Search Results

The KMTI S141 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine 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. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Kyocera Medical Technologies, Inc. (KMTI) KMTI S141 Lumbar Interbody Fusion System (also called S141 LIF System) consists of cages which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion. The S141 LIF System includes the Tesera-P, Tesera-T, PEEK Straight TLIF, and PEEK TLIF families. The implants are offered in additively manufactured Titanium Alloy (Titanium-6Aluminum-4Vanadium) per ASTM F2924 and PEEK (Polyetheretherketone) per ASTM F2026.This submission updates the subject titanium alloy material specifications and standards, modifies the additive printing process, and expands the for the previously cleared S141 Lumbar Interbody Fusion System.

The KMTI S141 Lumbar Interbody Fusion System is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. The implants may be inserted via an open or minimally invasive approach. The Tesera P and PEEK PLIF use a posterior approach. The PEEK Straight TLIF, Tesera ST, and Tesera T use an oblique approach. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The superior and inferior surfaces of the Titanium Alloy implant consist of Tesera porous titanium structure to facilitate osseous integration. The superior and inferior surfaces of the S141 PEEK devices have "teeth" to help prevent the device from migration after surgically positioned. Additionally, the S141 PEEK devices contain tantalum markers (per ASTM F560) to assist the surgeon with proper placement of the device. The implants are provided terminally sterilized via gamma irradiation prior to end-user receipt.

This document describes a 510(k) premarket notification for the KMTI S141 Lumbar Interbody Fusion System, which is a medical device for spinal fusion.

Here's the breakdown of the acceptance criteria and the study performed, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated. The text mentions "mechanical testing" was conducted, but does not provide details on the number of devices or iterations tested.
• Data Provenance: The testing was conducted by Kyocera Medical Technologies, Inc. within the context of a 510(k) submission to the FDA. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable as the study presented is a mechanical performance study, not a clinical study involving ground truth established by experts.

4. Adjudication method for the test set

• This question is not applicable as the study presented is a mechanical performance study, not a clinical study requiring adjudication of expert opinions.

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

• This question is not applicable. The device is an intervertebral body fusion system, a physical implant, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable as the device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the mechanical testing would be defined by engineering specifications and established performance standards for spinal implants, as derived from the predicate devices and relevant ASTM standards (e.g., ASTM F136, F2924, F2026, F560 mentioned for materials). The device's mechanical strength was compared to these standards and to the performance of predicate devices to establish substantial equivalence.

8. The sample size for the training set

• This question is not applicable This is a mechanical device, not an AI/machine learning system that requires a training set.

9. How the ground truth for the training set was established

• This question is not applicable This is a mechanical device, not an AI/machine learning system that requires a training set.

Ask a specific question about this device