(82 days)
The University AM Plate™ Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for attachment to the sacrum. Specific indications are fracture, tumor, previous failed fusion and pseudoarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
The University AM Plate™ Anterior System Plates are fabricated from ASTM F-136 implant grade titanium alloy. The plates have a contoured low profile to match the curvature of the lateral aspect of the thoracolumbar vertebral bodies. The slot pattern allows a wide range of screws and bolt placement, while the spherical countersinks allow up to 15 degrees of screw angulation. The University AM Plate™ Anterior System plates are either rectangular or distally tapered, and come in a variety of lengths. Distally tapered plates are used at the L4 level to allow the common iliac vessels to cross without undue pressure. The University AM Plate™ Anterior System Bolts and Screws are fabricated from ASTM F-136 implant grade titanium alloy. Bolts are 7.0mm in diameter and screws are 6.25mm in diameter. Bolts and screws are available in 5mm length increments. When inserted, the tip of each bolt or screw should extend one thread through the opposite cortex of the vertebra to increase holding power. The University AM Plate™ Anterior System Drill Guide is designed to allow precise drilling of the vertebral bodies and to act as a sizing template for the plates.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AcroMed UniversityAM Plate™ Anterior System:
It's important to note that the provided document is a 510(k) summary for a medical device and not a detailed clinical study report. Therefore, it focuses on demonstrating "substantial equivalence" to existing devices rather than presenting a novel clinical trial with the detailed performance metrics you've requested.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Testing | "perform consistently with previously cleared components." |
| Fatigue Testing | "perform consistently with previously cleared components." |
Explanation:
The document does not specify quantitative acceptance criteria (e.g., minimum load strength in Newtons, cycles to failure). Instead, the performance is benchmarked against "previously cleared components" via "substantial equivalence." This is typical for a 510(k) submission where the device is considered similar enough to existing, legally marketed devices that new, extensive clinical trials are not required.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "Static and fatigue testing," which typically involves multiple test samples, but the exact number isn't reported.
- Data Provenance: The document does not provide details on data provenance (e.g., country of origin, retrospective/prospective). It describes laboratory-based mechanical testing, not human or patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this document. "Ground truth" for mechanical testing is established by engineering parameters and measurements (e.g., load cells, displacement sensors) and adherence to ASTM standards, not by expert medical review.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical data review, not for mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes mechanical testing of the device itself, not a study evaluating human readers' performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a surgical implant (anterior spinal plate system), not a software algorithm that would have "standalone" performance in the context often used for AI/diagnostic devices.
7. The Type of Ground Truth Used
The ground truth for the "PERFORMANCE DATA" section is based on engineering measurements and material science standards (ASTM F-136 specifications) related to the mechanical properties of the plate and screw system under static and fatigue loading.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical implant, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.