(53 days)
The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
The Lumfuse-TP cage consists of PEEK 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782).
This FDA 510(k) summary is for a medical device (LumFuse-TP, an intervertebral body fusion device) and therefore primarily focuses on substantial equivalence to a predicate device based on mechanical and material properties, rather than AI model performance. As such, the requested information regarding AI model acceptance criteria, study details, and expert involvement is largely not applicable in this context.
However, I can extract the relevant information regarding the device itself and explain why the AI-related questions are not addressed by this document.
Device: LumFuse-TP (Intervertebral Body Fusion Device)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| Static Axial Compression (ASTM F2077-14) | Evaluated on worst-case devices |
| Dynamic Axial Compression (ASTM F2077-14) | Evaluated on worst-case devices |
| Static Compression-Shear (ASTM F2077-14) | Evaluated on worst-case devices |
| Subsidence (ASTM F2267-04 (2011)) | Evaluated on worst-case devices |
| End-user Cleaning and Sterilization | Evaluated |
| Implantable Device Biocompatibility Endpoints | Evaluated |
Note: The document states that "The worst case devices were evaluated for mechanical performance...". While it lists the standards, it does not provide specific numerical acceptance criteria or performance values. This is typical for a 510(k) summary, which generally affirms compliance to standards rather than detailing raw test results.
The following questions are NOT APPLICABLE as this document describes a physical medical device (intervertebral body fusion cage) and its mechanical/biocompatibility testing, not an AI/software as a medical device (SaMD).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable for this device. (Relates to AI/software validation)
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 for this device. (Relates to AI/software validation)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable for this device. (Relates to AI/software validation)
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 for this device. (Relates to AI/software validation)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable for this device. (Relates to AI/software validation)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable for this device. For physical devices, "ground truth" generally refers to validated test standards and material specifications.
8. The sample size for the training set
Not Applicable for this device. (Relates to AI/software development)
9. How the ground truth for the training set was established
Not Applicable for this device. (Relates to AI/software development)
Summary from the document:
- Clinical Testing: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This reinforces that the evaluation was based on non-clinical (mechanical, material, sterilization, biocompatibility) testing.
- Purpose: The submission's purpose was to gain initial marketing authorization by demonstrating substantial equivalence to an existing predicate device (Medtronic® CAPSTONE).
- Conclusion: "Based on the information provided in this premarket notification, we believe that the subject Lumfuse-TP demonstrates substantial equivalence to the identified predicate device."
§ 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.