(48 days)
The Amendia Cervical Plate System is intended for use in anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), tumor, pseudoarthosis or failed previous fusion.
The Amendia Cervical Plate System is a multiple component system comprised of non-sterile, single-use implantable components fabricated from Titanium alloy (Ti-6Al-4V, ASTM F136). The Amendia Cervical Plate System provides stabilization of cervical segments of the spine. The system consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
This document describes the Amendia Cervical Plate System, a medical device. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for AI/ML-based medical devices.
Instead, this is a 510(k) premarket notification for a traditional medical device (a cervical plate system) where substantial equivalence to a predicate device is being demonstrated. Therefore, most of the requested information (sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types) is not applicable to this type of submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| Not applicable. The document does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for the device. | Not applicable. The document states "The Subject Device was shown to be identical to the predicate device in terms of design, intended use, performance specifications, material specifications, and technological characteristics." and "Based on the comparison to predicate devices and performance testing, the Amendia Cervical Plate System has been shown to be substantially equivalent to the legally marketed predicate device." It doesn't provide specific device performance metrics against predefined acceptance criteria. |
Explanation: In a 510(k) for a traditional device like this, the "acceptance criteria" generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparative testing (e.g., mechanical, biocompatibility) rather than clinical performance metrics related to diagnostic accuracy or treatment efficacy as would be seen in an AI/ML context. The document mentions "performance testing" but does not detail the specific tests, their acceptance criteria, or the results.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This document does not describe a test set for evaluating diagnostic or predictive performance in the context of AI/ML. The "testing" referred to is likely engineering/mechanical testing to ensure the device meets its design specifications and is comparable to the predicate.
- Data Provenance (country of origin, retrospective/prospective): Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert consensus on image findings) is not relevant to this submission for a traditional spinal implant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For a traditional medical device like a spinal plate, the "ground truth" for demonstrating safety and effectiveness often comes from engineering standards, material properties, and potentially clinical literature or experience with similar predicate devices, rather than a diagnostic 'ground truth'.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is a 510(k) clearance letter and summary for a traditional medical device (spinal implant). It establishes substantial equivalence to a predicate device based on design, intended use, materials, and "performance specifications." It does not involve AI/ML technology, and therefore, the questions about acceptance criteria, study design, sample sizes, and expert adjudication for AI/ML performance evaluation are not relevant to this specific document.
§ 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.