(67 days)
The Reflex™ ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformities or curvatures (including kyphosis, lordosis or scoliosis), pseudoarthrosis, failed previous fusion, decompression of the spinal cord following total or partial cervical vertebrectomy, spondylolisthesis and spinal stenosis.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Reflex " ACP System consists of bone plates and screws. Both components are available in a variety of lengths in order to accommodate patient physiology. The components are fabricated from titanium alloy. The implants will be provided non-sterile.
The provided text describes a 510(k) premarket notification for the Reflex™ Anterior Cervical Plate System, focusing on adding indications to the device. However, it does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of AI/ML or a clinical study with human readers and ground truth.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Synthes' Cervical Spine Locking Plate (CSLP) System) through mechanical properties.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties | Reflex ACP System demonstrated comparable mechanical properties to the predicate device (Synthes' CSLP System). |
| Intended Use Equivalence | Substantially equivalent for the stated indications to the predicate device. |
| Material Equivalence | Both components (bone plates and screws) fabricated from titanium alloy, similar to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The study described is a mechanical test comparing the Reflex ACP System to a predicate device. There is no mention of a "test set" in the context of patient data, nor any data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. Ground truth in the context of clinical outcomes or expert consensus is not relevant to the type of study (mechanical testing) described.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods are typically used in clinical studies involving interpretation or outcome assessment, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses solely on demonstrating substantial equivalence through mechanical testing, not on clinical performance or the impact of AI assistance on human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical implant (anterior cervical plate system), not an AI/ML software device.
7. The Type of Ground Truth Used
The "ground truth" used for this device's evaluation was primarily the mechanical performance and material characteristics of the legally marketed predicate device (Synthes' Cervical Spine Locking Plate (CSLP) System). The stated criterion is "comparable mechanical properties" to the predicate.
8. The Sample Size for the Training Set
This information is not provided. The concept of a "training set" is not applicable to the mechanical testing described for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. The concept of "ground truth for a training set" is not applicable. The basis for comparison was the established mechanical properties of the predicate 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.