(68 days)
The Smith & Nephew PLC Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
The Smith & Nephew PLC Screw is a canulated, sterile, single use bone screw, made of an ostecconductive biodegradable material, poly DL-lactide-co-glycolide and calcium carbonate
The Smith & Nephew PLC Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction. The study conducted for this device was a summary performance data study that included:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility | The PLC Screw is biocompatible. |
| Equivalent fixation to predicate (BioRCI Screw) | The PLC Screw exhibits equivalent fixation to the BioRCI Screw. |
| Timely degradation | The PLC Screw is capable of degrading in a timely manner. |
| Elicit osteoconductive response in vivo | The PLC Screw elicits an osteoconductive response in vivo. |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated, but the study included "product validation testing," "in vitro degradation testing," and an "in-vivo ovine study." The number of samples for each of these components is not detailed.
- Data Provenance: The "in-vivo ovine study" indicates an animal model was used. This is prospective data from a controlled experimental setting. The location where this study was conducted is not mentioned.
3. Number of Experts and Qualifications:
- Not applicable. The study involved in-vitro and in-vivo testing, not expert-based assessment.
4. Adjudication Method:
- Not applicable. The study involved in-vitro and in-vivo testing, not expert-based adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is a bone screw, not an imaging or diagnostic device that would typically involve human readers.
6. Standalone Performance:
- Yes, the performance data presented is for the device itself (algorithm only in analogy), not involving human interaction or interpretation with the device's function. The focus is on the physical and biological properties of the screw.
7. Type of Ground Truth Used:
- Experimental Data/Biomaterial Performance Standards: The ground truth is established through direct experimental measurements and observations from the "product validation testing," "in vitro degradation testing," and "in-vivo ovine study." This includes assessment of fixation strength, degradation rates, and biological response (osteoconduction). The comparison is against the predicate device (BioRCI Screw) for equivalence.
8. Sample Size for Training Set:
- Not applicable. This device is a medical implant, not an AI/ML algorithm that requires a training set in the typical sense. The "training" in this context would be the design and engineering process based on known materials science and biomechanics.
9. How Ground Truth for Training Set was Established:
- Not applicable, as there is no training set in the AI/ML context. The development and design of the screw would be based on established scientific principles, previous device performance data ( predicate devices like HAPLA Interference Screw and BioRCI Screw), and engineering specifications.
§ 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.