(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 Tibial ACL 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 provided text describes modifications to the Scandius TriTis™ Tibial ACL Reconstruction System and its substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving that the device meets specific performance metrics in terms of clinical accuracy, diagnostic performance, or human reader improvement. The device is a physical implant system, not an AI or diagnostic tool.
Therefore, many of the requested fields are not applicable to the provided document.
Here's a breakdown of the information that can be extracted or inferred, and what is not present:
Acceptance Criteria and Device Performance Study Details (Based on K063499)
Given that this device is a physical implant (Scandius TriTis™ Tibial ACL Reconstruction System) and not an AI or diagnostic software, the typical acceptance criteria and study designs for AI/diagnostic devices (e.g., sensitivity, specificity, reader studies, ground truth establishment) are not applicable or described in this 510(k) summary.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, particularly for modifications (addition of a new implant size). This typically involves showing that the safety and effectiveness are maintained, often through bench testing and verification of design integrity, rather than clinical trials with human subjects or diagnostic performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated in terms of quantitative performance metrics for clinical acceptance (e.g., accuracy, sensitivity, specificity). The "acceptance criteria" for this type of submission are generally related to demonstrating that the modified device maintains its design integrity and safety and effectiveness as compared to the predicate, as evidenced by the performance data mentioned.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Design Integrity | Confirmed (via simulated use test) |
| System Strength | Confirmed (via system strength test) |
| Safety & Effectiveness | No new questions raised (based on bench testing, comparison to predicate) |
| Material Equivalence | Uses the same implant materials as predicate |
| Intended Use Equivalence | Has the same intended and indication for use as predicate |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: Not applicable. The "test set" here refers to physical bench tests (simulated use, system strength), not a dataset of patient cases. The document does not specify the number of units tested.
- Data Provenance: Not applicable in the context of patient data. The "data" comes from engineering bench testing.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Not applicable. Ground truth in the context of diagnostic/AI performance is not relevant here. The "ground truth" for the device's mechanical performance would be established by engineering standards and test specifications.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists) in diagnostic studies. This document describes mechanical device testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size
- No, an MRMC study was NOT done. This type of study assesses human readers' performance with and without AI assistance, which is irrelevant for a physical surgical implant system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used
- Not applicable in the AI/diagnostic sense. For the device's mechanical performance, the "ground truth" is defined by engineering specifications and standards for tensile strength, fixation, etc., which are verified through the simulated use and system strength tests.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth for it.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as reported in K063499):
The submission for the Scandius TriTis™ Tibial ACL Reconstruction System (K063499) did not involve a clinical study in the typical sense of measuring patient outcomes or diagnostic performance. Instead, the study that demonstrated the device meets the (implied) acceptance criteria for substantial equivalence consisted of bench testing.
Specifically, the "performance data" generated in support of the substantial equivalence determination included:
- Simulated use test: To confirm that the design integrity of the modified device (including the new 12mm graft cleat and dilator) is maintained.
- System strength test: To confirm that the overall system's design integrity and mechanical strength are maintained.
These tests would have been performed against predetermined engineering specifications to ensure that the modifications did not negatively impact the device's performance compared to the previously cleared predicate device. The document states that "Bench testing demonstrates that any minor technological differences do not raise any new questions of safety and effectiveness." This implies that the tests confirmed the modified device performs comparably and safely.
The 510(k) process for device modifications often relies on such bench testing rather than extensive clinical trials, especially when the changes are minor and the predicate device has a well-established safety and effectiveness profile.
§ 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.