(74 days)
The ACL TightRope and ACL TightRope Double Bundle are to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL repair and reconstruction.
The ACL TightRope consists of an adjustable nonabsorbable suture loop and titanium button. The ACL TightRope Double Bundle consists of nonabsorbable suture loops, titanium button, and a PEEK Femoral Wedge. The ACL TightRope and ACL TightRope Double Bundle is to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.
The provided document K112990 is a 510(k) summary for the Arthrex ACL TightRope and ACL TightRope Double Bundle devices, seeking to expand their indications to include Posterior Cruciate Ligament (PCL) repair and reconstruction. This document does not describe a study involving an algorithm or AI. Instead, it focuses on the substantial equivalence of the subject devices to existing predicate devices based on design and mechanical testing.
Therefore, many of the requested sections regarding AI/algorithm performance and study methodology are not applicable to this submission.
Here's an analysis based on the information available in the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical strength: Substantial equivalence to predicate devices (K100652, K101837, K110123) by demonstrating similar safety and effectiveness. | "Bench testing was conducted to determine the tensile load to failure strength of the ACL TightRope devices." The submission concludes that "the ACL TightRope and ACL TightRope Double Bundle with expanded indications are substantially equivalent to the currently marketed predicate devices." This implies that the tensile load to failure strength met comparable levels to the predicate devices, satisfying the acceptance criterion for mechanical strength and safety for the expanded PCL indication. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for the "bench testing" mentioned. The document only refers to "tensile load to failure strength of the ACL TightRope devices" without providing specific numbers of samples tested.
- Data Provenance: Not applicable in terms of country of origin of patient data, as this was mechanical bench testing, not a clinical study. The testing was conducted by or for Arthrex, Inc., based in Naples, Florida, USA.
- Retrospective/Prospective: Not applicable. This was mechanical laboratory testing.
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. This submission concerns mechanical testing of medical devices, not an AI or diagnostic algorithm requiring expert ground truth for interpretation of images or patient data. The "ground truth" here is the physical measurement of tensile strength.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As described above, this was mechanical testing, not a clinical or diagnostic study requiring adjudication of expert opinions.
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, a multi-reader, multi-case comparative effectiveness study was not done. This submission is for a physical medical device, not an AI or software algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. No algorithm or AI device is being submitted or studied here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the tensile load to failure strength testing, the "ground truth" would be the objectively measured physical properties (e.g., maximum load at failure) of the devices under controlled laboratory conditions, according to established mechanical testing standards.
8. The sample size for the training set
- Not applicable. There is no AI or algorithm mentioned, hence no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no AI or algorithm mentioned, hence no training set or ground truth establishment for it.
Summary of Device Acceptance Criteria and Study:
The acceptance criteria for Arthrex ACL TightRope and ACL TightRope Double Bundle for expanded PCL indications were based on demonstrating substantial equivalence to existing predicate devices (K100652, K101837, K110123). This means the device, with its expanded indication, must be as safe and effective as the already cleared predicate devices.
The study that proves the device meets these criteria was bench testing. This testing specifically "determined the tensile load to failure strength of the ACL TightRope devices." The report concludes that based on this testing, the subject devices are "substantially equivalent" to predicate devices, implying that their mechanical performance (tensile strength) was comparable and therefore considered safe and effective for the expanded PCL indication. The document does not provide specific numerical results or sample sizes for this bench testing, but the FDA's clearance indicates satisfaction with the presented data.
§ 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.