(107 days)
The ACL TightRope 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) Repair.
The ACL TightRope consists of an adjustable non-absorbable suture loop and titanium button. The proposed device contains a titanium button and non-absorbable suture which are similar to the predicate devices. The proposed device contains an adjustable suture loop when compared to the predicate devices which contain constant loop lengths.
The provided document describes a 510(k) premarket notification for the Arthrex ACL TightRope device. It does not contain information about an AI/ML powered device, nor does it detail acceptance criteria or a study proving device performance in the context of AI.
The document discusses the substantial equivalence of the ACL TightRope to predicate devices based on mechanical testing. It states: "From the mechanical testing completed the ultimate load and cyclic displacement are substantially equivalent for the proposed device when compared to the predicate devices."
Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/ML device meets the acceptance criteria, as the input document is about an orthopedic surgical device, not an AI/ML system.
However, based on the information provided, I can infer the general nature of the "acceptance criteria" and "study" for this non-AI device:
Inferred Acceptance Criteria for the Arthrex ACL TightRope (Non-AI Device):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ultimate Load | Substantially equivalent to predicate devices (K062747: Arthrex RETROBUTTON™ and K031666: Arthrex Fiberwire® Button Repair Kit) |
| Cyclic Displacement | Substantially equivalent to predicate devices (K062747: Arthrex RETROBUTTON™ and K031666: Arthrex Fiberwire® Button Repair Kit) |
Inferred Study that Proves the Device Meets the Acceptance Criteria (Non-AI Device):
The document mentions "mechanical testing completed" as the basis for determining substantial equivalence. This would have been an in-vitro biomechanical study.
- Sample size used for the test set and the data provenance: Not explicitly stated in the document. This would typically involve a specific number of test samples of the ACL TightRope and the predicate devices subjected to mechanical loads. Data provenance would be from laboratory testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is typically defined by established engineering standards and measurement accuracy, not expert consensus.
- Adjudication method for the test set: Not applicable. The results are quantitative measurements interpreted against pre-defined performance metrics or direct comparison to predicate device performance.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable as this is a mechanical device, not a diagnostic AI system with human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Mechanical testing data, specifically ultimate load and cyclic displacement measurements. These are objective engineering measurements.
- The sample size for the training set: Not applicable. There is no "training set" for this type of mechanical device evaluation.
- How the ground truth for the training set was established: Not applicable.
Summary for the provided document (non-AI device):
The provided document describes a medical device (ACL TightRope) that is evaluated for substantial equivalence to predicate devices through mechanical testing. The "acceptance criteria" appear to be related to the device's ultimate load and cyclic displacement performance, which were found to be "substantially equivalent" to the predicate devices. The study involved biomechanical testing, not an AI/ML evaluation.
§ 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.