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The intended use of the Certex Spinal Implant System is to promote fusion of the subaxial cervical spine and cervico-thoracic junction (C3 - T3 inclusive). The indications for use are as follows:

• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• Spondylolisthesis, .
• . Trauma (i.e., fracture or dislocation),
• Spinal Stenosis, .
• Failed previous fusion, .
• Revision of previous cervical spine surgery,
• Spinal tumors.
  The use of screws is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

The Certex Spinal Implant System consists of screws, hooks, rods, and cross connectors. Various sizes of these implants are available so that adaptations can be made to take into account pathology and individual patient anatomy. The Certex Spinal Implant System is manufactured from Titanium alloy in accordance with ASTM F136 and will be provided non-sterile. All implants are intended for single use only and should not be reused under any circumstances.

The provided text describes a medical device, the Certex™ Spinal Implant System, and its substantial equivalence to predicate devices for regulatory clearance. It does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI/machine learning performance.

Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set data) cannot be extracted from the provided text.

Here's an attempt to answer the questions based only on the provided document:

Acceptance Criteria and Device Performance Study

The primary "acceptance criteria" discussed in this 510(k) summary pertain to demonstrating substantial equivalence to predicate devices, particularly in terms of mechanical performance and intended use. The study conducted to prove this equivalence was a biomechanical testing study.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for the biomechanical tests. Biomechanical testing typically uses a certain number of samples of the device components.
• Data Provenance: The document does not specify country of origin or if the data was retrospective or prospective, as it's a materials/mechanical performance test rather than a clinical study on patients.

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

• This question is not applicable to biomechanical testing where performance is measured against engineering standards (ASTM F1717) rather than human interpretation.

4. Adjudication method for the test set

• Not applicable to biomechanical testing.

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 MRMC or AI-related studies were mentioned. This is a spinal implant system, not an AI diagnostic device.

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

• Not applicable. This device is a physical implant.

7. The type of ground truth used

• The "ground truth" for the biomechanical testing was the established engineering standards outlined in ASTM F1717 and the performance of the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning study.

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

• Not applicable.

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