(163 days)
The Camber Spine Technologies SPIRA-C Integrated Fixation System consists of a stand-alone interbody device indicated for use at one or two contiguous levels in the cervical spine, from C2-C3 disc to the C7-T1 disc, in skeletally mature patients who have had six weeks of non-operative treatment for the cervical disk disease is defined as intractable radiculopathy and/or myelopathy with hermiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The SPIRA-C Integrated Fixation System must be used with internal screw fixation. The Camber Spine Technologies SPIRA-C Integrated Fixation System must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The SPIRA®-C Integrated Fixation System consists of a stand-alone interbody fusion device with internal screw fixation. The SPIRA®-C Integrated Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one or two levels from the C2-C3 disc to the C7-T1 disc. The system is comprised of a Titanium Alloy (Ti-6Al-AV ELI) interbody cage and screws. The SPIRA®-C Integrated Fixation System cages are provided in 7 degrees of lordosis, 6-12mm heights, 14-20mm widths and 13-16mm depths. This device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The SPIRA® C Integrated Fixation System is that has spiral supports to allow chamber to permit packing with autogenous and/ or allogenic bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The titanium alloy interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism. The bone screws used with this device are provided in self-tapping options, along with variable angle and fixed angle trajectories, and are manufactured from medical grade titanium alloy. The bone screws are provided in 3.5mm and 4.0mm diameters and 12-18mm lengths.
This document describes the SPIRA-C Integrated Fixation System, an intervertebral body fusion device. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Performance Testing Summary" section.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Compression-Shear | As mechanically sound as predicate devices (per ASTM F2077-18 and F2267-04) | Met acceptance criteria (specifically, predicate device performance was met) |
| Static Torsion | As mechanically sound as predicate devices (per ASTM F2077-18 and F2267-04) | Met acceptance criteria (specifically, predicate device performance was met) |
| Dynamic Compression | As mechanically sound as predicate devices (per ASTM F2077-18 and F2267-04) | Met acceptance criteria (specifically, predicate device performance was met) |
| Dynamic Compression-Shear | As mechanically sound as predicate devices (per ASTM F2077-18 and F2267-04) | Met acceptance criteria (specifically, predicate device performance was met) |
| Dynamic Torsion | As mechanically sound as predicate devices (per ASTM F2077-18 and F2267-04) | Met acceptance criteria (specifically, predicate device performance was met) |
| Subsidence | As mechanically sound as predicate devices (per ASTM F2077-18 and F2267-04) | Met acceptance criteria (specifically, predicate device performance was met) |
| Screw and Anti-backout Mechanism Resistance to Pushout Forces | Explicitly defined acceptance criteria (not detailed in the provided text, but implied as measurable) | Demonstrated resistance met acceptance criteria |
| 2. Sample size used for the test set and the data provenance: |
The document mentions "Testing performed" and "The results demonstrate" but does not specify the sample size for the mechanical tests. The data provenance is not explicitly stated as retrospective or prospective, but given the nature of mechanical testing for a medical device, it would be prospective laboratory testing conducted specifically for this submission. The "country of origin of the data" is not stated, but the submission is to the U.S. FDA, implying the data would be generated in a manner acceptable for U.S. regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a mechanical device test, not an AI or diagnostic imaging study. Therefore, the concept of "ground truth established by experts" in the clinical sense (e.g., radiologists interpreting images) does not apply. The "ground truth" here is based on engineering standards (ASTM) and performance relative to predicate devices. The expertise would lie in the engineers and technicians conducting and interpreting the mechanical tests according to these standards. The document does not specify the number or qualifications of the personnel who performed these tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a mechanical device test, not a clinical study involving human interpretation or adjudication.
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 document pertains to the mechanical safety and effectiveness of an intervertebral body fusion device, not an AI or diagnostic imaging system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
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 mechanical device testing is based on:
- Established ASTM standards (F2077-18 and F2267-04): These standards define methodologies and criteria for evaluating spinal implant performance.
- Performance of legally marketed predicate devices: The device's performance is accepted if it is "as mechanically sound as predicate devices." This implies that the 'ground truth' for acceptable performance is benchmarked against the established performance of existing, cleared devices.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no training set for a physical medical device.
§ 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.