(271 days)
The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous 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. 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 ELEVATE™ Spinal System consists of polyetheretherketone (PEEK) with tantalum markers and titanium expandable cages of various length and heights, which can be surgically implanted between two lumbar or lumbarsacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. This system also includes stainless steel and silicone instruments used to facilitate the implantation of the subject cages. Finally, the subject system includes case, trays, and lids used to package, ship and can be used to sterilize the non-sterile instruments in the subject system. The case, trays, and lids are manufactured from aluminum with either silicone or nylon coated brackets.
This document, K142559, is a 510(k) premarket notification for the ELEVATE™ Spinal System, which is an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data, rather than providing details of a study against specific acceptance criteria for a new clinical claim or an AI algorithm.
Therefore, many of the requested sections (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size and ground truth establishment) are not applicable or cannot be extracted from this document as it does not describe a study involving clinical performance or an AI device with such evaluation metrics.
However, I can extract information related to the acceptance criteria for the mechanical and biocompatibility testing that was performed to support substantial equivalence.
Here's the information that can be extracted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Materials conform to specific ASTM standards and have a history of safe use. Devices conform to FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993". | Implants manufactured from identical materials as predicate devices (PEEK, tantalum, titanium alloy) in accordance with ASTM F2026, ASTM F560, ASTM F136. Instruments manufactured from same medical grade stainless steel and silicone as predicate devices in accordance with ASTM F899, ASTM A564, ASTM A693. No biocompatibility testing was conducted as materials have a long history of safe and effective use. |
| Mechanical Testing: Devices meet the requirements of relevant ASTM standards for intervertebral body fusion devices. | Testing completed in accordance with ASTM F2077-11 "Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267-4 (2011) "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression". Tests included: Static Compression, Compression Fatigue, Static Compression-Shear, Compression-Shear Fatigue, Subsidence. All tests met the predetermined acceptance criteria. |
| MR-Safety: Devices meet the requirements of relevant ASTM standards for MR-safety of passive implants. | Evaluated for MR-safety in accordance with ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document describes engineering (mechanical, materials) testing, not a clinical study involving a test set of patients or medical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of clinical or AI studies, is not relevant here as this document describes physical product testing.
4. Adjudication method for the test set:
- Not Applicable. Adjudication is not relevant for the type of engineering testing described.
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 physical spinal implant, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Biocompatibility: The "ground truth" was established by prior regulatory clearances of predicate devices and the well-documented safe use of the specific materials (PEEK, tantalum, titanium alloy, medical grade stainless steel, silicone) in medical implants.
- For Mechanical and MR-Safety Testing: The "ground truth" was the specified requirements and methodologies defined in the referenced ASTM standards. Meeting these standards serves as the acceptance criterion.
8. The sample size for the training set:
- Not Applicable. No training set as this is not an AI or machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. See above.
Summary of the study that proves the device meets the acceptance criteria (from the document):
The ELEVATE™ Spinal System demonstrated substantial equivalence by undergoing a series of non-clinical performance tests.
- Biocompatibility Evaluation: This was addressed by leveraging the known biocompatibility of the materials (PEEK, tantalum, titanium alloy, stainless steel, silicone). The materials are identical to those used in previously cleared predicate devices and conform to relevant ASTM standards (ASTM F2026, F560, F136, F899, A564, A693). The evaluation adhered to FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993". No new biocompatibility testing was performed due to the long history of safe use of these materials.
- Mechanical Testing: This involved design verification testing on the subject device according to ASTM F2077-11 ("Test Methods for Intervertebral Body Fusion Devices") and ASTM F2267-4 (2011) ("Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression"). Specific tests performed included Static Compression, Compression Fatigue, Static Compression-Shear, Compression-Shear Fatigue, and Subsidence. The document states that all these tests "met the predetermined acceptance criteria."
- Radiographic Verification Testing: Additional radiographic verification testing was completed to further demonstrate substantial equivalence. (Details on criteria not provided, but implies visual and structural integrity under imaging).
- MR-Safety Evaluation: The device's MR-safety was evaluated in accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" and specific ASTM standards (F2052, F2213, F2119, F2182) for magnetic displacement, torque, artifact, and radio frequency induced heating.
The conclusion drawn from this performance data, along with risk analysis and other supporting documentation, was that the ELEVATE™ Spinal System is "as safe and effective" as the listed predicate devices.
§ 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.