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

The Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

This document describes the FDA 510(k) clearance for Black Box Medical LLC's Pedicle Screw System (K201751). It does not contain information about acceptance criteria or a study proving the device meets those criteria.

This submission is a declaration of substantial equivalence to a predicate device (Stowe Pedicle Screw System, K181554) and explicitly states: "Performance data is not included in this submission. The design changes being included for review are the same changes implemented and approved under K181554. No additional changes have been made for this submission that would require additional performance testing."

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because this document indicates that such information was not part of this specific 510(k) submission (K201751). The clearance is based on substantial equivalence to a previously cleared device.

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

The FUSE Pedicle Screw System consists of longitudinal rods and polyaxial screws. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

This document is a 510(k) premarket notification for the FUSE Pedicle Screw System and does not contain information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The document states: "Performance data is not included in this submission. The design changes being included for review do not present a new worst-case configuration that would require additional performance testing." This indicates that the submission relies on the substantial equivalence to a predicate device (ACME Talon Pedicle Screw System, K071824) rather than new performance studies for the FUSE Pedicle Screw System itself.

Therefore, I cannot provide the requested information based on the provided text.

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

The STOWE Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

Here's a breakdown of the requested information based on the provided text:

Important Note: The provided document is an FDA 510(k) clearance letter for a medical device (Stowe Pedicle Screw System), not a study report for an AI/ML powered device. Therefore, much of the requested information regarding acceptance criteria, performance studies, expert involvement, and ground truth for an AI/ML device is not present in this document. The document describes a traditional medical device and its substantial equivalence to a predicate device.

Acceptance Criteria and Study Information (Based on the Provided Document)

As this document pertains to a traditional medical device (spinal pedicle screw system) and not an AI/ML-powered one, the concepts of "acceptance criteria" and "study" as they relate to AI/ML performance (e.g., sensitivity, specificity, F1-score) are not applicable.

Instead, for this type of medical device, "acceptance criteria" would refer to demonstrating substantial equivalence to a previously cleared predicate device, typically through comparisons of:

• Intended Use
• Indications for Use
• Technological Characteristics (design, materials, dimensions)
• Performance (mechanical, biocompatibility, sterilization, etc. if changes warrant new testing)

The "study" that proves the device meets these criteria is a comparative analysis against the predicate device, often supported by engineering analysis, materials testing, and sometimes bench testing or animal studies if there are significant design changes. However, the document explicitly states:

"Performance data is not included in this submission. The design changes being included for review do not present a new worst-case configuration that would require additional performance testing."

This indicates that the "study" for this particular 510(k) relied primarily on the technical characteristics and equivalence to the predicate device rather than new, extensive performance data.

Here's an attempt to populate the table and answer the questions based on the document's context:

1. Table of Acceptance Criteria and Reported Device Performance

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. This is not a study involving patient data or an algorithm's test set. The "test set" here would refer to the device itself and its components, and the "testing" would be engineering analysis or bench testing. No specific sample sizes for such testing are detailed beyond the statement that no additional performance testing was required.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable. For this type of device submission, "ground truth" as it relates to clinical outcomes or image interpretation (which would require experts) is not the primary focus of the 510(k) for substantial equivalence. The expertise involved would be in engineering, materials science, and regulatory affairs to assess the device's design and compare it to the predicate.
• Qualifications of Experts: Not specified in the document, but would typically involve engineers and regulatory professionals at the manufacturing company and the FDA.

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

• Adjudication Method: Not applicable. This term usually refers to resolving discrepancies in expert labeling or diagnoses for AI training/testing. For a traditional device, substantial equivalence is determined by regulatory review based on presented data and comparisons.

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

• MRMC Study: No. This type of study is relevant for AI-powered devices affecting human interpretation.

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

• Standalone Performance: No. This is not an AI algorithm.

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

• Type of Ground Truth: For this type of device, the "ground truth" for demonstrating safety and effectiveness is largely established by:
  • Regulatory standards: Adherence to material specifications (e.g., ASTM F136).
  • Predicate device's established safety and effectiveness: The historical performance and clearance of the ACME Talon Pedicle Screw System (K071824) serve as the benchmark.
  • Engineering principles and biomechanical testing (if performed): To ensure the device performs as intended under expected loads. However, the document explicitly states no additional performance testing was needed for this submission.

8. The sample size for the training set

• Sample Size: Not applicable. This is not an AI/ML device requiring a training set.

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

• Ground Truth Establishment: Not applicable. This is not an AI/ML device requiring a training set.

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