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

The CASCADIA implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondvlolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intents who have had six months of non-operative treatment.

For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.

The subject submission describes the Cascadia Interbody System. The implants consist of hollow tube structures made of titanium alloy. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is for a line addition to the lumbar intervertebral body fusion devices previously cleared in the K2M Aleutian Intervertebral Body Fusion System, to include implants additively manufactured from titanium alloy.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the Cascadia Interbody System, which focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than providing detailed performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

Ask a specific question about this device