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The OrthoPediatrics Titanium PediPlates® System is used for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia), valgus, varus, or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The OrthoPediatrics Titanium PediPlates® System consists of two and four-hole plates featuring a contoured mid-section and a low profile for pediatric use. There is a small provisional fixation hole in the center of the O and I-Plates to aid in accurate placement of the device relative to the growth plate. The plates are available in various sizes to accommodate variations in bone size and geometry. The plate is affixed to the bone using two to four screws (solid and cannulated), depending on which plate is selected.

This document is a 510(k) premarket notification for a medical device called the OrthoPediatrics Titanium PediPlates® System. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria for an AI/ML model. Therefore, much of the requested information regarding AI/ML device performance, such as test set sample size, expert ground truth establishment, MRMC studies, and training set details, is not applicable to this document.

However, I can extract the relevant information regarding the performance data provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission for a non-AI/ML medical device (bone fixation system) seeking substantial equivalence, there are no specific "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for an AI model. Instead, the "acceptance" is based on demonstrating equivalence in performance to a predicate device.

The reported device performance is based on non-clinical tests comparing the subject device to the predicate. The "acceptance criteria" essentially boil down to performing equivalently to the predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated, but typically for mechanical testing of this nature, a certain number of samples per test type would be used to establish statistical significance. The document states "Testing concluded that the Titanium PediPlates® System will performed equivalently...", implying sufficient samples were used to draw this conclusion for the non-clinical tests.
• Data Provenance: Not specified, but likely from in-house testing or contracted testing laboratories. The data is retrospective in the sense that it was collected as part of the design verification and validation process prior to submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a mechanical device, not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" for mechanical testing is derived from the physical properties and behavior of the materials and designs under controlled conditions.

4. Adjudication method for the test set:

• Not Applicable. As this is not an AI/ML device with human-in-the-loop assessment, there is no need for adjudication methods like 2+1 or 3+1.

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 not an AI/ML device. No MRMC study was performed.

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

• Not Applicable. This is not an AI/ML device. No standalone algorithm performance was assessed.

7. The type of ground truth used:

• The "ground truth" for this device's performance is based on engineering and biophysical principles applied during mechanical testing. This includes:
  • Material properties: Conformance to ASTM F136 for Ti-6Al-4V.
  • Mechanical performance: Comparison of static bend, torsional, and four-point bend characteristics.
  • MR compatibility standards.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

• Not Applicable. As no training set exists for this type of medical device, ground truth establishment for a training set is irrelevant.

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