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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 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 devices subject to this notification are proposed for addition to the MatrixRIB Fixation System.
The subject devices consist of self-drilling screws and screw guides designed to be used with the previously cleared MatrixRIB 1.5mm plates and the splints.
The MatrixRIB Self-Drilling Screws are available as
• locking screws, for permanent fixation,
• and non-locking screws, for temporary fixation only.
The subject screws are manufactured from Titanium Alloy (Ti-6Al-7Nb). They are provided in a range of lengths
• locking: 13 lengths from 8mm to 20mm, with 1mm increments;
• non-locking: 2 lengths from 10mm to 12 mm, with 2 mm increments).
The MatrixRIB Screw Guides are to be used with the subject self-drilling screws to facilitate their fixation on patient's ribs and sternum. The subject screw guides are manufactured from Stainless Steel and are provided in 2 designs,
• one for the 1.5mm MatrixRIB plates,
• and one for the MatrixRIB IM splints.

The provided text does not contain information about the acceptance criteria or study details for a device that involves performance metrics such as reader studies or algorithm performance. The document describes a 510(k) premarket notification for the "MatrixRIB Fixation System" which is a metallic bone fixation appliance. The acceptance criteria and performance data discussed are related to the mechanical properties of the screws within the system, not diagnostic or AI-driven performance.

Therefore, I cannot fulfill the request for information on acceptance criteria, a table of acceptance criteria and reported device performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, or how training set ground truth was established, as this information is not present in the provided document.

The document does mention:

• Non-clinical performance data: "Non-clinical testing and analyses conducted as part of this submission include: Screw Pull-Out Testing per ASTM F543-17, Screw Failure Torque Testing per ASTM F543-17, Screw Cantilever Load Testing, Construct Dynamic Testing. The non-clinical performance data demonstrates that the mechanical performance of the proposed MatrixRIB Self-Drilling Screws met all acceptance criteria and is comparable to that of the predicates."
• Clinical testing: "Clinical testing was not necessary for the determination of substantial equivalence."

This indicates that the "acceptance criteria" referred to in the document are mechanical and material-specific, not related to diagnostic accuracy or AI performance.

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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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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

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.

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