(216 days)
The Trabecular Metal Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Trabecular Metal Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The Trabecular Metal Fusion Device is implanted via an anterior approach.
The Trabecular Metal™ Fusion Device is an interbody fusion device comprised wholly of porous tantalum Trabecular Metal. The Trabecular Metal™ Fusion Device is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrae onto another.
The Trabecular Metal™ Fusion Device is currently offered in three cross sectional sizes (11x11mm, 11x14mm, and 14x14mm) and in 7° lordotic and 0° non-lordotic configurations. Height options are available in 5, 6, 7, 8, 9, and 10mm sizes. The present 510(k) premarket notification seeks to extend the product line by offering three additional height options of 4, 1 l and 12mm sizes to the existing TM-S Fusion Device implant system.
The superior and inferior surfaces of the device have a pattern of ripples and a central hole in the device extending in the superior-inferior direction for placement of bone graft. Additionally, the proposed system contains a central slot on the anterior surface to allow interface with a central inserter.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Trabecular Metal™ Fusion Device:
The provided document is a 510(k) summary for a medical device (Trabecular Metal™ Fusion Device), which focuses on demonstrating substantial equivalence to a predicate device for the purpose of extending the product line with additional height options. As such, the "acceptance criteria" and "study" described are primarily related to mechanical performance rather than clinical or AI-driven performance.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The FDA's "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" recommends certain tests. The acceptance criteria for these tests are generally established industry standards (e.g., ASTM F2077-03) or comparison to the predicate device's performance, ensuring the new device's performance is at least equivalent or better. Specific numerical acceptance criteria values are not explicitly stated in this 510(k) summary, but rather implied by the statement of "substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet performance requirements of ASTM F2077-03. | Mechanical testing performed per ASTM F2077-03. |
| Exhibit performance substantially equivalent to the predicate device (Zimmer Trabecular Metal™ Fusion Device, K103033). | "The results of testing and analyses conducted demonstrate that the proposed system is substantially equivalent to the Zimmer Trabecular Metal Fusion Device in terms of mechanical performance." |
| New sizes do not present new issues of safety or effectiveness. | Concluded that the "introduction of new sizes does not present any new issues of safety or effectiveness." |
| Subsidence performance (not affected by height). | Subsidence is "not affected by the height of an interbody device, given the same cross-section and profile design" and therefore not re-tested for the new heights. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "mechanical testing" on the Trabecular Metal Fusion Device. For mechanical tests like those specified (ASTM F2077-03), a specific number of devices are typically tested for each configuration. However, the exact number is not provided in this summary.
- Data Provenance: Not explicitly stated, but it would be laboratory testing data generated by the manufacturer or a contract testing facility. No country of origin is mentioned beyond "Zimmer Spine" being located in Austin, TX, USA. The data is prospective for generating the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to a mechanical testing study like the one described. "Ground truth" and "experts" in this context typically refer to clinical or diagnostic assessment (e.g., radiologists for imaging studies, pathologists for tissue analysis). The study here is concerned with the physical integrity and performance of an implantable device under various loads.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements among multiple human readers/experts in subjective assessments, often in clinical or image-based studies. This mechanical performance study does not involve such human "adjudication."
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. A MRMC comparative effectiveness study is designed for evaluating diagnostic aids, often involving AI, where multiple human readers assess cases with and without the aid of a new device/software. This 510(k) pertains to an intervertebral body fusion device (an implant), not a diagnostic aid or AI system. Therefore, this type of study was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This question is also related to AI algorithm performance. The device in question is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
For the mechanical testing performed, the "ground truth" would be the physical measurements and observations during the mechanical tests (e.g., force applied, deformation, failure points) compared against the established specifications and requirements outlined in ASTM F2077-03 and the performance of the predicate device. It's an objective measurement rather than expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this mechanical performance study. Training sets are relevant for machine learning or AI algorithm development, which is not what this submission describes.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.