The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff 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.

In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

The modular humeral stem and epiphysis components are HA coated and intended for cementless use.

All other components are for cemented use only.

The Delta Xtend Reverse Shoulder prosthesis is intended for use in total or hemi-shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA components are for cementless use only.

Device Description

The Delta Xtend Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for a medical device, the DePuy Delta Xtend™ Reverse Shoulder System. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed study results against specific acceptance criteria for performance.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets them, in the context of an AI/algorithm-driven device.

The questions you've asked (about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are typically relevant for the regulatory review of AI/ML-enabled medical devices or diagnostic tools. The DePuy Delta Xtend™ Reverse Shoulder System is a physical orthopedic implant and its 510(k) submission process does not involve the types of performance studies you're inquiring about for AI-based systems.

To directly answer your request based on the provided text, while acknowledging it doesn't fit the AI/ML framework of your questions:

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

Response: Not applicable. The document does not define explicit "acceptance criteria" in terms of statistical performance metrics (e.g., sensitivity, specificity, AUC) or report device performance against such metrics. The basis for clearance is "substantial equivalence" to predicate devices, meaning the device is considered as safe and effective as a legally marketed device.

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

Response: Not applicable. This document does not describe a clinical performance study with a test set. Substantial equivalence for this type of device is typically demonstrated through bench testing (e.g., mechanical properties, wear), biocompatibility testing, and comparison of design, materials, and intended use to predicate devices, not through performance metrics on a clinical test set.

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)

Response: Not applicable. No clinical test set or ground truth establishment by experts is described in this regulatory submission for a physical implant.

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

Response: Not applicable. No clinical test set or expert adjudication is described.

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

Response: Not applicable. This device is a physical orthopedic implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to its regulatory clearance.

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

Response: Not applicable. This is not an algorithm-only device.

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

Response: Not applicable. No ground truth is established as part of this type of regulatory submission for a physical orthopedic implant.

8. The sample size for the training set

Response: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Response: Not applicable. No training set or ground truth establishment for a training set is relevant to this device.

In summary, the provided document is a 510(k) premarket notification for an orthopedic implant. It demonstrates substantial equivalence to existing devices based on characteristics like indications for use, materials, design, and manufacturing processes, rather than through clinical performance studies against specific quantitative acceptance criteria or the use of AI/ML algorithms.

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms a wave-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left and top of the design.

Public Health Service

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

November 2, 2016

DePuy Orthopaedics, Incorporated Ms. Dawn Sinclair Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K091751

Trade/Device Name: DePuy Delta Xtend™ Reverse 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, KWS, HSD Dated: June 12, 2009 Received: June 16, 2009

Dear Ms. Sinclair:

This letter corrects our substantially equivalent letter of July 14, 2009.

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}------------------------------------------------

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/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

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

Indications for Use Statement

510 (k) Number (if known): __

K091751

Device Name: DePuy Delta Xtend™ Reverse Shoulder System

Indications for Use:

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.

In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

The modular humeral stem and epiphysis components are HA coated and intended for cementless use.

All other components are for cemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line. Continue on another page if needed.)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)	kouta (Division Sign-Off:for mxmPage 1 of 1 Division of Surgic... Orthopedic,and Restorative Devices	kouta	(Division Sign-Off:	for mxm	Page 1 of 1
	kouta
(Division Sign-Off:	for mxm
	Page 1 of 1

510(k) Number

· Delta Xtend Reverse Shoulder XLK Cut

DePry Orthopaedics, Inc.

3 of 78

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

091751

JUL 1 4 2009

510 (k) Summary (As required by 21 CFR § 807.92 and 21 CFR § 807.93)

NAME OF SPONSOR:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910

510(K) CONTACT:

Dawn Sinclair Regulatory Affairs Associate Telephone: (574) 372-5023 Facsimile: (574) 371-4987 Electronic Mail: Dsincla3@its.jnj.com

DATE PREPARED:

COMMON NAME:

CLASSIFICATION:

PROPRIETARY NAME:

DEVICE PRODUCT CODE:

DePuy Delta Xtend™ Reverse Shoulder XLK Cup

Shoulder Prosthesis, Polyethylene Cup

May 18, 2009

Class II per 21 CFR § 888.3660, Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Cemented

87 KWS: Shoulder joint metal/polymer semi-constrained cemented prosthesis. 87 HSD: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

SUBSTANTIALLY EQUIVALENT DEVICE(S):

DePuy Delta Xtend Reverse Shoulder High Mobility Cup, K073676 DePuy Delta Xtend Reverse Shoulder System, K071379

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

DEVICE DESCRIPTION:

The Delta Xtend Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.

INDICATIONS AND INTENDED USE:

Indications:

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.

In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

The modular humeral stem and epiphysis components are HA coated and intended for cementless use.

All other components are for cemented use only.

Intended Use:

BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on the similarities in intended use, indications for use, materials, design, method of manufacture, sterilization and packaging methods, DePuy believes the subject Delta Xtend Reverse Shoulder XLK Cup is substantially equivalent to the previously cleared Delta Xtend Reverse Shoulder High Mobility Cup, K073676 and the Delta Xtend Reverse Shoulder System, K071379. The subject device does not raise any new issues of safety or 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.”