Search Results

The Synthes (USA) Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, screws and tacks may be used in non-load bearing applications for maintaining the relative position of, and /or containing, bony fragments, bone grafts, (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

The Synthes Rapid Resorbable Fixation System consists of Plates, Meshes, Sheets, Screws and Tacks. The system is provided in a variety of shapes and sizes and, when used in conjunction with resorbable screws, the system provides fixation and aids in the alignment and stabilization of craniofacial bones. To facilitate shaping to the contours of the anatomy, the thermoplastic implants may be heated above the glass transition temperature of 55°C or they may be cut to the desired shape.

The provided document describes the Synthes (USA) Rapid Resorbable Fixation System, a medical device used for craniofacial fracture repair and reconstructive procedures. However, the document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies on acceptance criteria and device performance.

Therefore, the document does not contain the information requested regarding acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for either training or test sets.

The information typically found in a 510(k) summary includes:

• Device Name: Synthes (USA) Rapid Resorbable Fixation System
• Intended Use: Fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. Also for maintaining the relative position of bony fragments, grafts, or substitutes in non-load bearing applications in craniofacial or mandibular areas.
• Predicate Device(s): Synthes (USA) Rapid Resorbable Tack System, Synthes (USA) Poly (L-Lactide-co-Glycolide) Resorbable Fixation System, Synthes (USA) Rapid Resorbable Cranial Clamp, Biomet, Inc., Lactosorb Trauma Plating System.
• Material: Poly (L-lactide-co-glycolide)
• Regulatory Class: Class II
• Substantial Equivalence: Claimed and accepted by the FDA.

To directly answer your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific performance acceptance criteria through studies.
2. Sample sized used for the test set and the data provenance: This information is not provided. The 510(k) process relies on demonstrating equivalence through comparison to existing devices, often involving material testing and functional comparisons rather than specific clinical outcome studies with defined test sets as might be seen for AI/software devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
4. Adjudication method for the test set: This information is not provided.
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 a physical medical device (fixation system), not an AI/software device. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided as it pertains to a physical device evaluated for equivalence rather than a diagnostic device requiring ground truth for accuracy.
8. The sample size for the training set: This information is not provided.
9. How the ground truth for the training set was established: This information is not provided.

In summary, the provided document is a regulatory approval document for a physical medical device and does not contain the detailed study results, acceptance criteria, or performance metrics typically associated with the evaluation of AI or software-as-a-medical-device (SaMD) products.

Ask a specific question about this device