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The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fosion for the 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 CastleLoc-S 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 CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System via rod to rod connector and transitional rod.

The CastleLoc-S Posterior Cervical Fixation System is a top-loading, multiple components, posterior (cervical-thoracic) spinal fixation system which consists of poly screw, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, set screw, hooks and accessories that can be used via an open surgical approach. The devices are manufactured from titanium alloy per ASTM F136 and cobalt chromium per ASTM F1537.

This document is a 510(k) Premarket Notification from L&K Biomed Co., Ltd. for their CastleLoc-S Posterior Cervical Fixation System. It asserts substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or provide new device performance data. Instead, it relies on the assertion of identicality and substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable because the device is stated to be identical to already cleared devices that met the necessary performance standards.

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

No new test set was used for this submission to establish substantial equivalence based on performance. The document states: "The CastleLoc-S Posterior Cervical Fixation System is identical to the predicates; mechanical testing is not required to establish substantial equivalence."

A risk assessment, including ASTM F1717 testing for static compression bending and static torsion mechanical testing, was conducted "to confirm that the additional components do not introduce new issues of safety or effectiveness." However, this testing was performed on predicate devices, and the data from those previous clearances (K103414, K120879, K143278, K162136, K200793) was leveraged.

Therefore, there is no distinct "test set" and no new data provenance for the CastleLoc-S system's performance.

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

Not applicable. No new studies requiring expert-established ground truth were performed for this submission, as the device's performance is asserted through substantial equivalence to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. No new studies requiring adjudication were performed.

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

No MRMC comparative effectiveness study was done. This type of study is typically associated with AI/software devices and would measure the improvement of human readers with AI assistance. The CastleLoc-S system is a physical medical device (spinal fixation system), not an AI diagnostic tool.

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

Not applicable. The CastleLoc-S system is a physical medical device, not an algorithm or software.

7. Type of Ground Truth Used:

Not applicable, as no new performance studies for the CastleLoc-S system were conducted for this submission. The "ground truth" for the predicate devices' performance would have been established through mechanical testing standards (e.g., ASTM F1717 for static compression bending and static torsion) which define acceptable physical properties and performance characteristics for spinal fixation systems.

8. Sample Size for the Training Set:

Not applicable. The CastleLoc-S system is a physical medical device. It does not employ a "training set" in the context of machine learning or AI models.

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

Not applicable. As above, there is no "training set" for this physical device.

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