(75 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. 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 include additional sizes of PEEK cages, an inserter and to make minor clarifications to the CAPSTONE® Spinal System IFU.
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.
Here's an analysis of the provided text regarding the CAPSTONE® Spinal System 510(k) summary, specifically addressing the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must achieve) | Reported Device Performance (How the device actually performed) |
|---|---|
| Mechanical Performance: The subject PEEK cages must demonstrate equivalent or superior mechanical properties compared to the predicate device. | Demonstrated Equivalence: Bench performance testing (ASTM F2077-03 and ASTM F2267-04) compared the subject PEEK cages to the predicate device. The testing supports that the subject devices are as safe, as effective, and perform as well as the predicate device(s). |
| Biocompatibility/Material Safety: The materials (PEEK, titanium alloy, titanium) must be safe for implantation. | Inferred Equivalence: The submission states that the subject and predicate CAPSTONE® PEEK cages and inserter are "identical in terms of...technological characteristics" and use the same materials. The predicate device's safety has already been established. |
| Functional Equivalence: The inserter must function correctly and safely. | Inferred Equivalence: The submission indicates that the subject and predicate CAPSTONE® PEEK cages and inserter are "identical in terms of...performance specifications." The new inserter is "specific to the subject device" but its performance is deemed equivalent through testing of the overall system. |
| Indications for Use: The device must be suitable for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1, with or without Grade 1 Spondylolisthesis/retrolisthesis. | Identical Indications: The subject CAPSTONE® Spinal System has "identical indications for use as the predicate CAPSTONE® Spinal System" and all supporting predicate devices. This indicates performance for the stated indications is expected to be the same as established predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention a clinical test set or human data. All testing described is non-clinical bench testing. Therefore, there is no information on sample size for a test set, nor data provenance (country of origin, retrospective/prospective) for clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical test set or ground truth established by experts is mentioned, as all testing was non-clinical bench testing.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical testing was performed." Therefore, no MRMC study was conducted, and no effect size on human readers' improvement with AI vs. without AI assistance can be reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device described is a spinal implant system, not a software algorithm or AI device.
7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" was established by standardized mechanical testing methodologies (ASTM F2077-03 and ASTM F2267-04) where the predicate device served as the benchmark for performance and safety equivalence.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or algorithm-based system that requires a "training set" in the computational sense. The "training data" for the device's design and manufacturing would implicitly be the specifications and performance data of the predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of an AI training set. For the design and development of the new PEEK cage sizes and inserter, the "ground truth" for the predicate devices' performance and safety was established through their prior FDA clearance (e.g., K073291, K103731, K120368, K110543, K094025), which would have involved their own comprehensive testing and review processes. The current submission relies on the established safety and effectiveness of these predicates.
§ 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.