(73 days)
The Altiva Classic ACP System is intended for anterior screw fixation to the cervical spine (C2 to C7). The system is intended for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- 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. fractures or dislocations), .
- tumors, .
- deformity (defined by kyphosis, lordosis, or scoliosis), .
- pseudoarthrosis, and .
- failed previous fusion. .
The Altiva Classic ACP System is an anterior screw fixation system for the cervical spine. It includes titanium alloy plates and screws which are provided clean and non-sterile. Various sizes of the implants are provided.
Here's an analysis of the provided text regarding acceptance criteria and study details:
The provided document (K070891) is a 510(k) Premarket Notification for the Altiva® Classic ACP System, a spinal intervertebral fixation orthosis. However, it is primarily a regulatory submission for substantial equivalence and does not contain detailed performance study data, acceptance criteria, or ground truth information in the way typically found for AI/software-as-a-medical-device (SaMD) clearances.
The document states: "Performance data were submitted to characterize the Altiva Classic ACP System." However, the details of these performance data, including specific acceptance criteria, study methodologies, sample sizes, and how ground truth was established, are not present within this summary document. 510(k) summaries often only state that performance data were submitted without detailing the results or methodology.
Therefore, I cannot fulfill all parts of your request based solely on the provided text, as much of the requested information (especially points 1-9 regarding a device's performance against detailed acceptance criteria and a study to prove it) is not included in this type of regulatory summary.
Here's what I can provide based on the given text, and where I must state that information is not available:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided 510(k) summary. This document focuses on the regulatory clearance for a physical orthopedic implant system, not a software-based diagnostic device with measurable performance metrics like sensitivity or specificity against a ground truth. The "performance data" mentioned would typically relate to mechanical testing (e.g., fatigue, static strength, torsion) to ensure the device's structural integrity and biocompatibility, not diagnostic accuracy in the way you've outlined.
2. Sample size used for the test set and the data provenance
Not available in the provided 510(k) summary. Given this is a physical implant, typical "test sets" would involve mechanical testing, not patient data in the context of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/available. Ground truth as typically understood for diagnostic device performance (e.g., expert reads, pathology) is not relevant for the regulatory clearance of a physical orthopedic implant.
4. Adjudication method for the test set
Not applicable/available.
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/SaMD product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD product.
7. The type of ground truth used
Not applicable. For a physical implant, "ground truth" would relate to engineering specifications for material properties and mechanical performance. The document states "Performance data were submitted to characterize the Altiva Classic ACP System," indicating engineering tests were conducted, but the specifics of these tests (e.g., fatigue strength, pull-out force, torsion) and their acceptance criteria are not detailed in this summary.
8. The sample size for the training set
Not applicable. This is not an AI/SaMD product.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD product.
Summary of What Is Available in the Document:
- Device Type: Spinal Intervertebral Fixation Orthosis (physical implant, screws and plates).
- Intended Use: Anterior screw fixation to the cervical spine (C2 to C7) for temporary stabilization during developing fusion for various conditions (degenerative disc disease, spondylolisthesis, trauma, tumors, deformity, pseudoarthrosis, failed previous fusion).
- Regulatory Clearance: 510(k) clearance based on substantial equivalence to a predicate device.
- Performance Data: The summary states "Performance data were submitted to characterize the Altiva Classic ACP System." This implies mechanical, material, and biocompatibility testing appropriate for an implant, but the details are not included in this public summary.
To obtain the detailed performance data, acceptance criteria, and specific testing methodologies for this device, one would typically need to review the full 510(k) submission, which is often not publicly available in its entirety. The provided document is a summary for public notification of regulatory clearance.
§ 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.