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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 fusion of the Occipital, Cervical, and Thoracic regions of the spine (Occiput-T3). The system consists of a variety of rods, occipital plates, occipital screws, polyaxial screws, cross-connectors, lateral offset, domino connectors, and hooks to achieve an implant construct that closely matches patient anatomy. The Reform POCT System implants are fabricated from titanium, 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 alloy, and medical grade cobalt chromium may be used together, however, should not be used with stainless steel. The system also includes the instruments 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.

Based on the provided K172495 document for the Precision Spine Reform® POCT System, here's a description of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) summary for a spinal fixation system, which is a medical implant. The "acceptance criteria" and "study" described in this document refer to mechanical and material performance testing for substantial equivalence against predicate devices, not a clinical study involving human patients or an AI algorithm’s performance. Therefore, many of the typical questions for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies) are not applicable to this type of device submission and thus cannot be answered from the provided text.

Acceptance Criteria and Device Performance for Precision Spine Reform® POCT System (K172495)

The acceptance criteria for the Reform® POCT System are not explicitly listed with numerical targets in the document. Instead, the study's goal was to demonstrate substantial equivalence to legally marketed predicate devices based on technological characteristics and mechanical performance. The implicit acceptance criterion is that the device's mechanical performance is "substantially equivalent" to the specified predicate devices.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

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 dynamic axial compression and dynamic torsion. It only states that "The Reform® POCT System has been tested in the following test modes." For mechanical testing, this typically involves a sufficient number of samples to generate statistically meaningful data for comparison.
• Data Provenance: The testing was "non-clinical testing" and was conducted to support the 510(k) submission. The document does not provide details on the location of the testing facility (e.g., country of origin), nor does it describe data as retrospective or prospective (as this terminology applies to clinical studies, not mechanical bench testing).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This is a mechanical device, not an AI/ML diagnostic tool. Ground truth in this context is established by standardized mechanical testing protocols (e.g., ASTM F2706) and the physical properties and performance of the device itself compared to predicate devices, not by expert interpretation of images or data.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is mechanical bench testing, there is no "adjudication method" in the sense of multiple human experts reviewing results. The results are quantitative measurements obtained through standardized test methods.

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

• No. This type of study is relevant to diagnostic devices and AI algorithms where human readers interpret medical images or data. It is not applicable to a spinal implant system like the Reform® POCT System, which is evaluated based on its mechanical and material properties.

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

• No. This is not an AI algorithm. Its performance is tested as a standalone mechanical device.

7. The Type of Ground Truth Used:

• The ground truth for this device's performance is established through standardized mechanical engineering tests (e.g., ASTM F2706 for dynamic axial compression and dynamic torsion) performed on the device components and constructs. The performance is then compared to the known performance of predicate devices or to established industry standards to demonstrate "substantial equivalence."

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that uses a "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.

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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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