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The ZION Anterior Cervical Fixation System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) defined as kyphosis, or scoliosis, 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.

The Astura Medical ZION Anterior Cervical Fixation System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths addressing multiple levels of fixation. The ZION ACFS plate incorporates graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with self-tapping or self-drilling thread options.

The provided document is a 510(k) premarket notification for a medical device called the ZION Anterior Cervical Fixation System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth from a diagnostic accuracy study is not applicable or available in this type of submission.

Here's a breakdown of the relevant information provided in the document:

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

The document does not present specific clinical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) for diagnosis or treatment outcomes. Instead, the "acceptance criteria" are implied by the performance of the predicate devices and the non-clinical testing performed on the ZION system.

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 applicable. No clinical test set data is provided. The tests were non-clinical (mechanical and corrosion testing of the device itself).
• Data Provenance: Not applicable. The data comes from laboratory non-clinical testing, not human subjects.

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. No clinical test set and thus no ground truth established by experts in a diagnostic context. The testing involved engineers and technicians conducting mechanical and material evaluations against established ASTM standards.

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

• Not applicable. As no clinical test set was used, there was no adjudication method for establishing ground truth from expert consensus.

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. This type of study is not relevant for a spinal fixation system 510(k) submission. MRMC studies are typically for diagnostic imaging software or AI-assisted diagnostic tools.

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

• Not applicable. The ZION Anterior Cervical Fixation System is a physical implant, not a diagnostic algorithm.

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

• The "ground truth" for this device's performance is based on engineering standards (ASTM) for mechanical strength and material properties. The device is shown to meet these standards and to be equivalent to predicate devices that have prior FDA clearance based on similar evidence.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device. The device is not an AI or machine learning system that requires training data.

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

• Not applicable, as there is no training set for this device.

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