Candidates for total knee replacement include patients with a severely painful and/ or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Device Description

The Attune medialized dome and medialized anatomic patellae are available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates 3 pegs to provide stability and recessed cement pockets for enhanced cement fixation. The patella components are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The articular surface is offset medially proportional to the size of the component.
The Attune CR Knee System is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the DePuy Attune™ Total Knee System, specifically focusing on the medialized dome and medialized anatomic patellae components. The submission aims to establish substantial equivalence to previously marketed devices.

Based on the provided information, here's an analysis regarding acceptance criteria and study details:

The document does not describe acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) or a study proving the device meets these criteria in the context of an AI/human reader study.

Instead, this is a Premarket Notification (510(k)) for a physical medical device (knee implant components). The "acceptance criteria" here refer to the regulatory thresholds for establishing substantial equivalence to predicate devices. The "study" proving acceptance is the non-clinical functional testing performed to demonstrate this equivalence.

Therefore, many of the requested points (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone algorithm performance, AI assistance) are not applicable to this type of device submission.

Here's a breakdown of the relevant information provided:

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

The "acceptance criteria" in this context are for demonstrating substantial equivalence to predicate devices for a physical orthopedic implant. They are not defined by specific performance metrics like sensitivity or specificity.

Acceptance Criterion (Implicit)	Reported Device Performance
Material Equivalence: Must use materials substantially equivalent to predicate devices, conforming to relevant standards.	Met: "AOX UHMWPE conforming to ASTM F648" is used. The predicate devices also use "AOX UHMWPE conforming to ASTM F648" (for Attune predicate) or similar (unspecified for others, but implied acceptable).
Design Characteristics Equivalence: Key design features (e.g., fixation, articular surface offset) must be similar to predicate devices.	Met:- Articular Surface Offset: "medial" for the new device, "medial" for Kinemax predicate.- Fixation Surface: "Cemented" for the new device, "Cemented" for Sigma predicate.- Sizes: Available in 29, 32, 35, 38, 41 mm, which is comparable to predicate sizes (e.g., Attune predicate: 29, 32, 35, 38, 41mm; Sigma: 32, 35, 38, 41mm; NexGen: 29, 32, 35, 38, 41mm).- Overall Design: "similar to the predicate devices including design and AOX material."
Functional Performance Equivalence: Must perform similarly to predicate devices under anticipated in vivo loading.	Met: "Functional testing was conducted in compliance with FDA guidance... to verify that the implant performance would be substantially equivalent to predicate devices for anticipated in vivo loading via constraint and contact tests."
Intended Use & Indications for Use Equivalence: Must have the same fundamental intended use and indications.	Met: Intended use is "Total knee replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation..." and indications for use cover "patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant," which is standard for total knee replacements and aligns with the purpose of predicate devices.

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

Test Set (Non-Clinical): Not applicable in the sense of a patient data set for AI. The "test set" here refers to the physical devices subjected to non-clinical functional testing. The document does not specify the number of physical samples tested.
Data Provenance: Not applicable in the sense of patient data. The "data" comes from engineering and biomechanical testing of the physical implant components.

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)

Not applicable. Ground truth in this context is established through engineering specifications, material standards (ASTM F648), and biomechanical testing protocols defined by FDA guidance for orthopedic implants ("Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA"). It does not involve human expert interpretation of images or clinical data for performance assessment.

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

Not applicable. Adjudication is not relevant for this type of non-clinical, functional testing.

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

No, not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.

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

No, not applicable. This is a physical medical device.

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

The "ground truth" for this device, to establish substantial equivalence, is based on:
- Published ASTM material standards (ASTM F648) for the polyethylene.
- FDA guidance documents for non-clinical testing of knee implants (e.g., "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA").
- Established engineering principles and biomechanical testing methods (e.g., constraint and contact tests).
- Comparison to the known characteristics and approved status of predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI model for this physical device.

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

Not applicable. There is no "training set" or associated ground truth establishment for an AI model.

Summary of the Study Proving Acceptance:

The submission relies on non-clinical testing to prove the device meets the (implied) acceptance criteria of substantial equivalence.

