(61 days)
The Hallmark™ Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis:
c) Fracture;
d) Spinal stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
f) Tumor;
g) Pseudoarthrosis;
h) Revision of previous surgery
The Hallmark Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (6AL-4V ELI, per ASTM F136) components that allow a surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation.
The provided text is a 510(k) summary for a medical device modification, specifically the "Hallmark Anterior Cervical Plate System Modification - Five-Level Cervical Plates." This document primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical evaluations, rather than reporting on a clinical study with an AI component or complex performance metrics.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-powered device or a study with detailed performance metrics are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
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Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to predicate devices. This is demonstrated through mechanical evaluations. While the document doesn't explicitly state quantitative acceptance values for these mechanical tests, the underlying assumption is that the modified device's performance in these tests is comparable to or better than previously cleared devices.
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Reported Device Performance: The document states:
"Mechanical evaluations were conducted to demonstrate that the Hallmark Anterior Cervical Plate System with the addition of the Five-Level Cervical Plates is substantially equivalent to predicate devices and systems that have been cleared by FDA for the purpose of building a spinal implant construct in the cervical spine."
No specific numerical performance data from these mechanical evaluations (e.g., fatigue strength, pull-out strength, stiffness values) are provided in the summary. The "performance" is implicitly deemed acceptable because it met the substantial equivalence standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This device is a mechanical implant. The "test set" would refer to physical prototypes or manufactured units subjected to mechanical testing. The document does not specify the number of devices tested or the provenance of any data (as no human data is involved). These would typically be lab-based mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. As a mechanical implant, there is no "ground truth" in the diagnostic sense or expert review of images. Mechanical testing results are objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication of data is mentioned or relevant for this type of submission.
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
- Not applicable. This is a mechanical device, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical devices undergoing engineering testing, the "ground truth" would be the objective measurements from the tests themselves, compared against established standards (e.g., ASTM standards for material properties or biomechanical performance) and existing predicate device data. The document does not explicitly detail the specific standards or predicate data used for comparison.
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."
Summary of Study Type:
The "study" conducted for this 510(k) submission was a series of mechanical evaluations (laboratory tests) designed to demonstrate that the modified Hallmark Anterior Cervical Plate System (with Five-Level Cervical Plates) performs equivalently to predicate devices under specified conditions. The objective was to show substantial equivalence for regulatory clearance, not to evaluate clinical performance or an AI algorithm.
§ 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.