(208 days)
The CAPSTONE® Spinal System is indicated for use 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. 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 Polyetheretherketone (PEEK) cages, titanium alloy and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to provide support and correction of the lumbar spine during lumbar interbody fusion surgeries. The hollow geometry of the CAPSTONE® implants allows them to hold autogenous bone graft material.
The provided text is a 510(k) summary for the CAPSTONE® Spinal System, which is an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in terms of clinical performance or device accuracy in the way an AI/ML device would.
Therefore, many of the requested categories, such as "acceptance criteria," "device performance," "sample size for test set," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for training set," are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted from the provided text, aligning with the spirit of the request where possible, and explicitly stating when information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as such for clinical performance) | Reported Device Performance / Basis for Equivalence |
|---|---|
| Premarket Review Goal: Substantial Equivalence to a Predicate Device | Demonstrated substantial equivalence to the predicate CAPSTONE® Spinal System device. |
| Indications for Use: Identical to Predicate | The subject and predicate CAPSTONE® Spinal System devices are identical in terms of indications for use. |
| Intended Use: Identical to Predicate | The subject and predicate CAPSTONE® Spinal System devices are identical in terms of intended use. |
| Performance Specifications: Identical to Predicate | The subject and predicate CAPSTONE® Spinal System devices are identical in terms of performance specifications. |
| Technological Characteristics: Identical to Predicate (excluding new inserter) | The subject and predicate CAPSTONE® Spinal System devices are identical in terms of technological characteristics. A new threaded inserter instrument was added. |
| Cleaning and Sterilization: Appropriate for new instrument | Cleaning and sterilization validation activities have been conducted to provide appropriate instructions for the CAPSTONE® Spinal System, including the new instrument. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is not based on a clinical test set for performance evaluation but rather a comparison to an existing predicate device. The "test" here refers to non-clinical tests for cleaning and sterilization, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Pertains to clinical performance studies, not substantial equivalence evaluations of this nature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Pertains to clinical performance studies, not substantial equivalence evaluations of this nature.
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 device is a surgical implant, not an AI/ML diagnostic tool or an assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a surgical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Pertains to clinical performance studies. The "ground truth" for this submission is the established performance and safety profile of the predicate device.
8. The sample size for the training set
- Not Applicable. This device is a surgical implant, not an AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established
- Not Applicable. This device is a surgical implant, not an AI/ML model.
Summary of the Study (or Basis for Clearance):
The "study" in this context is a premarket notification (510(k)) submission designed to demonstrate that the CAPSTONE® Spinal System is substantially equivalent to a legally marketed predicate device (also the CAPSTONE® Spinal System, implying an updated version or minor modification).
- Objective: To demonstrate that the subject device is as safe and effective as the predicate device, thereby not requiring a Premarket Approval (PMA) application.
- Methodology: The sponsor provided documentation (non-clinical tests and comparative analysis) to show that the subject device shares the same indications for use, intended use, performance specifications, and technological characteristics as the predicate device. The only noted change was the addition of a new threaded inserter instrument.
- Testing Conducted: Cleaning and sterilization validation activities were performed for the CAPSTONE® Spinal System, specifically addressing the new instrument, to ensure appropriate instructions were provided in the labeling.
- Conclusion: The FDA reviewed the submission and concurred that the device is substantially equivalent to the predicate device, allowing it to be marketed.
§ 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.