(230 days)
The Idys™ C device is indicated for cervical interbody fusion procedures in 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. This device is to be used in patients who have had six weeks of non-operative treatment. The Idys™ C device is to be used with supplemental fixation. The Idys™ C device is also required to be used with autograft and is to be implanted via an open, anterior approach.
The Idys™ C consists of medical grade INVIBIO PEEK OPTIMA LT1 cervical cages of various widths and heights, which can be inserted between two cervical or cervico-thoracic vertebral bodies to give support during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.
The Clariance Idys™ C device is a cervical intervertebral body fusion device. The acceptance criteria and supporting study information are outlined below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test) | Reported Device Performance (Results) |
|---|---|
| Static axial compression | Results determined to be substantially equivalent to legally marketed devices. |
| Dynamic axial compression | Results determined to be substantially equivalent to legally marketed devices. |
| Static compression shear | Results determined to be substantially equivalent to legally marketed devices. |
| Dynamic compression shear | Results determined to be substantially equivalent to legally marketed devices. |
| Subsidence testing | Results determined to be substantially equivalent to legally marketed devices. |
| Expulsion testing | Results determined to be substantially equivalent to legally marketed devices. |
| Wear testing | Results determined to be substantially equivalent to legally marketed devices. |
Study that Proves Device Meets Acceptance Criteria:
CLARIANCE conducted performance testing according to ASTM F2077 and ASTM F2267 standards. These tests included static and dynamic axial compression, static and dynamic compression shear, subsidence testing, expulsion testing, and wear testing. The results of these studies demonstrated that the Idys™ C device is "substantially equivalent" to legally marketed predicate devices, specifically the Medtronic Sofamor Danek, Inc.'s CORNERSTONE® PSR Spinal System (K100214) and Medicrea Technologies's IMPIX-C Cervical Interbody Device (K072226).
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes used for each performance test (e.g., number of devices tested for static compression). It refers to the testing being conducted "per ASTM F2077 and ASTM F2267," implying that the sample sizes would adhere to the requirements of these standards.
- Data Provenance: Not explicitly stated. The testing appears to be conducted by the manufacturer, CLARIANCE, based in France. The data would therefore be prospective, generated specifically for this regulatory submission.
3. Number of Experts and Qualifications for Ground Truth
This is a physical device performance study, not a study involving human interpretation of data (e.g., medical imaging). Therefore, there were no "experts" in the sense of clinicians or radiologists establishing ground truth. The "ground truth" for the device's performance is established by the defined parameters and methodologies of the ASTM standards, and the comparison is made against the performance of legally marketed predicate devices.
4. Adjudication Method
Not applicable. This is not a study requiring adjudication of expert opinions. The performance is objectively measured against standard criteria and compared to predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a study of a physical medical device's mechanical performance, not an AI-assisted diagnostic tool or an imaging study that would involve human readers.
6. Standalone Performance (Algorithm Only)
Not applicable. This device is a physical implant, not a software algorithm. The "standalone performance" here refers to the mechanical and structural integrity of the device itself under various simulated physiological conditions.
7. Type of Ground Truth Used
The ground truth used for these performance tests is objective physical measurements as defined by the ASTM F2077 and ASTM F2267 standards. These standards specify test methods to evaluate the mechanical characteristics of intervertebral body fusion devices, and the results are then compared to the known performance (or regulatory acceptance) of predicate devices.
8. Sample Size for Training Set
Not applicable. This is a physical device, and the concept of a "training set" is not relevant to its mechanical performance testing.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for this type of device performance study.
§ 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.