(113 days)
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Unison-C Anterior Cervical Fixation System is to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is implanted via an anterior approach. The Unison-C Anterior Cervical Fixation System must be used with two of the provided bone screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The Unison-C Anterior Cervical Fixation System is intended for stand-alone cervical interbody fusion procedures and does not require use of supplemental fixation. The Unison-C Anterior Cervical Fixation System is used to provide structural stability in skeletally mature individuals following discectomy. The Unison-C System implants consist of intervertebral body devices (with an integrated locking mechanism and radiographic pins) and screws. The intervertebral body device component is manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone), the radiographic markers consist of ASTM F560 tantalum, and the screws and locking mechanism are comprised of ASTM F136 Titanium Alloy. The Unison-C Anterior Cervical Fixation System is supplied with instrumentation that are necessary for use to facilitate the insertion and removal of the implants as well as general manual surgical instruments.
This document describes the Unison-C Anterior Cervical Fixation System and its substantial equivalence to predicate devices, based on performance data from mechanical testing. It is a 510(k) summary, which typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new clinical application.
Therefore, the requested information regarding acceptance criteria, device performance in clinical studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. The document focuses on non-clinical mechanical testing.
Here's an analysis of what can be extracted and what is explicitly not available given the provided text:
1. A table of acceptance criteria and the reported device performance
- Not available. The document states that the Unison-C Anterior Cervical Fixation System has been tested against several ASTM standards (F2077-11, F2267-04) for static and dynamic mechanical properties, and a locking mechanism disassociation and screw push-out test. However, it does not provide specific acceptance criteria values or the reported performance data against those criteria. It only states, "The results of this non-clinical testing show that the Unison-C Anterior Cervical Fixation System is substantially equivalent to legally marketed predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not available. The testing described is non-clinical mechanical testing, not a clinical study involving a "test set" of patient data. Therefore, concepts like data provenance or retrospective/prospective studies do not apply. The document does not specify the number of samples used for each mechanical test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not available. This information is relevant to clinical studies where expert consensus might establish ground truth for a diagnostic device. The provided document describes mechanical testing of an orthopedic implant, where "ground truth" as typically defined for AI/diagnostic studies is not relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not available. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to resolve discrepancies in expert opinions. This is not mentioned as the study is mechanical.
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
- No. An MRMC study is a type of clinical study, often used for diagnostic devices involving human readers (e.g., radiologists) and AI. This document pertains to mechanical testing of an intervertebral fusion device, not a diagnostic tool or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This question is also relevant to AI/diagnostic devices. The Unison-C system is a physical surgical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not available. As discussed, the concept of "ground truth" in the context of clinical or diagnostic studies does not apply to the mechanical testing described. The "truth" in mechanical testing is typically measured physical properties against engineering specifications or established standards.
8. The sample size for the training set
- Not applicable / Not available. This would be relevant for an AI device. The Unison-C is a physical medical implant.
9. How the ground truth for the training set was established
- Not applicable / Not available. This would be relevant for an AI device.
In summary, the provided document describes a 510(k) premarket notification for a physical medical device (an anterior cervical fixation system). The evidence presented for substantial equivalence is based on non-clinical mechanical testing against established ASTM standards. The document does not provide specific numerical acceptance criteria or performance results from these tests, nor does it involve clinical studies, AI, or human reader performance that would necessitate the other requested details.
§ 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.