(69 days)
The Kaneda SR Anterior Spinal System is intended for anterolateral screw fixation to the T10-L3 levels of the spine, with all metal at least 1 cm. from a major vessel. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, kyphosis, lordosis), tumor, fracture and revision of previous surgery. The Kaneda system is used in conjunction with the Isola Spine System. Specifically, the 1) Isola ¼" Rods 2) Isola Open Caps and 3) the Isola Set Screws are interchangeable parts.
The components of the Kaneda SR Anterior Spinal System consist of spinal plates, anterior vertebral body screws, transverse rod couplers and rods. This system can also be used in conjunction with some components of the Isola Spine System. Specifically, 1) the Isola ¼" rods 2) the Isola Open Caps and 3) the Isola Set Screws. The contoured spiked plates are designed to help the construct anchors resist axial forces and serve as a guide for placement of the screws. The plates are available in three sizes (small, medium and large) and are designed as pairs with specific caudal and rostral components. The screws serve to anchor the vertebral bodies to the longitudinal rods. The screws are available in open and closed formats designed to fit the 1/4" rod in cancellous lengths of 35 mm to 60 mm. The Kaneda Anterior Spinal System utilizes the 1/4" diameter rod, available in 18" lengths or in precut lengths from 45 mm to 150 mm.
The provided text pertains to the 510(k) summary for the AcroMed Kaneda SR Anterior Spinal System, a medical device. This document describes the device, its intended use, and its substantial equivalence to previously cleared devices. It also includes the FDA's clearance letter with specific conditions.
However, the provided text does not contain information regarding detailed acceptance criteria for device performance, nor does it describe a specific study (like a clinical trial or performance study with metrics such as sensitivity, specificity, or F1 score) that proves the device meets such criteria.
The "PERFORMANCE DATA" section states: "Static and fatigue testing show the Kaneda SR Anterior Spinal System to perform consistently with previously cleared components." This is a very high-level statement and does not provide:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for a test set or data provenance. The testing mentioned is mechanical ("static and fatigue").
- Number of experts used to establish ground truth or their qualifications. This is not applicable to mechanical testing of physical implants.
- Adjudication method. Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study. Not applicable, as this is a physical medical device (spinal implant), not an AI/software device that assists human readers.
- Standalone performance. The device is a physical implant; its "performance" is mechanical strength and durability, not an algorithm's output.
- Type of ground truth used. For mechanical testing, this would typically be engineering specifications and standards, not expert consensus or pathology in a clinical sense.
- Sample size for the training set. Not applicable for mechanical testing.
- How ground truth for the training set was established. Not applicable for mechanical testing.
Conclusion based on the provided text:
The provided document (K971248 510(k) Summary) states that "Static and fatigue testing show the Kaneda SR Anterior Spinal System to perform consistently with previously cleared components." This implies that the device met certain mechanical performance standards, which are usually defined by industry standards (e.g., ASTM) or internal specifications of the manufacturer, and these standards would constitute the "acceptance criteria" for such a physical implant. However, the exact numerical acceptance criteria, the specific test results, the sample sizes of the tested components, or the detailed methodology of these tests are not disclosed in the provided 510(k) summary. These details would typically be found in the full 510(k) submission, not the summary intended for public release.
Therefore, I cannot populate the requested table or answer the specific questions related to clinical performance, expert ground truth, or AI/software evaluation, as the provided text only refers to mechanical testing for a physical spinal implant.
§ 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.