(24 days)
The 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 I 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.
This submission is for a line extension to the Solitaire PEEK Anterior Spinal System to add an additional style of spacer with a modified screw angle. This modified device will be marketed as Solitaire-35.
The provided text describes a 510(k) submission for a medical device, the Solitaire PEEK Anterior Spinal System line extension (Solitaire 35°), which is a lumbar stand-alone intervertebral body fusion device. The focus of the submission is to demonstrate substantial equivalence to predicate devices, primarily through mechanical performance testing.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Special Controls Guidance Document: Intervertebral Body Fusion Device) | Reported Device Performance | Comments |
|---|---|---|
| Static Axial Compression (ASTM F-2077) | Mechanical testing shows the strength of the subject device is sufficient for its intended use. | Specific values (e.g., failure loads or displacement) are not provided in the summary, only a general statement of sufficiency. |
| Dynamic Axial Compression (ASTM F-2077) | Mechanical testing shows the strength of the subject device is sufficient for its intended use. | Specific values are not provided. |
| Static Compression-Shear (ASTM F-2077) | Mechanical testing shows the strength of the subject device is sufficient for its intended use. | Specific values are not provided. |
| Dynamic Compression-Shear (ASTM F-2077) | Mechanical testing shows the strength of the subject device is sufficient for its intended use. | Specific values are not provided. |
| Implant Subsidence Analysis (Engineering Analysis) | An engineering analysis regarding implant subsidence was presented. | No details on the acceptance criteria or the specific findings of the analysis are provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes mechanical testing of the device prototypes, not a clinical trial involving human subjects or patient data. Therefore, the concepts of "test set" in the context of patient data, data provenance, or retrospective/prospective studies are not applicable here. The sample size for the mechanical tests (e.g., number of devices tested for each condition) is not specified in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is a mechanical performance evaluation of a physical device, not an assessment requiring expert interpretation of clinical data or images to establish ground truth.
4. Adjudication Method for the Test Set
This is not applicable for mechanical testing. Adjudication methods are typically employed in clinical studies or studies involving human readers/interpreters where disagreements in assessment need to be resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted or described in the provided text. The study focuses purely on the mechanical performance of the device itself, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical intervertebral body fusion device and not an algorithm or AI system.
7. The Type of Ground Truth Used
For mechanical testing, the "ground truth" would be the physical properties and performance characteristics of the device under specific load conditions, measured by calibrated testing equipment. The adherence to ASTM standards for these tests establishes the methodology for determining this performance.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
Summary of Study and Findings:
The study described is a set of mechanical performance tests conducted on the Solitaire PEEK Anterior Spinal System line extension (Solitaire 35°). The purpose of these tests was to demonstrate that the device meets the special controls guidance document "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." The tests included:
- Static Axial Compression (ASTM F-2077)
- Dynamic Axial Compression (ASTM F-2077)
- Static Compression-Shear (ASTM F-2077)
- Dynamic Compression-Shear (ASTM F-2077)
- An engineering analysis regarding implant subsidence.
The conclusion drawn from these tests is that "Mechanical testing shows the strength of the subject device is sufficient for its intended use." This conclusion, along with the technological characteristics and indications for use, supported the determination of substantial equivalence to predicate devices. No specific quantitative performance metrics or sample sizes for the mechanical tests are provided in this summary.
§ 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.