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The Genesys Matryx™ is for attaching soft tissue to bone in orthopedic surgical procedures. Genesys Matryx™ is intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.

The Genesys Matryx is a threaded, cannulated, bioabsorbable interference screw composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and betatricalcium phosphate (ß-TCP). The Genesys Matryx maintains accurate position of a tendon/ligament graft. The manufacturing process preserves the high initial mechanical strength and stiffness, which allows secure fixation, in combination with appropriate immobilization/controlled mobilization until clinical determination of healing. The Genesys Matryx completes resorption within several years. Resorption also depends on patient variables. The Genesys Matryx need not be removed prior to revision surgery, if such is needed. The Genesys Matryx is sterile and non-collagenous.

This document describes a 510(k) premarket notification for the "Genesys Matryx™" bioabsorbable interference screw. This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than establishing de novo performance criteria through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, specific study design, sample sizes, expert ground truth, MRMC studies, and standalone performance might not be fully available or directly applicable in the context of this 510(k) summary.

However, I can extract the relevant information from the provided text to address your points as much as possible, interpreting "acceptance criteria" as the basis for substantial equivalence for this device.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as legally marketed predicate devices. The "reported device performance" is then characterized through non-clinical testing to support this substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Non-clinical testing was submitted to aid in the characterization of the Genesys Matryx device and to support a determination of substantial equivalence. This testing included in vivo animal testing, in vitro degradation, shelf life, transportation and distribution, verification by analysis, insertion, pullout, cyclic (reliability) and bioburden testing."

• Test Set Sample Size: The document does not specify exact sample sizes for each of these non-clinical tests. For non-clinical tests, sample sizes are typically determined based on statistical justification for demonstrating material properties and mechanical performance, rather than patient cohorts.
• Data Provenance: The testing is described as "non-clinical," which implies it was conducted under controlled laboratory conditions or using animal models for in vivo studies. There is no mention of human clinical data or patient-derived data in this 510(k) summary. Given the non-clinical nature, country of origin specifics are not provided, but these tests would typically be performed in a controlled research facility. The data is entirely retrospective in the sense that it's generated for submission, not from ongoing patient care.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this is a non-clinical 510(k) submission, there is no mention of "experts used to establish ground truth" in the context of clinical interpretation, especially not like radiologists for image analysis. The "ground truth" for the non-clinical tests (e.g., pullout strength, degradation rate) would be the objective measurements and analysis performed by engineers, material scientists, and laboratory personnel following established protocols and standards. Their qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies with human readers/assessors. As this is a non-clinical testing summary for a 510(k) submission, such methods are not relevant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC comparative effectiveness study is a type of clinical study involving human readers interpreting cases, often in the context of diagnostic imaging. This 510(k) summary only mentions non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The "Genesys Matryx™" is a physical medical device (an interference screw), not a software algorithm. Therefore, its performance is inherently "standalone" in function, meaning it acts independently once implanted according to its mechanical and absorbable properties. The non-clinical tests assess the device's inherent performance characteristics without human interpretation as part of its function.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on objective, quantifiable measurements from the specified non-clinical tests:

• In vivo animal testing: Physiological responses, integration, or degradation in a living system. Ground truth would be derived from histological analysis, imaging, and necropsy findings.
• In vitro degradation: Chemical and physical analysis (e.g., mass loss, mechanical property changes) over time in a simulated environment.
• Shelf life, transportation and distribution: Stability and integrity of the device under stress conditions, assessed against pre-defined specifications.
• Verification by analysis: Engineering calculations and simulations.
• Insertion, pullout, cyclic (reliability) testing: Direct mechanical measurements (e.g., force, displacement, cycles to failure) using standardized test methods.
• Bioburden testing: Microbiological analysis to quantify microbial contamination levels.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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The Matryx™ Interference Screw is intended for use in interference fixation of bone - patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.

The Matryx™ Interference Screw is not intended for use in and is contraindicated for 1) Insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitations and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active sepsis or infection, 5) Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs which would not be appropriate for fixation with metallic screws.

The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-calsium phosphate. The predicate device previously cleared Matryx Interference Screw is made of the very same raw material.
Lengths of implant are 25 38 mm .
Diameters of implant are 9 mm-11mm. .

The only modifications that were made are:
Amendment of a new screw sizes. -
Thread profile for longer 9 mm screw is similar with already cleared Matryx™ ... Interference Screws (K052080). The thread profile of diameter 10 mm and 11 mm screws is similar with predicate device ConMed Linvatec BioScrew (K933719, K952831, K973758)
Amendment of Bone Taps for screws of 9 mm x 38 mm, 10 mm and 11 mm. -
Reference numbers for these new screw versions. These changes are updated in . labelling.
Revision of insert sheet covering the new screw sizes. -

This document describes a 510(k) premarket notification for the ConMed Linvatec Biomaterials Matryx™ Interference Screw. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not found in this type of regulatory document.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not include a table of acceptance criteria or reported device performance in the way a clinical study report would. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, meaning it has the same intended use, technological characteristics, and safety and effectiveness.

The document states:

• "The applied modifications do not raise any new concerns of safety and efficacy of the implant."
• The device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

This implies that the acceptance criterion for a 510(k) is meeting the substantial equivalence requirements to the predicate devices, rather than predefined performance metrics from a new standalone study.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. This 510(k) submission does not describe a "test set" in the context of an algorithm or a clinical study for performance evaluation that would require a sample size or data provenance details. The submission is a regulatory filing for a medical device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This document does not pertain to the evaluation of an algorithm or diagnostic device where expert ground truth would be established for a test set.

4. Adjudication Method for the Test Set

Not Applicable. There is no "test set" or adjudication method described in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done, as this document is a 510(k) premarket notification for a physical medical device (an interference screw), not an AI or diagnostic algorithm where human reader performance would be a relevant metric.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is not a submission for an algorithm or software device.

7. The Type of Ground Truth Used

Not Applicable. As this is a 510(k) for a physical implant, the concept of "ground truth" as typically used for diagnostic algorithms or imaging interpretation studies does not apply. The "truth" in this context is the safety and effectiveness of the device, which is established by demonstrating substantial equivalence to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" described in this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no "training set" or establishment of ground truth for such a set in this 510(k) submission.

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The Matryx™ Interference Screw is intended for use in interference fixation of bone-patellar tendon -- bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.

The Matryx™ Interference Screw is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active sepsis or infection, 5) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs, which would not be appropriate for fixation with metallic screws.

The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-" calsium phosphate. The predicate device Osteo ACL Screw is made of the very same raw material. Lengths of implant are 20 30 mm - Diameters of implant are 7mm-9mm. - The only modifications that were made are: - Change of trade name. This change is updated in labelling. - Minor modifications and further definition of tolerances of screw design.

The provided text (K052080) describes a 510(k) premarket notification for the Matryx™ Interference Screw. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a submission to the FDA for substantial equivalence, focusing on comparisons to a predicate device (Linvatec Biomaterials Ltd Osteo ACL Screw, K032894) and minor modifications to an existing design. It discusses the device's composition, dimensions, intended use, and substantial equivalence to a cleared predicate device.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm-only) performance study.
7. The type of ground truth used (pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in performance studies, validation reports, or clinical trial summaries, which are not present in this 510(k) summary document. The 510(k) process for this device focused on demonstrating substantial equivalence based on material composition and design similarity to a previously cleared device, rather than new performance studies with specific acceptance criteria that would require the detailed information you are requesting.

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