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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 CastleLoc-P Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:

• · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• · spondylolisthesis,
• · trauma (i.e. fractures or dislocations),
• · tumors,
• · deformity (defined as kyphosis, lordosis, or scoliosis),
• · pseudoarthrosis.
• · failed previous fusion,
• · spinal stenosis.

The AccelFix Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.

The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, four-level fusion configurations (13~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile.

The AccelFix Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The AccelFix Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.

This document is a 510(k) Pre-Market Notification from the FDA, which declares substantial equivalence for medical devices to legally marketed predicate devices. It typically does not contain acceptance criteria or study results demonstrating performance in the way a clinical trial or AI device validation would.

Instead, the FDA 510(k) process focuses on demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device that is not subject to pre-market approval (PMA).

Based on the provided text, here's what can be extracted and inferred regarding "acceptance criteria" and "study":

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

This document does not contain a table of acceptance criteria or reported device performance in the context of diagnostic accuracy or clinical outcomes for the CastleLoc-P Anterior Cervical Plate System or the AccelFix Lumbar Plate System. The submission is a 510(k) for spinal intervertebral body fixation orthoses, which are mechanical implants, not AI/diagnostic devices.

The "performance testing" section, specifically for the CastleLoc-P Anterior Cervical Plate System and AccelFix Lumbar Plate System, states:

"The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the CastleLoc-P Posterior Anterior Cervical Plate System."
"Therefore, we substitute mechanical test data of CastleLoc-P Anterior Cervical Plate System (predicate devices K113509, K143279, K190425) and AccelFix Lumbar Plate System (predicate device K 192481) for additional components with the predicate device data."

This indicates that instead of new performance tests for the new components, the company relied on the existing mechanical test data of the predicate devices. Therefore, the "acceptance criteria" implied are that the new components perform no worse than the predicate devices' mechanical properties. However, these specific mechanical properties (e.g., fatigue strength, torsional rigidity) and their quantitative acceptance limits are not detailed in this document.

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

Not applicable. As explained above, no new performance study with a test set of data (e.g., patient cases) was conducted for these devices as part of this 510(k). The evaluation relies on the substantial equivalence to predicate devices, including their prior mechanical testing.

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

Not applicable. This is not a study involving ground truth established by experts for a diagnostic or AI device.

4. Adjudication method for the test set:

Not applicable. No such test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Not applicable. This is not a diagnostic device for which an MRMC study would typically be performed.

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

Not applicable. This is a spinal implant, not an algorithm or AI device.

7. The type of ground truth used:

Not applicable. "Ground truth" in the context of diagnostic or AI studies is not relevant here. The evaluation instead relies on conformity to material specifications (ASTM F136) and the mechanical performance previously established for the predicate devices.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set" or corresponding ground truth establishment process described.

In summary:

This 510(k) submission for the CastleLoc-P Anterior Cervical Plate System and AccelFix Lumbar Plate System focuses on demonstrating substantial equivalence to existing predicate devices. The "study" mentioned for performance is the reliance on prior mechanical test data of the predicate devices. The document does not provide details on specific acceptance criteria and detailed performance data from new studies in the manner typically expected for AI/diagnostic software.

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