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The SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies):

• · Spondylolisthesis
• · Trauma (including fractures, dislocation)
• · Spinal stenosis
• Tumors
• · Deformity (defined as scoliosis, kyphosis, or lordosis
• · Pseudoarthrosis
• · Failed previous fusion

WARNING: The device is not approved for screw attachment or the posterior elements (nedicles) of the cervical, thoracic or lumbar spine.

The SECULOK™ ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6AI-4V ELI) in accordance with ASTM F136. All implants are single use only. The width of plates of to the proposed SECULOK™ ACP System was modified compared to the prior devices (K182055).

This document is a 510(k) summary for the SECULOK™ ACP System, a spinal intervertebral body fixation orthosis. It describes the device and its indications for use, and it demonstrates substantial equivalence to predicate devices based on non-clinical (bench) testing.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that the acceptance criteria for the SECULOK™ ACP System were "the acceptance criteria of the prior devices (K182055)." However, the specific quantitative values for these criteria are not provided in this document. It only states that the device met these unstated criteria.

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

• Sample Size for the Test Set: Not explicitly stated. The document refers to "the proposed devices" and "the data of the proposed devices," implying that multiple devices were tested for each performance evaluation. However, the exact number of units tested per test type is not provided.
• Data Provenance: The testing was "non-clinical setting (bench testing)." No information about country of origin of data in terms of patient data is relevant as it's bench testing. It's prospective in the sense that the testing was performed specifically to support this 510(k) submission.

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

• This question is not applicable as the study involved bench testing (mechanical performance evaluation of a physical device), not an evaluation of diagnostic accuracy or clinical outcomes requiring expert interpretation of medical data. Therefore, there was no "ground truth" established by experts in this context.

4. Adjudication Method for the Test Set:

• This question is not applicable for the same reason as point 3. Bench testing results are typically quantitative measurements against defined engineering specifications, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. The presented study is a non-clinical (bench) performance evaluation of the device itself, not an assessment of human reader performance with or without AI assistance.

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

• This question is not applicable. The device (SECULOK™ ACP System) is a physical spinal fixation system, not a software algorithm or an AI-powered diagnostic tool. Therefore, a "standalone algorithm performance" study is irrelevant to this device.

7. The Type of Ground Truth Used:

• The "ground truth" in this context refers to the established mechanical performance specifications and safety profiles derived from recognized industry standards (ASTM F1717) and the prior predicate device (K182055). The performance of the new device was compared against these pre-defined, acceptable mechanical limits and characteristics.

8. The Sample Size for the Training Set:

• This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm that requires training data.

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

• This question is not applicable as there is no training set for this type of device.

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The SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
O Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);

• □ Spondylolisthesis
• □ Trauma (including fractures, dislocation)
• Spinal stenosis
• □ Tumors
• □ Deformity (defined as scoliosis, kyphosis, or lordosis)
• □ Pseudoarthrosis
• □ Failed previous fusion

The SECULOK™ ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. All implants are single use only.

This document is a 510(k) premarket notification for the SECULOK™ ACP System, a spinal intervertebral body fixation orthosis. The request asks for details on acceptance criteria and study data for a medical device. However, the provided document describes a physical medical device (spinal fixation system) and not a software or AI-driven device that would typically have performance metrics like sensitivity, specificity, or AUC. The "performance testing" described refers to mechanical bench testing, not clinical performance or AI algorithm performance.

Therefore, many of the requested points are not applicable to the nature of this submission. Here's a breakdown based on the information provided:

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

2. Sample size used for the test set and the data provenance
Not applicable. This was mechanical bench testing, not a study involving human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is based on engineered specifications and industry standards (ASTM F1717).

4. Adjudication method for the test set
Not applicable.

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 device, not an AI or software product.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.

7. The type of ground truth used
For the mechanical performance tests, the "ground truth" is defined by the technical specifications and acceptance limits set by the ASTM F1717 standard for spinal implant testing and comparison to the predicate device's established performance.

8. The sample size for the training set
Not applicable. This is not a machine learning model.

9. How the ground truth for the training set was established
Not applicable.

Summary of Study:

The study referenced is a series of non-clinical bench tests conducted on the SECULOK™ ACP System to assess its mechanical performance.

• Tests Performed:

  • Static compression bending test according to ASTM F1717
  • Static torsion test according to ASTM F1717
  • Compression bending fatigue test according to ASTM F1717

• Purpose: To demonstrate that the device met established acceptance criteria and that its performance is substantially equivalent to the predicate devices (ASPIRON™ ACP System, K131200, K140234).

• Conclusion: "All tests met all acceptance criteria and that verifies performance of the SECULOK™ ACP System is substantially equivalent to predicate devices."

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