(104 days)
The CAPSTONE® L Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CAPSTONE® L Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.
The CAPSTONE® L Spinal System consists of spacers of various widths and heights made of PEEK with tantalum markers. The spacers can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The implant has non-lordotic and 6° lordotic options. The superior and inferior surfaces of the implant are designed with teeth that interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants are provided sterile by gamma irradiation, and are to be used with supplemental fixation. CAPSTONE® L Spinal System is used with new reusable instrumentation that enables the surgeon to implant the devices via a lateral approach.
The CAPSTONE® L Spinal System is a medical device designed for lumbar interbody fusion surgeries. The submission document focuses on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Compression | Based on predicate device performance and FDA guidance (ASTM F2077) | Met predetermined acceptance criteria |
| Static Compression-Shear | Based on predicate device performance and FDA guidance (ASTM F2077) | Met predetermined acceptance criteria |
| Dynamic Compression | Based on predicate device performance and FDA guidance (ASTM F2077) | Met predetermined acceptance criteria |
| Dynamic Compression-Shear | Based on predicate device performance and FDA guidance (ASTM F2077) | Met predetermined acceptance criteria |
| Subsidence (Static Axial Compression) | Based on predicate device performance and FDA guidance (ASTM F2267) | Met predetermined acceptance criteria |
| Expulsion Testing | Based on predicate device performance and FDA guidance | Met predetermined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of implants tested) for each mechanical test. It only mentions that "All mechanical testing met the predetermined acceptance criteria." The data provenance is from non-clinical tests performed by Medtronic Sofamor Danek. This is retrospective in the sense that the device was manufactured, and then tested, rather than a prospective study design with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves mechanical testing of a physical device, not subjective interpretation of data (e.g., images) by experts. The "ground truth" for these tests is the physical behavior of the device under defined loads, measured by standard testing equipment.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study involves mechanical testing, which does not require an adjudication method by experts. The results are quantitative measurements against predefined criteria.
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
Not applicable. This is not an AI/software device and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical intervertebral body fusion device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on established engineering principles, FDA guidance documents, and standardized test methods (ASTM F2077, ASTM F2267). The "ground truth" essentially refers to the expected mechanical performance parameters derived from these standards and comparison to the predicate device's known performance.
8. The Sample Size for the Training Set
Not applicable. This is a physical device undergoing mechanical testing, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not a machine learning study, 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.