(125 days)
MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/ plate fixation of the cervical spine until the bone fusion occurs.
The MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is indicated for use in the temporary stabilization of the anterior cervical (C2 to T1) spine during development of a solid fusion in patients with the following conditions:
· degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- · spondylolisthesis,
- · trauma (i.e., fracture or dislocation),
- · spinal stenosis,
- · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- · tumor,
- · pseudoarthrosis,
- · and failed previous fusion
This implant has to be used with an appropriate bone graft.
Patients should have been unresponsive for a minimum six (6) weeks to conservative treatment before the surgery.
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is an anterior system, which consists of a variety of cervical plate lengths and a variety of cervical bone screws.
The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications.
This document, a 510(k) Premarket Notification from the FDA, focuses on the substantial equivalence of a medical device (MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System) to existing predicate devices. It does not present acceptance criteria or a study proving the device meets specific acceptance criteria in the way a performance study for a diagnostic AI device would.
Instead, the document primarily demonstrates that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, materials, mechanical safety, and performance. This is a regulatory pathway that relies on comparison to existing devices rather than new clinical outcome studies for performance.
Therefore, many of the requested sections about acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this type of regulatory submission.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense of a performance study for a diagnostic device.
- The document implies "acceptance criteria" through demonstrating substantial equivalence to predicate devices. This means the device is considered acceptable if its features, materials, and mechanical performance are comparable to devices already on the market.
- Reported device performance: The "performance" reported here is mechanical testing results, comparing the device to industry standards (ASTM F1717-15) and implicitly to the predicate devices. The document states: "The components of MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System were mechanically evaluated in static and dynamic compression and static torsion tests following the ASTM F1717-15." The results are not explicitly detailed in a table beyond the statement that these tests were conducted.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a mechanical device, not a diagnostic AI device. The testing involves physical prototypes of the device, not a "test set" of patient data.
- The mechanical tests (static and dynamic compression, static torsion) would have been performed on a sample of the manufactured device components. The specific number of test articles is not detailed.
- "Data provenance" related to patient data is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant for the mechanical testing of this type of device. Mechanical testing results are based on objective physical measurements and engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used to establish ground truth in studies involving subjective interpretation (like AI diagnostics). Mechanical tests do not require this.
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
- Not Applicable. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. This device is a surgical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical surgical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical testing: The "ground truth" is defined by established engineering principles and the limits specified by the ASTM F1717-15 standard, as well as comparison to the known performance of predicate devices. There's no "expert consensus" on mechanical measurements in the way there is for medical diagnoses.
- For demonstrating substantial equivalence: The ground truth is the performance and safety profiles of the legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This device is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.
In summary, this FDA 510(k) submission primarily relies on demonstrating substantial equivalence through a comparison of design, materials, intended use, and mechanical testing to predicate devices already on the market. It does not involve a performance study against specific acceptance criteria for a diagnostic AI system, and therefore, many of the requested elements are not present in this document.
§ 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.