineering specifications or predicate device performance. These are established through standardized mechanical testing protocols.
8. The sample size for the training set:
- Not applicable. This device is a mechanical implant, not an AI system that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant here.
Summary of Missing Information:
The provided 510(k) summary is very high-level and only states that "Bench testing demonstrates that any minor technological differences do not raise any new questions of safety and effectiveness" for "Mechanical ultimate failure strength." It lacks specific quantitative acceptance criteria, actual performance values, detailed methodology of the bench tests, the number of samples tested, or any clinical study details. For a full answer to your request, more detailed engineering and device testing documentation would be required.
§ 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.