(147 days)
The Southern Spine Anterior Cervical Stabilization System (SSACSS) is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine (C2-T1) during the development of cervical spine fusions in patients with degeneration disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Southern Spine Anterior Cervical Stabilization System (SSACSS) is used as a temporary construct that assists in normal healing and is not intended to replace normal body structures. The system is implanted via an anterior approach to the cervical spine. The SSACSS includes various sizes of Titanium plates with or without Tissue Shields that may be used for One-Level, Two-Level, and Three-Level anterior cervical fusion procedures. There is a selection of Titanium screws and instrumentation for implantation. The implants and delivery instrumentation are provided Non-Sterile.
The provided document is a 510(k) summary for the Southern Spine Anterior Cervical Stabilization System (SSACSS). It outlines the device, its indications for use, and its substantial equivalence to a predicate device.
However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic or AI-driven systems.
This 510(k) is for a physical medical device (an implantable spinal stabilization system). For such devices, "acceptance criteria" are usually related to mechanical and material properties specifications (e.g., strength, durability, biocompatibility, dimensions) and "studies" are typically bench testing to demonstrate these physical properties and substantial equivalence to an existing predicate device.
The study referenced is a "Summary of Testing" that confirms the SSACSS has "the same indications for use, principles of operation, and mechanical characteristics as the predicate devices," and these conclusions were "verified in performance/bench testing."
Given the nature of the device and the provided document, the specific information requested in your prompt (especially regarding AI/ML product evaluation metrics like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance for AI) is not present and not applicable to this type of medical device submission.
Therefore, I cannot populate the table or answer most of your detailed questions. I can only extract what is present in the document about the "study" conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria (Not Explicitly Stated as Numerical AC) | Reported Device Performance (Summary of Findings) |
|---|---|---|
| Indications for Use | Same as predicate device (K021979) | Confirmed to have the same indications for use. |
| Principles of Operation | Same as predicate device (K021979) | Confirmed to have the same principles of operation. |
| Mechanical Characteristics | Same as predicate device (K021979) | Confirmed to have the same mechanical characteristics. |
| Material Specifications | Same as predicate device (K021979) | Confirmed to have the same material specifications. |
| Safety and Efficacy affected by modifications (Tissue Shields) | Modifications (Tissue Shields) do not affect safety or efficacy. | Verified that modifications do not affect safety or efficacy. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The "test set" in this context would refer to the materials or prototypes subjected to bench testing. The document does not specify quantities of devices or materials tested. Data provenance for mechanical testing would typically be from laboratory settings, but no details are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. This type of information is relevant for AI/diagnostic devices where expert consensus defines a "ground truth" for disease states. For a physical implant, "ground truth" relates to engineering specifications and mechanical performance, established by standard testing methods, not expert clinical consensus on a test set of data.
4. Adjudication method for the test set:
- Not applicable / Not provided. Adjudication methods (like 2+1) are used for resolving disagreements among multiple human readers in diagnostic studies. This is not relevant for bench testing of a physical implant.
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:
- No, not done. This is an implantable medical device, not an AI/ML diagnostic software, so an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not done. This is an implantable medical device; there is no algorithm or standalone performance in the context of AI.
7. The type of ground truth used:
- For the "Summary of Testing," the ground truth implicitly refers to established engineering standards and specifications for spinal implants, as well as the performance characteristics of the predicate device (K021979). The testing verified that the modified device met these implicit "ground truths" by demonstrating substantial equivalence.
8. The sample size for the training set:
- Not applicable / Not provided. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set for an AI/ML device, 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.