Type of Study: Non-clinical functional testing.
Objective: To verify that the implant performance (specifically the medialized dome and medialized anatomic patellae components) would be substantially equivalent to predicate devices for anticipated in vivo loading.
Methods: Performed via "constraint and contact tests." The testing was conducted "in compliance with FDA guidance, Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA."
Results: The testing presumably demonstrated that the new components perform comparably to the predicate devices, leading to the FDA's determination of substantial equivalence.
Clinical Testing: "None provided as it was not necessary to determine substantial equivalence between the Attune Knee System's medialized dome and medialized anatomic patellae and the predicate devices." This highlights that for this type of device and the 510(k) pathway, non-clinical data was sufficient to establish equivalence for regulatory clearance.

Summary

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K103756

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1 510(k) Summary

MAR 1 5 2011

Submitted by:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (574) 371-4923Fax: (574) 371-4987
Contact Person:	Nancy Friddle, Project Manager Regulatory Affairs
Date Prepared:	December 2, 2010
Proprietary Name:	DePuy Attune™ Total Knee System
Common Name:	Total Knee Replacement Prosthesis
Classification Name:	21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis.Class II
Product Code:	JWHOIY
Predicate Devices:	The DePuy Attune Medialized Dome and Medialized AnatomicPatellae are substantially equivalent to currently marketed devicesincluding:• Sigma Patella (cleared as the Darwin Knee System), K950010• PFC Cruciate Retaining Knee System, Size 1.5, K961685• Attune Modified Dome Patella, K101433• Kinemax Plus Patella, K910500• Zimmer NexGen CR Knee System, K933785
Device Description:	The Attune medialized dome and medialized anatomic patellae areavailable in sizes 29, 32, 35, 38, and 41mm. The fixation surfaceincorporates 3 pegs to provide stability and recessed cement pocketsfor enhanced cement fixation. The patella components aremanufactured from AOX ultra high molecular weight polyethyleneconforming to ASTM F648. The articular surface is offset mediallyproportional to the size of the component.The Attune CR Knee System is designed to accommodate kneeflexion to 150 degrees in those patients able to attain a high degreeof knee flexion.
Intended Use:	Total knee replacement is intended to provide increased patient

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K103756 *2/3

mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

The Attune CR Knee System is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.

The DePuy Attune™ Total Knee System is intended for cemented use as a Indications for Use: total knee replacement system.

Candidates for total knee replacement include patients with a severely painful and/ or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Technological Characteristics:

As shown in the following table, the technological characteristics of the Attune medialized dome and medialized anatomic patellae are similar to the predicate devices including design and AOX material.

Characteristic	Attune MedializedDome and MedializedAnatomic Patella(current submission)	Sigma 3-Peg Oval Patella (K961685, K950010)Attune Modified Dome Patella (K101433)NexGen Patella (K933785)Kinemax Plus Patella (K910500)
Material	AOX UHMWPEconforming to ASTMF648	Attune: AOX UHMWPE conformingto ASTM F648
Sizes	29, 32, 35, 38, 41 mm	Attune: 29, 32, 35, 38, 41mmSigma: 32 (K961685)35, 38, 41mm (K950010)NexGen: 29, 32, 35, 38, 41mm (standardsizes)
Articular SurfaceOffset	medial	Kinemax: medial
Fixation Surface	Cemented	Sigma: Cemented

Summary of Substantial Equivalence:

As part of the Attune CR total knee replacement system, the DePuy Attune medialized dome and medialized anatomic patellae are

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substantially equivalent to currently marketed devices as demonstrated with preclinical data.

Non-Clinical Testing:

Functional testing was conducted in compliance with FDA guidance, Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA, to verify that the implant performance would be substantially equivalent to predicate devices for anticipated in vivo loading via constraint and contact tests.

Clinical Testing:

None provided as it was not necessary to determine substantial equivalence between the Attune Knee System's medialized dome and medialized anatomic patellae and the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes extending from its back, all enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the border of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DePuy Orthopaedics. Inc. % Ms. Nancy Friddle Project Manager Regulatory Affairs 700 Orthopacdic Drive Warsaw, Indiana 46581

MAR 1 5 2011

Re: K103756

Trade/Device Name: DePuy Attune™ Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OIY, JWH Dated: December 22, 2010 Received: December 23, 2010

Dear Ms. Friddle:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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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Page 2 -- Ms. Nancy Friddle

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Afy B. Rh

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2. INDICATIONS FOR USE

K103756 510(k) Number (if known): _

Device Name: DePuy Attune™ Medialized Dome and Medialized Anatomic Patellae

Indications for Use:

The DePuy Attune™ Total Knee System is intended for cemented use as a total knee replacement system.

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, theumatoid arthritis, or a failed previous implant.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

for M. Mulberson

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K103756
510(k) Number

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.