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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; 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 provided text is a 510(k) summary for a medical device (Reform Pedicle Screw System) and does not describe acceptance criteria or a study proving that an AI/device meets acceptance criteria. Instead, it details the indications for use, technical characteristics, and a performance testing summary related to demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the context of an AI device. The document describes a physical medical device (pedicle screw system) and its regulatory clearance process based on substantial equivalence, not the performance of an AI algorithm against defined acceptance criteria.

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The Sure-Lok C Extended Tab PSS 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Sure-Lok C Extended Tab Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.

The Sure-Lok C Extended Tab PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of cannulated and non-cannulated pedicle screws, straight and pre-curved rods, and locking cap screws. All components are available in a variety of sizes to match more closely the patient's anatomy. The Sure-Lok C Extended Tab PSS System is suitable for the following procedures: open, mini-open, percutaneous MIS approach, or a combination of any during the same procedure. All components are made from medical grade stainless steel, titanium or titanium alloy which comply with such standards as ASTM F-138, ASTM F-136, ISO5832-1 or ISO5832-3. All components are supplied clean and "NON STERILE."

The provided text is a 510(k) summary for a medical device (Sure-Lok C Extended Tab Pedicle Screw System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding clinical study performance, sample sizes, expert ground truth, and comparative effectiveness is not applicable or not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be found for an AI/algorithm-based device. Instead, it focuses on compliance with established engineering standards for mechanical and material properties.

The justification for meeting these criteria is a statement of compliance with these recognized standards, rather than presenting detailed test reports. The document states: "Consistent with FDA's guidance document entitled "Use of Standards in Substantial Equivalence Determinations" (...) Precision Spine is including this statement that the Sure-Lok C Extended Tab Pedicle Screw System complies with the following recognized standards instead of providing the test reports demonstrating compliance with these standards."

2. Sample size used for the test set and the data provenance

Not applicable/Not available. No clinical test set or data provenance from patients is mentioned. The "study" here is demonstrating compliance with engineering standards.

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

Not applicable/Not available. No expert review or ground truth establishment relevant to an AI/algorithm is described. The ground truth for this type of device is compliance with material and mechanical standards.

4. Adjudication method for the test set

Not applicable/Not available. There is no test set in the context of an algorithm's performance review.

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/Not available. This device is a pedicle screw system, a physical implant, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant to its approval.

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

Not applicable/Not available. This device is a physical pedicle screw system, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's approval is based on:

• Compliance with recognized engineering and material standards: ASTM F-138, ASTM F-136, ISO5832-1, ISO5832-3, and ASTM F1717-12. This establishes the physical and mechanical properties.
• Substantial Equivalence to predicate devices: The modifications (slightly increased length of extended tab screw, changed rod edges) are deemed not to raise new questions of safety or effectiveness because "The Sure-Lok C Extended Tab Pedicle Screw System has the same intended use and fundamental scientific technology as our previously cleared Pedicle Screw System devices."

8. The sample size for the training set

Not applicable/Not available. There is no "training set" in the context of a pedicle screw system as it is not an AI or learning algorithm.

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

Not applicable/Not available. As there is no training set for an AI, this question is not relevant.

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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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, and cross 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ReForm Pedicle Screw System:

Based on the provided 510(k) summary, the device is a ReForm Pedicle Screw System, which is a medical device and not an AI/ML-based diagnostic or imaging device. Therefore, the questions related to AI/ML specific performance evaluation metrics, ground truth establishment for AI/ML models, and training/test set sample sizes in the context of AI/ML are not applicable.

The document describes a traditional medical device submission focusing on substantial equivalence to predicate devices, primarily through engineering analysis.

Description of Acceptance Criteria and Study:

The "acceptance criteria" for this device, in the context of a 510(k) submission, are met by demonstrating substantial equivalence to legally marketed predicate devices. The primary method used to prove this is through performance evaluation based on engineering analysis.

