(84 days)
The Vertebron SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
The device consists of a system of implantable metal plates and screws intended the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the system. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136-98. The device is supplied non-sterile and is intended for sterilization by hospital personnel.
The provided text is a 510(k) summary for the Vertebron SCP™ Cervical Plate System. It details the device's description, indications for use, and a general statement about testing. However, it does not contain the specific information required to answer all parts of your request regarding detailed acceptance criteria, sample sizes, ground truth establishment, or expert involvement in a study proving the device meets acceptance criteria.
The 510(k) summary states that the device was tested in accordance with ASTM F1717 and "found to perform comparably to other cervical plate systems." This indicates a reliance on a recognized standard for performance, but the detailed results or specific acceptance criteria are not provided in this document.
Here's what can be extracted and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided document. The basis for acceptance is comparability to predicate devices under ASTM F1717. | "The device was found to perform comparably to other cervical plate systems." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified, but generally, device performance testing for 510(k) submissions relies on laboratory or bench testing, not clinical data from patients in a specific country. This would be a prospective test against a standard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This type of information (expert review for ground truth) is typically relevant for studies involving qualitative assessments, such as image analysis for diagnostic devices. For a mechanical implant like a cervical plate, the "ground truth" is typically defined by engineering standards and measurable physical properties. Therefore, this information is not applicable to the type of testing described (ASTM F1717).
4. Adjudication Method for the Test Set
- Not applicable for the reported mechanical testing against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is relevant for diagnostic devices where human readers interpret data. The Vertebron SCP™ Cervical Plate System is a physical implant, and its performance is evaluated against mechanical and material standards, not through human reader interpretation of images/cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This concept pertains to AI/software performance. The device is a mechanical implant.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the performance of this device would be the requirements and specifications outlined in the ASTM F1717 standard for spinal plating systems. The device's performance characteristics (e.g., strength, fatigue resistance, biocompatibility) are measured against these standardized benchmarks.
8. The Sample Size for the Training Set
- Not applicable. The concept of "training set" is relevant for machine learning algorithms. For a medical device like a cervical plate, there is no "training set" in this context. Performance is established through laboratory physical testing.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set."
Summary of what the document does tell us about the study:
- Study Type: Bench testing.
- Standard Used: ASTM F1717.
- Outcome: The device was "found to perform comparably to other cervical plate systems" (predicate devices).
- Purpose: To demonstrate substantial equivalence to legally marketed predicate devices.
The provided document is a 510(k) summary, which is deliberately concise and focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed technical report of all testing. Detailed test reports would be part of the full 510(k) submission but are not typically included in the publicly available summary.
§ 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.