(15 days)
The TOSCA® Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: 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. fracture or dislocation), spinal stenosis, deformities on curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The TOSCA® Anterior Cervical Plate System consists of various sizes of bone plates and screws that are either fixed angle or variable angle. The screws are used to secure the plates to the vertebral bodies of the cervical spine though the anterior approach. The plates and screws are made from Titanium alloy Ti64A14V, are in conformance with ASTM F136-98, and are supplied non-sterile.
The provided document describes the TOSCA® Anterior Cervical Plate System, a medical device used for spinal fixation. It details the device's description, intended use, and the type of testing performed to support its safety and effectiveness.
However, the document is a 510(k) Summary for a predicate device clearance, which primarily focuses on demonstrating substantial equivalence to existing legally marketed devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the way envisioned by the posed questions (e.g., performance metrics like sensitivity/specificity, sample sizes, expert-based ground truth typical for AI/diagnostic device studies).
Therefore, many of the requested fields cannot be directly answered from the provided text because the nature of this document (a 510(k) for a mechanical spinal implant) does not typically involve the types of studies and criteria mentioned in the prompt (e.g., AI performance, reader studies, ground truth establishment with experts for diagnostic data).
Here's an attempt to extract the available information and explain why other fields cannot be filled:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Performance: | Withstands clinical loading |
| - Withstand clinical loading | Maintains mechanical integrity |
| - Maintain mechanical integrity | Performs according to specification |
| - Perform according to specification | Suited for its intended purpose |
| Material Conformance: | Conforms to ASTM F136-98 |
| - Conformance to ASTM F136-98 |
Explanation: The document explicitly states: "Mechanical testing was conducted, and data collected, in accordance with ASTM 1717 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose." It also mentions the materials "are in conformance with ASTM F136-98." These serve as the implied acceptance criteria and the device's reported performance against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. Mechanical testing typically involves a number of samples or specimens rather than patient data.
- Data provenance: Not specified. The testing was "conducted," but the location or whether it mimicked real-world clinical scenarios with data of origin is not detailed. Given it's mechanical testing, it's likely laboratory-based.
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. This device is a mechanical implant, not a diagnostic AI or imaging device that requires expert-established ground truth for its performance evaluation against diagnostic data. Its "performance" relates to mechanical integrity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As the performance relates to mechanical testing, there is no "adjudication method" in the sense of reconciling expert opinions on diagnostic interpretations. Mechanical testing results are typically objectively measured against defined standards.
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 a mechanical implant; it does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical implant; it is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Test Standards and Specifications: The "ground truth" or reference for this device's performance would be the specifications derived from standards like ASTM 1717 for mechanical properties and ASTM F136-98 for material composition. The device's ability to 'withstand clinical loading' and 'maintain mechanical integrity' is measured against these engineering specifications.
8. The sample size for the training set
- Not applicable. This device is a mechanical implant; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
§ 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.