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The Synthes ArcoFix System is indicated for use, via the lateral or anterolateral surgical approach, in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of the following:
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spondylolysis
• Fracture (including dislocation and subluxation)
• Spinal stenosis
• Deformities (i.e. scoliosis, kyphosis, lordosis whether neuromuscular or related to deficient posterior elements)
• Tumors (neoplastic disease)
• Pseudoarthrosis
• Failed previous fusion.

The Synthes ArcoFix System is an addition to Synthes' existing anterior/anterolateral/lateral thoracolumbar spine systems. The ArcoFix implant consists of an expandable plate and 4 bone screws, all manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as the predicates.

The provided text describes a 510(k) submission for the Synthes ArcoFix System, a spinal intervertebral body fixation orthosis. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies with acceptance criteria based on performance metrics.

Therefore, the study information requested regarding acceptance criteria and performance with specific metrics like sensitivity, specificity, or reader improvement does not apply to this 510(k) summary. The submission states directly: "Clinical data and conclusions were not needed for this device."

Instead, the submission focuses on non-clinical bench testing to demonstrate substantial equivalence.

Here's a breakdown based on the characteristics of this 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) for a device like this spinal implant, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through non-clinical testing that simulates the stresses and uses the device would undergo. The success criterion is the demonstration of "substantial equivalence" based on these tests.

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

• Sample Size for Test Set: Not specified in the provided summary. For mechanical bench testing, samples typically include a statistically relevant number of devices or components to account for manufacturing variability and to demonstrate conformance to specifications.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by Synthes Spine. It would be prospective in nature as the testing is specifically performed for the 510(k) submission.

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

• Not Applicable: For non-clinical bench testing of a spinal implant, "ground truth" as it relates to expert consensus on interpretation of clinical data (like images) is not relevant. The "ground truth" or reference for the bench tests would be established by engineering specifications, relevant ASTM or ISO standards, and the performance characteristics of the predicate devices. The experts involved would be engineers and material scientists.

4. Adjudication method for the test set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used for clinical study data where there is subjectivity in interpretation (e.g., image reading). For objective bench testing, the results are typically quantitative measurements, and "adjudication" in the clinical sense is not performed. Test results are compared against predetermined engineering specifications or predicate device performance.

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 type of study is specifically for evaluating the impact of AI systems on human reader performance, usually in diagnostics like radiology. The Synthes ArcoFix System is a medical implant, not an AI-assisted diagnostic tool.

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

• Not Applicable: This question pertains to the performance of an AI algorithm in isolation. The Synthes ArcoFix System is a physical medical device.

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

• Engineering Specifications and Predicate Performance: For the non-clinical bench testing, the "ground truth" would be defined by established engineering and material science principles, relevant international standards (e.g., ASTM, ISO) for spinal implants, and the known, acceptable performance characteristics of the predicate devices. Compliance with these established criteria constitutes meeting the "ground truth" for non-clinical substantial equivalence.

8. The sample size for the training set

• Not Applicable: Training sets are used in machine learning for AI algorithms. This is a physical medical device; thus, there is no "training set."

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

• Not Applicable: As there is no training set, this question is not relevant.

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