The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older).

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

The humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side.

The additional component bail out head is intended when, during primary surgery for the Duocentric® Reversed shoulder prosthesis 1) the glenoid bone stock appears to be insufficient to bear the implant of the glenoid components, or 2) the glenoid bone fractures intra-operatively.

Device Description

The Duocentric® Reversed shoulder prosthesis is a prosthesis that uses the biomechanical concepts of reverse shoulder arthroplasty as originally described by Paul Grammont.

The Duocentric® Reversed shoulder prosthesis is composed of a humeral stem, a humeral baseplate, a humeral insert, a gleonosphere (Duoglene), and a glenoid baseplate already cleared under K103251. It also includes a "bail out head" for use during rare occasions during surgery to salvage the procedure.

The humeral insert is made of ultra-high-molecular-weight polyethylene (UHMWPE), while all other components are made of wrought high nitrogen stainless steel M30NW. The humeral stem is intended for cemented use unless coated with hydroxyapatite (HA). The glenoid baseplate is coated with a double coating of pure titanium and hydroxyapatite (Ti/HA), is intended for cementless use, and is fixated with wrought high nitrogen stainless steel screws. The device is provided sterile.

The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580 and are performed by Medical Coating'(Vault-en-Velin, FR) according to their Master File MAF-1633.

This submission includes an additional component, a bail out head. This additional component is included to provide a solution to the surgeon 1) when during the primary surgery, the glenoid bone stock appears to be insufficient to bear the implant of the glenoid components or 2) glenoid bone fracture occurs intra-operatively.

AI/ML Overview

This document does not contain information about acceptance criteria or a study that proves a device meets them, as it is a 510(k) premarket notification for a medical implant (a shoulder prosthesis).

Here's a breakdown of why this type of document doesn't fit the request and what information it does provide:

Key Takeaway: The provided text is a 510(k) summary for a medical device (a shoulder prosthesis). The purpose of a 510(k) is to demonstrate substantial equivalence to an already legally marketed predicate device, not necessarily to prove adherence to specific performance acceptance criteria for a novel device through a standalone study with defined accuracy metrics. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for performance evaluation of a device (in the context of AI or diagnostic systems) is not present.

However, I can extract information related to the device and its regulatory submission:

Device Information:

Trade/Device Name: Duocentric® Reversed Shoulder Prosthesis
Regulation Number: 21 CFR 888.3660
Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: PHX, KWS, HSD
Indications for Use: Gross rotator cuff deficiency (including with osteoarthritis), revision of previous arthroplasty, or complex fracture of the humerus (3 fragments or more) in an older population (e.g., 65 years or older). Requires anatomically and structurally suited joint and a functional deltoid muscle.
Components: Humeral stem, humeral baseplate, humeral insert, gleonosphere (Duoglene), glenoid baseplate, and an additional "bail out head."
Materials: Humeral insert (UHMWPE), other components (wrought high nitrogen stainless steel M30NW). Glenoid baseplate coated with double layer of pure Titanium and Hydroxyapatite (Ti/HA). Humeral stem either polished (cemented) or HA coated.
Sterilization: Provided sterile.

Information Related to Substantial Equivalence and Performance (as described in the document):

A table of acceptance criteria and the reported device performance:
- This document does not present acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, or accuracy) derived from a clinical study for a diagnostic or AI device. Instead, the "performance" demonstrated is substantial equivalence to predicate devices based on design, materials, manufacturing, and preclinical testing results.
- The closest to "performance" stated is: "Pre-clinical performance testing concluded that the Duocentric® Reversed shoulder finished product with its bail-out head met all predetermined specifications and are adequate for their intended use." However, the document does not list these specific predetermined specifications or the exact results.
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This is not a study assessing the performance of a diagnostic algorithm or AI system on a test set of data. The assessment is primarily mechanical and material.
- Data Provenance: Not applicable in the context of a "test set" for diagnostic performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" derived from expert consensus in the context of assessing the performance of this orthopedic implant.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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 not an AI-assisted diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this type of device, ground truth relates to mechanical integrity, biocompatibility, and manufacturing quality standards, not diagnostic outcomes. The "ground truth" for showing safety and effectiveness in a 510(k) is typically demonstrated by meeting recognized standards (e.g., ASTM standards for materials and coatings) and showing equivalence to devices with a known safety and effectiveness profile.
The sample size for the training set:
- Not applicable. This is not an AI-based device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

What the document does say about "performance testing":

"An engineering analysis analyze the requirements for pre-clinical testing associated with the inclusion of the additional component."
"Testing results from K103251 remained applicable." (Referring to the predicate device)
"Pre-clinical performance testing concluded that the Duocentric® Reversed shoulder finished product with its bail-out head met all predetermined specifications and are adequate for their intended use."
Clinical data were not required for this device. This is a crucial point, indicating that substantial equivalence was demonstrated through non-clinical means (engineering analysis, material testing, comparison to predicates) rather than a clinical trial directly assessing patient outcomes or diagnostic accuracy.
Material and Coating Standards: The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580. This is a form of "acceptance criteria" for raw materials and processes, confirmed by Medical Coating's Master File MAF-1633.

