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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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The 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 CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI (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, three-level, four-level, four-level fusion configurations (19~97mm). 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 and sterile.

This document describes the premarket notification for the CastleLoc-P Anterior Cervical Plate System. It is a Special 510(k) submission to add new components to an already cleared device (K143271). Therefore, the provided information does not contain the typical details about acceptance criteria and comprehensive study results for an AI/ML medical device. In this case, the acceptance criteria are based on mechanical performance equivalence to a previously cleared device.

Based on the provided text, here's an analysis of the acceptance criteria and the "study" (mechanical performance testing) proving the device meets them:

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

• Static compression
• Static torsion
• Static tension
• Fatigue strength. | Demonstrated by Substitution: "Mechanical performance of additional components are the same with the legally marketed device (unmodified) CastleLoc-P Anterior Cervical Plate System (K143271). Therefore, we substitute mechanical test data of additional components of CastleLoc-P Anterior Cervical Plate System with the one of unmodified device (K143271)."
  The original tests were conducted according to ASTM F1717. |
  | Overall Equivalence: As safe, as effective, and performs as well as the predicate device. | Conclusion Stated: "The additional components of CastleLoc-P Anterior Cervical Plate System are as safe, as effective and perform as well as the predicate device. Therefore, the additional components of CastleLoc-P Anterior Cervical Plate System are substantially equivalent to the predicate device (K143271)." |

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

• Sample Size: Not explicitly stated as a number of devices or units. The "test set" here refers to the mechanical testing performed on the original cleared device (K143271). The submission substitutes this existing data for the new components. For mechanical testing of medical devices, specific sample sizes are typically defined by the relevant ASTM standards (e.g., ASTM F1717).
• Data Provenance: Not explicitly stated through location or retrospective/prospective. The data is from mechanical testing of the primary predicate device (K143271).

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):

• This is not applicable for this type of submission. This device is a mechanical implant, not an AI/ML diagnostic tool. Ground truth is established through engineering and biomechanical testing standards (ASTM F1717), not expert interpretation of medical images.

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

• Not applicable. See point 3.

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 not an AI/ML device, so no human reader studies were performed.

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

• Not applicable. This is not an AI/ML device.

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

• The "ground truth" for this device's performance is defined by biomechanical engineering standards (ASTM F1717), which establish the minimum mechanical properties (strength, fatigue life, etc.) required for such an implant. Compliance with these standards is the "truth" that determines acceptable performance.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable. See point 8.

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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 and stabilization 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),
• failed previous fusion (pseudoarthrosis) .
• spinal stenosis. .

The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6A1-4V ELI (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, three-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are selftapping and self-drilling threaded. This device is provided as non-sterile.

This document is a 510(k) premarket notification for the CastleLoc-P Anterior Cervical Plate System. It describes the device and claims substantial equivalence to a predicate device based on performance testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the mechanical performance tests. It mentions "a worst-case, cervical plate construct," implying a representative sample was tested.

The data provenance is from bench testing conducted by the manufacturer, L&K Biomed Company, Limited. There is no information regarding country of origin for the data beyond the manufacturer's location (Republic of Korea), or whether it was retrospective or prospective.

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

Not applicable. This is a premarket notification for a medical device (spinal intervertebral body fixation orthosis) based on mechanical (bench) performance data, not clinical data or data requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical bench testing; there is no adjudication process involving human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a physical medical device (spinal plate system), not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study is irrelevant.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this type of device is established by ASTM (American Society for Testing and Materials) standards for mechanical performance, specifically ASTM F1717 for Spinal intervertebral body fixation orthoses. Compliance with these established industry standards serves as the benchmark for performance.

8. The sample size for the training set

Not applicable. This is not a study involving machine learning or AI where a training set would be used. The "training" in this context would refer to the design and engineering process of the device, which doesn't involve a quantifiable "training set" in the computational sense.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The design and manufacturing of the device would adhere to engineering principles and regulatory requirements to achieve the desired mechanical properties.

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