(33 days)
The Hallmark™ Anterior Cervical Plating 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 Hallmarl™ 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, which assists in the surgical implantation of the devices.
This document (K050892) is a 510(k) Premarket Notification for the Hallmark™ Anterior Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
Crucially, this document is a 510(k) submission, which means it focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies or establishing independent acceptance criteria based on performance data.
Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in this type of regulatory submission. The 510(k) process generally relies on comparison to a device already on the market (the predicate) and does not typically require new clinical trials to prove safety and effectiveness from scratch if substantial equivalence can be demonstrated through design, material, and functional comparisons.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The 510(k) process for this type of device usually relies on demonstrating that the new device meets the same design, material, and functional specifications as the predicate devices, rather than establishing new, quantifiable performance acceptance criteria. | Not reported in the document. Since specific acceptance criteria for performance are not outlined, there is no direct "reported device performance" against such criteria. The device is deemed substantially equivalent based on its comparison to predicate devices. |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. This document does not describe a clinical study or a "test set" in the context of evaluating performance against specific acceptance criteria. The basis of substantial equivalence is a comparison to predicate devices, focusing on design, materials, and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. The substantial equivalence determination does not involve establishing ground truth from a test set of data by experts in the way a diagnostic AI study would.
4. Adjudication method for the test set
- Not applicable / Not provided. No test set or expert adjudication is described.
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 medical device (spinal implant), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable / No. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. The concept of "ground truth" for a spinal implant device in the context of a 510(k) submission is typically tied to demonstrating the device's ability to achieve its intended function (e.g., fixation) and safety profile in a way that is equivalent to already marketed devices. This is usually assessed through design analysis, material testing, and comparison with predicate devices, rather than establishing a new ground truth from clinical outcomes data for the purpose of a novel performance study.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As above, no training set is involved.
Summary of the K050892 document regarding acceptance criteria and studies:
The Hallmark™ Anterior Cervical Plate System received 510(k) clearance based on its substantial equivalence to two predicate devices: the Blackstone™ Fusion Anterior Cervical Plate System (K030595) and the Blackstone™ III° Anterior Cervical Plating System (K012184).
The "study" in this context is the comparison of the new device's design, materials, manufacturing processes, and intended use to those of the predicate devices. The acceptance criteria for a 510(k) submission like this are implicitly that the new device is as safe and effective as the predicate device(s) and does not raise new questions of safety and effectiveness. This is demonstrated by showing that the new device shares the same fundamental scientific technology, has similar indications for use, and meets similar performance standards (often through bench testing or engineering analysis) as the predicates. Specific quantifiable performance metrics or a clinical study with a test set, ground truth, or expert adjudication are generally not required for a typical 510(k) for this type of implantable 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.