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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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The LnK Posterior Cervical Fixation System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Failed previous fusion
• Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.

The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

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

This document is a 510(k) premarket notification for the "LnK Posterior Cervical Fixation System", seeking clearance for device modifications (adding sizes and additional components) rather than the introduction of a new AI/software-based medical device. Therefore, the questions related to AI performance, ground truth, expert adjudication, and training/test sets are not applicable to the content provided.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K120879) primarily through material and mechanical performance testing for spinal implants.

Here's an analysis of the available information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The primary study cited to demonstrate the device's performance is Static Compression Bending Testing per ASTM F1717. This standard is used to evaluate the mechanical properties of metallic spinal implant constructs. While the specific numerical results of the testing (e.g., stiffness, yield strength, ultimate strength) are not provided in this summary, the document states:

"Static compression bending testing was performed per ASTM F1717."

And concludes:

"The LnK Posterior Cervical Fixation System is substantially equivalent to legally marketed predicates."

This implies that the results of the ASTM F1717 testing demonstrated performance comparable or superior to the predicate device, thus meeting the mechanical performance acceptance criteria for spinal fixation systems.

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

This is not applicable as the study is a mechanical performance test on physical devices, not a study evaluating an AI algorithm with a test set of data. The "sample size" would refer to the number of physical implants tested. This information is not provided in the summary but would typically be detailed in the full test report.

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

Not applicable. This is not an AI/software device requiring expert ground truth for data.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/software device requiring expert adjudication.

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 is a physical spinal implant system, not an AI-assisted diagnostic or therapeutic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical spinal implant system, not a standalone algorithm.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" would be the established engineering standards and specifications outlined in ASTM F1717, which define acceptable mechanical properties for spinal implants. The physical measurements (e.g., load at failure, deflection) collected from the tested devices are compared against these engineering "truths."

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is a physical medical device, not an AI algorithm.

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

Not applicable. There is no training set for a physical medical device.

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