(85 days)
The ClariVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The ClariVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The ClariVy™ Cervical IBF System is to be used in patients who have six weeks of nonoperative treatment.
The ClariVy™ Cervical IBF System is comprised of implants components. The implant component, the ClariVyTM Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The ClariVy™ NanoVy™ Ti Cervical IBF components are made of PEEK Optima LT1 with CP Titanium coating. The ClariVyTM Cervical IBF System may also include Titanium alloy bone screws to secure the device to the vertebral body.
This document is a 510(k) summary for the ClariVy™ Cervical IBF System. It is focused on demonstrating substantial equivalence to predicate devices for a medical implant, not an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria, studies, ground truth establishment, expert involvement, and reader studies are not applicable to the information provided.
The document describes the device, its intended use, and substantial equivalence to legally marketed predicate devices primarily based on non-clinical testing of the implant's physical and mechanical properties.
Here's the relevant information that can be extracted from the provided text, while noting the inapplicability of AI/ML specific questions:
1. A table of acceptance criteria and the reported device performance
Since this is a medical implant and not an AI/ML device, the "acceptance criteria" are related to mechanical and material performance standards for intervertebral body fusion devices, rather than diagnostic accuracy metrics. The document states that non-clinical testing was performed using "various ASTM Standards" at a third-party facility. However, specific acceptance criteria values (e.g., minimum compression strength, fatigue life) and reported performance values are not detailed in this summary. It only states that the tests "demonstrate that the ClariVy™ Ti Cervical IBF is as safe, as effective, and performs as well or better than a legally marketed predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ASTM Standards for intervertebral body fusion devices (e.g., mechanical properties, material biocompatibility, structural integrity, fatigue performance). Specific standards are not listed. | Passed non-clinical testing demonstrating safety, effectiveness, and performance equivalent to or better than predicate devices. No specific quantitative performance data is provided in this summary. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This question relates to clinical or imaging study data. As this is for a medical implant and its clearance relies on non-clinical (mechanical and material) testing, the concept of a "test set" in the context of clinical/imaging data or data provenance is not applicable. The "testing" referred to is laboratory-based mechanical and material testing of the device itself.
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)
This question relates to studies involving human interpretation or clinical diagnosis. For a medical implant undergoing non-clinical testing, there is no concept of "experts establishing ground truth" in this manner. The "ground truth" for the device's performance is determined by established engineering and material science testing protocols and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This refers to clinical study result adjudication, which is not relevant for the non-clinical testing of a medical implant as described.
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 question concerns AI/ML diagnostic performance studies. The ClariVy™ Cervical IBF System is a physical medical implant, not an AI/ML device, and no such study was conducted or is relevant for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question concerns AI/ML device performance. The ClariVy™ Cervical IBF System is a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing described, the "ground truth" implicitly refers to the established scientific and engineering principles and standards (e.g., ASTM standards) against which the mechanical and material properties of the implant are measured. There is no biological or diagnostic "ground truth" as would be found in clinical or imaging studies.
8. The sample size for the training set
Not applicable. This question relates to AI/ML model training. The ClariVy™ Cervical IBF System is a physical medical implant.
9. How the ground truth for the training set was established
Not applicable. This question relates to AI/ML model training. The ClariVy™ Cervical IBF System is a physical medical implant.
§ 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.