(153 days)
The CAPSTONE® Spinal System is indicated for use with autogenous bone graft in patients 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 an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
The CAPSTONE® PEEK Spinal System consists of a variety of hollow vertebral body spacers featuring a convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is made of various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 16mm in height and from 22mm to 36mm in length.
This document describes a 510(k) submission for the CAPSTONE® Spinal System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial with specific acceptance criteria and performance studies in the way an AI algorithm might be evaluated. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: The CAPSTONE® Spinal System should be made of materials substantially similar to legally marketed predicate devices, ensuring biocompatibility and mechanical properties suitable for its intended use. | The CAPSTONE® PEEK Spinal System is made of PEEK, a material used in the predicate LT-CAGE® Peek Lumbar Tapered Fusion Device. The document implies that the material choice is consistent with previously cleared devices. |
| Design Equivalence: The device design (e.g., hollow vertebral body spacers, convex, bullet nose, axial void, angular teeth, range of heights/lengths) should be consistent with or have acceptable variations from predicate devices while ensuring proper function and safety. | The CAPSTONE® PEEK Spinal System features descriptions such as "hollow vertebral body spacers featuring a convex, bullet nose design and an axial void designed to hold bone graft material" and "angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance." This design is presented as substantially equivalent to the predicates. |
| Indications for Use Equivalence: The indications for use of the CAPSTONE® Spinal System should be the same as or very similar to the predicate devices. | Stated indications: "for use with autogenous bone graft in patients 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... skeletally mature and have had six months of non-operative treatment... intended to be used with supplemental fixation instrumentation." This matches the indications typically cleared for intervertebral body fusion devices. |
| Mechanical Performance Equivalence: The device's mechanical properties (e.g., strength, stability, expulsion resistance) must be demonstrated to be equivalent to predicate devices through testing. | "Documentation, including mechanical test results and published literature, was provided which demonstrated that the subject CAPSTONE® Spinal System is substantially equivalent" to the five predicate devices. Specific quantitative results are not provided in this summary but were part of the 510(k) submission. |
2. Sample Size Used for the Test Set and the Data Provenance
This is Not Applicable in the context of a 510(k) for a spinal implant. The evaluation is primarily based on demonstrating substantial equivalence to existing, legally marketed predicate devices through design comparison, material analysis, and in vitro mechanical testing. It does not involve a "test set" of patient data or clinical images like an AI device would.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is Not Applicable. Ground truth, expert review, and clinical outcomes for a "test set" are not part of a 510(k) substantial equivalence determination for this type of device. The "ground truth" here is established by the existing regulatory clearance and safety/effectiveness history of the predicate devices.
4. Adjudication Method for the Test Set
This is Not Applicable. There is no "test set" in the context of an adjudication method for this type of 510(k) submission.
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
This is Not Applicable. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical implant and does not involve AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is Not Applicable. This device is a physical surgical implant, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" for the device's acceptable safety and effectiveness is implicitly derived from the long-standing clinical use and regulatory clearance of the identified predicate devices. The submission demonstrates that the CAPSTONE® Spinal System shares fundamental technological characteristics (design, materials, indications for use) and performs similarly to these legally marketed predicates.
8. The Sample Size for the Training Set
This is Not Applicable. There is no "training set" for an AI algorithm in this context.
9. How the Ground Truth for the Training Set Was Established
This is Not Applicable. There is no "training set" for an AI algorithm in this context.
Summary of the Study that Proves the Device Meets Acceptance Criteria for this 510(k) Submission:
The provided text indicates that the CAPSTONE® Spinal System demonstrated substantial equivalence through:
- Documentation and Mechanical Test Results: The submission included data from mechanical tests to show that the device's physical and functional properties (e.g., strength, stability, expulsion resistance, as implied by the "angular teeth") are comparable to the predicate devices. While specific test details or quantitative results are not in this summary, they would have been part of the full 510(k) submission.
- Published Literature: Relevant scientific and clinical literature was likely used to support the safety and effectiveness of the design principles and materials used, especially concerning intervertebral body fusion devices.
- Comparison to Predicate Devices: The core of the evidence relies on a detailed comparison to five specific, previously cleared interbody cages:
- LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek)
- BAK® Cage (P950002, Zimmer Spine)
- RAY® Threaded Fusion Cage (P950019, Stryker)
- Lumbar I/F Cage (P960025, DePuy)
- PARAMOUNT INTERVERTEBRAL BODY FUSION Device (K072120, Innovative Spinal Technologies)
The study essentially demonstrated that the CAPSTONE® Spinal System is "as safe and effective as, and performs as well as" these predicate devices by showing equivalent design, materials (e.g., PEEK), indications for use, and mechanical performance.
§ 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.