The ARROW® Reverse Shoulder long keel and short keel glenoid base is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

Device Description

The ARROW® Reverse Shoulder long keel and short keel glenoid base consist of a metal-back glenoid base, used with bone screws for fixation and assembled with previously cleared glenosphere. These components are used in total reverse prosthesis and are designed to articulate with ARROW® Reverse Shoulder System cleared in K112193.

The bone fixation screws are cleared in K112193.

The ARROW® Reverse Shoulder long keel and short keel glenoid base is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis (and identical to those for ARROW® anatomical (K093599) and reverse shoulder system (K112193)).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (ARROW® Reverse Shoulder long keel and short keel glenoid base) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for a novel device or software. Therefore, much of the requested information regarding acceptance criteria, specific study designs, expert involvement, and ground truth establishment, which are typical for software-as-a-medical-device (SaMD) or diagnostic devices, is not directly applicable or available from this type of regulatory submission.

However, I can extract the information that is present and explain why other aspects are not applicable.

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

The document does not provide a table of explicit acceptance criteria with numerical targets and reported performance values in the way one would typically expect for a diagnostic or AI-driven device. Instead, the "performance" is assessed through a cyclic mechanical protocol to demonstrate substantial equivalence to predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical performance is substantially equivalent to predicate devices.	"The ARROW® Reverse Shoulder long keel and short keel glenoid base was tested according to cyclic mechanical protocol. After the testing was completed, it was determined that the ARROW® Reverse Shoulder long keel and short keel glenoid base performances were substantially equivalent to those of the selected predicate devices."
Risks to health are addressed.	"Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations."
Conformance to standards in force.	Implied by the declaration of substantial equivalence based on technical data and manufacturer's documents.

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

The "test set" for this device refers to the physical devices subjected to mechanical testing. The document does not specify the exact sample size (number of devices or components tested) used for the cyclic mechanical protocol.

Regarding data provenance, the testing was performed by the manufacturer, Fournitures Hospitalières Industrie, in France. The document does not specify if different batches or manufacturing runs were tested, nor does it refer to "countries of origin" for data in the context of clinical populations, as this is a mechanical testing scenario for an orthopedic implant.

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

This question is not applicable to this type of device and study. For a mechanical device like a shoulder implant component, "ground truth" is not established by human experts in the diagnostic sense. The "ground truth" for mechanical performance is typically defined by engineering specifications, material properties, and validated testing methods (e.g., ISO standards, ASTM standards) that simulate in-vivo conditions. The evaluation of whether the mechanical tests were performed correctly and meet the implicit equivalence criteria would be done by engineers and regulatory reviewers, not medical experts establishing a diagnostic ground truth.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth in diagnostic imaging cases, especially when there's inter-reader variability. For mechanical testing of a medical device, the results are typically quantitative and objective measurements (e.g., strength, fatigue life). The "adjudication" (if one could even call it that) of the test results themselves would be against predefined engineering acceptance criteria, potentially verified by internal quality control or external testing labs, not by a panel of 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

This question is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human readers (e.g., radiologists). The ARROW® Reverse Shoulder long keel and short keel glenoid base is an orthopedic implant (a physical device), not a diagnostic tool or an AI-assisted system.

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

This question is not applicable. This device is a physical implant, not an algorithm or software. Therefore, there is no "standalone algorithm only" performance to evaluate.

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

The document does not describe "ground truth" in terms of clinical or diagnostic data. For the mechanical testing, the "ground truth" is effectively the performance of the predicate devices and generally accepted mechanical engineering principles and standards for orthopedic implants under simulated physiological loads. The goal was to show that the new device's mechanical performance was "substantially equivalent" to these established benchmarks.

8. The sample size for the training set

This question is not applicable. As this is a physical medical device (an implant), there is no "training set" in the context of an AI algorithm or a statistical model derived from a dataset.

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

This question is not applicable (see response to #8).

Summary

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

March 20, 2015

Fournitures Hospitalieres Industrie Ms. Patricia Donnard Regulatory Affairs Manager Zi De Kernevez- 6 rue Nobel 29000 Quimper France

Re: K142778

Trade/Device Name: ARROW® Reverse Shoulder long keel and short keel glenoid base Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: February 17, 2015 Received: February 19, 2015

Dear Ms. Donnard:

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, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Lori A. Wiggins -S

for

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

Enclosure

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4. Indications for Use

510(k) Number (if known): K142778

Device Name: ARROW® Reverse Shoulder long keel and short keel glenoid base This device is composed of the following elements: A metal-back long keel glenoid base and a metal-back short keel glenoid base. These devices are designed to articulate with ARROW® Reverse Shoulder System cleared in K112193. Indications for Use: The ARROW® Reverse Shoulder long keel and short keel glenoid base is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR

Over the counter Use: No (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

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5. 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92.

Date prepared: September 11th 2014 The assigned 510(k) number is: K 142778 Fournitures Hospitalières industrie 5-1. Applicant: 6 Rue Nobel, Z.I. de Kernévez 29000 QUIMPER - FRANCE Tel: (+33) 2.98.55.68.95 Fax: (+33) 2.98.53.42.13 5-2. Company Contact: Franck HUNT, General Manager Tel: (+33) 2.98.55.68.95 5-3. Product : ARROW® Reverse Shoulder long keel and short keel Trade name: glenoid base Common name: Shoulder prosthesis ARROW® Reverse Shoulder long keel and short keel Classification: glenoid base components are included in the following classifications: Shoulder joint metal/ polymer semi-constrained cemented prosthesis Product code: PHX Regulation: 21 CFR 888.3660 Class: II

5-4. Predicate/ Legally Marketed Devices:

Information on devices to which substantial equivalence is claimed:

Manufacturer:	Fournitures Hospitalières industrie
Device Trade Name:	ARROW® Reverse Shoulder System
510 (K):	K112193
Manufacturer:	Aston Medical
Device Trade Name:	DUOCENTRIC® Reversed
510 (K):	K103251

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5-5. Device Description:

The bone fixation screws are cleared in K112193.

5-6. Indications for Use/ Intended Use:

As stated in the Indications for Use section and on the product related labeling (instructions for use and commercial documents):

The ARROW® Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

5-7. Comparison of Technological Characteristics:

The ARROW® Reverse Shoulder long keel and short keel glenoid base and the above selected predicate devices have the same intended use and substantial similar indications for use and share the following similarities:

they are made out of the same materials (titanium alloy),
they are available in similar ranges of sizes, ı
they bear design features similarities. -

5-8. Performances:

The ARROW® Reverse Shoulder long keel and short keel glenoid base was tested according to cyclic mechanical protocol. After the testing was completed, it was determined that the ARROW® Reverse Shoulder long keel and short keel glenoid base performances were substantially equivalent to those of the selected predicate devices.

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Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.

5-9. Substantial Equivalence:

The substantial equivalence of our products, when compared to the selected predicate devices, has been established following manufacturers' commercial documents, 510(k) submission's information available on FDA's website as well as conformance to standards in force.

The analysis of these technical data allows us to submit the ARROW® Reverse Shoulder long keel and short keel glenoid base as being substantially equivalent to the already cleared predicate devices selected to draw a comparison.

5-10. Conclusion:

Following the examination of all the above mentioned information, we believe that the ARROW® Reverse Shoulder long keel and short keel glenoid base are substantially equivalent to the selected predicate devices in terms of intended use, ranges of sizes, materials, performances, safety and effectiveness.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”