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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis:
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.

The KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem.

The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with:
• The Kyocera Corporation ("KYOCERA") Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head.

The Cemented Hip Stem is intended for cemented applications.

The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal Liners can be used with:
• The KYOCERA Initia femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head.

The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:
• The KYOCERA 28mm CoCr and 28mm BIOCERAM AZUL femoral heads and Initia femoral stem can be used with the KMTI 28mm ID Bipolar Head.
• The KYOCERA Initia femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head.

The Bipolar Head is for uncemented use only.

Bipolar outer heads are not for use with acetabular shells and liners.

The Kyocera Medical Technologies, Inc. ("KMTI") Hip Replacement System includes multiple subsystem offerings, including:
• K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System
• K141676: Renovis Porous Acetabular Cup System
Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification are additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation, Japan Initia Total Hip System (now known as Kyocera Corporation) that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI Universal Liners.

This document outlines the substantial equivalence of the KMTI Hip Replacement System to legally marketed predicate devices. The information provided primarily focuses on the physical and mechanical properties of the hip replacement components, rather than the performance of a software or AI-driven medical device. Therefore, many of the requested criteria related to AI/software performance, such as MRMC studies, ground truth establishment for AI training/testing, and expert adjudication, are not applicable to this submission.

However, I can extract information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text, specifically relating to the mechanical and physical performance of the hip prosthetic components.

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

The document describes the tests performed but does not explicitly state numerical acceptance criteria or numerical reported device performance in a table format. The evaluation focuses on compliance with established ISO and ASTM standards and comparison to predicate devices. The "acceptance criteria" are implicitly meeting the requirements of these standards for mechanical and physical properties.

Here's a breakdown of the tests conducted and the implied "performance" (successful evaluation and compliance):

2. Sample sizes used for the test set and the data provenance:

• Sample size: The document does not specify the exact number of physical samples (e.g., number of hip stems or heads) used for each mechanical test. Standard testing protocols (e.g., ISO, ASTM) typically define minimum sample sizes for such tests.
• Data provenance: The data provenance is from Kyocera Medical Technologies, Inc. (Redlands, CA, USA). The study is described as "successfully evaluated under Design Controls," indicating it's a prospective set of tests conducted for regulatory submission purposes.

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

• This is not applicable as the "ground truth" for this device is based on objective mechanical properties and compliance with engineering standards, not on expert medical opinion or interpretation of images. The tests are physical measurements.

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

• This is not applicable for mechanical testing. Test results are typically objective measurements, not subject to human adjudication in the same way as, for example, image interpretation by radiologists.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• This is not applicable as this submission is for a physical medical device (hip replacement system), not an AI/software product. Therefore, no MRMC study looking at human reader improvement with AI assistance was performed.

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

• This is not applicable as this is not an algorithm or AI product.

7. The type of ground truth used:

• The "ground truth" for this device is based on established engineering standards and physical test methodologies (e.g., ISO and ASTM guidelines for hip prostheses) that define acceptable mechanical performance, durability, and material properties. It also relies on demonstrated equivalence to predicate devices that have a history of safe and effective use.

8. The sample size for the training set:

• This is not applicable as there is no "training set" in the context of AI/machine learning for this physical device submission.

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

• This is not applicable as there is no "training set" for this physical device.

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The KMTI Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.

The Kyocera Medical Technologies, Inc. ("KMTI") Hip Replacement System includes multiple subsystem offerings, including:

• K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System
• K141676: Renovis Porous Acetabular Cup System
  Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification are additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation, Japan Initia Total Hip System (now known as Kyocera Corporation) that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI Universal Liners.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and study details.

Important Note: The provided document is a 510(k) Premarket Notification Summary for a medical device. This type of submission often focuses on demonstrating "substantial equivalence" to a previously cleared predicate device, rather than proving performance against specific clinical acceptance criteria in standalone clinical trials. Therefore, much of the requested information regarding "device performance," "sample size," "ground truth," and "MRMC comparative effectiveness studies" is not typically found in this type of regulatory document, as these are more common for novel devices or those undergoing PMA approval. The studies mentioned here are primarily mechanical and material tests to ensure the new device components are equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

• Static compression burst tests
• Post-fatigue static compression burst tests
• Oblique (off-axis) fatigue test
• Pull-off tests
• Static torsion tests

Compliance with Standards:

• ISO 7206-10:2018 Implants for surgery Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
• ASTM F2345-03(2013) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
• ISO 7206-13:2016 Implants for surgery Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
• Guidance Document For The Preparation Of Premarket Notification For Ceramic o Ball Hip Systems, Draft, January 10, 1995 |

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

• Sample Size: Not specified in the document. The studies conducted are mechanical tests of components, not clinical studies involving patient data. Therefore, the concept of a "test set" in the context of clinical data or AI systems with patient samples does not apply here.
• Data Provenance: Not applicable. The "data" comes from in vitro mechanical testing, not patient-derived data.

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

• Number of Experts: Not applicable. For mechanical tests, the "ground truth" is determined by the physical properties and performance measured according to established engineering standards (e.g., ISO, ASTM). Expert opinion is typically involved in designing the tests and interpreting the results against those standards, but not in establishing a "ground truth" for individual test items in the way it would be for an AI diagnostic system.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. While engineers and material scientists would be involved in conducting and evaluating these tests, their role is not to establish "ground truth" via consensus for a test set.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in studies involving human interpretation (e.g., radiologists reviewing images). Mechanical tests rely on objective physical measurements against predefined criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This document describes a medical device (hip replacement system) that is not an AI diagnostic tool and does not involve human readers interpreting cases. Therefore, an MRMC study is not relevant.

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

• Standalone Performance: Not applicable. This device is a physical hip replacement system, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical tests performed, the "ground truth" is defined by established engineering standards, material properties, and mechanical performance limits (e.g., fatigue strength specified by ASTM, static load resistance specified by ISO). The tests aim to demonstrate that the device components meet these objective engineering benchmarks and are equivalent to predicate devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI system that requires a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.

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