(29 days)
LIGAFIX® interference screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
LIGAFIX® / ComposiTCP® range of products consists of resorbable cannulated screws available in several models designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
LIGAFIX® / ComposiTCP® interference bone screw is made of a ceramic (beta-TCP) / polymer (Poly Lactic Acid -PLA) composite.
LIGAFIX® / ComposiTCP® interference screw is available in several sizes and in two beta-TCP/ PLA ratios 60/40 (LIGAFIX® 60/ ComposiTCP® 60) and 30/70 (LIGAFIX® 30/ ComposiTCP® 30)
LIGAFIX® / ComposiTCP® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches.
The provided text describes a 510(k) premarket notification for the LIGAFIX® / ComposiTCP® Resorbable Interference Screw. This document is a regulatory submission for a medical device seeking substantial equivalence to existing devices, not a study report proving the device meets an acceptance criterion with detailed findings. Therefore, much of the requested information regarding specific acceptance criteria and detailed study parameters for performance is not present in the provided text.
However, based on the information available, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document states: "Biological, mechanical and biocompatibility tests confirmed that LIGAFIX® / ComposiTCP® screws are highly biocompatible and presents the requisite strength to provide sustained fixation of the graft. LIGAFIX®/ ComposiTCP® screws strength retention profiles are compatible with the healing process."
This is a high-level summary of the reported performance, but specific quantitative acceptance criteria (e.g., "tensile strength must be >X MPa") and corresponding reported numerical performance values are not detailed in the provided text.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility | "highly biocompatible" |
| Requisite strength for sustained graft fixation | "presents the requisite strength to provide sustained fixation of the graft" |
| Strength retention profile compatibility with healing process | "strength retention profiles are compatible with the healing process" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The text mentions "Biological, mechanical and biocompatibility tests" but does not detail the methodology, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature) of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as the document describes a regulatory submission for a physical medical device (interference screw) and not an AI/diagnostic software. "Ground truth" in the context of expert review for diagnostic accuracy is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the reasons stated above.
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 as the device is an interference screw, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable for the reasons stated above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable as the document pertains to a physical medical device. The "truth" for the performance claims would be established through laboratory testing (mechanical, biological) rather than expert review of images or pathology.
8. The sample size for the training set:
This information is not applicable as the document is for a physical medical device and does not involve AI or machine learning models that require training sets.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.
§ 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.