(122 days)
IMPIX-C Cervical Interbody Device is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft.
IMPIX-C Cervical Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
IMPIX-L Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
IMPIX-L Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The IMPIX Cervical Interbody devices consist of implants with a convexity on the upper surface with anti-migration upper ridging and lower pins. The IMPIX Cervical Interbody device has a D-forro with two openings that allow the surgeon to fill it with bone graft. In order to adapt to the warying morphology of patients, both IMPIX Cervical Interbody devices are available in various sizes. The IMPIX Cervical Interbody device is machined from PEEK OPTIMA LT1.
The IMPIX Lumbar Interbody device is bi-convex in the sagittal plane. It possesses teeth on both superior and inferior surfaces that assist in the anchorage and stability of the device to the bone of the vertebrae. The upper and lower aspects of the MPIX-L are open, to allow the surgently pack the device with bone graft prior to insertion. Lateral holes exist to allow bone growth through the device. In order to adapt to the varying morphology of patients, the IMPIX Lumbar Interbody devices are available in various sizes. The IMPIX Lumbar Interbody device is machined from PEEK OPTIMA LT1.
The IMPIX Interbody Device is a medical device and not an AI or software device. Therefore, the traditional metrics of acceptance criteria, sample size for test/training sets, ground truth establishment, expert qualifications, and MRMC studies that apply to AI/ML devices are not relevant here.
Instead, its "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices and meeting established mechanical strength standards for intervertebral body fusion devices.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Substantial Equivalence | Device must be similar in:
- Design
- Material
- Intended Use
to legally marketed predicate devices cleared by FDA for intervertebral body fusion. | The IMPIX Interbody Fusion devices are stated to be "similar in design, material, and intended use to its predicate devices that have been cleared by FDA for intervertebral body fusion." This statement directly addresses the criteria for substantial equivalence. |
| Mechanical Strength | Device must meet "required mechanical strengths" for intervertebral body fusion devices. | "Tests performed according to ASTM F2077 indicate that the IMPIX Interbody Fusion devices meet required mechanical strengths." |
| Indications for Use | The device's indications for use (Cervical and Lumbar) must align with safe and effective applications for intervertebral body fusion as defined by current medical standards and established for predicate devices. | IMPIX-C Cervical Interbody Device: Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7, used with autogenous bone graft and supplemental fixation after at least six weeks of non-operative treatment.
IMPIX-L Lumbar Interbody Device: Indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, possibly with up to Grade I spondylolisthesis or retrolisthesis, used with autogenous bone graft and supplemental fixation after at least six months of non-operative treatment. |
| Material Composition | Material should be biocompatible and suitable for long-term implantation in the spine. | Both the IMPIX Cervical and Lumbar Interbody devices are machined from PEEK OPTIMA LT1. This material is widely accepted in spinal implants. An explicit performance metric is not stated beyond its use. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of an AI/ML test set. The performance data refers to mechanical tests. The number of devices tested for mechanical strength is not specified.
- Data Provenance: The mechanical tests were performed internally or by a testing laboratory according to the ASTM F2077 standard, which is an international standard for spinal implant testing. The country of origin of this specific test data is not mentioned, but the submitter is from France. The nature of these tests is prospective (performed for this submission) rather than retrospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as there is no "ground truth" to be established by clinical experts in the context of a mechanical performance study or substantial equivalence review. The "truth" for mechanical testing is adherence to the ASTM F2077 standard. The FDA reviewers are experts in regulatory compliance and medical device safety.
4. Adjudication Method for the Test Set
- Not applicable. There's no clinical "test set" requiring adjudication. Mechanical test results are objective measurements against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This device is not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant. The effectiveness is determined by its mechanical properties and long-term clinical outcomes (which are typically post-market surveillance for 510(k) devices, not pre-market studies).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This is a physical intervertebral body fusion device, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for this submission relies on:
- Mechanical Engineering Standards: Specifically, ASTM F2077 for intervertebral body fusion devices.
- Regulatory Precedent: The FDA's existing clearances for predicate devices, establishing what is considered safe and effective in terms of design, materials, and intended use.
- Material Science: The properties of PEEK OPTIMA LT1 as a biocompatible and structurally sound material for implantation.
8. Sample Size for the Training Set
- Not applicable as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as this is not an AI/ML 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.