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The DePuy Synthes MatrixSTERNUM Fixation System is indicated for use in adults with normal bone quality.

MatrixSTERNUM Sternal Body Plates are indicated for internal fixation of bone discontinuities following sternotomy.

MatrixSTERNUM Thoracotomy Plates are indicated for internal fixation of bone and/or cartilage discontinuities following thoracotomy.

The DePuy Synthes MatrixSTERNUM Fixation System consists of two families of plates, namely the MatrixSTERNUM Sternal Body Plates and MatrixSTERNUM Thoracotomy Plates, and two families of screws, namely the MatrixSTERNUM Self-Drilling Locking and Non-Locking Screws.

The DePuy Synthes MatrixSTERNUM Fixation System is intended for the stabilization and fixation of bones in the anterior chest wall. The subject plates are available in different shapes and sizes and are made from Titanium Alloy or commercially pure Titanium. The system also consists of non-implantable dedicated use screw guides, a screw guide handle, trays and modules, as well as general use instruments to be used as accessories with the subject implants.

The provided text describes a 510(k) premarket notification for the DePuy Synthes MatrixSTERNUM Fixation System, which is a metallic bone fixation appliance.

It is crucial to understand that this document describes a submission for a medical device (hardware), not an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.

Therefore, the information regarding acceptance criteria and studies that prove the device meets acceptance criteria are focused on the mechanical, material, and biological performance of physical implants, not on the performance of an AI algorithm in tasks like image interpretation or diagnosis.

Because the request is specifically about AI/SaMD performance criteria (e.g., sample size for test set, expert ground truth establishment, MRMC studies, standalone performance, training set data), the provided text does not contain the information needed to answer these questions for an AI/SaMD product.

The document states:

• "Clinical testing was not necessary for the determination of substantial equivalence." This directly indicates that no clinical performance study, multi-reader multi-case (MRMC) study, or standalone algorithm performance study (as would be typical for AI/SaMD) was conducted.
• The performance data provided is under "Non-clinical Performance Data" and includes:
  • Mechanical performance evaluation and testing: Comparing the subject plates to predicate devices.
  • Magnetic resonance compatibility assessment.
  • Endotoxin testing.
  • Biocompatibility evaluation and testing (in accordance with ISO 10993-1).

These are standard non-clinical tests for orthopedic implants to demonstrate safety and effectiveness and substantial equivalence to existing devices. They are not metrics or study designs relevant to AI/SaMD performance.

Therefore, I cannot populate the requested table and answer the subsequent questions in the context of an AI/SaMD product, as the provided text pertains to a physical medical device.

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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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