(260 days)
LIGAFIX® is indicated for use in anterior cruciate ligament reconstruction to provide interference fixation of grafts.
LIGAFIX® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (β-ΤCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
LIGAFIX® is a resorbable cannulated screw designed for the interference fixation of grafts in anterior cruciate ligament reconstruction. LIGAFIX® interference bone screw is made of a 30% ceramic (ß-TCP) / 70% polymer (Poly Lactic Acid -PLA)(6v composite. LIGAFIX® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches. LIGAFIX® screws present a socket which accepts a screwdriver of triangular cross-section that inserts deep into the core of the screw, to produce improved torque distribution.
The provided text is a 510(k) Premarket Notification for the LIGAFIX® Interference screw. This type of FDA submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies with complex acceptance criteria typically seen for new drug applications or high-risk devices.
Therefore, the study described here is primarily a comparative study to a predicate device rather than a standalone clinical trial with defined acceptance criteria for efficacy. The "acceptance criteria" for this submission are fundamentally the demonstration of substantial equivalence.
Here's an analysis based on the provided document:
Description of the Study and Acceptance Criteria
The submission for the LIGAFIX® Resorbable Interference Screw (K050407) is a 510(k) premarket notification. The primary "study" involved demonstrating that the device is substantially equivalent to legally marketed predicate devices, specifically the BioLok® Screw (K002070) and BIOSORB® Resorbable Void Filler (K021963).
The "acceptance criteria" for this type of submission are met when the FDA determines that the new device has the same intended use, technological characteristics, and performs similarly to the predicate device, or if it has different technological characteristics, that they do not raise new questions of safety and effectiveness.
1. A table of acceptance criteria and the reported device performance
For a 510(k), explicit, quantitative acceptance criteria for a new clinical outcome are generally not presented in the same way as a full clinical trial. Instead, the "acceptance criteria" are implied by demonstrating equivalence in key performance areas to the predicate device. The "reported device performance" is essentially the evidence provided to satisfy this equivalence.
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance (Evidence for Equivalence) |
|---|---|
| Intended Use Equivalence | "LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of intended use..." |
- Indicated for "anterior cruciate ligament reconstruction to provide interference fixation of grafts" (same as predicate, implied). |
| Material Equivalence | "LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of... material..." - LIGAFIX®: 30% ceramic (ß-TCP) / 70% polymer (Poly Lactic Acid -PLA) (6v composite)
- Predicate Material: Not explicitly detailed for BioLok® in this summary, but equivalence asserted. |
| Design Equivalence | "LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of... design..." - LIGAFIX®: Resorbable cannulated screw, socket accepts triangular screwdriver. Design features are presented as comparable to predicate. |
| Function/Performance Equivalence | "LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of... function." - Biological, mechanical and biocompatibility tests have been performed.
- Results confirmed that LIGAFIX® screws are highly biocompatible and presents the requisite strength to provide sustained fixation of the graft.
- LIGAFIX® screws strength retention profiles are compatible with the healing process. (These findings directly support functional equivalence to the predicate). |
| Safety (no new safety questions) | "highly biocompatible" and "requisite strength" (implied no new safety concerns compared to predicate due to materials and mechanical properties). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The summary does not describe a clinical trial with a "test set" of patients in the typical sense. The "performance data" mentioned are "Biological, mechanical and biocompatibility tests have been performed." These are typically bench tests and potentially in vitro or in vivo (animal) studies, not patient studies with a defined sample size.
- Sample Size for Test Set: Not applicable in the context of a human clinical test set. The sample sizes would refer to the number of screws or biological samples tested in laboratory/animal studies, which are not specified.
- Data Provenance: Not applicable for a clinical test set. The tests were performed by the manufacturer or a contracted lab. The submitter is from France ("Sciences et Bio Matériaux, ZI du Monge, F 65100 LOURDES - FRANCE"). These would be internal R&D test results.
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)
Not applicable. This is a medical device 510(k) submission based on bench testing and material characterization, not a study requiring expert clinical assessment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring 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
Not applicable. This is not an AI-enabled diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is established through objective scientific and engineering metrics from materials science, biomechanics, and biocompatibility testing, compared to established standards and the characteristics of the predicate device.
- Biocompatibility: Likely evaluated against ISO 10993 standards using in vitro and in vivo (animal) tests.
- Mechanical Strength: Measured through biomechanical testing (e.g., torque, pull-out strength, degradation profiles) using engineering standards.
- Material Composition: Verified through analytical chemistry techniques.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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.