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The Precision Spine Reform® POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Precision Spine Reform® POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Reform® POCT System is a posterior spinal fixation system intended for use in all the Occipital, Cervical and Thoracic regions of the spine (Occiput - T3). The system consists of a variety of rods, occipital plates, occipital screws, cross connectors, pedicle screws, domino connectors, and hooks to achieve an implant construct that matches adjacent anatomy. The Reform® POCT Implants are from titanium alloy, or cobalt chromium alloys as described by standards such as ASTM F136, ASTM F1537, or ISO 5832-3. Implants made from medical grade titanium, medical grade titanium, medical grade cobalt chromium may be used together, however, should not be used with stainless steel. The system also includes the instrument necessary for inserting and securing the implants. The components are supplied clean and "NON-STERILE". All implants are single use only and should not be reused under any circumstances.

This document is a 510(k) premarket notification from the FDA, specifically concerning the Reform® POCT System for spinal fixation. It details the device's indications for use and compares its technological characteristics and performance data to predicate devices to establish substantial equivalence.

Based on the provided text, here's a breakdown of the requested information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on mechanical performance testing to demonstrate substantial equivalence to predicate devices. It does not provide a table with specific numerical acceptance criteria (e.g., minimum load bearing capacity in kN) and corresponding numerical performance results for the Reform® POCT System. Instead, it states that the testing "show that the strength of the Reform® POCT System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The tests performed are:

Specific Test Modes Performed:

• Static axial compression bending per ASTM F1717-14
• Static torsion per ASTM F1717-14
• Dynamic axial compression bending per ASTM F1717-14
• Static axial compression bending per ASTM F2706-08 (2014)
• Static axial tension bending per ASTM F2706-08 (2014)
• Static torsion per ASTM F2706-08 (2014)
• Dynamic axial compression bending per ASTM F2706-08 (2014)
• Dynamic torsion per ASTM F2706-08 (2014)

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact number of devices or constructs tested for each of the mechanical tests performed. The tests are listed by standard (ASTM F1717-14, ASTM F2706-08), which typically define the minimum sample sizes for such testing.
• Data Provenance: This is a non-clinical performance study (mechanical testing), not a study involving patient data. The testing was conducted by Empirical Testing Corp. (presumably in Colorado Springs, Colorado, USA, based on the submitter's address). This is likely prospective testing conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of study (mechanical performance testing) does not involve experts establishing "ground truth" in the way a clinical study or AI model validation would. The "ground truth" is based on established engineering principles and the specified ASTM standards themselves, which define methodologies for evaluating mechanical properties. There are no radiologists or other clinical experts involved in this aspect.

4. Adjudication Method for the Test Set

Not applicable. As a mechanical performance study, there is no "adjudication" between human readers or experts. The results are quantitative measurements against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document describes mechanical performance testing, not a clinical study involving human readers or AI assistance.

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

No. This is a physical device, not an AI algorithm. The performance is the device's inherent mechanical properties.

7. The Type of Ground Truth Used

For this mechanical performance study, the "ground truth" is defined by the ASTM standards (F1717-14 and F2706-08 (2014)) themselves. These standards specify the methods, test conditions, and acceptable ranges (or comparisons to predicates) for evaluating spinal implant strength. The "ground truth" is rooted in engineering principles and established benchmarks for spinal fixation device performance.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI model. There is no "training set" in this context.

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

Not applicable, as there is no training set for a mechanical device. The design and manufacturing processes are validated against engineering specifications, and the device's performance is then verified through the described mechanical tests.

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