(83 days)
The KMTI Tesera-K SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-K SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.
The KMTI Tesera-K SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt.
When used without the locking bolt and two screws, the KMTI Tesera-K SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.
The Tesera-K SC System (Tesera-K SC) is a spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and locking bolts. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tesera-K SC implants are available in a variety of lordosis and footprint options with a superior and inferior porous face and internal lattice structure to offer increased capacity for bone growth.
The Tesera-K SC cages are additively manufactured then machined from Titanium alloy (Ti-6Al-4V) per ASTM F2924, and the bone screws and locking bolts are machined from Titanium alloy (Ti-6Al-4V) per ASTM F136.
The Tesera-K SC System may be implanted as a standalone with two internal fixation screws and the locking bolt and without supplemental fixation or may be implanted as a non-standalone system without the internal fixation screws and locking bolt but with FDA-cleared supplemental fixation.
The provided text is a 510(k) summary for the Tesera-K SC System, an intervertebral body fusion device. While it details the device's characteristics, indications for use, and a comparison to predicate devices, it does not contain information related to AI or algorithm performance, nor does it refer to acceptance criteria or studies involving AI performance metrics like sensitivity, specificity, or AUC.
The "Performance Data" section solely lists mechanical testing (static and dynamic compression, shear, torsion, and subsidence) designed to demonstrate the device's structural integrity and substantial equivalence to existing predicate devices, not the performance of an AI algorithm facilitating human reading or a standalone AI.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to an AI algorithm.
- Sample sizes and data provenance for an AI test set.
- Number and qualifications of experts for AI ground truth.
- Adjudication method for an AI test set.
- MRMC study details for AI assistance.
- Standalone AI performance.
- Type of ground truth for AI.
- Sample size for AI training set.
- Method for establishing ground truth for AI training set.
The document describes a physical medical device (spinal implant) and its mechanical properties, not an AI-powered diagnostic or assistive tool.
§ 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.