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The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/flium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. 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.

The provided text describes a medical device submission (K120291) for the OrthoPediatrics (OP) Spine System. However, it does not include information about acceptance criteria, device performance metrics, or study details in the format requested.

The document is a 510(k) summary and subsequent FDA determination letter, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria as would be found for a novel device requiring such proof for market clearance.

Here's a breakdown based on the provided text, highlighting what's missing in relation to your request:

Information not available in the provided text:

• Acceptance Criteria Table and Reported Device Performance: This document does not specify quantitative acceptance criteria or report device performance against them. It states that "Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated that the device performs as well as or better than the predicate devices," but no specific metrics or thresholds are provided.
• Sample size and data provenance for test set: Not applicable as no specific test set (for performance evaluation against acceptance criteria) is described.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method for test set: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

Information that is available (though not directly answering your questions in the requested format):

The document indicates "PERFORMANCE DATA: Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated that the device performs as well as or better than the predicate devices. Published clinical results for similar devices supported the safety and effectiveness of the device."

This suggests that the "acceptance criteria" were implied by meeting or exceeding the performance of the predicate devices in these specific mechanical tests, as per the ASTM F1717 standard. The "study" that proves this involves these mechanical tests. However, no specific numerical results are given.

The "ground truth" equivalent in this context for mechanical testing is adherence to the ASTM F1717 standard and comparison with known performance characteristics of predicate devices.

In summary, the provided document is a 510(k) submission for substantial equivalence based on materials, design, and mechanical testing against predicate devices, not a clinical trial report with specific acceptance criteria and detailed performance metrics.

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