(263 days)
The Triton Cage is indicated for use with bone graft (autograft bone graft composed of cancellous and or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Patients with previous non-fusion spinal surgery at the treated. These patients should be sketally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
The Medyssey, Triton Cage is an interbody fusion device utilized to achieve fusion in the lumbar spine. The cage is manufactured from PEEK (ASTM F2026) and additively manufactured titanium alloy (ASTM F136) available in three variants (LLIF, ALIF, OLIF) and a range of sizes to accommodate different surgical approaches and anatomies.
The provided text describes the 510(k) premarket notification for the Triton Cage, an intervertebral body fusion device. While it details the device's indications for use, materials, and substantial equivalence to predicate devices, it does not contain any information about a study proving the device meets specific acceptance criteria based on its performance in a clinical or imaging-based assessment where AI or human performance is evaluated.
The "Performance Testing Summary" section only mentions mechanical testing (Static Compression, Dynamic Compression, etc.) performed on the device to demonstrate substantially equivalent performance to predicate devices in a benchtop setting, not a clinical study involving human or AI perceptual performance.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this device based on the given document. The document focuses on regulatory clearance based on substantial equivalence of the physical device's characteristics and mechanical properties to previously cleared devices.
§ 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.