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The Signature Orthopaedics Freedom Cervical Screw and Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (C1 to C7) as an adjunct to fusion in the treatment of the following acute and chronic instabilities and deformities of the cervical spine:

• traumatic spinal fractures and/or traumatic dislocations
• instability or deformity; failed previous fusions (e.g. pseudarthrosis)
• degenerative disease, including neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability, and
• short term stabilization 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 expectancy is of insufficient duration to permit achievement of fusion.

The Freedom™ Posterior Cervical Screw System consists of screws, longitudinal rods and cross connectors in a variety of sizes to accommodate differing anatomic requirements. The cervical screws are inserted into adjacent vertebrae, then rods are clamped into the tulip of the pedicle screw using the cap screw, thus immobilising the instrumented vertebrae. The cross-connector may then be attached between rods to improve stability. The system components are made of Ti6Al4V alloy and are supplied sterile.

The provided FDA 510(k) clearance letter pertains to the Freedom Posterior Cervical Screws, which is a medical device and not an AI/ML-driven software system. As such, the information you've requested regarding acceptance criteria, study details, sample sizes, ground truth, and human reader performance is not applicable to this type of device submission.

The FDA clearance for this device is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing and engineering evaluations. These tests focus on the physical and mechanical properties of the screws to ensure they are safe and effective for their intended use as a spinal implant.

Here's a breakdown of the relevant information provided in the document concerning the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states that "worst-case sizes of the subject cervical screws" were tested.
• Sample size: Not explicitly quantified with a specific number of units, but implied it was a representative selection of "worst-case sizes."
• Data provenance: The tests were "non-clinical testing and engineering evaluations" conducted by the manufacturer, Signature Orthopaedics Pty Ltd, in Australia. This is a form of prospective testing done specifically for regulatory submission.

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

• Not applicable. This is a hardware device where "ground truth" is established through engineering principles and physical testing against established ASTM standards, not through expert human interpretation or diagnosis.

4. Adjudication method for the test set:

• Not applicable. This involves objective mechanical testing, where results are measured directly against predefined acceptance criteria from engineering standards. There is no subjective adjudication process for establishing a "ground truth" as would be the case for image interpretation or diagnostic 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 device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, no MRMC studies or human reader performance evaluations were conducted or are relevant.

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

• Not applicable. This is a physical product, not a software algorithm.

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

• The "ground truth" for this device's performance is derived from established mechanical and material engineering standards (ASTM standards). The device's components must meet or exceed the performance specifications (e.g., strength, fatigue resistance) outlined in these standards to be deemed safe and effective for their intended surgical purpose.

8. The sample size for the training set:

• Not applicable. This refers to a dataset used to train an AI model. This device is hardware and does not involve a training set.

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

• Not applicable. As above, there is no training set for this type of medical device submission.

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