The DePuy LPS System is intended for use in replacement of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

· malignant tumors (e.g., osteosarcomas, ciant cell tumors, bone tumors) requiring extensive resection and replacement;

· patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and

inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;

· revision cases for a failed previous prosthesis requiring extensive resection and replacement;

· severe trauma requiring extensive resection and replacement.

The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.

The porous-coated metaphyseal sleeves are intended for either cementless applications.

Device Description

The ATTUNE® Revision Sleeve LPS™ Femoral Adaptors are designed as a component in the replacement of the natural articular surface of the knee joint or of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The ATTUNE Revision Sleeve LPS Femoral Adaptors are to be used to connect an ATTUNE Revision Femoral Sleeve to LPS System Components.

AI/ML Overview

This document is a 510(k) summary for the ATTUNE® Revision Sleeve LPS™ Femoral Adaptors. It is a premarket notification for a medical device, which generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data for new acceptance criteria.

Based on the provided text, the device itself is a component of a knee replacement prosthesis, specifically an adaptor. The "performance data" section focuses on non-clinical tests to demonstrate substantial equivalence, not a study to prove acceptance criteria for a diagnostic AI device.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI performance, sample sizes, ground truth establishment, and MRMC studies are not applicable to this document as it describes a mechanical orthopedic implant, not an AI/ML-driven diagnostic device.

Here's a breakdown of the information that can be extracted or inferred:

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

Since this is a mechanical device, the "acceptance criteria" are related to mechanical strengths, biocompatibility, and MRI safety, not a diagnostic performance metric like sensitivity or specificity.

Acceptance Criteria (Non-clinical)	Reported Device Performance (Summary)
Taper Connections Tension Strength	Tested and found to be "equivalent to the LPS Universal Femoral to Sleeve Adaptor" (predicate device).
Taper Connections Torsion Strength	Tested (details not provided beyond "taper connections tension and torsion strength"). Implied to meet acceptance for substantial equivalence.
Biocompatibility	Biocompatibility testing was performed. Implied to meet acceptance criteria for substantial equivalence.
MRI Safety Evaluation	Evaluated worst-case components and constructs for magnetically induced force, torque, image artifact, and RF heating. Concluded: "no safety issues related to magnetic field interactions under specific conditions identified in the labeling."
Bacterial Endotoxin Testing	Met the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
Shelf Life	10 years (Same as predicate device, implying met acceptance criteria for substantial equivalence).
Material	Wrought, low carbon, cobalt chrome molybdenum alloy (Same as predicate device, implying met acceptance criteria for substantial equivalence).
Locking Design/Mating Design	Taper Lock (Same as predicate device, implying met acceptance criteria for substantial equivalence).
Sterilization Method	Gamma Radiation (Same as predicate device, implying met acceptance criteria for substantial equivalence).
Packaging	Polyurethane protective component sealed in two Tyvek-lidded PETG blister trays, packaged with an IFU and label stock, all contained in a folding carton with shrink wrap. (Same as predicate device, implying met acceptance criteria for substantial equivalence).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as the tests are non-clinical (mechanical, material, safety) rather than clinical studies with patient data. The "test set" would refer to the number of physical devices or components tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. Ground truth, in the context of expert consensus, is typically for diagnostic interpretation. For mechanical devices, material science and engineering standards define performance.

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

This is not applicable as it refers to expert adjudication for diagnostic ground truth.

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

A MRMC comparative effectiveness study is not applicable as this is not an AI/ML diagnostic or assistive device.

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 AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For mechanical aspects: Engineering standards and test methodologies serve as the "ground truth" for performance.
For biocompatibility: ISO standards for biological evaluation of medical devices.
For MRI safety: ASTM standards for testing medical devices in MRI environments.
For endotoxin testing: ANSI/AAMI ST 72:2019 standard.

8. The sample size for the training set

This is not applicable as there is no AI/ML model involved.

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

This is not applicable as there is no AI/ML model involved and therefore no "training set."

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

DePuy Ireland UC % Soraya Hori Project Leader Regulatory Affairs Depuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K202248

Trade/Device Name: Attune Revision® Sleeve LPSTM Femoral Adaptors Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: November 13, 2020 Received: November 16, 2020

Dear Soraya Hori:

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.

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

{1}------------------------------------------------

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 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-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 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. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

ATTUNE® Revision Sleeve LPS™Femoral Adaptors

Indications for Use (Describe)