In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.

The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain. The PERFORM Humeral System – Stem is indicated for use as a replacement of shoulder joints disabled by:

Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis .
Correction of functional deformity
Post-traumatic arthritis 0
o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.

All components are single use. The humeral stems are intended for cementless use.

The PERFORM Humeral System – Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty.

In Reverse:
The PERFORM™ Humeral System - Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:

o Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
Pseudoparalysis or anterior superior escape ●
Rotator cuff tear arthropathy
Correction of functional deformity
Post-traumatic arthritis
o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.

All components are single use. The humeral stems are intended for cemented or cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

Device Description

The PERFORM Humeral System - Stem is an inlay convertible humeral system intended for anatomic, reverse, and hemiarthroplasty of the shoulder system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The PERFORM Humeral System - Stem is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty.

The PERFORM Humeral System – Stem includes titanium humeral stems, cobalt chrome and titanium humeral heads, titanium humeral head couplers, conventional and Vitamin E UHMWPE reversed inserts, and titanium humeral spacers. The system also includes reusable instruments used to implant the shoulder prosthesis.

AI/ML Overview

This FDA 510(k) summary describes the Tornier PERFORM™ Humeral System - Stem, a shoulder prosthesis. The document does not describe an AI/ML powered device, therefore, the requested information cannot be fully provided.

However, based on the provided text, here is what can be extracted regarding the device (a physical medical implant) and its non-clinical performance testing:

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

The document does not provide a table with specific quantitative acceptance criteria or reported device performance values in a comparative format. Instead, it lists the types of non-clinical performance testing conducted to support substantial equivalence to a predicate device.

Test Type	Purpose/Standard(s)	Relationship to Acceptance Criteria/Performance
Fatigue testing	Not explicitly stated, but typically assesses the device's ability to withstand repeated stress without failure.	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the device met fatigue requirements comparable to the predicate. Specific acceptance criteria (e.g., number of cycles at a certain load) and reported performance are not detailed.
Static taper evaluation	ASTM F2009	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies compliance with the standard for static taper evaluation. Specific acceptance criteria and reported performance (e.g., pull-off strength, torque values) are not detailed.
Static Reversed Insert testing	Not explicitly stated what standard or specific aspects are tested, but likely related to the mechanical integrity and stability of the reversed insert.	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies meeting performance criteria for static reversed insert properties, comparable to the predicate. Specific acceptance criteria and reported performance (e.g., displacement, load-to-failure) are not detailed.
Wear and range of motion evaluations	Not explicitly stated what standard or specific aspects are tested, but typically assesses the wear rate of bearing surfaces and the range of motion provided by the implant.	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the device exhibited wear and range of motion characteristics comparable to or better than the predicate. Specific acceptance criteria (e.g., wear rate limits, degrees of motion) and reported performance are not detailed.
Vitamin E material characterization testing	Not explicitly stated, but likely involves testing physical and chemical properties of the Vitamin E UHMWPE material used in the reversed inserts.	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the Vitamin E material met specified characteristics (e.g., mechanical properties, stability). Specific acceptance criteria and reported performance (e.g., tensile strength, oxidative stability) are not detailed.
MRI compatibility evaluation	Not explicitly stated what standard, but usually ensures the device is safe for use in an MRI environment (e.g., heating, artifact, force).	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the device exhibited MRI compatibility comparable to the predicate. Specific acceptance criteria and reported performance (e.g., Mr conditional labeling, temperature rise, artifact size) are not detailed.
Biocompatibility evaluation	ISO 10993-1	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the device materials passed biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993-1. Specific acceptance criteria (e.g., pass/fail for each biological effect) and reported performance are not detailed.
Packaging and shelf life evaluations	ISO 11607-1, ISO 11607-2, ASTM F1980	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the packaging system maintained sterility and integrity over the claimed shelf life according to these standards. Specific acceptance criteria and reported performance (e.g., seal strength, burst strength, microbial ingress) are not detailed.
Distribution testing	ISTA Procedure 3A, ASTM D4169, ASTM F2096	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the packaged product safely withstood typical shipping and handling stresses, maintaining package integrity and device functionality. Specific acceptance criteria (e.g., no damage or breach of sterile barrier after testing) and reported performance are not detailed.
Sterilization evaluation	ISO 11137-1, ISO 11137-2	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the sterilization process successfully rendered the device sterile to the specified sterility assurance level (SAL). