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The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine; degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Reform Pedicle Screw System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes, and lateral offsets. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium alloy described by such standards as ASTM F158, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The products are supplied clean and "non-sterile". The Fenestrated Screws allow the augmentation of PMMA bone cement to the insertion site. These modular Fenestrated Screws are assembled during surgery with the Reform Standard Modular Tulips or the Reform Reduction Modular Tulips which were cleared under K150856 and their compatible rods and set screws. The Fenestrated Screws are to be used with the G21 V-Fast Bone Cement or V-Steady Bone Cement cleared under K150408. Bone Cement is delivered into the pedicle screw and bone through the delivery instrumentation.

The provided text is a 510(k) summary for the Reform Pedicle Screw System. This document focuses on the mechanical testing and equivalence of a medical device, specifically a pedicle screw system, rather than a diagnostic AI/ML device that would have acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC).

Therefore, the typical acceptance criteria and study design elements you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) for an AI/ML device are not applicable to this submission.

Instead, the performance data provided is entirely about mechanical and material testing to demonstrate the physical characteristics and safety of the implanted device.

Here's a breakdown of the relevant information from the provided text, framed within the context of a traditional medical device submission, recognizing that it doesn't fit the AI/ML paradigm:

1. A table of acceptance criteria and the reported device performance:

The document describes performance testing rather than specific acceptance criteria in a tabular format with quantitative metrics for a pass/fail. However, it states the following tests were conducted:

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

• Sample Size: Not specified in the summary. For mechanical testing, this would typically involve a specific number of test articles (e.g., screws, constructs) for each test.
• Data Provenance: The "study" is non-clinical mechanical bench testing performed according to ASTM standards. It's not human-centric data, so concepts like "country of origin" or "retrospective/prospective" studies are not applicable.

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

• Not applicable. Ground truth in this context is established by engineering specifications, standard ASTM testing methodologies, and objective mechanical measurements. It does not involve expert readers reviewing images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication is relevant for subjective expert reviews, not for objective mechanical testing.

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 device is a physical implant, not an AI-powered diagnostic tool. MRMC studies are used to evaluate the diagnostic performance of AI or imaging modalities.

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

• Not applicable. There is no algorithm or AI component in this device. The testing is entirely for the physical device's characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The "ground truth" for this type of device is established by engineering standards and physical test methodologies (e.g., ASTM F1717 for spinal implant constructs). The performance is measured against these established standards and compared to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning; therefore, there is 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.

In summary, the provided document details the substantial equivalence of a physical medical implant through mechanical testing, not the performance claims or evaluation of an AI-powered diagnostic device.

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