(300 days)
The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two 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.
Additionally, the CAPSTONE® Spinal System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.
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 implants are to be used with autogenous bone graft. 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® Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The devices are convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.
This document is a 510(k) summary for the CAPSTONE® Spinal System, seeking to expand its indications for use. It's important to note that this is a medical device submission, not a submission for an AI/ML powered device, therefore, many of the requested categories (e.g., ground truth, experts, training sets, MRMC studies) are not applicable in this context. The acceptance criteria for this type of submission are primarily focused on demonstrating substantial equivalence to previously cleared devices and safety/effectiveness for the expanded indication through clinical and non-clinical data.
Here's an analysis based on the provided document:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit from Submission Aims) | Reported Device Performance (Summary) |
|---|---|
| Demonstrate substantial equivalence to predicate devices (K121760, K120368, K103731, K082732) for the existing components. | "The CAPSTONE® Spinal System implants contained in this application are identical to those previously cleared in earlier 510(k) applications." "The fundamental scientific technology of the CAPSTONE® Spinal System has not been altered for this submission." |
| Demonstrate safety and effectiveness for the expanded indication (supplement to pedicle screw fixation in degenerative scoliosis). | "Published retrospective clinical data for the CAPSTONE® Spinal System as well as devices similar to the subject spinal system were provided in support of this application. This clinical data demonstrated that the use of interbody cages to treat deformity conditions posed no new risks to patients." |
| No new risks introduced by the expanded indication or existing device. | "No changes were made to the existing devices, nor were any new components added to the system." "This clinical data demonstrated that the use of interbody cages to treat deformity conditions posed no new risks to patients." |
| No additional testing required due to the nature of the change. | "Therefore, no additional testing was required or performed." |
| Conclusion of Substantial Equivalence for the expanded indication. | "The design features, materials used, manufacturing and sterilization methods are equivalent to the previously cleared CAPSTONE® Spinal System components with the exception of broadening a portion of the indications to include the aforementioned deformity conditions." |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a distinct "test set" in the context of device performance testing. The "clinical data" mentioned refers to retrospective studies.
- Data Provenance: "Published retrospective clinical data" - the country of origin is not specified, but the submission is to the US FDA. The data is retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission is for a physical medical device, not an AI/ML powered device where expert-established ground truth for a test set is typically required. The "truth" here is established from clinical outcomes observed in the retrospective studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this concept does not apply to this type of device submission. Clinical outcomes from the retrospective data would typically be reviewed and adjudicated by treating physicians in the original studies, but this level of detail is not provided here.
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. This is not an AI-powered device, so an MRMC study comparing human readers with and without AI assistance is not relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the expanded indication is based on outcomes data from the "published retrospective clinical data" on the CAPSTONE® Spinal System and similar interbody cages. The key finding from this data was that using these cages for deformity conditions posed "no new risks to patients."
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As above, a training set is not relevant for this type of device.
§ 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.