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PMT Posterior Cervical Stabilization System (PCSS) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.

PMT PCSS is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.

PMT PCSS is intended as an adjunct to posterior cervical fusion (PCF) and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF) at the same level(s).

PMT PCSS is indicated for skeletally mature patients with degenerative disc disease (DDD). DDD is defined as radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies.

PMT PCSS is to be used with autogenous bone and/or allogenic bone graft.

PMT PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. The device is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.

The device is manufactured from medical grade titanium alloy (6A14V) and supplied sterile for single use only with a pre-attached disposable delivery instruments. The implant is fenestrated and is to be used with autogenous bone and/or allogenic bone graft. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

CORUS® Spinal System is used to access and prepare the site for posterior fusion.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PMT Posterior Cervical Stabilization System (PCSS).

It's important to note that the provided FDA 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed acceptance criteria and performance data in the way a clinical trial publication might. Much of the information requested, particularly specific numerical acceptance criteria and detailed study design elements, is not explicitly present in this document.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Crucial Note: The document lacks explicit, numerical acceptance thresholds for most performance metrics. The primary clinical "acceptance" is framed as demonstrating a "superior fusion rate" compared to the control, sufficient for establishing substantial equivalence.

Study Design Elements

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

• Sample Size: "Over 200 subjects"
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Prospective.
  • Study Type: Multicenter, randomized, clinical trial.

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

• Not explicitly stated in the provided text. The document describes "Radiographic evaluations" in the clinical trial, which would typically involve expert readers (e.g., radiologists, spine surgeons) for assessing fusion. However, the number and qualifications of these experts are not detailed.

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

• Not explicitly stated in the provided text. While radiographic evaluations were performed, the method for adjudicating discrepancies among readers (if multiple readers were used) is not described.

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 document describes the clinical performance of a medical device (surgical implant) and not an AI algorithm. Therefore, an MRMC study related to AI performance or human reader improvement with AI assistance is not relevant to this submission.

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

• Not applicable. This pertains to a medical device (surgical implant), not an AI algorithm.

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

• For the primary endpoint of fusion success, the ground truth would have been established through radiographic evaluations (e.g., CT scans, X-rays) at 12 months. This typically involves expert assessment of bone bridging and stability.
• Other assessments included "peri-operative findings" and "patient reported outcomes," which are direct clinical data and patient surveys, respectively, serving as ground truth for safety and effectiveness metrics.

8. The sample size for the training set

• Not applicable/Not provided. This refers to a medical device (surgical implant), not an AI algorithm that would have a distinct training set. The "over 200 subjects" refers to the clinical trial participants.

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

• Not applicable/Not provided. As above, this is for a medical device, not an AI algorithm. The clinical trial data serves as the basis for assessing the device's performance against its stated indications.

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