(121 days)
Cure™ Anterior Cervical Plate (ACP) System 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), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.
Cure™ Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.
Cure™ Anterior Cervical Plate (ACP) System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
The provided text describes the 510(k) premarket notification for the CURE™ Anterior Cervical Plate (ACP) System. This kind of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against defined acceptance criteria (as might be found for a novel device or AI/software product).
However, I can extract the information relevant to non-clinical testing which serves a similar purpose in this context: to show the device meets certain performance standards and is equivalent to the predicate.
Here's an analysis based on the provided text, framed as closely as possible to your request, acknowledging the limitations for an AI/software product's type of study:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (Anterior Cervical Plate System), the "acceptance criteria" are implied by the ASTM standards and the "performance" is demonstrated through equivalency.
| Acceptance Criteria (Implied by ASTM Standards and Predicate Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Static Compression Bending performance as per ASTM F1717 and ASTM F543 | Equivalent to the predicate device |
| Static Tension performance as per ASTM F1717 and ASTM F543 | Equivalent to the predicate device |
| Static Torsion performance as per ASTM F1717 and ASTM F543 | Equivalent to the predicate device |
| Dynamic Compression Bending performance as per ASTM F1717 and ASTM F543 | Equivalent to the predicate device |
| Screw Insertion Torque performance as per ASTM F543 | Equivalent to the predicate device |
| Screw Pullout performance as per ASTM F543 | Equivalent to the predicate device |
| Screw Torque to Failure performance as per ASTM F543 | Equivalent to the predicate device |
| General mechanical function and properties | Equivalent to the predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of plates, screws, or test repetitions used for the mechanical testing. It states "Testing... was performed."
- Data Provenance: The data comes from non-clinical (mechanical) testing performed by Meditech Spine, LLC, to establish equivalency to the predicate device. It is not patient or human data, so terms like "country of origin" or "retrospective/prospective" are not applicable in the human data sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable to this type of device and study. The "ground truth" for mechanical testing is defined by the objective measurements according to the ASTM standards and the performance of the predicate device. Expert consensus or qualifications for reading images/data are not relevant here.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements and do not typically involve adjudication in the way clinical studies with human assessors would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for AI/software devices (especially in imaging) where human readers evaluate cases with and without AI assistance. This document is for a physical spinal implant device, and the evaluation is based on mechanical performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This is not an algorithm or software device. The "standalone performance" refers to the device's mechanical integrity and performance according to engineering standards.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing is based on:
- Established ASTM (American Society for Testing and Materials) Standards: F1717 and F543. These standards define the methodologies and expected performance ranges for such devices.
- Performance of the Predicate Device: The CURE™ ACP System's performance was compared to a legally marketed predicate device (K072650 IST Anterior Cervical Plate and K926453 Synthes CSLP) to establish substantial equivalence. The predicate device's known mechanical performance serves as the benchmark.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or software algorithm that uses a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.