(261 days)
The NeoOrtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4) deformity (defined by kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Note: this device system is intended for anterior cervical intervertebral body fusions only.
The NeoOrtho NEOPLATE Spine Anterior Fixation System consists of a variety of shapes and sizes of bone plates, screws and instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NEOPLATE Spine Anterior Fixation System, structured to address your specific points:
The provided document describes a 510(k) premarket notification for the NEOPLATE Spine Anterior Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or setting performance criteria for diagnostic accuracy. Therefore, many of your requested points pertain to diagnostic AI/medical imaging systems and are not applicable to this type of device (a surgical implant).
This document outlines the mechanical performance testing conducted to demonstrate substantial equivalence, not to establish specific clinical acceptance criteria or evaluate the performance of an AI algorithm.
Description of Acceptance Criteria and Study: NEOPLATE Spine Anterior Fixation System
The NEOPLATE Spine Anterior Fixation System is a surgical implant. The "acceptance criteria" in this context refer to demonstrating substantial equivalence to a predicate device, primarily through material characterization and mechanical performance testing, rather than clinical efficacy or diagnostic accuracy.
The study conducted was a mechanical testing study performed according to ASTM F1717, a recognized standard for testing spinal implant constructs. The purpose was to show that the device's mechanical properties are equivalent to or better than those of a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (for Substantial Equivalence) | Reported Device Performance / Evaluation Method |
|---|---|
| Material Composition | Manufactured from titanium alloy (ASTM F136), same as predicate. |
| Basic Design | Plate and screw system, same as predicate. |
| Size/Dimensions | Dimensions are within the ranges of the predicate device. |
| Mechanical Performance | Mechanical testing (ASTM F1717) demonstrated substantial equivalence to predicate. |
| - Compression Testing | Performed according to ASTM F1717. (Specific numerical results not provided in summary) |
| - Fatigue Testing | Performed according to ASTM F1717. (Specific numerical results not provided in summary) |
| - Static Torsional Testing | Performed according to ASTM F1717. (Specific numerical results not provided in summary) |
| Indications for Use | Same as predicate device (anterior interbody screw/plate fixation of the cervical spine). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "sample size" in the context of patients or clinical data. The "test set" here refers to the number of physical device units or components that underwent mechanical testing. This information (e.g., number of plates/screws tested for each mechanical test) is not provided in the summary.
- Data Provenance: The mechanical testing was likely conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility. The country of origin of this testing data is not explicitly stated, but the manufacturer is based in Brazil. This is not a retrospective or prospective clinical study on human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This device is a mechanical implant, not an AI or diagnostic imaging system. There was no "ground truth" established by experts in the context of diagnostic interpretation (e.g., radiologists interpreting images). The "ground truth" for mechanical testing is derived from engineering principles and the passed/failed status against pre-defined load/cycle specifications in the ASTM standard.
4. Adjudication Method for the Test Set
- Not Applicable. There was no adjudication method used for a "test set" in the sense of expert consensus on clinical or diagnostic outcomes. The mechanical tests have objective pass/fail criteria based on the ASTM F1717 standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is designed for evaluating the diagnostic performance of systems, often comparing human readers with and without AI assistance to interpret medical images. This is not relevant for a spinal fixation implant, which is evaluated based on its mechanical integrity and substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a physical surgical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for the mechanical testing was the engineering specifications and pass/fail criteria defined by the ASTM F1717 standard and compared against the performance of the predicate device. This is a mechanical/performance ground truth, not a clinical or pathological ground truth.
8. The Sample Size for the Training Set
- Not Applicable. This device did not involve the use of machine learning or AI, and therefore no "training set" was used.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there was no training set (no AI/ML involved), there was no ground truth for a training set.
In summary, the provided document details a 510(k) submission for a surgical implant, not a diagnostic AI device. The "study" described is mechanical performance testing, and the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device in terms of material, design, dimensions, and mechanical integrity, as opposed to clinical efficacy or diagnostic accuracy.
§ 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.