The Humelock II Reversible Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

Device Description

The Humelock II Reversible Shoulder is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The components of the system include a glenoid baseplate, standard and locking bone screws, optional baseplate post extensions, centered and eccentric glenospheres with and without a stabilization screw, 135/145° humeral cups, standard humeral cups and a 135/145° adaptor. These components are intended for use with the previously cleared Humelock II Cemented Humeral Stems and the Humelock II Cementless Humeral Stems. The design of the Humelock II Reversible Shoulder allows conversion from an anatomic shoulder configuration to a reverse shoulder configuration either intraoperatively or during revision of an anatomic shoulder with a well fixed humeral stem.

The glenoid baseplate, standard and locking screws, baseplate post extensions, glenosphere screws and 135/145° reverse adapters are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxylapatite coating. The glenospheres are manufactured from Co-Cr-Mo conforming to ISO 5832-12. The 135/145° Humeral Cups and standard Humeral Cups are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and UHMWPE conforming to ISO 5834-1 and ISO 5834-2.

AI/ML Overview

Based on the provided text, the device described is the Humelock II Reversible Shoulder System, which is a medical implant, not an AI/software device. Therefore, the questions related to acceptance criteria, study design for AI devices, and performance metrics for AI models are not applicable to this document.

The document is a 510(k) premarket notification summary for a medical device (a shoulder prosthesis), which aims to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than proving performance against specific acceptance criteria for an AI system.

However, I can extract information related to the physical device's "performance" as described in the "Non-Clinical Testing" section, which might be interpreted as "acceptance criteria" for a medical implant, and then address why other points are not applicable.

Here's a breakdown of the requested information based on the provided text, indicating where it's not applicable to this medical implant:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for Medical Implant)	Reported Device Performance (from "Non-Clinical Testing")
Range of Motion: Adequate for intended use.	"Range of motion analysis... indicate[s] that the performance of the Humelock II Reversible Shoulder is adequate for its intended use." (Specific quantitative criteria/results are not provided in this summary, but the conclusion of adequacy is stated.)
Construct Fatigue: Adequate for intended use.	"construct fatigue testing... indicate[s] that the performance of the Humelock II Reversible Shoulder is adequate for its intended use." (Specific quantitative criteria/results are not provided in this summary, but the conclusion of adequacy is stated.)
Glenosphere / Baseplate Connection: Adequate for intended use.	"testing of the glenosphere / baseplate connection... indicate[s] that the performance of the Humelock II Reversible Shoulder is adequate for its intended use." (Specific quantitative criteria/results are not provided in this summary, but the conclusion of adequacy is stated.)
Glenoid Baseplate Stability: Adequate for intended use.	"testing of the glenoid baseplate stability were conducted. The results of these tests indicate that the performance of the Humelock II Reversible Shoulder is adequate for its intended use." (Specific quantitative criteria/results are not provided in this summary, but the conclusion of adequacy is stated.)
Substantial Equivalence: To predicate devices in intended use, materials, design, and sizes.	"Differences between the subject device systems and the predicate device systems do not raise new types of safety and effectiveness questions." (This is the primary "acceptance criterion" for a 510(k) clearance.)

Regarding the AI/Software specific questions:

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

Not Applicable. This is a physical medical implant device, not an AI/software product, so there is no "test set" in the context of AI model evaluation. The "tests" mentioned are non-clinical biomechanical and material tests.

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 physical medical implant device. Ground truth, in the AI context of expert consensus, is not relevant here. The "ground truth" for the non-clinical tests would be the established engineering standards and biomechanical principles.

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

Not Applicable. As there's no "test set" for an AI model, adjudication methods are irrelevant.

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 physical medical implant device. MRMC studies are for evaluating diagnostic performance with or without AI assistance, which doesn't apply to a shoulder prosthesis.

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

Not Applicable. This is a physical medical implant device. There is no algorithm or standalone AI performance to evaluate.

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

Not Applicable in the AI context. For the non-clinical tests, the "ground truth" would be engineering specifications, material properties, and biomechanical stability benchmarks typically verified through laboratory testing against established standards.

8. The sample size for the training set

Not Applicable. This is a physical medical implant device. There is no AI training set.

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

Not Applicable. This is a physical medical implant device. There is no AI training set.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the department's focus on people and health.

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

November 13, 2015

Fx Solutions Ms. Chervl Hastings 1663 Rue De Majornas 01440 Viriat FRANCE

Re: K150488

Trade/Device Name: Humelock II Reversible Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: October 14, 2015 Received: October 15, 2015

Dear Ms. Hastings:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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/ResourcesforYou/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,

Mark N. Melkerson -S

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

Enclosure

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

Indications for Use

510(k) Number (if known): K150488

Device Name: Humelock II Reversible Shoulder System

Indications for Use:

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

Prescription Use X Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (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

{3}------------------------------------------------

510(k) Summary
Prepared:	October 14, 2015
Submitter:	Fx Solutions1663 Rue de MajornasViriat, France 01440
Contact:	Jean-Jacques Martin+33 4 74 55 35 55www.fxsolutions.fr
Proprietary Name:	Humelock II Reversible Shoulder System
Common Name:	Reverse Shoulder Prosthesis
Classification Names:	21 CFR 888.3660:Shoulder joint metal/polymer semi- constrainedcemented prosthesis; Class II
Product Codes:	PHX
Substantially Equivalent Devices:	Zimmer Anatomical Shoulder Inverse/Reverse TotalShoulder Prosthesis, K053274Fx Solutions Humelock II Cemented Shoulder System,K123814, K140071Fx Solutions Humelock II Cementless Shoulder System,K130759

Device Description:

Tornier Aequalis Reversed II Shoulder System, K132285

{4}------------------------------------------------

Intended Use / Indications:

The Humelock II Reversible Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

Summary of Technologies/Substantial Equivalence:

The Humelock II Reversible Shoulder is substantially equivalent to the predicate devices in regards to its intended use and indications, materials, design and sizes. Differences between the subject device systems and the predicate device systems do not raise new types of safety and effectiveness questions.

Non-Clinical Testing:

Range of motion analysis, construct fatigue testing, testing of the glenosphere / baseplate connection and testing of the glenoid baseplate stability were conducted. The results of these tests indicate that the performance of the Humelock II Reversible Shoulder is adequate for its intended use.

Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence of the Humelock II Reversible Shoulder to the predicate devices.

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.”