Search Results

The Axis Anterior Cervical Plate System is in skeletally mature patients for anterior screw fixation to the cervical spine (C2-T1) as an adjunct to fusion for the following indications: (a) degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); (b) trauma (including fractures); (c) tumours; (d) deformity (defined as kyphosis); (e) spondylolisthesis; (f) spinal stenosis; (g) pseudarthrosis and (h) revision of previous surgery.

The Axis Anterior Cervical Plate System (also called the Axis2 Anterior Cervical Fusion Plate in markets outside the US) is intended for anterior screw fixation to the cervical spine. The Axis Anterior Cervical Plate System consists of a variety of sizes of bone plates and screws to accommodate anatomical needs. The components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implants are provided in sterile and non-sterile packaging.

The provided text is a 510(k) summary for the Axis Anterior Cervical Plate System. It describes the device, its indications for use, and its technological characteristics. However, the document does not contain information about software, AI, or diagnostic performance studies that would involve acceptance criteria, test sets, expert ground truth, or MRMC studies for a device with those functionalities.

The performance data mentioned in the document is exclusively for non-clinical mechanical testing of the implant's structural integrity. Therefore, I cannot provide the requested information related to the acceptance criteria and study that proves a device meets diagnostic performance criteria because such data is not present in the provided text.

The closest information related to "acceptance criteria" is that the device was tested per ASTM F1717 for mechanical properties and the results showed "sufficient" strength and substantial equivalence to predicate devices.

Here's an overview of what is in the document regarding performance, and why it doesn't match your request:

Performance Data Section from Document:
"The Axis Anterior Cervical Plate System has been tested in the following test modes:

• Static & Dynamic Compression Bending per ASTM F1717
• Static Torsion per ASTM F1717
  The results of this non-clinical testing show that the strength of the Axis Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This information pertains to material science and mechanical engineering, not diagnostic accuracy or AI performance.

Therefore, I cannot populate the table or answer the questions related to diagnostic performance or AI effectiveness.

Ask a specific question about this device

The Axis Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as failed previous fusion).

Axis Anterior Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6Al-4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, Axis Anterior Cervical Plates come with a prelordosed curve. Various instruments are available to facilitate the implantation of the device.

This document is a 510(k) summary for the Axis Anterior Cervical Plate System. It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. The information provided is not about an AI/ML powered device, but a physical medical implant. Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for AI/ML validation studies, are not applicable here.

However, I can extract the information relevant to the performance assessment of this physical device as presented in the document itself.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this physical medical device are related to its mechanical performance, demonstrating equivalence to a predicate device based on specific ASTM standards.

Study Proving Device Meets Acceptance Criteria:

A performance assessment was conducted through mechanical testing.

• Study Type: Mechanical performance testing.
• Standards Used: ASTM F1717-15 and ASTM F543-13e1.
• Objective: To demonstrate that the Axis Anterior Cervical Plate System is equivalent to a predicate device with respect to the testing recommended in these ASTM standards.

The following sections are not applicable as this is not an AI/ML device:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This refers to physical testing of the device components, not data analysis.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and material science specifications and testing.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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): The ground truth here is the established mechanical performance standards as outlined in ASTM F1717-15 and ASTM F543-13e1, and the performance of the 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.

Ask a specific question about this device