MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:

1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed.

Device Description

The modular Ceramic Femoral Head is composed of alumina matrix composite, manufactured as per ISO 6474-2. It has a 12/14 taper which is identical to the taper on MicroPort Orthopedics' range of femoral heads. The device articulates with an acetabular liner and is compatible for use across any of MicroPort Orthopedics' total hip component range.

AI/ML Overview

This document is a 510(k) premarket notification summary for a medical device, specifically a "Ceramic Femoral Head." This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and human-in-the-loop studies.

Therefore, the information requested in your prompt regarding acceptance criteria for an AI/device, human reader studies, and ground truth establishment for such studies, is not applicable to this specific document.

The document primarily focuses on non-clinical (mechanical) testing to demonstrate that the new Ceramic Femoral Head, manufactured from a different material (Permallon Tru by CoorsTek), performs equivalently or better than the predicate device.

Here's a breakdown of what is available in the document, related to the general concept of "acceptance criteria" for the device's mechanical performance:

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

The document general states: "Non-clinical (mechanical) testing results met the applicable acceptance criteria; therefore, acceptable mechanical performance is expected of the Ceramic Femoral Head manufactured by CoorsTek."

While a table of specific numerical acceptance criteria and their corresponding reported performance values is not explicitly presented, the document lists the types of tests performed:

Axial compression test
Fatigue test
Post-fatigue ultimate compression strength test
Static pull off test
Static torsion test
MR Safety Evaluation (per ASTM F2182-19, FDA Guidance, ASTM F2052-21, ASTM F2119-07)

The "acceptance criteria" for these tests would inherently be standard specifications or thresholds defined within the referenced ASTM standards and FDA guidance for orthopedic implants, ensuring the device's mechanical integrity and MR compatibility. The "reported device performance" is summarized as having "met the applicable acceptance criteria."

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

Test Set (Mechanical Testing): The specific sample sizes for each mechanical test are not mentioned in this summary document. These would typically be specified in the full test reports, but are not required for the 510(k) summary. Given these are mechanical tests on physical devices, the "provenance" is the manufacturing process of the Ceramic Femoral Head by CoorsTek.
Data Provenance: The data comes from engineering evaluations performed by the manufacturer, MicroPort Orthopedics, Inc. These are laboratory-based mechanical tests, not human data.

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

Not applicable. This document describes mechanical testing of a physical medical device, not an AI or diagnostic device that requires expert human interpretation for "ground truth." The "ground truth" here is the physical performance measured against established engineering standards.

4. Adjudication method for the test set:

Not applicable. There is no "adjudication" in the context of mechanical testing. The results are objective measurements from laboratory equipment.

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

No. This is not an MRMC study. MRMC studies compare human reader performance with and without AI assistance, which is irrelevant to verifying the mechanical properties of a ceramic femoral head.

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

Not applicable. This is not an algorithm, but a physical implant.

7. The type of ground truth used:

For mechanical testing, the "ground truth" is defined by established engineering standards and material properties (e.g., ISO 6474-2, ASTM F2182-19, ASTM F2052-21, ASTM F2119-07). The device's performance is measured against the requirements of these standards and compared to the predicate device's established performance under these standards.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

Not applicable. See point 8.

In summary, this 510(k) notification focuses on demonstrating substantial equivalence of a physical medical implant through established non-clinical mechanical testing, not through AI performance evaluation or human clinical studies.

Summary

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April 12, 2024

MicroPort Orthopedics, Inc. Hunter Williams Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002

Re: K240452

Trade/Device Name: Ceramic Femoral 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: February 15, 2024 Received: February 15, 2024

Dear Hunter Williams:

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 (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/cdrb/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.

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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" (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 QS 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.

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 mediation-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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Sincerely,

Limin Sùn -S

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240452

Device Name

Ceramic Femoral Head

Indications for Use (Describe)

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dvsplasia:

1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a red star inside, followed by the text "MicroPort" in blue, and "Orthopedics" in blue below it. The logo is clean and modern, with a focus on the company's name and area of expertise.

510(k) Summary of Safety and Effectiveness

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the Ceramic Femoral Head.

Submitted by:	MicroPort Orthopedics Inc.5677 Airline Rd, Arlington TN, 38002USAPhone: 901-451-6511Fax: 855-446-2247
Date:	April 12, 2024
Contact Person:	Hunter E. Williams, Manager, Regulatory Affairs
Proprietary Name:	Ceramic Femoral Head
Common Name:	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis
Classification Name andReference:	21 CFR 888.3353 - Prosthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedClass II
Subject Product Code andPanel Code:	Orthopedics/87/LZO
Primary Predicate Device:	BIOLOX delta Option and Extra-long Heads (K173776)
Predicate Devices:	Signature Ceramic Femoral Head (K190704)MicroPort Orthopedics Total Hip Systems MR Labeling (K173898)

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Image /page/5/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a white circle inside, containing a red diamond shape. To the right of the icon is the text "MicroPort" in a bold, blue font, and below that is the word "Orthopedics" in a smaller, blue font.

DEVICE INFORMATION

A. Intended Use/Indications for Use Statement

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed.

B. Device Description

C. Substantial Equivalence Information

The indications for use for MicroPort Orthopedics' Ceramic Femoral Head (CoorsTek) remain the same as the indications for use for the MicroPort Orthopedics' Femoral Head (CeramTec) and subject device shares the same indications for use as the Signature Orthopaedics' Signature Ceramic Femoral Head.

The ceramic femoral head (Permallon Tru) manufactured by CoorsTek has the same geometry as the previously cleared ceramic femoral head (Biolox delta) manufactured by CeramTec with identical conical bore which is a 12/14 taper that can accept a MicroPort trunnion having 12/14 taper, in the form of either a monolithic classic hip stem or modular femoral neck.

The femoral head offset and gauge diameter, taper, bore straightness, bore surface roughness, articulating surface roughness, sphericity and defect requirements are identical to the predicate device. There are no significant differences in these technological characteristics between the subject and predicate devices affecting performance or safety.

The only difference compared to the predicate femoral head (BIOLOX delta) is the manufacturing of the Ceramic Femoral Head from alumina matrix composite (Permallon Tru) provided by CoorsTek.

D. Nonclinical Testing

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Image /page/6/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a red star-like shape inside on the left. To the right of the square is the text "MicroPort" in a bold, blue font, with the word "Orthopedics" underneath in a smaller, blue font.

Engineering evaluations were conducted to verify that the performance of the Ceramic Femoral Head manufactured from alumina matrix composite (Permallon Tru) is equal to and/or better than the predicate device and therefore adequate for the anticipated in-vivo use. The following V&V activities were conducted:

Axial compression test
Fatigue test
Post-fatigue ultimate compression strength test
Static pull off test
Static torsion test

• MR Safety Evaluation per ASTM F2182-19 and FDA Guidance for "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices" issued March 2016, ASTM F2052-21, ASTM F2119-07 (reapproved 2013). Results were compared to non-predicate benchmarks.

Non-clinical (mechanical) testing results met the applicable acceptance criteria; therefore, acceptable mechanical performance is expected of the Ceramic Femoral Head manufactured by Based on comparability of mechanical performance data, the subject device is CoorsTek. substantially equivalent to the predicate devices.

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.