1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis:
Fracture/dislocations of the proximal humerus where the articular surface is severely comminuted, 2. separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
నే. Other difficult clinical problems where shoulder anthrodesis or resection arthroplasty are not acceptable (c.g., revision of a failed primary component).

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;
1. Avascular necrosis of the humeral head.
1. Rotator cuff tear arthropathy.

Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are indicated for press-fit uncemented use or for use with bone cement.

This is a single use device.

Device Description

This sterile modular total and hemi shoulder system is comprised of a humeral stem, two styles of humeral heads (standard and exentric) and two styles of glenoids (pegged or keeled). The heads mate on the stems through a locking taper. The heads are highly polished and articulate with the glenoids.

The humeral stems are offered in two lengths: standard (110mm with diameters of 6 to 16mm) or long (200 to 220mm in length with diameters of 8 to 14mm). The stems are fluted, except for the 6mm diameter stem. The stems also have fins with suture holes. The head is available in 15 standard sizes (40 to 56mm in heights of 15, 18 and 21 mm) and 10 eccentric sizes (40 to 56mm in heights of 18mm or 21mm).

Materials include titanium humeral stems, cobalt chrome humeral heads and ultrahigh molecular weight polyethylene glenoids.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the DVOTM Total and Hemi Shoulder System. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed performance studies.

Therefore, the document does not contain details about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would be typical for an AI/software device or a novel medical device requiring de novo authorization.

Instead, the submission for the DVOTM Total and Hemi Shoulder System primarily relies on demonstrating substantial equivalence to predicate devices based on:

Intended Use: Similar for total or hemi shoulder replacement.
Performance Characteristics: Overall comparable.
Materials of Construction: Titanium alloy, cobalt chrome alloy, and UHMWPE are common in both.
Methods of Sterilization, Packaging, Manufacturing Methods, and Design: All are similar.
Technological Characteristics and Dimensional Analysis: These were compared.
Nonclinical Testing: This is mentioned as evidence, specifically stating that the subject device's "fatigue load carrying capability exceeds the predicate devices." This is the closest thing to a performance metric and a "study" result, but it's a nonclinical bench test, not a clinical study.

Given this context, I cannot provide the requested information in the format of acceptance criteria and a study demonstrating performance because the type of device registration (510(k)) and the provided document do not include such details.

However, I can extract information related to what was presented to establish equivalence:

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

As explained above, specific clinical acceptance criteria and device performance metrics from a human or clinical study are not applicable to this 510(k) submission as presented. The primary "performance" discussed is nonclinical:

Criterion (Nonclinical)	Reported Device Performance
Fatigue load capability	"Exceeds the predicate devices."

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

This information is not provided in the document. The "test set" for the fatigue load capability would refer to the number of devices or components tested during nonclinical bench testing.

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)

This information is not provided in the document, as it pertains to nonclinical testing, not expert-adjudicated clinical data.

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

This information is not provided. It is not relevant for nonclinical bench testing which does not involve human adjudication.

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

No, an MRMC comparative effectiveness study was not done. This is a submission for an orthopedic implant, not an AI or imaging diagnostic device.

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

This question is not applicable. This is an orthopedic implant and does not involve an algorithm.

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

For the stated "fatigue load carrying capability," the "ground truth" would be the engineering specifications and test standards (e.g., ISO standards for implant testing) to which the device was subjected. It is not based on expert consensus, pathology, or outcomes data, as those apply to clinical evaluations.

8. The sample size for the training set

This question is not applicable. This is an orthopedic implant, not a software device, and therefore does not have a "training set" in the context of machine learning.

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

This question is not applicable for the reasons stated above.

