(242 days)
The UniSpace™ SA Cervical Cage is a standalone anterior cervical interbody fusion device indicated for skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radios. The UniSpace™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. The cage of the UniSpace™ SA Cervical Cage must be used with the two internal fixation screws provided. UniSpace™ SA Cervical Cage implants with ≥ 20° lordosis must be used with an additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine," in addition to the two integrated fixation screws provided. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The UniSpace™ SA Cervical Cage is product for cervical spinal column stability. The implants of the UniSpace™ SA SA Cervical Cage consist of the cages manufactured through additive manufacturing (ASTM F3001) and the machined variable screws and locking cover plate (ASTM F136). The locking cover plate consists of a locking plate and a locking screw and is an optional device for the anti-backout of the variable screw. This optional implant can provide the more stability to prevent the anti-backout besides the self-locking mechanism. The cages and variable screws are offered in a variety of sizes to accommodate each patient's individual clinical case. The cages are designed to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The cage of the UniSpace™ SA Cervical Cage is provided as a sterile pack. The UniSpace™ SA Cervical Cage is implanted by using the instruments manufactured from stainless steel material that conform to ASTM F899.
The information provided describes the UniSpace™ SA Cervical Cage, a medical device, and its successful application for 510(k) clearance based on substantial equivalence to predicate devices. The documentation focuses on engineering (bench) testing, not on clinical studies involving human patients or AI performance. Therefore, I cannot provide details on AI-specific criteria, sample sizes for medical imaging data, expert qualifications, or multi-reader multi-case studies.
Here's an analysis based on the provided text for the aspects that are covered:
Acceptance Criteria and Device Performance (Bench Testing)
The "acceptance criteria" for this device are established by demonstrating that its mechanical performance is "substantially equivalent" to predicate devices, and that it meets specific ASTM (American Society for Testing and Materials) standards. The reported device performance is that "The testing meets all acceptance criteria and verifies that performance of the UniSpace™ SA Cervical Cage is substantially equivalent to the predicate devices."
Specifically, the device performance is within the established ranges for the predicate devices across the following tests:
| Acceptance Criteria (ASTM Standards & Predicate Equivalence) | Reported Device Performance |
|---|---|
| Static compression test according to ASTM F2077 | Met standards and was substantially equivalent to predicate devices |
| Static torsion test according to ASTM F2077 | Met standards and was substantially equivalent to predicate devices |
| Static compression shear to ASTM F2077 | Met standards and was substantially equivalent to predicate devices |
| Dynamic compression test to ASTM F2077 | Met standards and was substantially equivalent to predicate devices |
| Dynamic torsion test to ASTM F2077 | Met standards and was substantially equivalent to predicate devices |
| Dynamic compression shear to ASTM F2077 | Met standards and was substantially equivalent to predicate devices |
| Subsidence test to ASTM F2267 | Met standards and was substantially equivalent to predicate devices |
| Torsional properties test to ASTM F543 (for screws) | Met standards and was substantially equivalent to predicate devices |
| Axial pullout test to ASTM F543 (for screws, by reference to predicate) | Met standards (by reference to the predicate Velofix™ SA Cervical Cage data due to identical critical parameters) |
| Driving Torque test to ASTM F543 (for screws, by reference to predicate) | Met standards (by reference to the predicate Velofix™ SA Cervical Cage data due to identical critical parameters) |
Non-applicable/Not Provided Information (as per the document's scope)
- Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to physical device units undergoing bench testing, not a dataset of medical images or patient records. No information on the number of devices tested is provided, nor is data provenance relevant in the AI context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI performance requires expert labeling of data, which is not part of this device's mechanical performance evaluation.
- Adjudication method: Not applicable for a mechanical bench test.
- 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 device is a physical intervertebral cage, not an AI diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
- The type of ground truth used: For mechanical testing, the "ground truth" is defined by the physical properties measured according to the ASTM standards and the performance of the established predicate devices. No expert consensus, pathology, or outcomes data is relevant for the mechanical aspects of this submission.
- The sample size for the training set: Not applicable. No AI model was trained.
- How the ground truth for the training set was established: Not applicable. No AI model was trained.
In summary, this FDA submission focuses solely on the mechanical and material equivalence of a physical medical device (intervertebral cage) through bench testing, not on the performance of a medical AI 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.