(49 days)
The Curiteva Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.
The Curiteva Anterior Cervical Plate System consists of screws and plates. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. All implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Curiteva Anterior Cervical Plate System." It confirms that the device is substantially equivalent to legally marketed predicate devices.
Let's break down the information provided in the context of acceptance criteria and a study proving the device meets them:
Critique of the Provided Document Regarding Acceptance Criteria and Study:
The provided document is an FDA 510(k) clearance letter and a 510(k) Summary. It does NOT contain the detailed information typically found in a clinical study report or a pre-defined set of acceptance criteria for algorithm performance.
This document is for a mechanical medical device (spinal plate system), not an AI/ML software or diagnostic device. Therefore, the "acceptance criteria" and "study" described in the prompt are referring to mechanical and material performance testing, not AI performance metrics like sensitivity, specificity, or AUC, nor are they clinical trials with human readers.
The prompt's questions are geared towards the evaluation of an AI/ML-based medical device. My response will highlight how the provided document addresses, or doesn't address, these questions in the context of a mechanical device clearance.
Here's an attempt to answer your questions based solely on the provided text, interpreting "acceptance criteria" and "study" within the context of mechanical device testing:
Based on the provided FDA 510(k) clearance letter and summary for the Curiteva Anterior Cervical Plate System, the "acceptance criteria" and "study" refer to the mechanical and material performance testing required for this type of implantable device, rather than the AI/ML performance metrics that your questions typically relate to.
Acceptance Criteria and Device Performance (Mechanical Device Context)
| Acceptance Criteria Category (Implied) | Reported Device Performance (from "Performance Data") |
|---|---|
| Mechanical Strength & Durability | The Curiteva Anterior Cervical Plate System was mechanically tested in the following test modes: static and dynamic compression bend per ASTM F1717, static torsion per ASTM F1717, and axial screw pushout. The results of this non-clinical testing show that the strength and performance of the Curiteva Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (Exact numerical thresholds or specific pass/fail values are not provided in this summary, but would have been defined in the underlying test protocols.) |
| Biocompatibility | (Implicitly met as the material is Titanium alloy (Ti-6Al-4V) conforming to ASTM F136, a standard for implantable materials. No specific test results are detailed in this summary.) |
| Dimensional & Design Equivalence | The subject device was shown to be substantially equivalent and to have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes. |
Study Details (Interpreted for a Mechanical Device)
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of plates/screws tested. For mechanical testing, samples are usually a representative number of units per size/configuration tested to ISO/ASTM standards.
- Data Provenance: The testing was "non-clinical testing," implying it was conducted in a laboratory setting (e.g., in vitro mechanical testing), not on human subjects. The location (country) of the testing is not specified, but it would have been conducted by the manufacturer or a certified testing lab. This would be considered "prospective" for the purpose of demonstrating device performance against pre-defined test protocols.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of mechanical device testing. "Ground truth" for mechanical testing is established by adhering to widely accepted international standards (e.g., ASTM F1717) and engineering principles. The "experts" would be the engineers and technicians performing and interpreting the mechanical tests according to these standards.
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Adjudication Method for the Test Set:
- Not applicable. Mechanical testing results are objectively measured (e.g., force, displacement, cycles to failure). There is no "adjudication" in the sense of reconciling human interpretations.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and their performance might be enhanced by an AI tool. This device is a surgical implant, not a diagnostic tool requiring human interpretation for its function.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, in a way relevant to a mechanical device. The "performance data" presented is effectively "standalone" performance of the device itself under specified mechanical stress conditions, without human interaction during the test. There is no algorithm here; it's a physical product.
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The Type of Ground Truth Used:
- For mechanical testing, the "ground truth" is defined by established engineering standards (e.g., ASTM F1717) and the physical properties and failure points of the materials and designs under controlled loads. The comparison to predicate devices also serves as a benchmark for acceptable performance.
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The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML product that undergoes a "training set" process. It's a manufactured medical device.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no "training set" or "ground truth" establishment in the AI/ML sense for this mechanical device. Design validation and verification are based on engineering principles and compliance with standards.
Summary in relation to your prompt's original intent (AI/ML):
This document pertains to a traditional Class II mechanical implantable medical device. Therefore, the specific questions regarding AI/ML performance metrics (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI) are not directly addressed or applicable in the context of this 510(k) submission. The "study" described is entirely focused on demonstrating the physical and mechanical equivalence and safety of the implant compared to existing cleared devices through bench testing.
§ 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.