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, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).

The Affiniti Hemi-Shoulder System is also indicated for:

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

Notes:
Glenoid components are labeled "for cemented use only" and are indicated only for use with bone cement.
Humeral stems are indicated for press-fit un-cemented use or for use with bone cement.
This is a single use device.

Device Description

The sterile Affiniti Total and Hemi-Shoulder System is comprised of a :
Humeral stem, .
Humeral heads in two styles (standard and eccentric) .
Glenoids in two styles (pegged or keeled). .

The humeral heads mate on the stems through a locking taper. The humeral heads are highly polished and articulate with the glenoids.

The humeral stems are offered in two versions Non-coated humeral stems and Porous coated humeral stems :
Non-Porous coated humeral stems and Porous coated humeral stems are offered . . I in two lengths:
o Standard
o long

The humeral heads are available in:
15 standard sizes .
. 10 eccentric sizes
8 extended head sizes (Product line addition to K060988 via K073331) .

The Glenoid is available in multiple sizes in 2 different configurations(pegged or keeled).

This submission corresponds to a change made to the Affiniti Total and Hemi-. Shoulder System (previously cleared in 510(k) K060988), The change correspond to the addition of a porous coated to Humeral stems of the Affiniti Shoulder System.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the Tornier Inc. Affiniti Total and Hemi-Shoulder System. This is a submission for a modification to an already cleared device, specifically the addition of a porous coating to humeral stems. The "study" conducted for this submission is focused on demonstrating substantial equivalence to the predicate device by verifying and validating the changes through a series of bench tests.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Implicitly Met)
Bench Tests:	Performance equivalent to or better than the predicate device without introducing new or higher risks.	"The results of those evaluations allow us to conclude that the proposed Tornier Inc. Affiniti Total and Hemi-Shoulder described in this submission does not induce any new or higher risk compared to the predicate device and therefore both device (proposed and predicate) are substantially equivalent."
- Fatigue testing	Performance equivalent to the predicate device.	(Details not provided, but implicitly met statement above)
Porous coating Characterization and evaluation:
- Static Tensile Test	Performance equivalent to the predicate device.	(Details not provided, but implicitly met statement above)
- Static Shear Test	Performance equivalent to the predicate device.	(Details not provided, but implicitly met statement above)
- Shear Fatigue Test	Performance equivalent to the predicate device.	(Details not provided, but implicitly met statement above)
- Bending Fatigue Test	Performance equivalent to the predicate device.	(Details not provided, but implicitly met statement above)
- Abrasion Resistance Test	Performance equivalent to the predicate device.	(Details not provided, but implicitly met statement above)

Note: For 510(k) submissions involving modifications, the primary acceptance criterion is typically "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as the legally marketed predicate. The specific quantitative acceptance criteria for each bench test are not detailed in this summary, but the general conclusion statement suggests they were met.

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

Sample Size: Not explicitly stated for each test. Bench tests usually involve a specific number of samples tested for each condition (e.g., n=3 or n=6 for mechanical tests), but these numbers are not present in the provided summary.
Data Provenance: The document does not specify the country of origin of the data. It's a submission by Tornier Inc., a US-based company with a specific address in Massachusetts. The testing would have been conducted to support this US FDA submission. The data is from prospective bench testing performed on the modified device. It is not patient data (retrospective or prospective).

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

This is a bench testing study for a physical implant, not a diagnostic device or a study involving interpretation of medical images. Therefore, the concept of "ground truth established by experts" in the way it applies to image analysis or clinical diagnosis is not relevant here. The "ground truth" for these tests would be defined by engineering standards, test protocols, and material specifications, with the evaluation performed by engineers and technicians.

4. Adjudication method for the test set

Not applicable as this is a bench testing study, not a study requiring reader adjudication (e.g., for clinical interpretations). The results of the mechanical tests are quantitative and objective.

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 submission for a physical orthopedic implant (shoulder system), not an AI-powered diagnostic tool, and therefore no MRMC study was performed or is relevant.

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

Not applicable. This is a physical orthopedic implant, not an algorithm or AI-powered device.

7. The type of ground truth used

The "ground truth" for this engineering evaluation is based on established engineering standards, material properties, and performance requirements for orthopedic implants, specifically shoulder systems. The performance of the modified device (porous-coated humeral stem) is compared against these standards and implicitly to the performance of the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI algorithm.

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

Not applicable. There is no "training set."

