The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.

Device Description

The proposed size 37 humeral head is manufactured from Cobalt Chromium (CoCr) and will be offered with a 16mm offset. The proposed size 37 trunnion is manufactured from Titanium alloy (Ti6Al4V) with its underside coated with a Titanium Plasma Spray (TPS) coating. The trunnion will be offered in a slotted design. The Size 37 Head and Trunnion will be used with the existing hollow screws cleared under the predicate.

AI/ML Overview

This FDA 510(k) summary describes a modification (a new size) to an existing shoulder prosthesis system, the Arthrex Eclipse Shoulder Prosthesis System. It does not involve an AI/ML powered device, and therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample sizes for test and training sets, expert adjudication, MRMC studies) are not applicable.

The core of this submission is to demonstrate substantial equivalence of a new component (size 37 Humeral Head and Trunnion) to a previously cleared device. The acceptance criteria and "study" are primarily focused on mechanical performance and ensuring the new component maintains the same safety and effectiveness profile as the existing predicate device.

Here's an attempt to populate the requested table and information based on the provided text, indicating "Not Applicable" (N/A) where the information is absent or irrelevant for this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What needs to be demonstrated)	Reported Device Performance (How the device meets the criteria)
Mechanical Strength & Fatigue Resilience: The new size 37 Humeral Head and Trunnion must withstand physiological loads and demonstrate fatigue resilience comparable to the predicate device.	Leveraged Predicate Data: "Static and dynamic compression testing presented in the predicate 510(k) clearance is leveraged to demonstrate the fatigue resilience of the proposed Arthrex Eclipse Shoulder Prosthesis." This implies that the design and materials of the new component are sufficiently similar to the predicate that the previously performed tests are considered valid for the new size, or that engineering analysis confirms mechanical equivalence.
Material Composition: New components must be made of materials suitable for surgical implantation and consistent with predicate.	Specified Materials: "The proposed size 37 humeral head is manufactured from Cobalt Chromium (CoCr)... The proposed size 37 trunnion is manufactured from Titanium alloy (Ti6Al4V) with its underside coated with a Titanium Plasma Spray (TPS) coating." These materials are standard for orthopedic implants and consistent with predicate devices.
Intended Use: The modified device must maintain the same intended use as the predicate device.	Identical Indications for Use: The "Indications for Use" section for K201542 is identical to the one provided in the general information, stating: "The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis." This confirms the intended use remains unchanged.
Fundamental Scientific Technology: The new component must not introduce any new fundamental scientific technology or principles of operation.	Same Fundamental Scientific Technology: "The Arthrex Eclipse Size 37 has the same intended use and the same fundamental scientific technology as the Arthrex Eclipse Shoulder Prosthesis System."

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

Sample size for the test set: Not applicable for this type of mechanical device submission in the context of an AI/ML device. The "test" here refers to mechanical testing of physical samples, not a dataset for an algorithm. The exact number of physical samples tested is not specified in the summary, but typically involves a statistically relevant number for mechanical evaluations.
Data provenance: Not specified in the summary. For mechanical testing, this would typically involve samples manufactured under controlled conditions, often within the company's facilities.

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. This is a mechanical device, not an AI/ML algorithm requiring expert interpretation of outputs or ground truth for a test set. Ground truth for mechanical properties is established through standardized engineering tests, not human expert consensus.

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

Not Applicable. As above, this is a mechanical device. Adjudication methods are relevant for subjective interpretations of data, such as medical image analysis by multiple experts.

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 is a mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool for human readers.

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

Not Applicable. There is no algorithm discussed or included in this device submission.

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

Mechanical Testing Standards & Engineering Specifications: The "ground truth" for this device's performance is established by adhering to recognized mechanical testing standards (e.g., ISO, ASTM for orthopedic implants) for properties like fatigue strength, compressive strength, and material biocompatibility. The predicate device's cleared performance against these standards serves as the benchmark.

8. The sample size for the training set

Not Applicable. This is a mechanical device, not an AI/ML algorithm requiring a training set.

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

Not Applicable. As above, no training set for an algorithm is involved.

Summary

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July 8, 2020

Image /page/0/Picture/1 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

Arthrex, Inc. David L. Rogers Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K201542

Trade/Device Name: Arthrex Eclipse Shoulder Prosthesis System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHQ, PKC Dated: June 5, 2020 Received: June 9, 2020

Dear David Rogers:

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 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

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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 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).

Sincerely.

For Michael Owens Acting 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

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Indications for Use

510(k) Number (if known)

K201542

Device Name Arthrex Eclipse Shoulder Prosthesis System

Indications for Use (Describe)

The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.

The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.

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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510(k) Summary

Date Prepared	July 8, 2020
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	David L RogersManager, Regulatory Affairs1-239-643-5553david.rogers@arthrex.com
Name of Device	Arthrex Eclipse Shoulder Prosthesis System
Common Name	Shoulder Prosthesis
Product Code	PKC, QHQ
Classification Name	21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class	Class II
Predicate Device	K183194: Arthrex Eclipse Shoulder Prosthesis
Purpose of Submission	This Special 510(k) premarket notification is submitted to obtain FDA clearance for asize 37 Humeral Head and Trunnion as a line extension to the Arthrex Eclipse ShoulderProsthesis System cleared under K183194.
Device Description	The proposed size 37 humeral head is manufactured from Cobalt Chromium (CoCr) andwill be offered with a 16mm offset. The proposed size 37 trunnion is manufacturedfrom Titanium alloy (Ti6Al4V) with its underside coated with a Titanium Plasma Spray(TPS) coating. The trunnion will be offered in a slotted design. The Size 37 Head andTrunnion will be used with the existing hollow screws cleared under the predicate.
Indications for Use	The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/ordisabled joint resulting from osteoarthritis or traumatic arthritis.The humeral component is fixated with a hollow screw and the glenoid components areintended for cemented fixation in the joint and must only be used with appropriatebone cement.
Performance Data	Static and dynamic compression testing presented in the predicate 510(k) clearance isleveraged to demonstrate the fatigue resilience of the proposed Arthrex EclipseShoulder Prosthesis.
Conclusion	The Arthrex Eclipse Size 37 has the same intended use and the same fundamentalscientific technology as the Arthrex Eclipse Shoulder Prosthesis System. Based on thenon-clinical data presented in this 510(k), Arthrex concludes that the proposed device issubstantially equivalent to the currently marketed predicate device.

Regulation Number and Section