(119 days)
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.
| Aspect of Equivalence | Acceptance Criteria (Demonstrated through comparison to predicates) | Reported Device Performance (as characterized by non-clinical testing) |
|---|---|---|
| Intended Use | "for attaching soft tissue to bone in orthopedic surgical procedures" and "interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate." Must be consistent with predicate devices. | The Genesys Matryx™ serves this intended use. |
| Design Characterization | Threaded, cannulated, bioabsorbable interference screw composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and beta-tricalcium phosphate (ß-TCP). | The device is described as a "threaded, cannulated, bioabsorbable interference screw composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and beta-tricalcium phosphate (ß-TCP)." |
| Material Characterization | Composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and beta-tricalcium phosphate (ß-TCP). Similar materials to predicate devices. | The device is composed of "ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and beta-tricalcium phosphate (ß-TCP)." |
| Mechanical Performance | Maintains accurate position of a tendon/ligament graft, preserves high initial mechanical strength and stiffness, allows secure fixation. Must be comparable to predicate devices to allow "appropriate immobilization/controlled mobilization until clinical determination of healing." Resorption profile consistent with bioabsorbability. | "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." Non-clinical tests included insertion, pullout, and cyclic (reliability) testing. |
| Biological Performance (Resorption) | Complete resorption within several years, depending on patient variables. Similar resorption profile to predicate devices. | "Resorption also depends on patient variables. The Genesys Matryx completes resorption within several years." In vitro degradation testing was performed. |
| Safety and Biocompatibility | Sterile, non-collagenous. Must meet safety standards similar to predicate devices. | "The Genesys Matryx is sterile and non-collagenous." In vivo animal testing and bioburden testing were performed. |
| Other Performance Characteristics | Demonstrated stability during transport and shelf life. | Shelf life and transportation and distribution testing were performed. |
| Substantial Equivalence | Demonstrated equivalence in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the listed predicate devices: Linvatec Biomaterials Ltd Osteo ACL Screw (K032894), Linvatec Biomaterials Matryx Interference Screw (K052080), Depuy Metik MILAGRO Interference Screw (K060830), and Biocomposites Ltd. Bilok Screw (K071091). | The submission claims the Genesys Matryx is "substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics" to the listed predicates based on the non-clinical testing performed. |
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.
§ 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.