Summary

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K060988 page 143

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DEC - 6 2006

Extremity Solutions720 E. Winona Ave., Warsaw, IN 46580	510(k) Summary of Safety and Effectiveness
SUMMARY PREPARED:	28 NOVEMBER 2006
510(k) SPONSOR/APPLICANT:	DVO TM Extremity Solutions, LLC720 E. Winona Ave., Warsaw IN 46580
510(k) PREPARER andCONTACT PERSON:	Dina L. Weissman, J.D.P.O. Box 205, Derby CT 06418Tel: (203) 736-8631, Email: dina.weissman@sbcglobal.net
TRADE NAME:	Total and Hemi Shoulder System
COMMON NAMES:	Shoulder prosthesis, humeral head
CLASSIFICATION, CLASS andDEVICE PRODUCT CODE:	21 CFR 888.3660 Class II, 87 KWS21 CFR 888.3690, Class II, 87 HSD
PREDICATE DEVICES:	The DePuy Global shoulder system cleared in:• Total Shoulder, K905786, K914000• Advantage Shoulder Humeral Stem and Eccentric Head, K992065

DEVICE DESCRIPTION:

Materials include titanium humeral stems, cobalt chrome humeral heads and ultrahigh molecular weight polyethylene glenoids.

(Continued on next page)

Page 1 of 2

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510(k) Summary of Safety and Effectiveness

INTENDED USE:

The DVOTM Total and Hemi Shoulder System is intended for use in total or hemi-arthroplasty.

INDICATIONS FOR USE:

The DVO™ Total and Hemi Shoulder System is indicated for:

A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or: 1. rheumatoid arthritis:
1. Fracture/dislocations of the proximal humeru:) where the articular surface is severely comminuted. separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
1. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary : omponent).

Hemi-shoulder replacement is also indicated for:

Ununited humeral head fractures; 1.
1. Avascular necrosis of the humeral head.
1. Rotator cuff tear arthropathy.

Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are also indicated for press-fit uncemented use or for use with bone cement.

This is a single use device.

(Continued on next page)

Page 2 of 3

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510(k) Summary of Safety and Effectiveness

COMPARISON TO PREDICATES:

The DVO Total and Hemi Shoulder System is similar to the listed predicate devices in intended use for total or hemi shoulder replacement, performance characteristics, materials of construction (titanum alloy, cobalt chrome alloy and UHMWPE), methods of sterilization (gamma irradiation), packaging, manufacturing methods and design. This is evidenced by comparison of technological characteristics, dimensional analysis and nonclinical testing.

Specifically, both the DVO subject devices and the Dr.Puy predicate devices are comprised of a humeral stem and a humeral head mating together with an articulating UHMWPE glenoved. The locking tapers for the head and stem are similar in both the subject and predicate systems,

The stems of both systems are offered in similar lengths (standard and long), with similar diameters. The stems are also similar in being tapered, fluted and having fins with suture holes,

The heads of both systems are of similar size and shape and are offered in standard or eccentric styles. Curvature sizes range from 40mm to 56mm with head heights of 15mm, 18mm and 21 coven

The UHMWPE glenoids of both systems are offer in both pegged and keeled configurations.

The systems also share equal indications for use.

From the standpoint of strength analysis, the subject @rvice is substantially equivalent to the predicate stems because its fatigue load carrying capability exceeds the predicate devices.

Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black.

DEC - 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DVO Extremity Solutions, LLC % Ms. Dina L. Weissman, J.D. P.O. Box 205 Derby. Connecticut 06418

Re: K060988

Trade/Device Name: DVOTM Total and Hemi Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained, cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: November 29, 2006 Received: December 1, 2006

Dear Ms. Weissman:

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 commercc 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Dina L. Weissman, J.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buehler

Mark N. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K060988

Indications for Use

510(k) Number (if known): K060988

Device Name: DVOTM Total and Hemi Shoulder System

Indications for Use: The DVO™ Total and Hemi Sl»vulder System is indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis:
Fracture/dislocations of the proximal humerus where the articular surface is severely comminuted, 2. separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
నే. Other difficult clinical problems where shoulder anthrodesis or resection arthroplasty are not acceptable (c.g., revision of a failed primary component).

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;
1. Avascular necrosis of the humeral head.
1. Rotator cuff tear arthropathy.

Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are indicated for press-fit uncemented use or for use with bone cement.

This is a single use device.

Prescription Use XXXXXX 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー

Sarbaue Bosens Armson
Division Sign. Off.

Division of Ger Compt 11:10:00 and Neurological Device

Page 1 of 1

510(k) Number Kolo0988

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.”