(90 days)
The Reflex Anterior Cervical Plate (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 and decompression of the spinal cord following total or partial cervical vertebrectomy.
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 a bone plates (an anti-migration mechanism is preassembled to 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 as described in ASTM F-136, ISO 5832-3 and ASTM F-1813. The implants will be provided nonsterile.
The provided text (K010115) is a 510(k) Premarket Notification for the Reflex Anterior Cervical Plate System. This document is a regulatory submission for a medical device and describes its intended use, design, and claim of substantial equivalence to already marketed devices.
However, the 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or clinical effectiveness studies as typically found for AI/imaging devices. Instead, it focuses on demonstrating substantial equivalence through similarities in materials, design, and intended use, and indicates "Testing has been conducted demonstrating substantial equivalence to a currently marked device." Such testing for an implantable device like an anterior cervical plate system would typically involve non-clinical performance testing (e.g., mechanical strength, fatigue, biocompatibility) rather than a clinical study with human readers or AI algorithms.
Therefore, most of the requested information regarding clinical studies, ground truth, expert opinions, sample sizes for test/training sets, or MRMC studies is not applicable to this 510(k) document.
Here's a breakdown of the information that can be extracted or inferred, and what is not present in the document based on your questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Type | Acceptance Criteria (Not Explicitly Stated for Clinical Performance) | Reported Device Performance (Inferred/Implied) |
|---|---|---|
| Substantial Equivalence | To a legally marketed predicate device (materials, design, intended use). | "Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed anterior cervical plate systems." |
| Mechanical/Biocompatibility Performance | (Not explicitly detailed, but implied through standard medical device testing for implants). | "Testing has been conducted demonstrating substantial equivalence to a currently marked device." (This would typically include bench testing for mechanical properties and biocompatibility). |
| Clinical Performance (e.g., accuracy, sensitivity, specificity, patient outcomes) | (Not applicable for this type of 510(k), as it's not a diagnostic or AI device and no clinical efficacy study is described). | Not reported in this document. |
2. Sample size used for the test set and the data provenance
- Not applicable for a clinical test set. The "testing" mentioned refers to non-clinical performance (bench testing) to demonstrate substantial equivalence, not a clinical study with a patient test set.
- The document does not provide details on the specifics of this non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is an implant, not a diagnostic tool requiring expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method for the test set
- Not applicable. See point 3.
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 not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI or algorithm device.
7. The type of ground truth used
- Not applicable in the context of clinical "ground truth." For substantial equivalence of an implant, the "ground truth" equates to the established performance characteristics of the predicate device, which would be based on its intended use, materials, design, and previously demonstrated safety and effectiveness (likely through non-clinical testing and clinical history).
8. The sample size for the training set
- Not applicable. This device does not involve an AI algorithm or a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of what the 510(k) document states about "proving" the device meets criteria:
The document states:
- "Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed anterior cervical plate systems."
- "Testing has been conducted demonstrating substantial equivalence to a currently marked device."
This means the device's "acceptance criteria" revolve around demonstrating that it is substantially equivalent to a device already on the market (the predicate device) in terms of its intended use, design, materials, and performance (likely mechanical and biocompatibility). The study proving this involves comparing these aspects of the Reflex Anterior Cervical Plate System to a predicate device and conducting relevant non-clinical tests to show similar performance characteristics. The specific details of these non-clinical tests (e.g., fatigue testing, tensile strength, biocompatibility studies) are not disclosed in this 510(k) summary but would be part of the full 510(k) submission.
§ 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.