(158 days)
The MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for the fixation, stabilization, and reconstruction of:
- fractures, fusions, osteotomies, and/or resections of the ribs and sternum, including spanning gaps and/or defects
- Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
The MatrixRIB Fixation System consists of locking plates, locking screws, and intramedullary splints for fixation and stabilization of the chestwall. These implants are available in multiple sizes and are manufactured from titanium alloy (Ti-6Al-7Nb).
The provided text describes the 510(k) summary for the MatrixRIB Plating System (K133616) and focuses on demonstrating its substantial equivalence to predicate devices rather than establishing specific acceptance criteria and proving device performance through a clinical study with detailed statistical outcomes.
Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert qualifications, and specific study designs (MRMC, standalone) is not present in this document.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical Performance: Device is comparable to predicates in: | The non-clinical performance data demonstrate that the mechanical performance of the proposed MatrixRIB Fixation System is comparable to that of the predicates. |
| - Dynamic compression bending of plates | Not quantitatively specified, but deemed "comparable" to predicates. |
| - Cantilever bending of plates | Not quantitatively specified, but deemed "comparable" to predicates. |
| - Torque testing of screws | Not quantitatively specified, but deemed "comparable" to predicates. |
| - Pull-out strength of screws | Not quantitatively specified, but deemed "comparable" to predicates. |
| Clinical Performance: Device does not raise new questions of safety and effectiveness compared to predicates. | "Clinical testing was not necessary for the determination of substantial equivalence." The mechanical testing demonstrated that "Any differences in technological characteristics of the predicates do not raise any new questions of safety and effectiveness" and "The proposed devices are at least as safe and effective as the predicates." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable and not provided. No clinical test set as part of a comparative effectiveness study or standalone study was performed. Non-clinical testing would have involved material and mechanical samples, but these numbers are not disclosed.
- Data provenance: Not applicable. The "study" was non-clinical mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth was established by experts for a clinical test set as part of this submission. The "ground truth" for mechanical testing would be the measured physical properties compared against established engineering standards or predicate device performance.
4. Adjudication method for the test set
- Not applicable. No clinical test set requiring adjudication was used.
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
- No. This device is a mechanical implant system (plates, screws, splints) for bone fixation, not an AI software device involving human readers or interpretation of medical images. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is not an algorithm or AI. It is a physical medical implant.
7. The type of ground truth used
- For the non-clinical performance data, the "ground truth" for comparison would be mechanical and material specifications/performance data of the predicate devices and potentially relevant engineering standards for bone fixation devices.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "development" would involve engineering design and iterative physical testing rather than data-driven training.
9. How the ground truth for the training set was established
- See answer to #8.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes a non-clinical performance study designed to demonstrate that the new MatrixRIB Fixation System is "comparable" to existing predicate devices.
- Study Type: Non-clinical mechanical testing.
- Tests Performed:
- Dynamic compression bending of plates
- Cantilever bending of plates
- Torque testing of screws
- Pull-out strength of screws
- Comparison Basis: The results of these tests were compared to the mechanical performance of the predicate devices (Synthes MatrixRIB Fixation System K081623, Synthes Sternal Fixation System, and MedXpert STRATOS).
- Conclusion: The submission states that "The non-clinical performance data demonstrate that the mechanical performance of the proposed MatrixRIB Fixation System is comparable to that of the predicates." This "comparable" performance is the basis for meeting the acceptance criteria for substantial equivalence regarding safety and effectiveness.
- Clinical Data: No clinical testing was deemed necessary to establish substantial equivalence for this 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.