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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

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.

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LigaFix® interference screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX® are resorbable cannulated screws made of ceramic (β-ΤCP) / polymer (Poly Lactic Acid) composite and designed for the interference fixation of grafts in anterlor cruciate ligament reconstruction.

To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of LIGAFIX Interference screws comprise:

• 2 material specifications: LIGAFIX® 30 (30% TCP/70% PLA) and LIGAFIX® 60 (60% o TCP/40% PLA)
• 3 head design: standard reduced -- rounded ಂ
• Diameters from 7 mm to 11 mm 0
• Lengths from 20 mm to 35 mm ಂ

LIGAFIX® interference screws are supplied sterile and individually packaged In double heat sealed pouches.

This 510(k) Special submission is for an extension of the range of products for the LIGAFIX® Resorbable Interference Screw. It focuses on demonstrating substantial equivalence to previously cleared devices (K050407 and K061262) rather than presenting a de novo study with new acceptance criteria and performance data for a novel device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of a new device, are largely not applicable in the context of this specific 510(k) submission.

This submission asserts that the expanded product range (new material specifications, head designs, diameters, and lengths) of the LIGAFIX® Interference Screws shares the "same fundamental scientific technology, operating principle and intended use" as the predicate devices. The review process for such a submission typically involves evaluating whether the new product variations introduce any new questions of safety or effectiveness that would necessitate new performance studies. Since this document is a 510(k) summary, it doesn't contain detailed study reports.

Here's a breakdown of why most of the requested points cannot be answered from the provided text, and what can be inferred:

1. A table of acceptance criteria and the reported device performance

• Not Applicable in this context. The document does not provide a table of acceptance criteria or reported device performance for a new study. The submission relies on the substantial equivalence to previously cleared devices which would have undergone performance testing during their initial clearance. The "performance" being demonstrated here is the similarity 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)

• Not Applicable. No new test set or associated data provenance is mentioned as this is a Special 510(k) for an expansion of an existing device line, not a new device requiring a new clinical or performance study.

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. No test set or ground truth establishment by experts is described in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or adjudication method is described.

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 device is a resorbable interference screw, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies or AI-related effectiveness are entirely irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. As above, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not Applicable. No new ground truth is established for this submission. The "ground truth" for the clearance of the predicate devices would have been based on established engineering principles, biocompatibility testing, mechanical testing, and potentially animal or clinical studies to demonstrate safety and effectiveness for their intended use.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device; thus, there is no "training set."

9. How the ground truth for the training set was established

• Not Applicable. No training set is involved.

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LIGAFIX 30 is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (30% β-TCP) and Poly Lactic Acid (70% PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX 30° resorbable cannulated screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX 30® interference screws are made of a ceramic (30% ß-TCP) / polymer (70% Poly Lactic Acid -PLA) composite.

LIGAFIX 30° interference screws are supplied sterile and individually packaged in double heat sealed pouches.

This document is a 510(k) summary for the LIGAFIX® Resorbable Interference Screw. It describes the device and its intended use, and states that substantial equivalence is based on similar fundamental scientific technology, operating principle, and intended use as a previously cleared predicate device (K050407), with modifications limited to additional screw sizes and a slightly modified head design.

Therefore, the submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission for substantial equivalence based on modifications to an already cleared device, not a performance study.

Thus, I cannot answer the questions as the requested information is not present in the provided text.

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