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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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The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are intended to provide immobilization and stabilization 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 spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy, 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 and CastleLoc-S Posterior Cervical Fixation Systems are 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. LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System via rod to rod connector and transitional rod.

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

The provided text is a 510(k) summary for the LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily for mechanical performance and material compatibility, rather than the performance of an AI/ML powered medical device that would have specific acceptance criteria for algorithm performance.

Therefore, the information required to answer your specific questions about acceptance criteria for an AI/ML powered device and the study that proves the device meets the acceptance criteria (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, ground truth establishment) is not present in this document.

This document describes a medical device, which is a spinal fixation system, and its premarket notification to the FDA. The "acceptance criteria" here refers to the FDA's regulatory acceptance for substantial equivalence, not performance metrics of a diagnostic or AI-powered analytical tool. The "performance testing" mentioned (Section 7) is mechanical testing to ensure the device components meet engineering and material standards, not the evaluation of an algorithm's accuracy or clinical utility.

In summary, this document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML powered device.

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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

• Static and Dynamic Compression Bending
• Static Torsion
• Static Tension | Not explicitly stated what the acceptance criteria were for these tests, nor the quantitative reported performance. The implication is that the device met the relevant ASTM standards for spinal implant mechanical properties to demonstrate substantial equivalence to predicate devices. |
  | ASTM F1798 standards for:
• Axial Gripping Capacity
• Torsional Gripping Capacity
• Transverse Moment | Not explicitly stated what the acceptance criteria were for these tests, nor the quantitative reported performance. The implication is that the device met the relevant ASTM standards for spinal implant mechanical properties to demonstrate substantial equivalence to predicate devices. |

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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