(114 days)
The Talos® Lumbar (HA) PEEK IBF device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis 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 radiographic studies. Talos® Lumbar (HA) PEEK IBF devices are intended to be used with autograft and/ or allograft comprised of cancellous and/or corticocancellous bone graft.
The Talos® Lumbar (HA) PEEK IBF Device is to be used in patients who have had six months of non- operative treatment.
Talos® Lumbar (HA) PEEK IBF devices are to be implanted via a direct posterior, transforaminal, laterior or anteriolateral approach in the lumbosacral spine. The Talos®-P WB (HA), Talos®-TL (HA), Talos®-T (HA), Talos®-L (HA), and Talos®-A (HA) are intended to be used with supplemental fixation.
Additionally, the use of Hyperlordotic Talos®-A (HA) devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.
The Talos® Lumbar (HA) PEEK IBF Devices are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The Talos® Lumbar (HA) PEEK IBF Device is available in six configurations: Talos®-P (HA), Talos®-P WB (HA), Talos®-T (HA), Talos®-TL (HA), Talos®-L (HA), and Talos®-A (HA). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-P (HA), Talos®-P WB (HA), Talos® –TL (HA) and Talos® –L are rectangular devices. The Talos® –T (HA) and Talos® – A (HA) have curved lateral walls and rounded edges. The implants are available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient anatomy. In addition, tantalum or titanium markers at the opposite ends are offered which allow radiological confirmation for proper IBF positioning.
The provided text describes the regulatory clearance for a medical device, the Talos® Lumbar (HA) PEEK IBF Devices, and demonstrates its substantial equivalence to a predicate device. However, this document does not contain information about an AI/ML-based medical device. Therefore, a study proving the device meets acceptance criteria for an AI/ML device is not applicable and cannot be derived from this text.
The acceptance criteria and study details requested in the prompt (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth establishment) are specific to the validation of AI/ML algorithms, particularly in image analysis. The Talos® Lumbar (HA) PEEK IBF Devices are physical implants used in spinal fusion surgery.
The document primarily focuses on non-clinical testing to establish substantial equivalence with a predicate device, as required for 510(k) clearance by the FDA. This typically involves:
- Mechanical Testing: As mentioned, "Testing per ASTM F2077 (Static Compression, Static Compression Shear, Dynamic Compression, Dynamic Compression Shear) and ASTM F2267 (Subsidence) was performed." These are standard tests for the mechanical integrity and performance of spinal implants.
- Biocompatibility Testing: "Bacterial endotoxin testing (BET) has been performed." This is relevant for patient safety regarding the material.
- Material Comparison: The key difference highlighted is the material composition (HA PEEK vs. PEEK) and the study aims to prove equivalent performance despite this material difference.
In summary, the provided document relates to a traditional medical device (an implant) and its regulatory clearance based on non-clinical performance data, not an AI/ML device requiring a clinical performance study with human readers or AI algorithm performance metrics.
§ 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.