(112 days)
The AccuFit Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
The AccuFit Lateral Plate System consists of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates and bones screws of varying sizes and lengths. The plate attaches by means of screws to the lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The Lateral Plate System implants and instruments are provided non-sterile. Thev require sterilization prior to use.
This document is a 510(k) premarket notification decision letter from the FDA for the AccuFit™ Lateral Plate System. It confirms that the device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or categorical format for specific performance metrics. Instead, it indicates that the device has undergone performance testing according to recognized ASTM standards and the results lead to a conclusion of substantial equivalence to predicate devices. This implies that the performance met the standards expected for such devices, which is to perform comparably to existing, legally marketed devices.
The performance testing mentioned are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static Axial Compression (per ASTM F1717 standards for equivalence) | Tested per ASTM F1717 (concluded substantially equivalent) |
| Static Torsion (per ASTM F1717 standards for equivalence) | Tested per ASTM F1717 (concluded substantially equivalent) |
| Dynamic Axial Compression (per ASTM F1717 standards for equivalence) | Tested per ASTM F1717 (concluded substantially equivalent) |
The overarching acceptance criterion is achieving substantial equivalence to the predicate devices based on these mechanical tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Performance Testing Summary" which includes mechanical tests (Static Axial Compression, Static Torsion, Dynamic Axial Compression). These are typically benchtop mechanical tests performed on physical device samples, not human or patient data. The document does not specify the sample size (number of devices tested) for these mechanical tests. It also does not provide information about the country of origin or whether "data provenance" (as in, patient data) is relevant for these types of tests, as they are not clinical studies.
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)
This question is not applicable to the information provided. The "test set" here refers to the physical devices undergoing mechanical stress tests, not clinical data requiring expert human interpretation or ground truth establishment in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations of medical data. The tests described are mechanical engineering tests, not clinical evaluations.
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
No, an MRMC comparative effectiveness study was not done. The device is a spinal plate system, a physical implant, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. The device is a physical spinal implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance tests would be the established scientific and engineering principles and the performance benchmarks set by the ASTM F1717 standard for spinal implants, as well as the performance characteristics of the predicate devices. There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for these specific performance tests.
8. The sample size for the training set
This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" for a mechanical device would involve engineering design, material selection, and manufacturing processes, not numerical data sets.
9. How the ground truth for the training set was established
This question is not applicable for the reasons mentioned in point 8.
§ 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.