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The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.

The RECON system – MPJ Plates consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used for adult patients. Additional information is provided in the corresponding surgical techniques.

MP-Joint Fusion Plates 2.7

The MP-Joint Fusion Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for the arthrodesis of the first metatarso-phalangeal joint.

• Plate size S is indicated for standard MP-Joint fusions.
• . Plate Sizes M/L are indicated for standard MP-Joint fusion and interpositioning / revision fusions with bone graft (f.e. for revision of Keller-Brandes).

Universal Reconstruction Plates 2.7

The Universal Reconstruction Plates 2.7 combined with Standard/Locking Screws 2.7 are indicated for revision of MP-joint fusion and for reconstruction procedures in forefoot and midfoot.

docPrice Revision Plates 2.7/3.5

The docPrice Revision Plates 2.7/3.5 combined with the Standard/Locking Screws 2.7/3.5 are indicated for MTP I lengthening osteotomy and/or arthrodesis, especially indicated for cases of Keller-Brandes revisions, revisions after MTP I prosthesis and lengthening of short first toe.

The RECON system – MPJ plates is a plate system intended for internal fracture fixation. The system consists of the following plates:

• MP - Joint Fusion Plates 2.7,
• . Universal Reconstructions Plates 2.7,
• . docPrice Revision Plates 2.7/3.5

of different sizes and designs.

The plates are either made of titanium alloy Ti-6Al-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).

The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.

The provided document is a 510(k) premarket notification for the RECON System - MPJ Plates, a metallic bone fixation appliance. This type of document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel study with specific acceptance criteria and detailed performance metrics of a new AI/software device.

Therefore, the information required to answer your questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/software device is not present in this document.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is a medical device clearance based on substantial equivalence, not a performance study against predefined criteria for an AI/software. The document mentions "similar mechanical properties and performance" to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "testing" referred to is biocompatibility and engineering analysis, not a clinical study with a test set in the context of AI performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This document pertains to a physical medical implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document states:

• "Non-Clinical Performance Data: Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1. All testing passed. Cross sectional engineering analysis of the plates, proof load, bending strength, bending stiffness, equivalent bending stiffness and fatigue strength of the RECON System-MPJ plates and the predicate devices... resulted in similar mechanical properties and performance."
• "Clinical Performance Data: There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

This indicates the device's acceptance was based on non-clinical (biocompatibility and mechanical) testing and demonstration of substantial equivalence to existing devices, not on a clinical performance study with AI-specific metrics.

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