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The DePuy Synthes MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation, where:

DePuy Synthes MatrixRIB pre-contoured plates are indicated for the fixation, stabilization and reconstruction of:

• Rib fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
• Pectus Excavatum, Pectus Carinatum, and other chest wall deformities

DePuy Synthes MatrixRIB straight plates are indicated for the fixation, stabilization and reconstruction of:

• Rib and sternum fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
• Pectus Excavatum, Pectus Carinatum, and other chest wall deformities

DePuy Synthes MatrixRIB sternal plates, 2.8mm thickness, are indicated for the fixation, stabilization and reconstruction of:

• Sternum fractures, fusions, and/or osteotomies
• Pectus Excavatum, Pectus Carinatum, and other chest wall deformities

The DePuy Synthes MatrixRIB intramedullary splints and the universal plate are indicated for the fixation and stabilization of ribs.

The proposed additions to the MatrixRIB Fixation System include sternal plates (straight plates, I-plates and T-plates) for fixation and reconstruction of the chest wall manufactured from commercially pure titanium (CP Ti Grade 4).

The previously cleared devices in the MatrixRIB Fixation System (K133616 and K081623) include locking plates, locking screws, and intramedullary splints for the fixation and stabilization of the chest wall for use in patients with normal or osteoporotic bone quality. These implants are available in multiple sizes and are manufactured from titanium alloy (Ti-6A-7Nb).

The provided information is a 510(k) Summary for the MatrixRIB Fixation System, which is a medical device for chest wall fixation. This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

Based on the provided text, the acceptance criteria and study information are largely related to non-clinical performance data and not to clinical performance data or AI model performance.

Here's an analysis of the provided text in response to your request, with an emphasis on what is present and what is explicitly stated as not present:

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

The document states: "The non-clinical performance data demonstrates that the mechanical performance of the proposed MatrixRIB Fixation System is comparable to that of the predicates." However, it does not provide a specific table of acceptance criteria with numerical values or detailed reported device performance. It only lists the types of tests conducted.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: The document does not specify the sample sizes (number of implants tested) for the non-clinical tests.
• Data Provenance: The document does not specify the country of origin of the test data or whether it was retrospective or prospective. Given these are mechanical laboratory tests, such classifications are not typically applicable in the same way as clinical data.

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):

This question is not applicable. The device is a physical fixation system, not an AI or diagnostic imaging device that requires human expert interpretation to establish ground truth for a test set. The "ground truth" for mechanical testing would be defined by engineering standards and test methodology.

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

This is not applicable for mechanical, non-clinical performance testing. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI model development where human evaluators are involved.

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:

This is not applicable. The MatrixRIB Fixation System is a physical medical implant, not an AI-assisted diagnostic or clinical decision support system. Therefore, no MRMC study, human reader improvement with AI, or effect size related to AI assistance would be performed or reported for this device.

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

This is not applicable. The MatrixRIB Fixation System is a physical medical implant. There is no algorithm or AI component to this device.

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

For the non-clinical performance data, the "ground truth" is established through engineering standards and validated test methods. For example, the "Intraoperative Contouring Dynamic Test Method" and "Comparative Four Point Static Test Method" would have defined parameters and criteria based on established biomechanical principles and regulatory guidelines (though these specific criteria are not detailed in the summary).

8. The sample size for the training set:

This is not applicable. There is no AI component requiring a training set for this physical medical device.

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

This is not applicable for the same reason as point 8.

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