(106 days)
The Solitaire™ and Solitaire™ PEEK Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Additionally, the Solitaire™ Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The Solitaire™ Osseotite® Screws are used with the spacers in the Solitaire™ and Solitaire™ PEEK Anterior Spinal System. The screws are fabricated from Titanium alloy and are acid closed to create a roughened surface.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Solitaire™ and Solitaire™ PEEK Anterior Spinal System with Solitaire™ Osteotite® Screws:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific quantitative acceptance criteria or reporting detailed performance metrics against those criteria in a typical clinical study sense. The "acceptance criteria" here is met by showing that the device is "adequate for its intended use" and "substantially equivalent" to existing, legally marketed devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability | |
| (Adequacy for intended use, biomechanical integrity) | "Mechanical testing demonstrates that the Solitaire™ Osseotite® Screws when used with the spacers in the Solitaire™ and Solitaire™ PEEK Anterior Spinal System are substantially equivalent to other spacers currently on the market and is adequate for its intended use." |
| "The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period." | |
| Osseointegration & Fixation Strength | |
| (Specific to Osteotite® Screws) | "animal testing has demonstrated that the roughened surface area of the screw increases osseointegration and enhances screw fixation strength in the spine in a healthy sheep model." |
| Substantial Equivalence (Overall Safety/Effectiveness) | "The Solitaire™ Osseotite® Screws when used with the spacers in the Solitaire™ PEEK Anterior Spinal System are substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for specific quantitative tests on human subjects. The primary "test" for this submission appears to be mechanical testing and animal studies, and comparability to predicate devices.
- Data Provenance:
- Mechanical Testing: Performed on the device itself. No information on location or specifics of the labs.
- Animal Testing: Conducted in a "healthy sheep model." No specific country of origin is mentioned beyond this. This is a pre-clinical/animal study, not a human clinical study. The document explicitly states: "Although animal data is not necessarily indicative of human clinical outcomes..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The study described is primarily mechanical and animal-based, not involving human expert consensus on diagnostic or prognostic performance.
- The FDA review process involves their own experts, but this refers to the study design itself.
4. Adjudication Method for the Test Set:
- Not applicable or not provided. As this is primarily mechanical and animal testing, there wouldn't be an adjudication method in the context of human reader disagreement.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a spinal implant, not an AI-assisted diagnostic or treatment planning tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical spinal implant, not an algorithm or AI system. Standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used:
- Mechanical Testing: Engineering specifications and ASTM/ISO standards for material properties and device performance serve as the "ground truth" for mechanical integrity.
- Animal Testing: Biological outcomes (osseointegration, screw fixation strength) measured directly in the sheep model constitute the ground truth for that specific pre-clinical study.
- Substantial Equivalence: The ground truth for this aspect is the established safety and effectiveness of the predicate devices that are already legally marketed.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical device, not an AI/machine learning model that requires a training set. The "design" and "technological characteristics" are developed through engineering and manufacturing processes, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, this is not an AI/ML device, so there is no training set or ground truth in that context.
§ 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.