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510(k) Data Aggregation
(100 days)
Unison-C Anterior Cervical Fixation System
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. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system 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 to provide structural stability in skeletally mature individuals following discectomy. The system includes intervertebral body implants (with an integrated locking mechanism and radiographic pins) and screws, and does not require the use of supplemental fixation.
These implants are manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone) (ASTM F2026)), to allow radiographic imaging inside the implant to evaluate fusion status. The implants are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant positioning. The screws and locking mechanism are manufactured from of titanium alloy (ASTM F136). Sterile implants are provided sterile by gamma irradiation.
Implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments. Cases and caddies are supplied for sterilization and transport of the non-sterile implants and instruments.
The purpose of this submission is to obtain clearance of modifications to the predicate system (K152793).
The provided text describes a medical device, the "Unison®-C Anterior Cervical Fixation System," and its clearance by the FDA. However, it does not detail a study proving the device meets specific acceptance criteria in the context of AI/ML performance.
The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance (mechanical testing) rather than clinical studies or performance against specific AI/ML criteria. Therefore, most of the requested information regarding AI/ML device performance and ground truth establishment cannot be extracted from this document.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Performance) | Reported Device Performance |
|---|---|
| Non-Clinical Performance | |
| Static axial compression (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Static compressive shear (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Static torsion (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Static Subsidence (per ASTM F2267-04) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Dynamic axial compression fatigue (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Dynamic compressive shear (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Dynamic torsion (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Locking mechanism disassociation testing | Testing performed. Results deemed substantially equivalent to predicate system. |
| Screw push-out | Testing performed. Results deemed substantially equivalent to predicate system. |
| Screw-interbody torque-to-failure testing | Testing performed. Results deemed substantially equivalent to predicate system. |
| Locking mechanism torque-to-failure testing | Testing performed. Results deemed substantially equivalent to predicate system. |
| Pyrogenicity (endotoxin level) | Evaluated using LAL assay. Device will be tested to ensure endotoxin level meets requirements ( |
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(113 days)
Unison-C Anterior Cervical Fixation System
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.
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