The Reverse Humeral Socket Shell is indicated for revision surgeries in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. 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 socket shell is only indicated for use with a well fixed Turon Humeral Stem.

Device Description

In cases of revision surgeries to a well fixed Turon Humeral socket shell can be mated with the Turon stem to convert to a reverse shoulder application.

AI/ML Overview

The provided document is a 510(k) summary for the "Reverse Humeral Socket Shell" device. It outlines non-clinical testing performed, but explicitly states "Clinical Testing: None provided." Therefore, based on the provided text, there is no study that proves the device meets acceptance criteria through clinical performance.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and by having comparable features to predicate devices.

Here's the information parsed from the document regarding the non-clinical testing, which serves as the "study" demonstrating equivalence and meeting certain performance standards:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Test Performed / Standard Met	Reported Device Performance
Mechanical Strength	Fatigue Testing (per ASTM standards)	The socket shell assembled with the Turon stem withstood minimum load conditions. The results determined that the socket shell could withstand the load conditions, "showing equivalence to the cleared Turon socket and stem interface."
Locking Feature Strength	Torsional Strength	Applied results from predicate RSP socket shells, indicating the locking feature geometry is the same.
	Lever out Strength	Applied results from predicate RSP socket shells, indicating the locking feature geometry is the same.
	Push Out Strength	Applied results from predicate RSP socket shells, indicating the locking feature geometry is the same.
Mating Geometry Strength	Pull-out Testing	Applied results from the cleared Turon stem due to the same morse taper connection mating geometry.

Note: The document doesn't explicitly state numerical acceptance criteria for these tests, but rather indicates that the device met "minimum load conditions" and demonstrated "equivalence to the cleared Turon socket and stem interface" or applied results from predicate devices due to identical geometry.

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

Sample Size: Not specified in the document for any of the non-clinical tests.
Data Provenance: The tests were performed as part of the device's 510(k) submission, likely by the manufacturer (DJO Surgical / Encore Medical, L.P.). It's a prospective experimental study conducted in a lab setting, not involving human or patient data.

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

This is not applicable as the "ground truth" for mechanical testing is defined by engineering standards (e.g., ASTM) and direct measurement of physical properties, not by expert consensus.

4. Adjudication method for the test set:

Not applicable for this type of non-clinical mechanical testing. Results are typically determined by instrumentation and direct comparison to a standard or predicate device's performance.

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 medical device for orthopedic surgery (a shoulder implant component), not an AI/imaging diagnostic device. No MRMC study was performed.

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

Not applicable. This is a physical medical implant, not an algorithm or AI.

7. The type of ground truth used:

For the non-clinical testing, the "ground truth" is based on:
- Engineering Standards: Adherence to ASTM standards provides a baseline for acceptable performance.
- Predicate Device Performance: Equivalence to the mechanical performance and design of previously cleared predicate devices (e.g., Turon Humeral socket, RSP socket shells, Turon Humeral Neck).
- Direct Measurement: Physical properties and resistance to loads are directly measured through experimental setups.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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

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 logo is a stylized image of three human profiles facing right, with flowing lines above them.

Public Health Service

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 Blvd Austin, Texas 78758

Re: K111629

Trade/Device Name: Reverse Humeral Socket Shell 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: September 8, 2011 Received: September 9, 2011

Dear Ms. Hutto:

This letter corrects our substantially equivalent letter of September 16, 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

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

Page 2 - Ms. Teffany Hutto

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

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

111629 510(k) Summary

Date: September 8, 2011

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

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djosurgical.com

11 . 1. 1998, 12 . 1978, 1997, 1997, 1997, 1992, 1992, 1995, 1955, 1955, 1955, 1955, 19Proguct	Classification .1. 22 3. 13. 16 12. 1. 1.	Product Code
Turon to RSP Conversion Shell	1855	KWS

· Regulation and Classification NameProduct Code.:

KWS Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660

Description: In cases of revision surgeries to a well fixed Turon Humeral socket shell ! can be mated with the Turon stem to convert to a reverse shoulder application.

There is no change to the intended use or fundamental scientific technology. This includes no changes to currently cleared devices, packaging or sterilization.

Indications for Use:

The Turon to RSP Conversion Shell is indicated for revision surgeries in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. 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 socket shell is only indicated for use with a well fixed Turon Humeral Stem.

Predicate Device:

DJO Surgical Reverse® Shoulder Prosthesis K041066 ●
Turon Shoulder System K080402 ●

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, indications, sterilization, and intended use.

Non-Clinical Testing:

Fatigue Testing was performed on the socket shell assembled with the Turon stem to demonstrate that . the component would withstand minimum load conditions per ASTM standards. The results of the testing determined that the socket shell could withstand the load conditions showing equivalence to the cleared Turon socket and stem interface.
Because the locking feature geometry of the Reverse Humeral Socket Shell is the same as the . predicate RSP socket shells, Torsional Strength, Lever out Strength, and Push Out Strength performed against the RSP socket shell can be applied to the Reverse Humeral Socket Shell.
Because the mating geometry of the morse taper connection is the same as the predicate Turon ● Humeral Neck, Pull-out Testing conducted with the cleared Turon stem can be applied.

The above testing demonstrated the device's ability to perform under expected conditions and is equivalent to the predicate devices.

Clinical Testing: None provided.

Image /page/2/Picture/21 description: The image shows the words "Page 1 of 1" written in black ink on a white background. The handwriting is somewhat stylized, with the word "Page" having a distinct curve. The phrase indicates that this is the first page of a document that is only one page long.

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Reverse Humeral Socket Shell

Indications for Use:

. ﺎ ﻣ

Reverse Humeral Socket Shell Indications for Use

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)

P.L.M

(Division Sign-Off) (Division Sign-Off)
Division of Surgical. Orthopedic,
Division of Surgical. Devices Division of Surgion
and Restorative Devices

111629

510(k) Number

Page 1 of 1

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.”