(88 days)
The SpineFrontier Indus™ ACP System (Indus™ Invue™, Indus™ Invue™2, Indus Inset") 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 SpineFrontier Indus™ ACP 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 SpineFrontier Indus™ ACP System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V El.I) that conforms to ASTM F 136.
The provided text describes a medical device, the SpineFrontier Indus™ ACP System, and its clearance process through a 510(k) premarket notification. This type of submission relies on demonstrating "substantial equivalence" to a predicate device, primarily through non-clinical performance data. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/software performance metrics (like accuracy, sensitivity, etc.) is not applicable here.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from device guidance) | Reported Device Performance (as demonstrated) |
|---|---|
| Substantial equivalence to predicate devices in: | Substantially equivalent to predicate devices in: |
| - Indications for Use | - Indications for Use |
| - Function | - Function |
| - Operating Principles | - Operating Principles |
| - Materials | - Materials (Titanium alloy - Ti-6Al-4V El.I) |
| - Performance (Mechanical Testing) | - Performance (Mechanical testing per ASTM Standard F1717) |
The document explicitly states: "The SpineFrontier Indus™ ACP 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."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This device clearance was based on mechanical testing, not clinical studies with human participants or data.
- Data Provenance: Not applicable. The "data" refers to the results of mechanical tests, not 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, in the context of expert consensus on patient data, is not relevant to mechanical testing.
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 a medical device (spinal implant) and not an AI/software device that assists human readers.
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
- The "ground truth" for this medical device would be adherence to the specifications for materials and the established performance standards set by ASTM F1717 for spinal implant constructs. These are objective, rather than expert-derived, measures.
8. The sample size for the training set
- Not applicable. There is no AI component or training set involved in the clearance of this physical medical device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study Proving Device Meets Acceptance Criteria:
The SpineFrontier Indus™ ACP System demonstrated its acceptance criteria by performing mechanical testing in accordance with ASTM Standard F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This testing allowed the manufacturer to show that the device's performance, along with its indications for use, function, operating principles, and materials, was substantially equivalent to legally marketed predicate devices (K093776, K050588, K073275, K030866).
The FDA guidance "Spinal System 510(k)s, May 3, 2004" dictated that clinical data was not required for this device, emphasizing the reliance on non-clinical, mechanical performance data for clearance. The successful completion of this mechanical testing, demonstrating equivalence to the predicate devices, served as the "study" proving the device met the required regulatory "acceptance criteria" for substantial equivalence.
§ 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.