The Reverse Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

. In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
In cases of bone defect in proximal humerus. .

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

Device Description

The Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff. failed hemi or total shoulder arthroplasty with irreparable rotator cuff, and for fracture in which the tuberosity and rotator cuff are irreparable. The RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. The components included in this system are a glenoid head, a humeral socket, a humeral stem, a glenoid baseplate, and baseplate screws.

The Monoblock design consists of:

. a non-modular stem designed by joining the humeral socket with the humeral stem (sizes 6, 7, 8, 10 and 12);
. humeral inserts in size 44 semi-constrained UHMWPe and +4 offset inserts in sizes 32, 36, 40 and 44 (standard and semi-constrained UHMWPe). Currently cleared sizes of inserts (32, 36, 40, and 44 in standard poly and size 32, 36, and 40 semi-constrained UHMWPe) are also compatible with the monoblock design.
. glenoid components will be the same as currently cleared under K 100741, K092873, K051075, and K041066

AI/ML Overview

Here's an analysis of the provided text regarding the Reverse® Shoulder Prosthesis Monoblock, focusing on the requested acceptance criteria and study information:

Based on the provided text, the device is a medical implant (shoulder prosthesis), and the information is from an FDA 510(k) clearance document. For this type of device, "acceptance criteria" and "device performance" are typically related to mechanical and material properties, biocompatibility, and functional integrity under simulated physiological conditions. The document does NOT describe the acceptance criteria or reported device performance for a software-based AI/ML device. The questions about AI-specific criteria (sample size, experts, adjudication, MRMC, standalone performance, training data) are not applicable to this medical device submission.

Here's a breakdown of what is available in the document related to testing, rephrased to fit the structure of your request where possible, and indicating where information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical medical implant and not a software AI/ML device, the table below reflects the type of information that would be relevant for such a device. The provided text does not include specific numerical acceptance criteria or detailed reported performance values for the device's mechanical properties, as these studies were already completed for previous versions.

Acceptance Criteria Category (Hypothetical for Mechanical Device)	Reported Device Performance (Summary from Document)
Mechanical Strength/Fatigue Life	"additional testing was not necessary to support equivalence" (referring to prior non-clinical testing)
Material Biocompatibility	Implied as part of "prior non-clinical testing" for previously cleared components.
Wear Resistance / Articulation Properties	Implied as part of "prior non-clinical testing" for previously cleared components.
Fit and Function with existing components	"Currently cleared sizes of inserts... are also compatible with the monoblock design."

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

Sample Size: Not explicitly stated for specific mechanical tests in this document. The document refers to "prior non-clinical testing" performed for previously cleared components (K100741, K092873, K051075, and K041066). The current submission states no additional testing was necessary.
Data Provenance: Not applicable in the context of clinical data for AI/ML. For mechanical testing, this typically refers to the lab where the tests were conducted, which is not detailed here.

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 as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from data.

4. Adjudication method for the test set

This question is not applicable as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool that requires adjudication of expert opinions.

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 as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool. The document explicitly states "Clinical Testing: None provided."

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

This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm.

7. The type of ground truth used

This question is not applicable in the context of AI/ML ground truth from expert consensus, pathology, or outcomes data. For a mechanical device, "ground truth" would be the known mechanical properties of materials, validated engineering models, and the performance of predicate devices against established standards during non-clinical testing.

8. The sample size for the training set

This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm.

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

This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm. The "ground truth" for mechanical testing is established through standardized engineering test methods and material science principles.

Summary of Device-Specific Information from the Text:

The document concerns the "Reverse® Shoulder Prosthesis Monoblock," an update to an existing shoulder implant. The submission is for a 510(k) clearance, indicating it is a "substantially equivalent" device to a predicate (K082120 - Tornier Aequalis@-Reversed Fracture prosthesis).

The key takeaway regarding testing is:

Non-Clinical Testing: "After completing review of prior non-clinical testing conducted for this system and submitted under K100741, K092873, K051075, and K041066, it was concluded that additional testing was not necessary to support equivalence." This means the current device leverages prior testing data for its components or overall system design, implying that component-level mechanical, material, and biocompatibility requirements were met previously and are assumed to hold for the new configuration due to design similarities to the predicate and previously cleared components.
Clinical Testing: "None provided." This is common for 510(k) submissions, especially for modifications of existing devices or when non-clinical testing is deemed sufficient to establish substantial equivalence.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.

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

November 2, 2016

Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin. Texas 78758-5445

Re: K103208

Trade/Device Name: Reverse® Shoulder Prosthesis Monoblock Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: October 29, 2010 Received: November 1, 2010

Dear Ms. Hutto

This letter corrects our substantially equivalent letter of January 31, 2011.

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/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 i (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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510(k) Number (if known):

Device Name: Reverse Shoulder Prosthesis Monoblock

Indications for Use:

Reverse® Shoulder Prosthesis Monoblock Indications for Use

. In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
In cases of bone defect in proximal humerus. .

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

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)

for M. Melkerson

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

510(k) Number K103208

Page 1 of 1

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K103208
p.1/2

JAN 3 1 201

Summary of Safety and Effectiveness

Date: January 26, 2011

Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (760) 597-8466 Email: teffany.hutto@djosurgical.com

Product	510(k) Number, Classification	Product Code	Product Code	Regulation and Classification Name
Reverse® Shoulder Prosthesis Monoblock	K103208, Class II	KWS	KWS	Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660

Description:

The Monoblock design consists of:

. a non-modular stem designed by joining the humeral socket with the humeral stem (sizes 6, 7, 8, 10 and 12);
. humeral inserts in size 44 semi-constrained UHMWPe and +4 offset inserts in sizes 32, 36, 40 and 44 (standard and semi-constrained UHMWPe). Currently cleared sizes of inserts (32, 36, 40, and 44 in standard poly and size 32, 36, and 40 semi-constrained UHMWPe) are also compatible with the monoblock design.
. glenoid components will be the same as currently cleared under K 100741, K092873, K051075, and K041066

Indications for Use:

In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
In cases of bone defect in proximal humerus. .

The patient's joint must be anatonically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application of screws for fixation. The humeral stem is intended for cemented use only.

Predicate Device:

· K082120 - Tornier Aequalis@-Reversed Fracture prosthesis

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K103208
p. 2/2

Comparable Features to Predicate Device(s):

Single cup diameter accepts multiple articular t diameters
Multiple stem diaphysis diameters .
Titanium alloy construction
. Coated Metaphysis
. Single piece stem/metaphysis construction
. Anatomic positioning of tuberosities
. Bone graft attachment
. Medial cerclage suture hole

Non-Clinical Testing: After completing review of prior non-clinical testing conducted for this system and submitted under K100741, K092873, K051075, and K041066, it was concluded that additional testing was not necessary to support equivalence.

Clinical Testing: None provided.

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.”