Search Results

The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis,

• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,

• Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

The BIOCERAM AZUL HEAD (the modified device) is identical to the unmodified predicate device in materials, taper system, articulating surface, packaging, sterilization and shelf life, but it differs from the unmodified predicate device in size variation. Labels are different only in reference to the model number and size.

The modified device is manufactured from the same high purity alumina matrix with zirconia reinforcement, which complies with ISO 6474-2. Two additional sizes (outer diameters) will be offered: 22 mm and 26 mm. There are 2 offsets (+0, +3 mm) for the 22 mm size and 2 offsets (+0, +3.5 mm) for the 26 mm size; and the current 28 mm head will be offered in an additional offset of +7 mm. These new ODs and offsets are the same or similar to those of the Metal Heads also cleared by K160895.

The provided document is a 510(k) summary for a medical device called BIOCERAM AZUL® HEAD. It outlines the device description, indications for use, and a discussion of substantial equivalence to a predicate device. However, it does not contain any information about an AI/ML-based device.

Therefore, I cannot provide an answer that includes:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for an AI/ML test set or data provenance.
• Number/qualifications of experts for AI/ML ground truth.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study results for AI assistance.
• Standalone performance for an AI/ML algorithm.
• Type of ground truth used for an AI/ML study.
• Sample size for AI/ML training set.
• How ground truth for AI/ML training set was established.

The document focuses on the mechanical and material equivalence of a ceramic femoral head component for hip arthroplasty, based on bench testing (e.g., static compression burst test, static pull-off test, static torsion test) against ISO and ASTM standards.

The "Non-Clinical Performance Data" section does describe the study that proves the device meets acceptance criteria, but these criteria are for physical properties of a medical implant, not the performance of an AI/ML algorithm.

Summary of Device Performance and Acceptance Criteria (from the provided text, not related to AI/ML):

The device is a non-AI/ML medical implant with acceptance criteria related to its mechanical and material properties. The study conducted to prove the device meets these criteria involved bench testing.

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated in the provided text. Bench testing typically uses a defined number of physical samples per test.
• Data Provenance: The tests were conducted internally by KYOCERA Corporation in accordance with internal procedures and international standards. This suggests laboratory data, not clinical patient data. The country of origin of the data is not specified beyond "KYOCERA Corporation" being located in Japan.
• Retrospective or Prospective: Not applicable, as this refers to physical bench testing, not data collection from patients over time.

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

• Not applicable as this pertains to the performance of a physical implant being tested against international engineering standards, not human interpretation of medical images or data. The "ground truth" is established by the specifications and pass/fail criteria of the referenced ISO/ASTM standards.

4. Adjudication method for the test set:

• Not applicable. The testing involves objective measurements against engineering standards, not human-based adjudication.

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 device is a physical medical implant, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used:

• The ground truth for this device's performance is the adherence to specified mechanical and material properties as defined by international standards (ISO 6474-2, ISO 7206-10, ISO 7206-13, ASTM F2345).

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of machine learning.

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

• Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

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

Qualifier:

The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:

-The KYOCERA Medical Corporation ("KYOCERA") Initia Total Hip System 28mm CoCr and 28mm BIOCERAM AZUL femoral head and Initia femoral stems can be used with the KMTI 28mm ID Bipolar Head.

-The KYOCERA Initia Total Hip System 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 Renovis Surgical Hip Replacement System (K112897) includes multiple subsystem offerings, including:

• K131354: Renovis Bipolar Hip 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 is additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation. Japan Initia Total Hip System (now Kyocera Corporation, Japan; "KCJ") that may be used with the KMTI K131354 Kyocera Bipolar Hip System.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance results, or any study details that would allow me to answer your request.

The document is a 510(k) premarket notification from the FDA, which primarily focuses on establishing substantial equivalence to a predicate device. It discusses:

• Device name and classification.
• Intended use and indications for use.
• Comparison to a predicate device.
• Compliance with design controls and FDA guidance.

It does not contain any data from performance studies, clinical trials, or validation tests that would outline acceptance criteria and how a device achieved them. Specifically, there is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

Therefore, I cannot fulfill your request for this specific document.

Ask a specific question about this device

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.

Qualifiers:
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 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 Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. Bipolar outer heads are not for use with acetabular shells and liners.

The Renovis Surgical Hip Joint Replacement System (K112897) 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 Kyocera Corporation, Japan; "KCJ") that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI universal acetabular liners.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (hip replacement system). This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria through clinical studies or AI algorithm evaluations.

Therefore, this document does not contain the information required to answer the questions about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document primarily focuses on:

• Device Name: Kyocera Medical Technologies, Inc. (KMTI) Hip Replacement System, including the Tesera Trabecular Technologies (T3) Acetabular Shell System and Porous Acetabular Cup System.
• Regulatory Information: Class II device, regulation number, product codes, and predicates.
• Indications for Use: Specifies the conditions for which the hip replacement system is intended.
• Substantial Equivalence: States that there are no changes in intended use, implant materials, manufacturing, packaging, or sterilization, and that the equivalence of certain components has been demonstrated.
• Compliance: Mentions assessment under Design Controls and compliance with ISO and ASTM standards for mechanical testing.

There is no mention of AI, software algorithms, or clinical studies that would involve establishing ground truth with experts, performing multi-reader multi-case studies, or evaluating standalone algorithm performance. The "performance" discussed in this document refers to the mechanical and biological performance of the implant, typically evaluated through bench testing and material analyses to ensure safety and effectiveness, rather than a diagnostic or predictive AI algorithm's performance.

Ask a specific question about this device