(29 days)
The NEO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal cord stenosis; deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); tumors: pseudarthrosis; and / or failed previous fusions.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The NEO™ Anterior Cervical Plate consists of various sizes of anterior cervical bone plates, screws and screw locking tabs. Components are available in a variety of sizes to fit popient. anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V EIJ per ASTM F-136. The NEO™ Anterior Cervical Plate components will be supplied clean and "NON-STERILE".
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NEO™ Anterior Cervical Plate:
This document is a 510(k) Summary of Safety and Effectiveness for a medical device called the NEO™ Anterior Cervical Plate. In the context of 510(k) submissions, the “acceptance criteria” and "study that proves the device meets the acceptance criteria" are generally framed in terms of demonstrating substantial equivalence to a predicate device, rather than detailed performance metrics against specific, quantitative acceptance criteria common in software or diagnostic device evaluations.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biomechanical Performance (Strength, Durability, Stability) | Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence. |
| Material Compatibility/Safety | Manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6AL-4V-ELI). |
| Indications for Use Equivalence | Shown to be substantially equivalent to previously cleared devices in indications for use. |
| Design Equivalence | Shown to be substantially equivalent to previously cleared devices in design. |
| Function Equivalence | Shown to be substantially equivalent to previously cleared devices in function. |
Note: For a 510(k) submission of this type of orthopedic implant, "acceptance criteria" are generally demonstrated through equivalence to a predicate device in terms of safety and effectiveness, which is supported by material testing and biomechanical testing aligning with recognized standards. Specific quantitative performance targets are less frequently disclosed in the summary documents, especially for devices establishing substantial equivalence to prior-generation predicate devices.
Study Information:
2. Sample Size Used for the Test Set and Data Provenance
- The document mentions "Biomechanical testing in accordance with ASTM F1717." ASTM F1717 is a standard for "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This standard typically outlines how tests should be performed and what parameters to measure (e.g., stiffness, displacement, fatigue life), but it does not specify a "sample size" in the clinical sense (e.g., number of patients).
- For biomechanical testing, the "sample size" would refer to the number of test specimens (e.g., number of device constructs tested). This specific number is not provided in the document.
- The data provenance is laboratory testing, not human or patient data. Therefore, the concepts of "country of origin of the data" and "retrospective or prospective" do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable to this type of device and study. The "ground truth" for biomechanical testing is typically established by the adherence to and results of a recognized international standard (ASTM F1717) and engineering principles, not through expert consensus on clinical cases. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the standard and predicate device data.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving human readers or evaluators, not for direct biomechanical engineering tests.
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. This is a hardware orthopedic implant (anterior cervical plate). An MRMC study is relevant for diagnostic devices, particularly AI-powered ones. There is no AI component mentioned or implied.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is a hardware orthopedic implant. This question pertains to AI/software.
7. The Type of Ground Truth Used
- The "ground truth" for demonstrating substantial equivalence for this device is based on engineering standards and direct physical measurements derived from biomechanical testing, compared to the known performance of a predicate device. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set."
In summary:
The provided document describes a 510(k) submission for a physical medical implant. The primary "study" mentioned is biomechanical testing in accordance with ASTM F1717. This testing serves to demonstrate that the device performs mechanically in a manner substantially equivalent to its predicate device(s), thereby establishing its safety and effectiveness for its intended use and material composition. The questions regarding AI, expert consensus, clinical sample sizes, and adjudication methods are not relevant to this type of regulatory submission or device.
§ 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.