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

The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, non-unions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in both adult and pediatric patients.

The RECON system – V-TEK-IVP Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:

• V-TEK™ IVP Micro XS Plate 2.7, ●
• V-TEK™ IVP S Plate 2.7, .
• V-TEK™ IVP S. L-Plate 2.7 .
• . V-TEK™ IVP M Plate 2.7
• V-TEK™ IVP M Plate 3.5 .
• . V-TEK™ IVP L Plate 2.7
• V-TEK™ IVP L Plate 2.7 / 3.5
• . Titanium Screw Fully Treaded 2.7/3.5

of different sizes and designs.

The plates and screws are made of titanium alloy Ti-6AI-4V (ASTM F136).

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.

This document is a 510(k) premarket notification for the RECON system - V-TEK-IVP Plates and Screws. It describes the device and its intended use, and argues for its substantial equivalence to several predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail sense for device performance. Instead, it relies on comparison to predicate devices and established standards. The reported device "performance" is primarily described as having "similar mechanical properties and performance" to the predicate devices.

2. Sample Size for the Test Set and Data Provenance:

The document describes non-clinical performance data which includes biocompatibility and mechanical testing.

• Sample Size: The document does not specify the exact sample sizes used for the mechanical testing or biocompatibility studies. It only states that testing was "conducted and evaluated."
• Data Provenance: The data is from non-clinical laboratory testing performed on the devices themselves, not from human or animal subjects. Thus, there is no country of origin of data or retrospective/prospective classification in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This document does not involve a study with a "test set" requiring expert ground truth establishment in the context of diagnostic or interpretive performance. The studies are engineering and biocompatibility tests of a physical medical device (bone plates and screws).

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" requiring expert adjudication for ground truth.

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 is a submission for a physical orthopedic implant (bone plates and screws), not a diagnostic or AI-assisted device. Therefore, no MRMC study or AI performance evaluation was conducted or is relevant.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical performance data, the "ground truth" is based on:

• Biocompatibility: Adherence to the Pass/Fail criteria defined within the ISO 10993-1 standard for biological evaluation of medical devices.
• Mechanical Testing: Comparison of the measured mechanical properties (proof load, bending strength, fatigue strength, torque, pullout, etc.) of the subject device against those of the legally marketed predicate devices, with the aim of demonstrating "similar" performance. The implicit ground truth here is that the predicate devices have established safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or AI, and therefore has no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set for this type of device submission.

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