(90 days)
Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1 and is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2)trauma (including fractures); 3)tumors: 4)deformity(defined as kyphosis, lordosis,or scoliosis); 5)pseudoarthrosis; 6)failed previous fusions
Cervical Plate System consist of anterior cervical spine plate II, anterior cervical spine plate IV and screws. The anterior cervical spine plate is fixed to the front of the cervical vertebrae by screws to play an auxiliary role in maintaining the stability of the surgical segment and preventing the fusion implant from coming out. Screws are available for fixed angle or variable angle implantation.
Bone plates in Cervical Plate System are made of unalloyed titanium following ASTM F67 and titanium alloy following ASTM F1472 as well as ASTM F1295, and bone screws in Cervical Plate System are made of titanium alloy following ASTM F136.
Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
This document, K223753, is a 510(k) premarket notification for a Cervical Plate System. It seeks to demonstrate substantial equivalence to a legally marketed predicate device (K141632 ZEVO™ Anterior Cervical Plate System).
The request asks for acceptance criteria and a study that proves the device meets these criteria. However, the provided text does not contain information about an AI/ML-based medical device, nor does it describe a study involving human-in-the-loop performance, expert consensus on images, or training/test sets for an algorithm.
Instead, this submission details the regulatory approval process for a physical orthopedic implant used in spinal surgery. The "acceptance criteria" discussed are primarily related to biocompatibility and mechanical testing of the physical device to ensure its safety and efficacy, not performance metrics of an AI algorithm.
Therefore, I cannot provide the requested information. The document explicitly states:
- "No clinical performance data was provided to demonstrate substantially equivalence." (Section 5.8)
- The non-clinical performance data focuses on biocompatibility testing (ISO 10993-1) and mechanical testing (ASTM F1717) for the physical implant (Static compression bending test, Static torsion test, Dynamic compression bending test).
To explicitly answer your questions based only on the provided text, and acknowledging the mismatch with your request for AI/ML study details:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied from tests performed): The Cervical Plate System must demonstrate biocompatibility and mechanical performance (static compression bending, static torsion, dynamic compression bending) that is substantially equivalent to the predicate device, as per ASTM F1717 and ISO 10993-1.
- Reported Device Performance: The document states these tests were "performed... to demonstrate substantially equivalent of safety and efficacy with the predicate device," but it does not provide numerical results or specific performance metrics from these tests. It only states that the information provided "demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device." This implies the acceptance criteria were met, but the specific data is not in this summary.
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Sample sizes used for the test set and the data provenance: This is not applicable to this document as it does not describe an AI/ML study with test sets of data. The "test set" here refers to physical samples of the cervical plate subjected to mechanical and biocompatibility tests. No information on the number of physical samples tested is provided, nor is the "provenance" of such samples described in terms of geographical origin or retrospective/prospective collection.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. Ground truth, in the context of an AI/ML study, would involve expert labeling of medical images or data. No such process is described for this physical device. The "ground truth" for a physical device is its material properties and mechanical behavior under stress.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is not applicable as there is no data labeling or consensus-building process for an AI/ML system.
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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: This is not applicable to this submission. The device is a physical implant, not an AI assistance tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. There is no algorithm described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, "ground truth" refers to established material properties and biomechanical standards. The document refers to ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ISO 10993-1 (Biological evaluation of medical devices). These standards serve as the "ground truth" for evaluating the physical and biological characteristics of the device.
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The sample size for the training set: This is not applicable as there is no AI/ML model or training set.
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How the ground truth for the training set was established: This is not applicable as there is no AI/ML model or training set.
In summary, the provided document is a 510(k) summary for a physical medical device (Cervical Plate System) and does not involve AI/ML technology or studies with expert reading of medical images.
§ 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.