(54 days)
The Stabilis SA Cervical Stand-Alone System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space.
The Stabilis SA Cervical Stand-Alone System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Stabilis SA Cervical Stand-Alone System cages may be used as a stand-alone device when two (2) vertebral body bone screws are used. Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may be used as a stand-alone device when at least two (2) vertebral body bone screws are utilized with one inferior and one superior screw trajectory on opposite sides of the cage. If the physician chooses to use Stabilis SA Cervical Stand-Alone System cages with fewer than two (2) screws, then an additional supplemental spinal fixation system cleared for use in the cervical spine must be used.
Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may only be used at contiguous levels if at least two (2) vertebral body bone screws are utilized in each cage with one inferior and one superior screw trajectory on opposite sides of the cage, such that no more than two (2) vertebral body bone screws are implanted at the shared vertebral body with one inferior and one superior screw trajectory on opposite sides of the cages. Additionally, a cage with four (4) screw holes and a cage with two (2) screw holes can be implanted contiguously only if the cage with four (4) screw holes uses at least (2) vertebral body bone screws with one inferior screw on the left side of the cage and one superior screw on the right side of the cage.
The Stabilis SA cages are intervertebral body fusion devices intended for cervical interbody fusion using an anterior approach. The devices are intended to improve stability of the spine while supporting fusion. Stabilis SA constructs are intended for use at one or two contiguous levels in the cervical spine (C2-T1). The components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy.
Stabilis SA Cervical Stand-Alone System cages are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. All cages are manufactured using the L-PBF (laser powder bed fusion) additive manufacturing method. L-PBF allows for the formation of solid, non-porous cages with a layered porous lattice structure on the surfaces of the components, including the surfaces of the interior graft window. This intricate structure facilitates bone in-growth by providing a larger surface of implant/bone contact than a buffed surface. The cages are also titanium anodized to allow for identification of various heights by color. The Stabilis SA Cervical Stand-Alone System cages are secured on the vertebral bodies using bone screws. The bone screws are machined from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and passivated according to ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants.
Stabilis Ti SA 2 Interbody, Stabilis Ti SA 2 Interbody, Curved, Stabilis Ti SA 4 Interbody, Stabilis Ti SA 4 Interbody, Curved, Stabilis Ti ZP Interbody, Stabilis Ti ZP Interbody, Curved cages, and bone screws are also available with a hydroxyapatite coating to increase implant anchoring by facilitating osseointegration and enhancing early bone growth. All Stabilis SA Cervical Stand-Alone implants are only available sterile packaged.
Non-sterile, reusable surgical instruments to support implantation of the system are provided for use with Stabilis SA Cervical Stand-Alone devices are provided in steam sterilization trays.
Here's an analysis of the provided FDA 510(k) clearance letter for the Stabilis SA Cervical Stand-Alone System, focusing on the acceptance criteria and study information:
This document describes the mechanical testing performed on an intervertebral body fusion device and does not involve AI. Therefore, many of the typical questions regarding AI device studies are not applicable.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Stabilis SA Cervical Stand-Alone System (Intervertebral Body Fusion Device)
| Acceptance Criteria (Test Methods) | Reported Device Performance |
|---|---|
| Mechanical Performance Testing (per ASTM F2077, ASTM F2267): | The performance testing demonstrated substantial equivalence between the subject and predicate devices. The results of the non-clinical testing did not identify any new or increased risks. Performance equivalence demonstrated that the subject device met the acceptance criteria of the standards and is substantially equivalent to the predicate devices. |
| - Static Axial Compression | Meets acceptance criteria (implied by overall statement) |
| - Static Axial Compression Shear | Meets acceptance criteria (implied by overall statement) |
| - Static Torsion | Meets acceptance criteria (implied by overall statement) |
| - Dynamic Axial Compression | Meets acceptance criteria (implied by overall statement) |
| - Dynamic Axial Compression Shear | Meets acceptance criteria (implied by overall statement) |
| - Dynamic Torsion | Meets acceptance criteria (implied by overall statement) |
| - Static Subsidence (per ASTM F2267) | Meets acceptance criteria (implied by overall statement) |
| Material/Manufacturing Testing (per ASTM F3001, ASTM F136, ASTM F86): | The results of the non-clinical testing did not identify any new or increased risks associated with the change in additive manufacturing supplier. |
| - Tensile Testing | Meets acceptance criteria (implied by overall statement) |
| - Microstructure Assessment | Meets acceptance criteria (implied by overall statement) |
| - Chemical Composition Assessment | Meets acceptance criteria (implied by overall statement) |
| - Passivation (for bone screws) | Meets acceptance criteria (implied by overall statement) |
| - Biocompatibility Testing | Meets acceptance criteria (implied by overall statement) |
| - Sterilization and Packaging Validation | Meets acceptance criteria (implied by overall statement) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the mechanical performance testing (e.g., number of devices tested for each mechanical test). It refers to the tests as being conducted on "the worst-case subject device" and "new implant sizes and configurations."
The data provenance is from non-clinical (mechanical and material) testing performed on the physical device, not patient data. Therefore, concepts like country of origin or retrospective/prospective do not apply in the typical sense for clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable as this is a non-clinical device clearance for an intervertebral body fusion device, not an AI/software device requiring "ground truth" derived from expert interpretation of clinical data. The "ground truth" here is the adherence to established mechanical and material standards and the performance equivalence to predicate devices.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to how expert disagreements are resolved when establishing ground truth in clinical data interpretation studies. This document describes mechanical and material testing, not clinical data assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or prognostic AI/software devices where human reader performance is being evaluated with and without AI assistance. This document pertains to the mechanical and material safety and effectiveness of a physical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This device is a physical implant, not an algorithm. Standalone performance typically refers to the diagnostic or predictive capability of an AI algorithm without human input or modification of the output.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Adherence to recognized industry standards: ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices), ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices Under Static Axial Compression), ASTM F3001 (Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI), ASTM F136 (Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy), and ASTM F86 (Practice for Surface Preparation and Marking of Metallic Surgical Implants).
- Performance equivalence to previously cleared predicate devices, as demonstrated through mechanical and material testing.
8. The Sample Size for the Training Set
Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the device's design is based on engineering principles, material science, and the performance characteristics of previously cleared predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set in the context of AI/ML, there is no ground truth established for it. The standards and predicate devices guide the design and manufacturing, but this is a different concept than ground truth for machine learning.
§ 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.