(239 days)
The subject device is intended to stabilize the spine as an aid to fusion by transfacet fixation.
The subject device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels including: 1)Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm.
The SpineFrontier, Inc. CHAMELEON™ Fixation System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine.
The facet screw included in the CHAMELEON™ Fixation System is a partially threaded 4.5mm diameter screw offered in lengths of 30-50mm (in 5mm increments). The device is composed no mairal grade Titanium (Ti6Al4V) that complies with ASTM F-136. The devices are offered with in washer or without a washer.
Washers: Integral to the screw design, washers increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screws to provide optimal bony contact over a range of screw trajectories.
The devices are sold non-sterile and are packaged in a clear poly bag. These devices are sterilized by a healthcare professional using Steam Autoclave in accordance to the instructions for use provided by SpineFrontier, Inc., as well as the instructions provided by the manufacturer of the Autoclave.
The SpineFrontier, Inc. CHAMELEON™ Fixation System is a medical device and, as such, the provided text describes its performance data and compliance with standards rather than "acceptance criteria" and "device performance" in the context of an AI/ML algorithm. Therefore, the information requested for AI/ML studies (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this document.
The document describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting results from an AI/ML clinical study.
Here's an interpretation of the relevant information provided in the context of a medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standards/Guidance) | Reported Device Performance |
|---|---|
| ASTM F-2003 (Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System) | Device performed well during various mechanical tests, including comparison to predicate devices. |
| ASTM F-543 (Standards Specifications and Test Methods for Metallic Bone Screws) | Device performed well during various mechanical tests, including comparison to predicate devices. |
| Overall Goal: Substantial Equivalence to Predicate Devices (K012773, K994308) | The device is composed of biocompatible materials that have a long successful history in the orthopedic industry. The device satisfies the applicable performance standards and demonstrates substantial equivalence in physical and performance characteristics. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study. Performance was demonstrated through mechanical testing against standards.
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 defined for AI/ML is not relevant here. Device performance was assessed through engineering tests.
4. Adjudication method 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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this medical device submission is compliance with established ASTM standards and successful mechanical performance relative to predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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