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The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; kyphosis; and/or lordosis); spinal tumor; degenerative disc disease (DDD); pseudoarthrosis; 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.

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The pedicle screws are included with or without hydroxyapatite (HA) coating.

This document is a 510(k) premarket notification for the "Reform Pedicle Screw System" by Precision Spine, Inc. It seeks to add hydroxyapatite (HA) coated pedicle screws to an already cleared system. As such, the document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a novel study evaluating the performance against specific acceptance criteria.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not present in this document. This submission relies on substantial equivalence and clinical literature assessment, not a dedicated performance study with specific acceptance criteria.

However, I can extract and infer some information based on the provided text:

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

This document does not present specific acceptance criteria in the typical sense (e.g., a specific numerical threshold for a performance metric). Instead, the "acceptance criteria" for a 510(k) submission is substantial equivalence to legally marketed predicate devices. The "reported device performance" in this context is the assertion that the device is substantially equivalent based on its technological characteristics and a clinical literature assessment.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. This submission relies on a "clinical literature assessment" and "mechanical engineering analysis" to demonstrate substantial equivalence, not a specific test set. The literature assessment would draw from numerous studies, each with its own sample size.
• Data Provenance: The general provenance of the data would be from "published clinical data for pedicle screw fixation." The specific country of origin or whether it's retrospective or prospective is not detailed in this document, as it refers to a broad body of existing literature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "test set" and no "ground truth" were established by experts for this submission in the context of a performance study. The expertise involved would be in the "clinical literature assessment" but the number and qualifications of those performing that assessment are not specified.

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

Not applicable. No "test set" or adjudication method described for performance evaluation.

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-assisted device, and no MRMC study was conducted. This is a spinal implant system.

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

Not applicable. This is not an algorithm, but a physical medical device.

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

Not applicable to a performance study with a test set. The "ground truth" for the submission's argument of substantial equivalence rests upon:

• The known safety and effectiveness of the predicate devices.
• The conclusion drawn from the "clinical literature assessment" that "pedicle screw fixation is safe and effective for use in pediatric patients" (which would be based on outcomes data, expert consensus, etc., from the reviewed literature).

8. The sample size for the training set

Not applicable. No "training set" is relevant here, as this is not a machine learning model.

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

Not applicable. No "training set" is relevant here.

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