(97 days)
The INDUS™ Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in whom stability is desired following anterior cervical fusion. The levels of treatment range from C2 to C7. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.
The INDUS™ Anterior Cervical Plate System consists of a variety of shapes and sizes of plates, screws, locking crowns, and the associated instruments. The plates are available in four levels to accommodate one to four levels of fixation. The screws come as self tapping or self drilling in various lengths and diameters. The INDUS™ Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136.
The provided text describes the 510(k) summary for the SpineFrontier INDUS™ Anterior Cervical Plate System. This is a spinal implant system, not an AI/ML device, and therefore the acceptance criteria and study details are based on physical device performance, not AI/ML performance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets performance standard of ASTM Standard F1717-04, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." | The INDUS™ Anterior Cervical Plate System meets the performance standard of ASTM Standard F1717-04. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size (number of constructs tested) used for the performance testing. It mentions "Representative samples of the device underwent testing." Data provenance information (country of origin, retrospective/prospective) is also not provided, as this type of mechanical testing typically doesn't involve human data subjects.
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 a physical spinal implant device's performance testing. "Ground truth" in this context refers to established engineering standards (ASTM F1717-04), not expert medical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation, not for mechanical performance testing against a standard.
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
This question is not applicable. The device is a physical spinal implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or AI-related effect size would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by the ASTM Standard F1717-04, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This is a standardized engineering test method, not a medical ground truth based on expert consensus, pathology, or outcomes data in humans.
8. The sample size for the training set
This question is not applicable. The device is a physical spinal implant, not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable. The device is a physical spinal implant, not an AI/ML system.
§ 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.