(77 days)
The PEEK Spinal Fusion Cage 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 are to be used with autogenous bone graft.
The PEEK Spinal Fusion Cage may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an 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 PEEK Spinal Fusion Cage consists of INVIBIO PEEK-OPTIMA LTI lumbar cages of various lengths 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 cages contain radiographic tantalum markers used for both intra and post-operative positioning and visualization. The implants are single-use and non-sterile provided.
The provided document is a 510(k) premarket notification for a medical device called the "PEEK Spinal Fusion Cage." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving that the device meets specific performance criteria through a study involving AI or human readers evaluating imaging.
Therefore, many of the requested elements for describing AI/human reader performance studies (such as acceptance criteria for AI, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and training set details) are not applicable to this type of submission.
The document discusses bench performance testing to show the device's physical and mechanical properties are comparable to the predicate device.
Here's a breakdown of the relevant information provided, and where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present acceptance criteria and performance in a direct "table" format as one would for an AI model's diagnostic accuracy. Instead, it states that various standard tests were "utilized to complete bench performance testing" and that the non-clinical data demonstrates substantial equivalence to the predicate device. The underlying assumption is that the device performed comparably or better than the predicate in these tests.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (Implied) |
|---|---|
| Mechanical properties (static/dynamic compression, compression-shear, subsidence) are comparable to the predicate device (CAPSTONE® Spinal System - K073291). | "Bench performance: static and dynamic compression, static and dynamic compression-shear and subsidence test" were conducted. "Non-clinical data demonstrates the PEEK Spinal Fusion Cage is substantially equivalent to the predicate device." |
| Biocompatibility meets ISO standards. | Biocompatibility tests according to a comprehensive list of ISO 10993 standards were conducted. |
| Material characterization meets relevant ASTM/ISO standards. | Material characterization tests according to ISO 13782:2019 and ASTM F2026-17 were conducted. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. This is not an AI/diagnostic study with a test set of images/patient data. It involves physical and chemical tests of the device itself.
- Data Provenance: Not applicable. The "data" refers to the results of bench testing of the physical medical device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable. Ground truth for a physical medical device (like a spinal fusion cage) is established through standardized engineering and biocompatibility testing, not expert review of images.
- Qualifications of Experts: Not applicable. While engineers and scientists with relevant expertise conducted the tests, this is not a study requiring medical expert consensus on diagnostic images.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC study was not done. This device is a physical implant, not a diagnostic AI tool that assists human readers.
- Effect Size of Human Readers Improvement: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used:
- Ground Truth Type: For this device, "ground truth" is established by adherence to recognized national and international standards for material properties, biocompatibility, and mechanical performance (e.g., ASTM F2077, ASTM F2267, ISO 10993 series, ISO 13782, ASTM F2026). The performance is compared to the predicate device.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable.
Summary of Relevant Information from the Document:
- Device Name: PEEK Spinal Fusion Cage
- Intended Use: 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).
- Predicate Device: CAPSTONE® Spinal System (K073291) manufactured by Medtronic Sofamor Danek USA, Inc.
- Studies Conducted (Non-Clinical):
- Material Characterization Testing: Utilizing ISO 13782:2019 and ASTM F2026-17.
- Biocompatibility Testing: Utilizing various ISO 10993 standards (Parts 1, 3, 5, 6, 10, 11, 12, 13, 18).
- Bench Performance Testing: Utilizing ASTM F2077-18 (Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04 (Reapproved 2018) (Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression). These tests included static and dynamic compression, static and dynamic compression-shear, and subsidence tests.
- Clinical/Animal Studies: No animal or clinical study data was submitted for this 510(k).
- Conclusion: The non-clinical data demonstrates that the PEEK Spinal Fusion Cage is substantially equivalent to the predicate device, with minor differences (device sterilization method, bench performance tests) that do not raise new questions of safety and effectiveness.
§ 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.