(151 days)
ASCOT® is intended for anterior cervical fixation (C2-C7) 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 or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis and failed previous fusion.
ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to accommodate anatomic requirements. Fixed and variable angle screws are available in numerous length/diameter combinations. In addition, a center graft screw is offered.
The provided text describes the 510(k) summary for the ASCOT® anterior cervical plate system. This is a medical device and not an AI or software-based diagnostic tool. Therefore, the questions related to AI performance, ground truth, sample sizes for training/test sets, expert adjudication, and MRMC studies are not applicable.
The "acceptance criteria" for this type of device are related to its mechanical performance and substantial equivalence to predicate devices, rather than diagnostic accuracy metrics.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate devices as per ASTM F1717 (static & dynamic compression bending, static torsion) | "The mechanical test results demonstrate that the ASCOT® device performance is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a hardware medical device; performance was evaluated through mechanical testing, not a diagnostic test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant for this mechanical device.
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. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an AI device.
7. The type of ground truth used
- Not Applicable. The "ground truth" for this device would be the physical properties and mechanical stability under specified loads, measured against established engineering standards (ASTM F1717) and compared to predicate devices. This isn't a diagnostic ground truth.
8. The sample size for the training set
- Not Applicable.
9. How the ground truth for the training set was established
- Not Applicable.
Summary of Relevant Information Regarding Device Acceptance:
The acceptance of the ASCOT® device for 510(k) clearance was based on demonstrating substantial equivalence to existing legally marketed predicate devices (TOSCA®, TOSCA® II, VERTEBRON SCP™, Uniplate™). This was primarily achieved by showing:
- Mechanical Testing: According to ASTM F1717, static and dynamic compression bending, and static torsion tests were performed on the "worst case" ASCOT® configuration. The results showed performance "substantially equivalent" to the predicate devices.
- Technological Characteristics: The device possesses the "same technological characteristics" as the predicates, including:
- Performance (as described by mechanical testing).
- Basic design (plate and screw system).
- Material (titanium alloy - Ti-6Al-4V ELI, ASTM F136).
- Sizes (component dimensions are within the ranges offered by the predicates).
- Intended Use: The intended use for anterior cervical fixation (C2-C7) for specific indications (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities/curvatures, tumor, pseudarthrosis, failed previous fusion) is the same as the predicate devices.
The FDA's decision letter (K132310) confirms the determination of substantial equivalence, allowing the device to be marketed.
§ 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.