(23 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 purpose of this 510(k) submission is to add additional CAPSTONE® Spinal System implants with 3°. 6° and 9° options for angles of lordosis. The subject devices are being included to this system in order to provide the surgeon with additional options to accommodate varving patient anatomies. Additionally, subject trial instruments corresponding to the angles of lordosis of the subject implants are included in this submission.
The CAPSTONE® Spinal System consists of PEEK cages, titanium allov cages and titanium cage 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 CAPSTONE® Spinal System includes various instruments, including trials, used to assist in placement of the implants.
The provided text is a 510(k) Summary for the CAPSTONE® Spinal System, a medical device. It describes the device, its indications for use, and its substantial equivalence to previously marketed predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text:
Based on the provided 510(k) summary, the device is a spinal implant, and the submission is to add additional angles of lordosis options. For this type of device, the "acceptance criteria" and "study" are not based on diagnostic performance metrics (like sensitivity, specificity, AUC) or clinical trials directly comparing the device to a standard of care in human patients for effectiveness. Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices through non-clinical testing and risk analysis.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (Summary of Findings) |
|---|---|
| Technological Characteristics: Subject device must be identical or "substantially equivalent" in terms of indications for use, intended use, performance specifications, and technological characteristics to predicate devices. | Subject and predicate CAPSTONE® Spinal System implants and trials are "identical in terms of indications for use, intended use, performance specifications and technological characteristics." The key differences are additional lordosis options for implants and corresponding lordosis trials. |
| Safety and Effectiveness: Modifications must not introduce new issues of safety or effectiveness. | A risk analysis was completed and, in conjunction with an engineering rationale, "demonstrated that the subject CAPSTONE® Spinal System does not introduce new issues of safety or effectiveness." |
| Performance Testing: Non-clinical tests to support safety and performance. | Based on the risk analysis and "additional supporting documentation provided in this submission," the subject devices demonstrated substantial equivalence. (Specific test results are not detailed in this summary, but typically would include mechanical, material, and biocompatibility testing if design changes impacted these aspects). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical or diagnostic imaging study. The "test set" here refers to the device modifications themselves.
- Data Provenance: The data provenance for demonstrating substantial equivalence comes from the manufacturer's internal risk analysis and engineering rationale. This is typically based on design specifications, material properties, and potentially bench testing data (which isn't detailed here but is implied by "additional supporting documentation"). This is not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable for this type of device submission. The "ground truth" for a spinal implant is its mechanical integrity, biocompatibility, and ability to perform its intended function, which are assessed through engineering and material science principles, not expert consensus on image interpretation or clinical outcomes in a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like "2+1" typically refer to reconciling disagreements between multiple human readers in a diagnostic study. This submission relies on engineering and regulatory assessment, not human reader adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a spinal implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's acceptance is based on engineering and material science principles, demonstrating that the device modifications (additional lordosis angles) maintain the same levels of safety and performance as the previously cleared predicate devices. This involves demonstrating that the mechanical strength, materials, and design features are equivalent or superior such that no new risks are introduced.
8. The sample size for the training set
- Not applicable. "Training set" refers to data used to train an AI algorithm. The CAPSTONE® Spinal System is a physical medical device.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI algorithm.
In summary, this 510(k) submission for the CAPSTONE® Spinal System is a demonstration of substantial equivalence to predicate devices for minor design modifications. The "acceptance criteria" and "study" are primarily based on non-clinical engineering assessments and risk analyses, rather than clinical trials or diagnostic performance studies involving human subjects or AI.
§ 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.