The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.

Candidates for total knee replacement include patients with and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

Device Description

The ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically the ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology. This document is a regulatory submission to the FDA seeking clearance for a device based on its substantial equivalence to a legally marketed predicate device.

It's important to understand that a 510(k) summary focuses on demonstrating substantial equivalence primarily through non-clinical performance data (e.g., mechanical testing, material properties) when changes are minor and do not significantly alter the device's fundamental technology or intended use. Clinical studies are often waived when substantial equivalence can be shown through other means.

Therefore, the information you're requesting regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/machine learning device's performance study (e.g., sensitivity, specificity, MRMC studies, expert ground truth) is not applicable to this specific document. This document pertains to a mechanical orthopedic implant and its regulatory clearance based on engineering and material performance.

Here's why and what information is available:

This document describes the regulatory clearance of a mechanical orthopedic implant, not an AI/ML diagnostic device. The "acceptance criteria" and "study" described in the document are focused on the mechanical and material performance of the implant, demonstrating its equivalence to a predicate device.

Key Points from the Document Regarding "Acceptance Criteria" and "Study":

Device Type: ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology (a knee replacement component).
Purpose of Submission: Update Tensile Mechanical Properties In-Process Limits. This indicates a minor change related to manufacturing specifications, not a fundamental change in design or function.
Demonstration of Equivalence: The document states that the subject device is "identical to the predicate... in principle of operation, intended use, classification, design, materials and fixation."
Performance Data: The only "performance data" mentioned is "Tensile Testing." In addition, the device is stated to "continue to meet the requirement of bacterial endotoxin testing as specified in ASNI/AAMI ST 72:2019."
Clinical Testing: The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence."
Ground Truth: For a metallic implant, "ground truth" would relate to material properties, mechanical strength, biocompatibility, and long-term in-vivo performance, established through standardized testing, material specifications, and potentially animal/cadaver studies, rather than subjective expert interpretation of medical images.
No AI/ML Component: There is no mention of an AI/machine learning component to this medical device.

If we were to interpret your request in the context of this specific regulatory submission for a mechanical device, here's how some of your points would be addressed, with the understanding that they don't map directly to AI/ML study methodologies:

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

The document does not provide a detailed table of acceptance criteria for mechanical properties, nor specific reported performance values the way an AI/ML study would. It states that "Tensile Testing" was performed and that the device "continues to meet the requirement of bacterial endotoxin testing." For a 510(k) submission concerning a minor change, the full detailed test reports are typically kept on file by the manufacturer and are part of the full 510(k) submission, not necessarily summarized in detail in the publicly available 510(k) summary.

General "Acceptance Criteria" inferred:

Acceptance Criteria (Inferred for this type of device)	Reported Device Performance (as stated in document)
Tensile Mechanical Properties Limits	Met/Continue to meet
Bacterial Endotoxin Limits (ASNI/AAMI ST 72:2019)	Met/Continue to meet
Substantial Equivalence to Predicate	Achieved

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

Sample Size: Not specified in the summary document. For mechanical testing, this would refer to the number of test coupons or actual devices subjected to tensile testing.
Data Provenance: Not specified. Testing would typically be conducted by the manufacturer or a certified testing laboratory. The device's origin is Ireland, based on the submitter information, but testing could happen anywhere globally. The document is silent on whether it's retrospective or prospective data, but laboratory mechanical testing is generally conducted prospectively for regulatory submissions.

3. Number of experts used to establish the ground truth and qualifications

Not applicable in the AI/ML sense. For a mechanical device, "ground truth" is established by engineering standards, material specifications (e.g., ASTM F-136 for Titanium Alloy), and quantitative mechanical property measurements. There are no radiologists or other clinical experts adjudicating images for ground truth in this context.

4. Adjudication method for the test set

Not applicable. Adjudication methods are relevant for subjective interpretations (like image reads). Mechanical testing involves objective measurements against predefined engineering specifications.

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

No. This type of study is for evaluating human performance, often with AI assistance, in diagnostic tasks. It is not relevant to the clearance of a mechanical orthopedic implant.

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

Not applicable. This relates to AI algorithm performance. There is no AI algorithm in this device.

7. The type of ground truth used

Engineering Specifications and Material Standards: The ground truth for this device would be established by validated mechanical testing methods (e.g., ASTM standards for tensile strength, fatigue, material composition) and biological safety (e.g., bacterial endotoxin limits, biocompatibility as per ISO standards not explicitly mentioned but implied for implantable devices). This is an objective, quantitative ground truth.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system that requires a "training set."

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

Not applicable. As above, no training set.

