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The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The device is intended to be used with autograft and/or allograft.

The OP Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

This document describes the OrthoPediatrics (OP) Spine System, a spinal fixation device intended for pediatric patients. It's a Special 510(k) submission, which means it's claiming substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: Since this is a Special 510(k) claiming substantial equivalence to an existing device (OP Spine System [K120291]), the acceptance criteria for the new device are directly tied to demonstrating performance equivalent to the predicate. The document states that the fundamental scientific principles, technological characteristics, intended use, material, general design, and sizes are the same as the predicate device.

2. Sample Size and Data Provenance

The document does not specify the sample size used for the performance tests.
The data provenance is not explicitly stated. However, given that it's a submission to the FDA for a US medical device, the testing would typically be conducted according to internationally recognized standards (ASTM in this case), and the results presented to the FDA. The nature of the tests (mechanical testing) suggests a laboratory setting, not patient data.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission concerns mechanical performance testing of a physical device, not an AI or imaging system requiring expert interpretation or ground truth establishment by medical professionals.

4. Adjudication Method

Not applicable. Mechanical testing does not involve adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic or therapeutic device that would involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device (spine system), not an algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the established mechanical testing standards (ASTM F1798 and ASTM F1717) and the performance characteristics of the predicate device. The performance of the new device is compared directly to these established benchmarks.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that involves training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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