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The SIMPLEX Cervical Fixation System is intended for anterior screw fixation of the cervical spine. Indications for use include:

• degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• spondylolisthesis
• trauma (i.e., fracture or dislocation) .
• spinal stenosis
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or fordosis)
• tumor
• pseudoarthrosis
• failed previous fusion
  Warning: "This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine."

The SIMPLEX Cervical Fixation System consists of plates and is used to build a spinal construct. The purpose of the SIMPLEX Cervical Fixation System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes. Ease of intra-operative handling is enhanced by pre-contouring the plates in two directions to facilitate adaptation to the patient's anatomy and self-tapping uni-cortical screws, which shorten operating time. The screws are available in five lengths. The self-tapping thread of the screws eliminates the need for preliminary tapping.

This document describes the SIMPLEX Cervical Fixation System, a medical device used for spinal stabilization. The information provided is from a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria in the way you've outlined.

Therefore, many of the requested categories – particularly those related to a study proving performance against acceptance criteria for an AI or diagnostic device – are not applicable to this type of submission. This is a mechanical implant, and its "performance" is generally assessed through mechanical testing and comparison to similar devices, not through a clinical trial with human readers or AI algorithms.

Here's a breakdown based on the provided text, indicating where information is present and where it's not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The 510(k) summary primarily focuses on demonstrating that the SIMPLEX system is "substantially equivalent" to the predicate device (Radix Cervical Plate - K033951). For mechanical implants, this often involves showing similar materials, design principles, indications for use, and performance in standardized mechanical tests. Specific numerical acceptance criteria and a detailed comparison against them are typically part of the engineering design file, not usually summarized in this public 510(k) document. The key performance statement is that its "results [are] comparable to other cervical plates."

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

• Sample Size: Not specified in the provided summary. Mechanical testing usually involves a defined number of test specimens (e.g., N plates or N screws) per test type.
• Data Provenance: Not specified, but generally, mechanical testing data comes from laboratory tests conducted by the manufacturer or a third-party testing facility. It's not clinical data (retrospective or prospective).

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

• Not Applicable. This is a mechanical medical device, not an AI or diagnostic tool requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical performance is established by the physical properties of the materials and component designs, and validated through engineering tests.

4. Adjudication method for the test set

• Not Applicable. See point 3. Testing is against engineering specifications and industry standards, not subjective 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 device is a surgical implant, not an AI-powered diagnostic or assistive tool. No human reader or AI interaction is involved in its direct function.

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

• Not Applicable. This device is a surgical implant, not an algorithm.

7. The type of ground truth used

• Not Applicable in the traditional sense. For mechanical devices, "ground truth" is typically derived from:
  • Engineering specifications: Material properties, dimensional tolerances.
  • Standardized test methods (e.g., ASTM 1717): These methods define how to measure performance (e.g., fatigue, static strength) and provide benchmarks or comparative data.
  • Benchmarking against predicate devices: Showing similar performance characteristics to already-approved devices.

8. The sample size for the training set

• Not Applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Not Applicable. See point 8.

Summary regarding "Study that proves the device meets the acceptance criteria":

The document states: "Testing was performed according to ASTM 1717 with results comparable to other cervical plates."

This single sentence is the "study" summary for this 510(k) submission. It indicates that the device underwent mechanical testing adhering to the ASTM F1717 standard, which is "Standard Test Methods for Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants." The key "proof" is the statement that the "results comparable to other cervical plates." This suggests that the SIMPLEX system met the expected mechanical performance profiles (e.g., static strength, fatigue life) typical for devices of its kind, as defined by industry standards and comparison to its predicate device. This comparison of performance to similar, legally marketed devices is the core of a 510(k) submission for this type of implant.

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