(147 days)
The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.
The proposed device is a cortical fixation system composed of titanium button, adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leading suture (UHMWPE and green Polyester (PET) co-braid) and training suture (green PET). Length of the suture loops is adjustable to the desired length. The proposed device provides a fixation in cruciate ligament reconstructive surgery. The device is provided as sterile for single patient use only.
The provided text describes a medical device, the RIGIDLOOP™ Adjustable Cortical Fixation System, and its 510(k) summary for FDA clearance. This document type (510k summary) typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.
Based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Fixation Strength | Substantial equivalence to predicate device's fixation strength. | "Fixation strength testing (bench-top) was conducted. The testing demonstrated substantial equivalence of device performance." |
| Biocompatibility | Suitable for intended use without adverse biological reactions. | "The proposed device has been determined biocompatible for the intended use based on biocompatibility data." |
| Safety and Efficacy | Raise no new issues of safety and efficacy compared to predicate devices. | "The proposed device has raised no new issue of safety and efficacy." |
| Technological Characteristics | Substantial equivalence to predicate devices' technological characteristics (titanium button, non-absorbable sutures, adjustable suture). | "Technological characteristics and fixation strength are substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document only states "Fixation strength testing (bench-top) was conducted." This implies an engineering test, not a clinical study with human subjects.
- Data Provenance: Not specified, but likely laboratory/bench testing data rather than human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to the type of testing described. The "ground truth" for bench testing would be measured physical properties, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the described testing is bench-top, not a clinical study requiring adjudication of expert interpretations.
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:
- This information is not applicable. The RIGIDLOOP™ system is a medical device for orthopedic surgery, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant to this device's clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The RIGIDLOOP™ system is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the fixation strength testing, the "ground truth" would be direct physical measurements of load, displacement, and failure points, consistent with engineering and biomechanical bench-top testing standards. For biocompatibility, it would be results from standardized biocompatibility assays.
8. The sample size for the training set:
- This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training suture" mentioned in the description is for surgical training, not algorithm training.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as above (not an AI/machine learning 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.