Summary

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K103007

SECTION 5

NOV - 9 2010

ﺴﺴ ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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Special 510(k) Premarket Notification : , October 8 2010 Summary of Safety and Effectiveness information

Tornier Inc. Affiniti Total and Hemi-Shoulder System

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

1) Device name

Trade name:	Affiniti Total and Hemi-Shoulder SystemAffiniti Shoulder System
Common name:	Shoulder prosthesis, humeral head
Classification name:	Shoulder joint metal/polymer semi-constrained cementedShoulder joint humeral (hemi-shoulder) metallic uncemented
Classification number:	888.3660 and 888.3690

2) Submitter

Tornier Inc. 7701 France Ave. S, Suite 600 Edina, MN 55435 Registration Number: 9100540

3) Company contact

Brahim Hadri

Sr. Regulatory Affairs Specialist 100 Cummings Center, Suite 444C, Beverly, MA 01915, U.S.A Phone: 1 978 232-9997 ext: 617 1 978-232-9998 Fax:

bhadri@tornier.com

4) Classification

Device class:	Class II
Classification panel:	Orthopedic
Product code:	KWS and HSD

510(k) Submission: Tornier Inc. Affiniti Total and Hemi-Shoulder System

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

5) Equivalent / Predicate device

Tornier DVO Total and Hemi Shoulder System: K060988 .

Note:

The Tornier DVO Total and Hemi Shoulder System (K060988) is presently o named Affiniti Total and Hemi-Shoulder System and hereafter will be referred to as such.
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

、

6) Device description

The sterile Affiniti Total and Hemi-Shoulder System is comprised of a :

Humeral stem, .
Humeral heads in two styles (standard and eccentric) .
Glenoids in two styles (pegged or keeled). .

The humeral heads mate on the stems through a locking taper. The humeral heads are highly polished and articulate with the glenoids.

The humeral stems are offered in two versions Non-coated humeral stems and Porous coated humeral stems :

Non-Porous coated humeral stems and Porous coated humeral stems are offered . . I in two lengths:
- o Standard
- o long

The humeral heads are available in:

15 standard sizes .
. 10 eccentric sizes
8 extended head sizes (Product line addition to K060988 via K073331) .

The Glenoid is available in multiple sizes in 2 different configurations(pegged or keeled).

This submission corresponds to a change made to the Affiniti Total and Hemi-. Shoulder System (previously cleared in 510(k) K060988), The change correspond to the addition of a porous coated to Humeral stems of the Affiniti Shoulder System.
510(k) Submission: Tornier Inc. Affiniti Total and Hemi-Shoulder System

Page 2 of 3

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-103007

7) Materials

Materials include titanium humeral stems (some stems coated with pure titanium); cobalt chrome humeral heads and ultrahigh molecular weight polyethylene glenoids.

8) Indications

The Affiniti™ Total and Hemi-Shoulder System are indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
1. Fracture/dislocations of the proximal humerus; 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 component).

The Affiniti™ Hemi-Shoulder System is also indicated for:

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

Notes:

Glenoid components are labeled "for cemented use only" and are indicated . only for use with bone cement.
Humeral stems are indicated for press-fit un-cemented use or for use with bone . cement.

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This is a single use device. .

9) Substantial Equivalence

The modifications made to the proposed Tornier Inc. Affiniti Total and Hemi-Shoulder System were verified and validated by performing:

Bench test: .
Fatigue testing 0

Porous coating Characterisation and evaluation: .

Static Tensile Test O
Static Shear Test 0
Shear Fatigue Test O
Bending Fatigue Test 0
Abrasion Resistance Test o

The results of those evaluations allow us to conclude that the proposed Tornier Inc. Affiniti Total and Hemi-Shoulder described in this submission does not induce any new or higher risk compared to the predicate device and therefore both device (proposed and predicate) are substantially equivalent.

510(k) Submission: Tornier Inc. Affiniti Total and Hemi-Shoulder System

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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 features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Tornier, Inc. % Mr. Brahim Hadri Senior Regulatory Affairs Specialist 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

NOV - 9 2010

Re: K103007

Trade/Device Name: Affiniti 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: October 12, 2010 Received: October 12, 2010

Dear Mr. Hadri:

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

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Page 2 - Mr. Brahim Hadri

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Вавваевиченко

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

10 300 7

510(k) Number (if known):

Device Name: Affiniti Total and Hemi-Shoulder System

NOV - 9 2010

Indications For Use:

The Affiniti Total and Hemi-Shoulder System are indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
1. Fracture/dislocations of the proximal humerus; 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 component).

The Affiniti Hemi-Shoulder System is also indicated for:

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

Notes:

Glenoid components are labeled "for cemented use only" and are indicated only for use with . bone cement.
Humeral stems are indicated for press-fit un-cemented use or for use with bone cement. .
. This is a single use 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)

510(k) Submissjon: Tornier Inc. Affiniti Total and Hemi-Shoulder System

Harboe Buent

(Division Sign-Off) Division of Surgic J. Orthopedic, and Restorative Devices

510(k) Number K103007

Page 10 of 66

p. l of /

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.”