(189 days)
The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have three locking tabs to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters of 4.0mm (Variable Angle Implant Screw and Fixed Angle Implant Screw) and 4.4mm (Rescue Screw) and lengths of 12mm, 14mm and 16mm.
This document is a 510(k) premarket notification for the Asfora Anterior Cervical Plate System. It describes a medical device, and the information requested pertains to the performance evaluation and regulatory approval of AI/ML-driven medical devices. Therefore, a direct extraction of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML device performance is not applicable to this document.
However, I can extract the relevant information about the non-AI device's performance testing as described in the document.
Acceptance Criteria and Device Performance for the Asfora Anterior Cervical Plate System (Non-AI device):
The document does not explicitly present acceptance criteria in a table format with corresponding performance results. Instead, it states that "Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14 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."
The types of tests performed indicate the areas where performance had to be satisfactory to meet the specified standards.
Table of Performance Testing (Interpreted from the document):
| Performance Metric Area | Reported Device Performance (Implied) |
|---|---|
| Mechanical Integrity & Clinical Loading Endurance | "able to withstand clinical loading and maintain mechanical integrity": This is the overarching implied acceptance criteria. The specific tests performed to demonstrate this include: |
| Dynamic Compression Bending | Conformed to specifications of "Guidance for Industry and FDA Staff: Spinal System 510(k)s" and "ASTM F 1717-14". (Specific values are not provided in this summary document, but the implication is that the device met the required thresholds for dynamic compression under these standards.) |
| Static Compression Bending | Conformed to specifications of "Guidance for Industry and FDA Staff: Spinal System 510(k)s" and "ASTM F 1717-14". (Specific values are not provided). |
| Static Torsion | Conformed to specifications of "Guidance for Industry and FDA Staff: Spinal System 510(k)s" and "ASTM F 1717-14". (Specific values are not provided). |
| Screw Insertion Torque Evaluation | Conformed to specifications of "Guidance for Industry and FDA Staff: Spinal System 510(k)s" and "ASTM F 1717-14". (Specific values are not provided, but implies satisfactory torque characteristics for surgical use). |
| Screw Retention Force Evaluation | Conformed to specifications of "Guidance for Industry and FDA Staff: Spinal System 510(k)s" and "ASTM F 1717-14". (Specific values are not provided, but implies screws remained securely in place under tested conditions). |
| Device performs according to specification | "ensure the device performs according to specification": Overall device functionality and design specifications were met. |
| Suited for its intended purpose | "suited for its intended purpose": The accumulated mechanical testing demonstrated the device is appropriate for its stated indications for use. |
Regarding the specific questions about AI/ML device studies:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes mechanical testing of a medical implant, not an AI/ML device analyzing data.
- 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. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on data interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is objective physical measurement against established engineering standards (ASTM F 1717-14) and FDA guidance for spinal systems.
- The sample size for the training set: Not applicable. There is no AI/ML model for which to describe a training set.
- How the ground truth for the training set was established: Not applicable.
Summary for this document:
The document K143688 is a 510(k) premarket notification for a physical medical device (Asfora Anterior Cervical Plate System), not an AI/ML device. Therefore, the specific questions related to AI/ML device performance evaluation (such as test set sample size, data provenance, expert ground truth, MRMC studies, training set details) are not applicable to the information provided in this regulatory submission.
The "study" proving the device meets acceptance criteria is described as "Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14". The acceptance criterion is implied that 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" as defined by those standards. Specific quantitative results are not included in this summary document.
§ 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.