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.

Device Description

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.

AI/ML Overview

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:

Test Method	Acceptance Criteria (Implied by Standards)	Reported Device Performance
Static compression burst test (ISO 7206-10)	Meets or exceeds minimum strength requirements defined by ISO 7206-10 for femoral heads.	"The modified device passed the testing"
Post-fatigue static compression burst test (ASTM F2345 / ISO 7206-10)	Maintains mechanical integrity and strength after fatigue, as per ASTM F2345 and ISO 7206-10.	"The modified device passed the testing"
Static Pull-off test (ISO 7206-10)	Withstands specified pull-off forces as per ISO 7206-10.	"The modified device passed the testing"
Static torsion test (ISO 7206-13)	Withstands specified torsional forces as per ISO 7206-13.	"The modified device passed the testing"

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.

Summary

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December 5, 2024

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration".

KYOCERA Corporation % Audrey Swearingen Regulatory Affairs Consultant Swearingen Regulatory Consulting, LLC 16856 Circle Hill Drive Dexter, Missouri 63841

Re: K243444

Trade/Device Name: BIOCERAM AZUL® HEAD Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO Dated: November 6, 2024 Received: November 6, 2024

Dear Audrey Swearingen:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Image /page/2/Figure/2 description: The image shows a digital signature block. It includes the name "RYAN TROMBETTA" followed by "-S". The signature indicates it is for Limin Sun, Ph.D., Assistant Director, and includes the date "2024.12.05 16:30:09 -05'00'". The block also lists DHT6A: Division of Joint Arthroplasty Devices, OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.

Enclosure

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Indications for Use

510(k) Number (if known) K243444

Device Name BIOCERAM AZUL® HEAD

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

BIOCERAM AZUL® HEAD

1. Submission Sponsor

KYOCERA Corporation 6 Takeda Tobadono-cho, Fushimi-ku, Kyoto 612-8501 Japan Contact: Ms. Yoshimi Amano Title: Senior Manager of Regulatory Affairs Section, Medical Division

2. Submission Correspondent

Swearingen Regulatory Consulting, LLC Office Phone: (512) 818-3811 Email: Audrey@swearingenregconsulting.com Contact: Audrey Swearingen Title: Regulatory Consultant

3. Date Prepared

December 4, 2024

4. Device Identification

Trade/Proprietary Name:	BIOCERAM AZUL® HEAD
Regulation Name:	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
	uncemented prosthesis.
Regulation Number(s):	888.3353
Product Code:	LZO
Class:	2
Classification Panel:	Orthopedic

5. Legally Marketed Predicate Device(s)

Device name:	Initia Total Hip System & BIOCERAM AZUL® HEAD
510(k) number:	K160895
Manufacturer:	KYOCERA Medical Corporation

KYOCERA Corporation is also using the Metal Head cleared in K160895 as a reference device, as the new BIOCERAM AZUL HEAD sizes are shared by the Metal Head.

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6. Device Description

7. Indication for Use Statement

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, rheumatoid arthritis, post-traumatic 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 reconstructive techniques are less likely to achieve satisfactory results.

8. Substantial Equivalence Discussion

The new BIOCERAM AZUL Head has the same intended use as the predicate BIOCERAM AZUL Head. The new BIOCERAM AZUL Head has the same technological characteristics as the BIOCERAM AZUL Head of the predicate device, with respect to materials and design, except for these aspects:

Size 22 mm OD now offered in +0 and +3 mm offsets;
Size 26 mm OD now offered in +0 and +3.5 mm offsets;
Size 28 mm OD now offered in +7 mm offset

However, these new sizes and offsets are the same or very close to those of the metal heads also cleared in K160895. The worst-case design was tested to demonstrate equivalency to the predicate device. The minor differences of the subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of modified BIOCERAM AZUL HEAD and to show substantial equivalence to the predicate device, KYOCERA Corporation conducted the following performance bench tests in accordance with internal procedures and international standards shown below. The modified

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device passed the testing, supporting its safety and its substantial equivalence to the predicate device.

Static compression burst test (ISO 7206-10)
. Post-fatigue static compression burst test (ASTM F2345 / ISO 7206-10)
Static Pull-off test (ISO 7206-10)
. Static torsion test (ISO 7206-13)

10. Statement of Substantial Equivalence

The modified BIOCERAM AZUL HEAD has the same intended use and the same or similar technological characteristics as the predicate device. The new sizes represented by the subject device were successfully evaluated through appropriate safety and performance testing, demonstrating that the subject device does not raise any new questions of safety and effectiveness when compared to the predicate device, and is at least as safe and effective as the predicate device. Therefore, the modified BIOCERAM AZUL HEAD is substantially equivalent to the predicate BIOCERAM AZUL HEAD.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.