(76 days)
The AperFix™ Interference Screw is intended for use with bone-patellar tendon-bone (BPTB) grafts to provide fixation during arthroscopic or open ACL reconstruction procedures.
The Cayenne Medical AperFix™ Interference Screw is intended for the bone-patellar tendonbone (BPTB) reconstruction of the anterior cruciate ligament (ACL). During an ACL reconstruction procedure, BPTB grafts are fixed to the femur and tibia utilizing the AperFix™ Interference Screw. BPTB grafts are typically harvested from the patient's ipsilateral leg, but cadaveric grafts are also acceptable. The AperFix™ Interference Screw is packaged STERILE. The AperFix™ Interference Screw provides interference fixation of the BPTB graft within the femoral and tibial tunnels.
The provided document is a 510(k) Premarket Notification for the AperFix Interference Screw. It describes the device, its intended use, and its equivalence to marketed products. However, it does not contain information regarding studies to prove the device meets specific acceptance criteria in the format requested, particularly for an AI/ML device.
The document states: "Mechanical testing was performed on the AperFix Interference Screw. It was shown that pullout strength is significantly higher than that of a predicate interference screw." This is the extent of performance data provided.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's a response based on the available information:
Based on the provided 510(k) Premarket Notification for the AperFix™ Interference Screw, the following information regarding acceptance criteria and performance studies can be extracted or deduced:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Mechanical pullout strength | Significantly higher pullout strength than a predicate interference screw. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified, but generally, mechanical testing for such devices is conducted in a laboratory setting. This is a physical device, not an AI/ML system, so concepts like "country of origin of data" in the AI/ML context are not directly applicable.
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, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from medical images or clinical data.
4. Adjudication method for the test set
Not applicable. This device is a mechanical implant. The "adjudication method" concept is typically relevant to subjective expert reviews for AI/ML performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This type of study (MRMC for human readers with/without AI assistance) is specific to AI/ML diagnostic or screening devices and is not relevant for a mechanical implant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The AperFix™ Interference Screw is a physical medical device (an implant), not an algorithm or software requiring standalone performance evaluation in the context of AI/ML.
7. The type of ground truth used
For mechanical testing, the "ground truth" would be the direct physical measurements of the device's properties (e.g., force required for pullout). There is no "expert consensus, pathology, or outcomes data" ground truth in the AI/ML sense.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML model, there is no "training set" or establishment of ground truth for such a set.
§ 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.