(121 days)
The Idys™ ALIF (Anterior Lumbar Integrated Fusion) System is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF System should be used with the integrated fixation screws provided.
The Idys™ ALIF System is intended to be used with autograft.
The Idys™ ALIF System is manufactured from medical grade polyetheretherketone (INVIBIO PEEK OPTIMA LT1) and is to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates and helps resist back out.
The Idys™ ALIF System is connected to a plate with four screws for a standalone implantation. The Idys™-ALIF System are made of ASTM F2026 compliant polyetheretherketone (PEEK) and markers made of Tantalum according to ASTM F560, the plate and screws are made of ASTM F136 titanium alloy.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is available and noting what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Outcome) |
|---|---|
| Modified ASTM F2077 (for static and dynamic axial compression) | Determined to be substantially equivalent to legally marketed devices. |
| Modified ASTM F2077 (for static and dynamic compression shear) | Determined to be substantially equivalent to legally marketed devices. |
| Modified ASTM F2077 (for subsidence testing) | Determined to be substantially equivalent to legally marketed devices. |
| Modified ASTM F2077 (for expulsion testing) | Determined to be substantially equivalent to legally marketed devices. |
| Modified ASTM F2077 (for torsion testing) | Determined to be substantially equivalent to legally marketed devices. |
| Modified ASTM F2077 (for wear particle characterization) | Determined to be substantially equivalent to legally marketed devices. |
| ASTM F2267 (specific tests not detailed, but generally for spinal systems) | Determined to be substantially equivalent to legally marketed devices. |
| ISO 11137-1 (Sterilization of health care products - Radiation) | Complies |
| ISO 11137-2 (Sterilization of health care products - Radiation) | Complies |
| ISO 11607-1 (Packaging for terminally sterilized medical devices) | Complies |
| ISO 11607-2 (Packaging for terminally sterilized medical devices) | Complies |
| (Mechanical performance of smaller footprint) | No adverse impact on mechanical performance. |
| (Differences in plate width/profile vs. predicate) | Do not raise new or different issues of safety and effectiveness; supported by testing. |
| (Differences in shape vs. Idys LIF) | Do not raise different types of safety or effectiveness questions; mechanical testing shows at least equivalent performance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes bench testing for mechanical performance. Therefore, typical "test set sample sizes" for clinical or image-based studies, and "data provenance" (country of origin, retrospective/prospective) are not applicable here. The "test set" would refer to the number of devices tested for each mechanical assessment, but this specific number is not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable as the studies described are bench tests for mechanical performance, not clinical studies or studies requiring expert interpretation of data.
4. Adjudication Method for the Test Set
This is not applicable for the type of bench testing performed. Adjudication methods are typically used for clinical endpoints or image interpretation where human judgment is involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a series of bench tests comparing the physical and mechanical properties of the device to predicate devices and standards.
6. Standalone (Algorithm Only) Performance Study
No, this is not applicable. The device is an intervertebral body fusion system, not an algorithm or AI software for which standalone performance would be assessed.
7. Type of Ground Truth Used
The "ground truth" for the performance studies primarily consisted of:
- Established ASTM (American Society for Testing and Materials) standards: F2077, F2267.
- Established ISO (International Organization for Standardization) standards: 11137-1, 11137-2, 11607-1, 11607-2.
- Performance of legally marketed predicate devices: DIVERGENCE-L (K150135) and Idys LIF (K131178) serve as the benchmark for "substantial equivalence."
8. Sample Size for the Training Set
This is not applicable. The device is a physical medical implant, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this device.
§ 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.