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The VertiFlex® Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies); spondylolisthesis; Irauma (i.e., fracture or dislocation); and/or tumor. The VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.

The VertiFlex® Spinous Process Fixation (SPF) Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The SPF Plate is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6AL-4V allov. The SPF Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the SPF Plate is available for both conventional and minimally-invasive surgical procedures.

The provided text describes the VertiFlex® Spinous Process Fixation Plate, a medical device for spinal fixation. It details the device's indications for use, comparison to predicate devices, and a summary of non-clinical tests. However, it explicitly states, "No clinical testing was conducted to support this submission."

Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics from clinical trials, a test set, ground truth, expert involvement, or AI-related data, is not available in the provided text.

Based on the document, here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific clinical study for device performance. The "acceptance criteria" for regulatory submission seems to be substantial equivalence to predicate devices, based on design, materials, indications, and non-clinical performance.
• Reported Device Performance:
  • Non-Clinical Tests: The device demonstrated "substantial equivalence... in terms of performance" to a commercially available predicate through tests conducted in accordance with ASTM F1717-12 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), static pull-off testing in synthetic bone, and static dissociation testing. Specific performance values (e.g., load limits, displacement) are not provided.

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. No clinical test set data is provided. The non-clinical tests likely used test samples of the device and synthetic bone models.

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 medical experts for device performance are mentioned.

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

• Not applicable. No clinical test set is mentioned.

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 device is a mechanical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory pathway as described.

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

• No. This device is a mechanical implant. The concept of "standalone algorithm performance" is not applicable.

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

• Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate devices against which the VertiFlex® plate was compared for substantial equivalence.

8. The sample size for the training set

• Not applicable. No machine learning or AI training set is mentioned as this is a mechanical device.

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

• Not applicable. No machine learning or AI training set is mentioned.

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