In summary, the provided document is a regulatory communication for a mechanical orthopedic implant, not an AI/ML-driven device. Therefore, the detailed criteria and study structures relevant to AI/ML performance evaluation (like those involving expert interpretation, MRMC, sensitivity/specificity, etc.) are entirely outside the scope of this particular submission.

Summary

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January 18, 2022

DePuy Ireland UC % Hannah Foley Regulatory Affairs Associate Director DePuy Orthopaedics. Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K213781

Trade/Device Name:	ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPTechnology
Regulation Number:	21 CFR 888.3565
Regulation Name:	Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated UncementedProsthesis
Regulatory Class:	Class II
Product Code:	MBH, JWH
Dated:	December 21, 2021
Received:	December 22, 2021

Dear Hannah Foley:

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 (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 located 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely,

for Ting Song, Ph.D., R.A.C. Acting 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

510(k) Number (if known)

K213781

Device Name

ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology

Indications for Use (Describe)

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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Section 5 – 510(k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg, RingaskiddyCo. Cork Munster, IRELAND
Phone number	786-494-2755
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Hannah Foley
Date prepared	December 21, 2021
Name of device
Trade or proprietary name	ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology
Common or usual name	Total Knee Prosthesis
Classification name	Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesisKnee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	Primary: 21 CFR 888.3565Secondary: 21 CFR 888.3560
Product Code(s)	Primary: MBHSecondary: JWH
Legally marketed device(s) towhich equivalence is claimed	Primary Predicate for ATTUNE Porous Fixed Bearing Tibial Base:ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology - K202194 – Cleared 11/25/2020
Reason for 510(k) submission	Update Tensile Mechanical Properties In-Process Limits.
Device description	The ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without porous coating. The tibial component may
	be comprised of a metal tibial base with or without porous coating, and apolyethylene insert and locking components, or be an all polyethylene device.
Intended use of the device	Total knee arthroplasty is intended to provide increased patient mobility andreduced pain by replacing the damaged knee joint articulation in patients wherethere is evidence of sufficient sound bone to seat and support the components inskeletally mature patients. Total knee replacement may be considered foryounger patients if, in the opinion of the surgeon, an unequivocal indication fortotal knee replacement outweighs the risks associated with the age of the patient,and if limited demands regarding activity and knee joint loading can be assured.This includes severely crippled patients with multiple joint involvement forwhom a gain in knee mobility may lead to an expectation of significantimprovement in the quality of their lives.
Indications for use	The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patellaand Medialized Anatomic Patella with AFFIXIUM 3DP Technology areintended for cementless use within the ATTUNE® Total Knee ReplacementSystem. Porous coated implants may be used with or without cement.Candidates for total knee replacement include patients with a severelypainful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate boneis present).

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

The DePuy ATTUNE Porous Fixed Bearing (FB) Tibial Base with AFFIXIUM 3DP Technology is identical to the predicate DePuy ATTUNE Porous Fixed Bearing (FB) Tibial Base with AFFIXIUM 3DP Technology (K202194) in principle of operation, intended use, classification, design, materials and fixation.

The ATTUNE Porous FB Tibial Base with AFFIXIUM 3DP Technology is manufactured from Titanium alloy (Ti-6Al-4V), available in sizes 1-10, and intended for cemented use within the ATTUNE Total Knee Replacement System. The bone apposing surfaces are comprised of 3D printed fixation features with a porous and solid geometry that enable biological fixation of the bone. The proximal surface is designed to work with currently available ATTUNE FB tibial inserts.

Tibial BaseCharacteristics	Subject Device:DePuy ATTUNE Porous FB Tibial Base withAFFIXIUM 3DP Technology	Primary Predicate Device:DePuy ATTUNE Porous FB TibialBase with AFFIXIUM 3DPTechnology(K202194)
Material	Titanium Alloy ASTM F-136Titanium Alloy ASTM F-3001	Same
Fixation	Cementless or Cemented	Same
Sizes	Sizes 1 to 10	Same

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PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The following test was performed to demonstrate substantial equivalence of safety and efficacy with the predicate device:

ATTUNE Porous Fixed Bearing (FB) Tibial Base with AFFIXIUM 3DP Technology:

Tensile Testing ●
The proposed devices continue to meet the requirement of bacterial endotoxin testing as specified in ASNI/AAMI ST 72:2019.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Clinical testing was not required to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The DePuy ATTUNE Porous FB Tibial Base with AFFIXIUM 3DP Technology are substantially equivalent to the predicate devices; DePuy ATTUNE Porous Fixed Bearing (FB) Tibial Base with AFFIXIUM 3DP Technology (K202194)

Regulation Number and Section

N/A