(16 days)
The Osteonics® ACCP System components are intended to provide stabilization at single or multiple levels of the cervical spine, thus aiding in the development of a solid spinal fusion. Additionally, the Osteonics® ACCP System may be used to aid in the restoration of disc height in the presence of a tumor, vertebral trauma, or degenerative disease, pseudarthrosis, or previously failed fusions.
The indications for the use of the Osteonics® ACCP System are as follows:
- degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
- decompression of the spinal cord following total or partial cervical vertebrectomy.
- trauma (fractures)
- tumors
- pseudarthrosis
- failed previous fusions
The Osteonics® ACCP System is an anterior cervical single or multi-level plate that incorporates either a monoblock or modular design, which is measured from end to end. Modular end plate sections are secured to each other using locking screws, and are provided preassembled. The Osteonics® ACCP is placed longitudinally on the long axis of the cervical spine and is affixed by unicortical bone screws. All Osteonics® ACCP System components are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.
The provided text is a 510(k) Premarket Notification Summary for the Osteonics® ACCP System - Line Extension. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study with specific acceptance criteria, device performance, and detailed methodologies typically associated with new device efficacy or safety studies.
Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not present in this type of submission. This document aims to show that the new device line extension is as safe and effective as the original Osteonics® ACCP System.
Here's an analysis of what can be extracted from the provided text according to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics from a dedicated study. The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is typically achieved by comparing design, material, intended use, and safety/effectiveness considerations.
| Acceptance Criteria | Reported Device Performance (as implied by 510(k)) |
|---|---|
| Substantial Equivalence to Predicate Device | The Osteonics® ACCP System Line Extension components are substantially equivalent in design and intended use to the monoblock cervical plates in the predicate Osteonics® ACCP System. Both are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. 510(k) submissions for line extensions or devices demonstrating substantial equivalence often leverage existing data or generally accepted engineering principles rather than conducting new clinical trials with specific test sets and patient data.
3. 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)
This information is not provided. The concept of "ground truth" as it relates to expert consensus on clinical data is not applicable in this 510(k) summary. The "ground truth" for a substantial equivalence claim revolves around engineering specifications, material properties, and intended use as compared to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant in clinical trials where expert review of patient outcomes or imaging is required. This 510(k) summary does not describe such a study.
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
No such study is mentioned or implied. This document is not about AI-assisted diagnostics or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is a spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in the context of this 510(k) summary is the established safety and efficacy of the predicate device, the original Osteonics® ACCP System. The manufacturer asserts that the line extension shares the same fundamental design, materials, and intended use, and therefore can be considered equally safe and effective.
8. The sample size for the training set
This information is not provided. "Training set" is a concept typically used in machine learning or AI development, which is not relevant to this device submission.
9. How the ground truth for the training set was established
Not applicable for the reasons stated above.
§ 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.