(108 days)
The Indus™ Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. 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, and 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 nonsterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.
This document describes a 510(k) premarket notification for the Indus 100 Anterior Cervical Plate System.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in terms of indications for use, function, operating principles, and materials. | The Indus™ Anterior Cervical Plate System was shown to be substantially equivalent to predicate devices in these aspects. |
| Performance equivalence to predicate devices (specifically mechanical testing). | The Indus™ Anterior Cervical Plate System has been shown to be substantially equivalent to predicate devices in terms of performance (mechanical testing). Actual test results or specific metrics for mechanical testing (e.g., tensile strength, fatigue life) are not detailed in the provided summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document explicitly states, "Clinical data was not required for this device." The evaluation of this device for substantial equivalence was based on mechanical testing and comparison of technical characteristics to predicate devices, not on clinical or human study data.
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 information is not applicable for the same reason as point 2. No ground truth based on expert review of clinical data was established for evaluating this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 2 and 3.
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 information is not applicable. This is a physical spinal implant device, not an AI or imaging-related medical device. Therefore, an MRMC study related to human readers or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device, in the context of substantial equivalence, appears to be the performance and characteristics of the legally marketed predicate devices. The new device's mechanical performance and design characteristics are compared against these established predicates to demonstrate equivalence. No traditional "ground truth" as derived from clinical outcomes or expert labels was used.
8. The sample size for the training set
This information is not applicable as there was no training set in the context of clinical data or AI model development. The device's evaluation was based on mechanical testing.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
Summary of the Study Proving Acceptance Criteria:
The study proving the device's acceptance criteria was primarily a mechanical testing study and a comparison of technological characteristics against legally marketed predicate devices.
The document explicitly states:
- "The Indus™ Anterior Cervical Plate System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials."
- "The Indus™ Anterior Cervical Plate System has been shown to be substantially equivalent to predicate devices in terms of performance (mechanical testing)."
- "Clinical data was not required for this device."
This means the "study" involved:
- Mechanical Testing: The device underwent mechanical tests to assess its performance characteristics (e.g., strength, fatigue, stability) and these results were compared to the known or expected performance of the predicate devices. The specific tests performed and their quantitative results are not detailed in this summary.
- Design and Material Comparison: A detailed comparison was made between the design, materials (Titanium alloy - Ti-6AI-4V ELI conforming to ASTM F 136), and intended use of the Indus 100 Anterior Cervical Plate System and those of the identified predicate devices (K073232, K030866, K052292, K062831). The goal was to demonstrate that any differences did not raise new questions of safety or effectiveness.
§ 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.