(113 days)
The UniSpace® Stand-Alone C 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 radiographic studies. The UniSpace® Stand-Alone C Cage implants are to be used with either autogenous bone graff and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. The Cages of the UniSpace® Stand-Alone C Cage must be used with the two internal fixation screws provided. The Cages 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® Stand-Alone C Cage is product for cervical spinal column stability. The implants of the UniSpace® Stand-Alone C Cage consist of the Cages manufactured through additive manufacturing (ASTM F3001) and the machined Variable screws and Locking plates (ASTM F136). The Locking plate consists of a Blocking plate and a Locking screw and is an additional device for the anti-backout of the Variable screw. This optional implant can help users who feel uncomfortable with the primary self-locking mechanism or when rescue screws are utilized. The Cages and Variable screws are provided 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 Cages of the UniSpace® Stand-Alone C Cage are provided as a sterile pack. The UniSpace® Stand-Alone C Cage is implanted by using the instruments manufactured from stainless steel material that conform to ASTM F899.
The provided text describes the UniSpace® Stand-Alone C Cage, an intervertebral body fusion device. However, it does not contain information about acceptance criteria and device performance in the context of a clinical study or a study involving human readers and AI. The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to predicate devices, supported by bench testing.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
- Standalone (algorithm-only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
The provided text only details the mechanical (bench) testing performed for the device. Here's what can be extracted regarding the bench testing:
1. A table of acceptance criteria and the reported device performance
The document states: "The mechanical performance of UniSpace® Stand-Alone C Cage falls within the acceptance criteria which have been established from the predicate devices." and "The testing meets all acceptance criteria and verifies that performance of the UniSpace® Stand-Alone C Cage is substantially equivalent to the predicate devices and reference devices."
However, the specific numerical acceptance criteria or the reported device performance metrics (e.g., specific load values, displacement, cycles to failure) are not provided in the text. It only lists the types of tests performed.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static compression test (ASTM F2077) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Static torsion test (ASTM F2077) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Static compression shear test (ASTM F2077) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Dynamic compression test (ASTM F2077) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Dynamic torsion test (ASTM F2077) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Dynamic compression shear test (ASTM F2077) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Subsidence test (ASTM F2267) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Axial pullout test (ASTM F543) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Torsional properties test (ASTM F543) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Driving Torque test (ASTM F543) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Locking band strength test (ASTM F04-25-02-02, ASTM F543) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Locking plate strength test (ASTM F04-25-02-02, ASTM F543) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
| Torsional strength test for Locking screw (ASTM F543) | "Falls within acceptance criteria established from predicate devices" (specific criteria not provided) | Not provided |
The remaining points (2-9) are not applicable as the document describes a bench testing study for a physical medical device (intervertebral cage) and not a study involving AI, human readers, or a test/training set of data for diagnostic purposes.
§ 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.