(69 days)
LIGAFIX® / ComposiTCP® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (beta-TCP) and Poly Lactic Acid (PLA) 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 purpose of this 510(k) was to address modifications to the head of certain screw configurations, along with modifications to the cannula to allow use with 1.1mm guide wire. The subject system offers screws in diameters ranging from 7 mm to 12 mm with lengths ranging from 20 mm to 35 mm.
This is a medical device 510(k) submission for a resorbable interference screw, not an AI/ML device. Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) are not applicable.
Here's an analysis based on the provided text, focusing on the available information for a traditional medical device:
Acceptance Criteria and Device Performance for LIGAFIX Interference Screw
The device, LIGAFIX Interference Screw, is a traditional medical device and not an AI/ML algorithm. Therefore, the acceptance criteria and study data are presented in terms of mechanical and biocompatibility performance rather than metrics typically associated with AI/ML (e.g., AUC, sensitivity, specificity, F1-score).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials (beta-TCP and PLA) must be safe for implantation and not cause adverse biological reactions. | "Mechanical tests and dimensional analysis confirmed that LIGAFIX / ComposiTCP screws are biocompatible..." (This indicates the device passed relevant biocompatibility assessments, likely according to ISO 10993 standards, although specific tests are not detailed in this summary.) |
| Mechanical Strength | The screw must possess sufficient mechanical strength to provide sustained fixation of the graft in anterior cruciate ligament reconstruction. | "Mechanical tests and dimensional analysis confirmed that LIGAFIX / ComposiTCP screws are... presents the requisite strength to provide sustained fixation of the graft." (Specific strength values or comparative data to predicates are not provided in this summary, but the statement implies successful performance against a defined standard or in comparison to predicate devices.) |
| Dimensional Conformance | The modified head and cannula of certain screw configurations must conform to specified dimensions to allow use with a 1.1mm guide wire. | "Mechanica tests and dimensional analysis confirmed that LIGAFIX / ComposiTCP screws are... presents the requisite strength to provide sustained fixation of the graft." (The summary explicitly mentions "modifications to the head of certain screw configurations, along with modifications to the cannula to allow use with 1.1mm guide wire." The dimensional analysis would have confirmed these changes met the design specifications.) |
| Substantial Equivalence | The modified device must be substantially equivalent to predicate devices in terms of intended use, material, design, mechanical properties, and function. | "The additional LIGAFIX / ComposiTCP Interference screws are substantially equivalent to their predicate devices LIGAFIX / ComposiTCP Interference screw (K050407, K061262, K070507 and K090994) in terms of intended use, material, design, mechanical properties and function." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. For mechanical and biocompatibility testing of traditional medical devices, sample sizes are typically determined by regulatory standards (e.g., ISO, ASTM) and statistical considerations for material property testing, rather than a clinical "test set" in the AI/ML sense. The text mentions "mechanical tests and dimensional analysis," which would involve testing a specific number of manufactured units.
- Data Provenance: Not specified, but generally, such testing is conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility. The manufacturer is "SCIENCE FOR BIOMATERIALS" located in France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/ML (e.g., expert consensus on image labels) is not relevant here. Device performance is assessed through objective physical and chemical tests based on established standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this is not an AI/ML device, there's no "adjudication method" in the sense of resolving discrepancies between expert opinions on a dataset. Performance is determined by compliance with engineering specifications and regulatory standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- Not Applicable. MRMC studies are specific to evaluating the diagnostic performance of imaging devices or AI algorithms involving human readers. This device is an implantable screw.
6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) Was Done
- Partially Applicable (in a different context). The "standalone performance" of the device refers to its physical and biological performance (biocompatibility, mechanical strength) as an implantable object, independent of a human-in-the-loop diagnostic process. The text states: "Mechanical tests and dimensional analysis confirmed that LIGAFIX / ComposiTCP screws are biocompatible and presents the requisite strength to provide sustained fixation of the graft." This represents the device's inherent performance characteristics.
7. The Type of Ground Truth Used
- For physical and chemical properties: Objective Measurement/Standard Compliance. Ground truth is established by physical measurements (e.g., dimensions, load-to-failure), chemical analysis for material composition, and biological assays for biocompatibility, all compared against pre-defined engineering specifications and relevant regulatory standards (e.g., ISO standards for medical devices, ASTM standards for materials testing).
- For substantial equivalence: Comparison against the characteristics of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/ML device that learns from data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no "training set" for this type of medical device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.