In summary, for a medical implant like the Duocentric® Reversed Shoulder Prosthesis seeking 510(k) clearance, the "study" is primarily a demonstration of substantial equivalence through engineering analysis, adherence to material standards, and leveraging existing data from predicate devices, rather than a clinical performance study with statistical metrics typically associated with AI or diagnostic device evaluation.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

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

November 2, 2016

Aston Medical % Ms. Catherine Gloster, MS, RAC Gloster Biomedical International 577 North Hope Avenue Santa Barbara, California 93110

Re: K133462

Trade/Device Name: Duocentric® Reversed Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD Dated: December 9, 2013 Received: December 11, 2013

Dear Ms. Gloster:

This letter corrects our substantially equivalent letter of February 7, 2014.

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

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Page 2 - Ms. Catherine Gloster, MS ,RAC

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 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/Resourcesfor You/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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Indications for Use and Intended Use

510(k) K133462

Duocentric® Reversed shoulder prosthesis: Aston® Medical

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

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

Attachment 1

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FEB - 7 2014

510(k) Summary K133462

This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) and 21CFR § 807.92

Submitted by:	Aston Medical19, rue Victor Grignard42000 Saint-EtienneFrance
Contact Person:	Catherine Gloster, Regulatory Affairs ConsultantGloster Biomedical International577 North Hope AveSanta Barbara, CA 93110 - USAPhone: 805-679-1258Fax : 805-682-1250Email: c.gloster@GlosterBiomedical.com
Date Prepared:	December 9, 2013
Proprietary Name:	DUOCENTRIC® Reversed
Common Name:	Reverse shoulder prosthesis
Classification:	Class II, 21 CFR 888.3660Shoulder joint metal/polymer semi-constrainedcemented prosthesisKWSClass II, 21 CFR 888.3690Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesisHSD
Predicate Devices:	K103251 - Aston Medical, France - Duocentric®Reversed Shoulder Prosthesis - cleared 10/28/2011K091751 - Depuy Orthopaedic, Inc. USA - DepuyDelta Xtend Reverse Shoulder - cleared 7/14/2009
Device Description:

The Duocentric® Reversed shoulder prosthesis is a prosthesis that uses the biomechanical concepts of reverse shoulder arthroplasty as originally described by Paul Grammont.

The Duocentric® Reversed shoulder prosthesis is composed of a humeral stem, a humeral baseplate, a humeral insert, a gleonosphere (Duoglene), and a glenoid baseplate

Aston Medical	Confidential	Page 1 of 3
K133462 - A001	Attachment 2

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already cleared under K103251. It also includes a "bail out head" for use during rare occasions during surgery to salvage the procedure.

The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580 and are performed by Medical Coating'(Vault-en-Velin, FR) according to their Master File MAF-1633.

Indications for use and intended use:

Implantation of a joint prosthesis is to be considered only when all other surgical options have been carefully examined and found less appropriate.

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

The humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the additional of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side.

The additional component bail out head is intended when, during primary surgery for the Duocentric® Reversed shoulder prosthesis I) the glenoid bone stock appears to be insufficient to bear the implant of the glenoid components, or 2) the glenoid bone fractures intra-operatively.

Basis for substantial equivalence:

Duocentric® Reversed shoulder prosthesis is substantially equivalent in intended use and design principles, materials, dimensions, design, packaging, sterilization processes and

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results of pre-clinical testing to the following predicate devices previously cleared by FDA:

Aston Medical, Duocentric® Reversed shoulder prosthesis cleared under . K103251
Depuy Orthopaedic, Inc. USA, Delta Xtend Reverse Shoulder cleared under . K091751

Performance Data:

An engineering analysis analyze the requirements for pre-clinical testing associated with the inclusion of the additional component. Testing results from K103251 remained applicable. The connection and material of the bail out head are the same as those of the humeral baseplate included in K103251. Also the predicate device Delta Xtend Reverse Shoulder cleared under K091751 (itself a predicate device to the original K103251), has similar specifications as the additional component included in this submission: it includes a bail out head (called CTA head). Any differences in technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy. Pre-clinical performance testing concluded that the Duocentric® Reversed shoulder finished product with its bail-out head met all predetermined specifications and are adequate for their intended use.

Clinical data were not required for this device.

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.”