(28 days)
The Leva™ Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
The Leva™ Spacer System is a lumbar intervertebral body fusion device fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. The device is available in both expandable and fixed configurations. The expandable device is provided in a collapsed form and is expanded to a predefined height in-situ using the Leva™ Inserter Instrument. Both the fixed and expandable implants are provided in different heights to accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.
This document is a 510(k) summary for the Leva™ Spacer System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria related to a diagnostic or AI algorithm.
Therefore, many of the requested criteria for AI or diagnostic devices (such as reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) are not applicable to this submission content.
However, I can extract information relevant to the device's performance data based on the provided text, which serves as the "study that proves the device meets acceptance criteria" in the context of a 510(k) for a physical medical implant.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| Static Axial Compression (ASTM F2077) | Met (Compared to previously tested constructs) |
| Dynamic Axial Compression (ASTM F2077) | Met (Compared to previously tested constructs) |
| Static Compression Shear (ASTM F2077) | Met (Compared to previously tested constructs) |
| Dynamic Compression Shear (ASTM F2077) | Met (Compared to previously tested constructs) |
| Subsidence (ASTM F2267) | Met (Compared to previously tested constructs) |
| Oblique Compressive Shear (ASTM F2077) | Demonstrated substantial equivalence (via Finite Element Analysis & mechanical testing) |
| Subsidence (ASTM F2267) | Demonstrated substantial equivalence (via Finite Element Analysis & mechanical testing) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The tests refer to "constructs previously tested" and "mechanical testing," which implies physical samples were used, but the number of samples is not provided.
- Data Provenance: Not specified, but generally, such biomechanical testing is conducted in a laboratory setting, not with human patient data or specific country of origin. It would be prospective testing of device prototypes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This relates to diagnostic/AI performance, not the biomechanical testing of an implant. The "ground truth" here is the physical performance under specified load conditions, as defined by ASTM standards.
4. Adjudication Method for the Test Set
- Not applicable. This relates to diagnostic/AI performance. The "adjudication" for mechanical testing would be the compliance of test results with the specified ASTM standards and internal acceptance limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical intervertebral body fusion device, not a diagnostic or AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical intervertebral body fusion device.
7. The Type of Ground Truth Used
- For the biomechanical tests, the "ground truth" is the established performance metrics and acceptance limits defined by the referenced ASTM international standards (ASTM F2077, ASTM F2267) for intervertebral body fusion devices. These standards specify how to conduct the tests and what constitutes acceptable performance for such devices.
8. The Sample Size for the Training Set
- Not applicable. This typically refers to machine learning models. For a physical device, "training set" doesn't directly apply in the same way. The design iterations and preliminary testing during development could be considered analogous, but no specific "training set size" is provided.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, for a physical device, there isn't a "training set" in the context of ground truth establishment similar to AI/diagnostic devices. The design process and adherence to engineering principles and regulatory standards guide the development and testing.
§ 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.