(15 days)
The AcroMed DOC™ Ventral Cervical Stabilization System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in whom stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma (including fracture), posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The DOC Ventral Cervical Stabilization System, in its fully assembled form, consists of two laterally placed rods joined by platforms, or a plate, which lie on the anterior vertebral surface. The system is anchored to the vertebrae with screws. The implant provides supplemental stability to the cervical spine following anterior cervical fusion. Depending upon the implant configuration, it may serve as either a fixed (load-bearing) or unfixed (load-sharing) construct.
The following types of components are available in the system: Rods, Platforms, Plates Screws and Cross Connectors. All components are manufactured from implant grade Titanium alloy which conforms to ASTM F136 specifications. Assemblies are also available for convenience of the surgeon. These are pre-assembled partial constructs consisting of one Platform, one Cross Connector, two Rods and two Locking Screws.
An instrument set is available specifically designed for use with the DOC Ventral Cervical Stabilization System.
The document provided is a 510(k) summary for a medical device called the DOC Ventral Cervical Stabilization System. It details the device's description, components, intended use, and provides a letter from the FDA stating substantial equivalence to a predicate device.
However, the document does not contain acceptance criteria or a detailed study description that proves the device meets specific acceptance criteria.
The "PERFORMANCE DATA: Non-Clinical" section briefly mentions: "Static bending compression and torsion were performed on the system to characterize its mechanical properties. Additionally; testing was also performed to characterize fatigue life."
This statement confirms that some mechanical testing was conducted, but it does not provide:
- Specific acceptance criteria: What were the pass/fail thresholds for static bending, compression, torsion, or fatigue life?
- Reported device performance: What were the actual results of these tests? Did they meet the (unstated) acceptance criteria?
- Sample size: How many devices were tested for each type of mechanical test?
- Details about the study design: Where was the testing done? What standards (e.g., ASTM, ISO) were followed?
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Based on the available information:
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Table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Not specified Not specified Not specified Not specified Not specified Not specified -
Sample size used for the test set and the data provenance: Not specified. The document only states "testing was performed."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to a clinical study with human data/diagnosis, not mechanical testing.
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Adjudication method for the test set: Not applicable. This refers to a clinical study.
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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: Not applicable. This is a medical device for spinal stabilization, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
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The type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and established mechanical testing standards. The document does not explicitly state which standards were followed or the specific thresholds.
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The sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established: Not applicable.
Conclusion: The provided 510(k) summary focuses on the description of the device and its substantial equivalence to a predicate device based on indications for use, rather than providing detailed acceptance criteria and study results for its mechanical performance. While it confirms non-clinical mechanical testing (static bending, compression, torsion, fatigue life) was performed, it does not include the specifics of these tests (criteria, results, sample sizes) as requested.
§ 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.