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The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion 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)
• Spondvlolisthesis .
• Trauma (i.e., fractures or dislocations) .
• Tumors .
• Deformity (defined as kyphosis, lordosis, or scollosis) .
• Pseudoarthrosis .
• Failed previous fusions .

The IST Anterior Cervical Plate is made of titanium alloy. The plate is offered in various lengths to meet individual patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text describes a medical device, the IST Anterior Cervical Plate System, and its 510(k) submission (K072650) to the FDA. The submission focuses on substantial equivalence to predicate devices rather than a standalone clinical study proving specific performance metrics against an acceptance criterion.

Therefore, the information traditionally found in a comprehensive acceptance criteria study (like those for AI/Software as a Medical Device - SaMD) is not present in this document. This submission relies on performance data based on mechanical testing.

Based on the provided text, the direct answers to your questions are as follows:

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

Explanation: In this 510(k) submission, the "acceptance criteria" for the device's performance are implicitly tied to demonstrating substantial equivalence through mechanical testing according to a recognized standard (ASTM F1717). There are no specific numerical clinical performance metrics (e.g., sensitivity, specificity, accuracy) defined in this document that the device had to meet. The performance reported is that it met the ASTM F1717 standard, indicating mechanical equivalence.

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

Not applicable. This submission primarily relies on mechanical testing, not a clinical test set with patient data. Therefore, there is no "test set" in the context of patient data, sample size for such a set, or data provenance. The "testing" refers to mechanical properties in a lab setting.

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)

Not applicable. As there is no clinical test set with patient data, there was no need for experts to establish ground truth for such a set.

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

Not applicable. Without a clinical test set requiring expert interpretation or labeling, there is no adjudication method.

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 physical implant (Anterior Cervical Plate System), not an AI/software device designed to assist human readers. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

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

Not applicable. For mechanical testing, the "ground truth" is defined by the physical standards and measurement methodologies outlined in ASTM F1717, which determine material properties and performance under stress. It does not involve clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary of this particular 510(k) submission: This 510(k) for the IST Anterior Cervical Plate System is a traditional submission for a physical medical implant. It primarily relies on mechanical testing (ASTM F1717) to demonstrate substantial equivalence to existing predicate devices. It does not involve clinical trials with patient data, AI algorithms, or human-in-the-loop performance studies. Therefore, many of the questions related to clinical performance, ground truth, and AI-specific evaluations are not applicable to the information provided in this document.

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