Essentially, the device is "accepted" if it can show that its technological characteristics and performance are comparable to (or do not represent a worst-case scenario compared to) already cleared devices with the same intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by standards such as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. |
| Biocompatibility: Materials used must be biocompatible for implantation. | Materials are standard medical grade alloys (stainless steel, cobalt chromium, titanium/titanium alloy), implying accepted biocompatibility that is equivalent to predicate devices. |
| Fit and Function: New designs and sizes (specifically additional cross connectors) must integrate properly and maintain the intended function of the system. | The purpose of the submission is to make modifications by adding "an additional design and sizes of cross connectors." The engineering analysis confirms these modifications "do not substantially differ from the legally marketed predicate devices." |
| Intended Use: The device must perform effectively for its stated indications. | The intended use and technological features of the modifications/additions "do not substantially differ from the legally marketed predicate devices." The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for a range of spinal instabilities and deformities, consistent with the predicates. |

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

• Sample Size: Not applicable in the traditional sense of a clinical or imaging study. The "test set" here refers to the specific modifications (additional design and sizes of cross connectors) and existing components that underwent engineering analysis. The number of physical units or designs tested is not specified but would typically involve a sufficient number to validate mechanical properties.
• Data Provenance: Not applicable. The "data" comes from engineering tests and material specifications, not from patient data or clinical trials.

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)

• This is not applicable for this type of device submission. There is no "ground truth" established by medical experts for a test set in a clinical or diagnostic context. The ground truth for mechanical performance relies on established engineering principles, material science, and regulatory standards. Experts involved would be engineers and material scientists conducting the tests and analyses. Their qualifications are not specified in this document.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation or diagnostic accuracy is being assessed. This submission focuses on engineering equivalence.

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/ML device, nor is it a diagnostic tool where human readers' performance with/without AI assistance would be relevant.

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

• Not applicable. This is not an algorithm or an AI/ML device.

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

• The "ground truth" in this context refers to established engineering standards, material specifications, and the mechanical performance of the predicate devices. The new device's components are evaluated against these validated benchmarks.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. Since there is no training set, the establishment of its ground truth is irrelevant.

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The ReForm Pedicle Screw System is intended to provide immobilization and stabilization of spinal re relevels in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and obginonic in sittlies or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spiral tumor, and failed previous fusion (pseudarthrosis).

The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patiently includion 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. It is also intended opine (Le to Gaeran) man reveal (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis) spinal tumor; pseudoarthrosis; and failed previous fusion.

The ReForm Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

The ReForm Pedicle Screw System is a medical device, and the provided text is a 510(k) summary for its clearance. Medical devices, especially implants like pedicle screw systems, typically demonstrate performance through mechanical testing rather than clinical studies or AI algorithm evaluations. Therefore, many of the requested categories related to AI performance, expert consensus, and human reader studies are not applicable to this device submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance limits (e.g., minimum load, cycles to failure) are not provided in this 510(k) summary, but the general outcome is stated as "equivalent to predicate device(s)". Equivalence implies that the ReForm Pedicle Screw System achieved performance comparable to, or better than, the predicate devices in these mechanical tests.

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

• Sample Size: Not explicitly stated. For mechanical tests, the "sample size" refers to the number of test specimens (e.g., screw constructs, rod-screw assemblies) subjected to testing. This information is typically found in the full test report, not usually in the 510(k) summary.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective clinical data, as this concerns mechanical testing of manufactured components. The data originates from non-clinical laboratory testing.

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

• Not applicable. This device is evaluated using objective mechanical engineering tests (ASTM F1717). There is no "ground truth" in the sense of expert medical diagnosis or interpretation required for these performance assessments. The performance is determined by physical measurements and engineering standards.

4. Adjudication Method for the Test Set

• Not applicable. As the performance is determined by objective mechanical testing against engineering standards, there is no need for an adjudication method by medical experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as this is a mechanical spinal fixation system, not an AI-driven diagnostic or assistive device for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This is a hardware medical device, not a software algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance. The "ground truth" for this device's performance is established by its ability to meet standardized mechanical test requirements (ASTM F1717) and demonstrate equivalence to the performance of previously cleared predicate devices.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. Its design and materials undergo engineering validation.

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

• Not applicable. As stated above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for its design and materials is established through engineering principles, material science, and compliance with relevant ASTM standards.

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