(9 days)
The C-JAWS Cervical Compressive Mini Frame, in conjunction with traditional rigid fixation, is intended for use in cervical fusion procedures as a means to maintain the relative position of weak bony tissue such as allograft or auto grafts. This device is not intended for load bearing applications.
The C-JAWS implant is a single component system of anterior cervical anchoring. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two notched arms, which engage the vertebral bodies and works by plastic deformation of the implant's body. The staples are available in multiple sizes the C-JAWS implant is manufactured from CP titanium and has a smooth anodized finish. The purpose of this submission is to add additional sizes to the C-JAWS implant range: height of 12.5, 17.5 and 22.5mm and arm lengths of 10, 12, 14 and 17mm. In addition, radii (R=0.2mm) have been added to the extremity of both legs to reduce the sharpness of the tips of the C-JAWS legs. The modification is effective on the new submitted C-JAWS implants and has been applied to the K062181 cleared implants. Additional instruments are also added.
The provided document is a 510(k) summary for a medical device (C-JAWS Cervical Compressive Mini Frame) and contains information about its intended use and a brief mention of performance data. However, it does not include detailed acceptance criteria or a comprehensive study plan with the specific information requested in your prompt (e.g., sample sizes for test and training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance).
Here's an analysis based on the available information and a breakdown of why many of your requested points cannot be answered from this document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in this document. Often, for devices like this, acceptance criteria would be related to: |
- Pull-out strength
- Fatigue life
- Compatibility with traditional rigid fixation
- Maintenance of relative position of allografts/autographs | Biomechanical testing, including pull-out fixation tests, were conducted.
(No specific numerical results or success/failure rates are provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "Biomechanical testing, including pull out fixation tests were conducted."
- Data Provenance: Not specified. This type of testing is typically done in a lab rather than using patient data for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. For biomechanical testing of a spinal implant, "ground truth" is typically established by engineering standards and measurement equipment, not clinical expert consensus.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified. This refers to how disagreements among expert readers are resolved in image-based diagnostic studies. For biomechanical testing, the "adjudication" is based on comparing results to established engineering specifications.
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
- MRMC Study: No. This document describes a mechanical implant, not an AI-assisted diagnostic device. Therefore, MRMC studies with human readers and AI assistance are not relevant.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: For the biomechanical testing mentioned, the ground truth would typically be defined by engineering specifications and measurements (e.g., maximum force before failure, displacement under load). It's not clinical ground truth like pathology or outcomes data in this context.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no mention of an algorithm or training set as this is a physical implant.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. There is no mention of an algorithm or training set.
Summary of Study Information Available in the Document:
The document states: "Biomechanical testing, including pull out fixation tests were conducted." This indicates that the device underwent physical laboratory testing to evaluate its mechanical properties relevant to its intended use (maintaining the relative position of weak bony tissue). The specific details of these tests (e.g., number of samples, test parameters, exact results, or acceptance criteria) are not provided in this 510(k) summary. These details would typically be found in a more comprehensive testing report.
§ 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.