(161 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 and shapes (convex or lordotic) 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 describes a 510(k) premarket notification for the Leva® Spacer System, specifically a line addition including new 10° lordotic implant sizes. It is a medical device, not an AI/ML product, and therefore the standard AI/ML acceptance criteria and study aspects you've asked for (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set sample size) are not applicable or described in this document.
The document discusses mechanical testing to demonstrate substantial equivalence to predicate devices, which is the relevant "performance data" for this type of medical device.
Here's an attempt to answer your questions based on the provided text, primarily focusing on what is present. Much of your requested information is for AI/ML devices and is not found in this document for a physical medical implant.
1. Table of acceptance criteria and the reported device performance
Since this is not an AI/ML device, the "acceptance criteria" discussed are primarily about mechanical performance and substantial equivalence to legally marketed predicate devices, rather than statistical performance metrics like sensitivity, specificity, or AUC.
| Acceptance Criteria (Mechanical Performance) | Reported Device Performance (Summary) |
|---|---|
| Static Axial Compression (ASTM F2077) | Demonstrated substantial equivalence to predicate device. |
| Dynamic Axial Compression (ASTM F2077) | Demonstrated substantial equivalence to predicate device. |
| Static Compression Shear (ASTM F2077) | Demonstrated substantial equivalence to predicate device. |
| Dynamic Compression Shear (ASTM F2077) | Demonstrated substantial equivalence to predicate device. |
| Subsidence (ASTM F2267) | Compared to constructs previously tested. Demonstrated substantial equivalence to predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This information is not provided in the document. The testing involved mechanical measurements on the device itself, not clinical data or data from a "test set" in the AI/ML sense.
- Data Provenance: Not applicable. The "data" refers to mechanical test results from the fabricated implants, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in the context of this device refers to established mechanical engineering standards and the performance of predicate devices, not expert human assessment of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no "adjudication" in the AI/ML sense for mechanical testing.
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
No. This is a physical medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating the safety and effectiveness of this device (a physical implant) is based on established mechanical engineering standards (ASTM F2077, ASTM F2267) and comparison to the performance of legally marketed predicate devices. These standards dictate acceptable performance parameters for intervertebral body fusion devices.
8. The sample size for the training set
Not applicable. There is no "training set" for physical implant device testing in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned or implied in the context of this device's evaluation.
§ 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.