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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.

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The KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) 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 Tesera SA ALIF 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 Tesera SA ALIF System is a standalone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

The Kyocera Medical Technologies, Inc. Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System is a change to the FDA cleared Kyocera S128 Anterior Lumbar Interbody Fusion (ALIF) System (Ti6Al4V and PEEK cages, Cover Plate, screws and instruments; K131122. K140106. and K180502). Only the Ti6Al4V cages are relevant to this application which describes a change in manufacturing and material standard. There are no other changes in cage dimensions (L, W, H and lordosis), sterilization, packaging or shelf-life. The new system will be marketed as the Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System ("Tesera SA ALIF System") and will include Ti6Al4V cages only.

The Tesera SA ALIF System includes cages of a variety of lengths, widths, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. Tesera SA ALIF System cages are standalone when implanted with the Cover Plate and screws with the exception of implants ≥20° which require supplemental fixation.

The Ti6Al4V is compliant with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
The Tesera SA ALIF System cages that are the subject of this application are gamma sterilized.

The system also includes the previously FDA cleared Cover Plate and screws; previously FDA cleared and new instruments to allow for implant determination, trialing and disc preparation. New instruments are manufactured from stainless steels compliant with ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

This document describes the KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System, which is a medical device. The information provided is primarily for a 510(k) premarket notification, indicating the device is substantially equivalent to previously cleared devices. Therefore, the "acceptance criteria" and "device performance" are primarily benchmarks against predicate devices and adherence to relevant ASTM standards, rather than clinical trial results with specific performance metrics like sensitivity or specificity for AI.

Here's an analysis based on the provided text, focused on aspects relevant to device performance and study methodology, even if not directly an "AI" study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not describe a clinical study with a "test set" in the context of an AI device. The performance evaluation is based on bench testing of the device itself and comparison to predicate devices. Therefore, a sample size for a test set of patient data, data provenance, or retrospective/prospective nature is not applicable here. The "sample" in this context refers to the manufactured devices tested. The document does not specify the exact number of devices or test specimens used for the bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI study involving human expert ground truth for interpretation of medical images or data. The "ground truth" for this device's performance is established by engineering standards and direct physical testing of the device.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication process described for the bench testing. Compliance with standards and successful performance are determined by the test results themselves.

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

Not applicable. This is not an AI device, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

Not applicable. This is not an algorithm or AI device. The device itself (an interbody fusion system) is "standalone" in the sense that it doesn't require "additional supplementary fixation" in most cases, but this is a physical characteristic, not an algorithmic performance metric.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's technical performance is based on:

• Established engineering standards: ASTM F2077-18, ASTM E8/E8M-16, ASTM F2924.
• Physical properties and performance characteristics measured during bench testing (e.g., dynamic shear compression).
• Comparison to previously cleared predicate devices based on design, materials, manufacturing processes, and intended use.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth established for it.

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The Renovis Tesera SC Stand-alone ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone ACF 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 Renovis Tesera SC Stand-alone ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

The Renovis Tesera C ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera C ACF 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 Renovis Tesera C ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

Tesera (or T3) describes Renovis' proprietary Tesera Trabecular Technology™ Porous Structure for the manufacture of the porous titanium on the superior and inferior surfaces of the implant.

The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is a single, cervical implant System that includes two (2) "subsystems", the:

• Renovis Tesera C Anterior Cervical Fusion (ACF) System
• Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System .

The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System cages are additively manufactured from Ti-6Al-4V and are available in a variety of sizes (widths, heights, and lordotic angles) to suit the individual pathology and anatomical conditions of the patient.

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes cages, and existing bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System cages require no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies. The cages have windows in the side for visualization of the bone graft. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF cages require supplemental fixation.

The Renovis Tesera C Anterior Cervical Fusion (ACF) System is not stand alone and requires supplemental fixation.

The Renovis Tesera C/Tesera SC ACF System cages comply with ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion.

The system also consists of reusable instrumentation. The instruments comply with ASTM A564/A64M-13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes or ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text describes a 510(k) premarket notification for the Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System. This submission focuses on establishing substantial equivalence to a predicate device through mechanical testing and does not involve a study evaluating AI performance. Therefore, many of the requested sections related to AI acceptance criteria, ground truth, expert involvement, and reader studies are not applicable.

Here's an analysis of the provided information, focusing on what is available:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the submission describes a medical device, not an AI/software device that would typically use a "test set" of data in the common sense. The testing described is bench testing of the physical implant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies evaluating human or AI performance on diagnostic tasks. This submission is for a physical implant, where ground truth is established through standardized engineering and biological tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations during diagnostic studies.

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 information is not applicable. MRMC studies are used to evaluate the impact of an AI system on human reader performance. This submission is for a physical medical implant.

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

This information is not applicable. "Standalone" performance refers to an AI algorithm operating independently, which is not relevant to a physical medical implant.

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

The "ground truth" for the device's performance is established through adherence to recognized ASTM, AAMI/ANSI, and ISO standards for mechanical properties, biocompatibility, and sterilization. For example, the mechanical strength of the implant components and assemblies is evaluated against the parameters outlined in ASTM F2077. The porous structure's characteristics were "successfully tested," implying adherence to relevant specifications.

8. The sample size for the training set

This information is not applicable. A "training set" is used for machine learning. This submission is for a physical implant.

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

This information is not applicable. This is relevant for machine learning models.

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