(89 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 nonoperative 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 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 offered in three cross sectional sizes and is available in various height options to accommodate variations in patient anatomy. The height is measured at the posterior aspect of the device is tranezoidal in shane and is offered in lordotic and non-lordotic configurations, i.e., with 7 degree and 0 degree profiles. 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, certain parts of the proposed system contain a central slot on the anterior surface to allow interface with a central inserter.
The provided document is a 510(k) summary for a medical device (Trabecular Metal™ Fusion Device), not a study report for an AI/ML powered device. As such, it does not contain information about acceptance criteria for an algorithm's performance, details of a study demonstrating such performance, or other specific metrics typically associated with AI/ML device evaluations.
Therefore, I cannot provide the requested information in the format requested. The document describes a traditional medical device (an intervertebral body fusion device) and demonstrates its substantial equivalence to predicate devices through mechanical testing and an animal study, not through assessment of an AI algorithm's performance.
Here's a summary of the available performance data for the Trabecular Metal™ Fusion Device, as presented in the document:
The study did not involve an AI/ML powered device and therefore does not have acceptance criteria or performance metrics related to AI. The performance data provided is for the physical medical device itself.
Performance Data for the Trabecular Metal™ Fusion Device:
-
Mechanical Testing:
- Tests Performed: Axial Compression - Static and Dynamic, Torsion - Static and Dynamic (per ASTM F2077), Expulsion (as recommended by FDA guidance), and Subsidence (per ASTM F2267).
- Acceptance Criteria & Reported Performance: The document states, "The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance." Specific numerical acceptance criteria or reported values are not detailed in this summary. These "predetermined requirements" would typically be derived from standards and predicate device performance.
-
Animal Study:
- Purpose: To compare the host bone response of the Trabecular Metal Fusion Device to a predicate device (Crystal by Spinal Elements, made from PEEK) in anterior cervical discectomy and interbody fusion procedures.
- Findings: "Histological results confirmed definitive bone ingrowth and showed that The Trabecular Metal cervical interbody fusion implant supports bone growth into and around the implant margins."
- Sample Size, Ground Truth, etc.: The document does not provide details on the sample size of animals used, the specific methodology of histological analysis, or who established the ground truth for bone ingrowth.
In summary, the provided document relates to a physical medical device and its mechanical and biological performance, not the performance of an AI/ML algorithm.
§ 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.