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CastleLoc-S Posterior Cervical Fixation System:
The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (TI-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); 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 Castelor Cervical Fixation 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 CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod.

LnK Posterior Cervical Fixation System:
The LnK Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The LnK Posterior Cervical Fixation 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 LnK Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod.

The CastleLoc-S Posterior Cervical Fixation System and LnK Posterior Cervical Fixation System are a top-loading, multiple component, posterior (cervicalthoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, transitional rod, set screw, hooks and accessories that can be used via an open surgical approach.

The provided document is a 510(k) Summary for the CastleLoc-S Posterior Cervical Fixation System and LnK Posterior Cervical Fixation System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The document primarily focuses on demonstrating substantial equivalence to previously cleared spinal fixation systems for mechanical properties and materials, rather than clinical performance or AI/ML-driven diagnostics. The "Performance Testing" section refers to ASTM standards for mechanical properties.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI/ML device meets them based on the provided text. The document is about a mechanical surgical implant, not an AI/ML powered medical device.

To directly answer the questions based on the provided text, many fields will be "Not Applicable" or "Information Not Provided".

Here's the breakdown:

1. A table of acceptance criteria and the reported device performance

Note: This document is for a traditional spinal fixation system, not an AI/ML powered device. The "acceptance criteria" here refer to mechanical performance standards, not diagnostic or predictive performance metrics typically associated with AI.

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

• Not Applicable. This document describes mechanical testing of a spinal implant, not a study involving clinical data or a test set for an AI/ML algorithm.

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)

• Not Applicable. This document does not pertain to establishing ground truth for clinical data, but rather mechanical device performance.

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

• Not Applicable. This document does not describe a process requiring adjudication of clinical observations or labels.

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

• No. A MRMC comparative effectiveness study was not done, as this is a mechanical spinal implant, not an AI/ML diagnostic or assistive device.

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

• Not Applicable. This is not an AI/ML algorithm.

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

• Not Applicable. The "ground truth" for this device would be its adherence to established mechanical performance standards (e.g., tensile strength, fatigue life), not clinical labels like pathology or expert consensus.

8. The sample size for the training set

• Not Applicable. This document does not describe an AI/ML algorithm requiring a training set.

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

• Not Applicable. This document does not describe an AI/ML algorithm requiring a training set or its associated ground truth establishment.

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