(79 days)
The Camber Spine Technologies Diagon Oblique Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Camber Spine Technologies Diagon Oblique Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
Camber Spine Technologies Diagon Oblique Cage implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Camber Spine Technologies, Diagon Oblique Cage is a device for interbody fusion of the anterior column of the spine. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces.
Camber Spine Technologies, Diagon Oblique Cage is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths, heights and shapes. Camber Spine designed the Camber Spine Technologies, Diagon Oblique Cage to be placed through a transforaminal or posterior approach and to address vertebrae in the lumbosacral region of the spine.
The Camber Spine Technologies, Diagon Oblique Cage is made from Implant grade (PEEK) per ASTM2026 (Solvay Zeniva ZA-500) which is a radiolucent material with embedded tantalum x-ray markers as specified in ASTM F560.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Camber Spine Technologies Diagon Oblique Cage:
It's important to note that the provided document is a 510(k) summary for a medical device (an intervertebral fusion cage), not an AI/software device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable. I will address the applicable sections and indicate where information is not present due to the nature of the device.
Acceptance Criteria and Device Performance Study for Camber Spine Technologies Diagon Oblique Cage
This document describes the non-clinical testing performed to demonstrate that the Camber Spine Technologies Diagon Oblique Cage is substantially equivalent to its predicate devices. The studies focus on mechanical properties relevant to an intervertebral fusion device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance (Met Criteria?) |
|---|---|
| Static Compression Test per ASTM F2077 | Met the acceptance criteria |
| Static Compression Shear Test per ASTM F2077 | Met the acceptance criteria |
| Subsidence Test per ASTM F2267 | Met the acceptance criteria |
| Static Expulsion Test | Met the acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (N) for each of the non-clinical tests conducted (Static Compression, Static Compression Shear, Subsidence, Static Expulsion).
Data provenance is not applicable in the context of these non-clinical, in-vitro mechanical tests. These tests are conducted in a laboratory setting on manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for mechanical performance tests of a physical device is determined by the results of the standardized tests themselves, measured against predefined engineering specifications and ASTM standards, not by human expert interpretation in the way AI ground truth is established.
4. Adjudication Method for the Test Set
This is not applicable to non-clinical mechanical testing. Test results are compared directly against established ASTM standards and internal specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging or AI algorithms where human interpretation is involved. The device in question is a physical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical intervertebral cage, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by engineering specifications and standardized test methods (ASTM standards F2077, F2267). The device's performance is objectively measured against the criteria outlined in these standards and internal design requirements.
8. The Sample Size for the Training Set
This is not applicable. There is no concept of a "training set" for the type of non-clinical mechanical testing described for this physical medical device. Manufacturing processes are validated, but this is distinct from training an AI model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of device and testing.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.