(202 days)
Blackstone™ III° 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) pseudarthrosis;
h) revision of previous surgery
The Blackstone™ III° Anterior Cervical Plating System is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the 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.
The provided text is a 510(k) summary for the Blackstone™ III° Anterior Cervical Plating System, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study in the way an AI/ML device would. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not applicable to this document.
However, I can extract the relevant information from the provided text as it pertains to medical device approval, focusing on the substantial equivalence argument, which served as the "proof" for this device's acceptance.
Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device 510(k) submission, "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to previously cleared predicate devices, rather than through specific performance metrics from a comparative clinical trial. The "performance" is implicitly accepted as being equivalent to the predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Substantial Equivalence) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|---|
| Intended Use | Anterior fixation to the cervical spine from C2 to C7 for specified indications. | Intended use is identical to predicate devices. |
| Indications for Use | a) degenerative disc disease; b) spondylolisthesis; c) fracture; d) spinal stenosis; e) deformities; f) tumor; g) pseudarthrosis; h) revision of previous surgery. | Indications for use are identical to predicate devices. |
| Technological Characteristics | Material (titanium alloy), multiple component system, non-sterile, single use, screws, plates, associated instrumentation, attachment to anterior aspect of vertebral body. | Technological characteristics are sufficiently similar to predicate devices to allow for substantial equivalence. |
| Safety and Effectiveness | Device is as safe and effective as predicate devices. | No new safety or effectiveness concerns raised beyond those of predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This information is N/A. The 510(k) submission for this device does not involve a "test set" in the context of an AI/ML device or a clinical trial with a defined sample size for performance evaluation. Substantial equivalence is based on comparison of design, materials, intended use, and indications to existing predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is N/A. There was no "test set" or "ground truth" to be established by experts in the context of a performance study for this 510(k) submission. The FDA, through its review division, acts as the ultimate body to agree with the claim of substantial equivalence.
4. Adjudication Method for the Test Set
This information is N/A. No "test set" requiring adjudication methods (like 2+1, 3+1) was part of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not done. This type of study is typically associated with evaluating AI/ML diagnostic tools or specific clinical comparisons, which is not the nature of this device's submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This device is a surgical implant (anterior cervical plating system), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used
This information is N/A in the context of a ground truth for a performance study. For a 510(k) submission, the "ground truth" for acceptance is essentially the established safety and effectiveness profile of the predicate devices to which the new device claims substantial equivalence. The predicate devices' long-standing clinical use and prior FDA clearance serve as the basis for this "truth."
8. The Sample Size for the Training Set
This information is N/A. There is no "training set" for this type of medical device submission. The device is a physical implant, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
This information is N/A. Since there is no "training set," there is no process for establishing its ground truth.
Summary of the "Study" (Basis for Acceptance) for the Blackstone™ III° Anterior Cervical Plating System:
The "study" in this context is the comparison to predicate devices to demonstrate substantial equivalence, as required by the 510(k) pathway.
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Basis of Substantial Equivalence: The Blackstone™ III° Anterior Cervical Plating System was deemed substantially equivalent to four predicate devices:
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Core Argument: The new device shares the same intended use, indications for use, and similar technological characteristics (titanium alloy, components, screws, plates, instrumentation for anterior fixation from C2 to C7) as the predicate devices, which the FDA had previously cleared for marketing. The implication is that because the new device is substantially equivalent to these already-approved devices, it is considered equally safe and effective.
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Evidence Presented: The 510(k) submission would have detailed comparisons of materials, design, manufacturing processes, and possibly some bench testing data to confirm functional equivalence (e.g., mechanical strength, corrosion resistance), but these are not explicitly detailed in the provided text. The text primarily focuses on the claim of equivalence and lists the predicate devices.
§ 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.