(45 days)
The 2 Hole Lateral Plating System is intended to be used as a non-pedicle lateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:
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Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
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Spondylolisthesis
-Spinal stenosis
- -Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-Tumor
-Pseudoarthrosis
-Failed previous fusion
-Trauma (i.e., fracture or dislocation)
The 2 Hole Lateral Plating System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.
The plates are manufactured in a variety of configurations with options including lengths of 16mm-26mm. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
The 2 Hole Lateral Plating System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
The provided text describes a 510(k) premarket notification for a medical device called the "2 Hole Lateral Plating System." This document is for a spinal implant, not an AI/ML-driven diagnostic device, which is typically what requires studies with expert adjudication and specific performance criteria like sensitivity, specificity, etc.
Therefore, many of the requested fields about AI/ML device performance (like expert involvement, ground truth establishment, training sets, MRMC studies, etc.) are not applicable to this type of medical device submission. The acceptance criteria in this context relate to demonstrating substantial equivalence to a predicate device, primarily through mechanical performance testing.
Here's the information that can be extracted or inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Benchtop Testing to demonstrate Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Static Compression per ASTM F1717 | Performance presented, demonstrating substantial equivalence. |
| Dynamic Compression per ASTM F1717 | Performance presented, demonstrating substantial equivalence. |
| Static Torsion per ASTM F1717 | Performance presented, demonstrating substantial equivalence. |
| Screw Push Out Testing (Benchtop) | Performance presented, demonstrating substantial equivalence. |
Note: The document states that the performance "was presented to demonstrate the substantial equivalency," but does not provide specific numerical results or the exact numerical thresholds for acceptance for each test. It implies that the test results met the criteria for substantial equivalence to the predicate devices.
2. Sample size used for the test set and the data provenance
- Not applicable for this type of medical device (spinal implant). The "test set" here refers to the physical devices undergoing benchtop mechanical testing. The number of samples for each mechanical test is not specified in this summary. There is no "data provenance" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for diagnostic algorithms (e.g., expert consensus on images, pathology results) is not relevant for this spinal implant. Substantial equivalence is determined by mechanical testing and comparison to predicate devices.
4. Adjudication method for the test set
- Not applicable.
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. This is not an AI-driven diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used
- For mechanical testing, the "ground truth" would be engineering specifications and standards (e.g., ASTM F-1717) and the performance characteristics of the predicate devices.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established
- Not applicable.
Summary regarding the nature of the submission:
The document is a 510(k) summary for a spinal implant (mechanical device), not an Artificial Intelligence/Machine Learning (AI/ML) diagnostic or therapeutic device. The "acceptance criteria" and "study" refer to mechanical benchtop testing to demonstrate that the new device is "substantially equivalent" to already legally marketed predicate devices. This means that its performance (strength, durability, etc.) is comparable, and it does not raise new questions of safety or effectiveness. The detailed requirements for AI/ML device evaluations (like ground truth, expert adjudication, training/test sets for algorithms) are therefore not relevant to this specific FDA submission.
§ 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.