(176 days)
The SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:
- Hip capsule repair
- Acetabular labrum reattachment
The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The SpeedLock HIP is a knotless fixation device: surgical knots are not necessary for the fixation of suture to tissue.
The SpeedLock HIP consists of two primary parts: a PEEK bone anchor and an anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The SpeedLock HIP Knotless Fixation System consists of the 3.4 mm SpeedLock HIP anchor and associated instruments for implanting the anchor into bone.
The provided text describes the SpeedLock® HIP Knotless Fixation Implant, a bone anchor device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing, rather than an AI/ML device. Therefore, a direct response to some of the AI/ML-specific questions (like sample sizes for training/test sets, expert adjudication methods, MRMC studies, or multi-reader multi-case studies) is not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical acceptance criteria for various mechanical tests. Instead, it broadly states that the device "meets all design, performance, and safety specifications" and that the "test results demonstrate... substantial equivalence" to predicate devices. The study performed was a comparative bench test.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Meets design specifications | Yes |
| Meets performance specifications | Yes |
| Meets safety specifications | Yes |
| Substantially equivalent to predicate devices (Smith & Nephew Bioraptor® Knotless Suture Anchor K071586, Smith & Nephew Knotless Instability Anchor K093428, ArthroCare's SpeedLock Knotless Fixation Device K111044) | Yes, demonstrated through side-by-side bench testing. |
| Performs as intended | Yes |
| Has acceptable mechanical properties | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "side by side bench testing" but does not specify the sample size (number of devices tested) for the proposed device or the predicate devices.
- Sample Size: Not specified.
- Data Provenance: The testing was "in vitro" using a "simulated human bone substrate." This indicates laboratory bench testing, not human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the study involved mechanical bench testing of a physical device, not an AI/ML algorithm requiring expert interpretation of data or images to establish ground truth.
4. Adjudication Method for the Test Set
This question is not applicable for a mechanical bench test. The "ground truth" (or reference standard) for mechanical properties would be derived from the testing equipment and established engineering principles, not expert consensus or adjudication.
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 (MRMC) comparative effectiveness study was not done. This study is for a physical medical device (bone anchor), not an AI/ML software.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the submission is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission was established through mechanical testing data (static and cyclic fatigue testing) against pre-defined engineering and performance specifications, and in comparison to the performance of predicate devices. This is based on objective measurements from laboratory equipment, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This question is not applicable. There is no training set mentioned or implied, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for an AI/ML device.
§ 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.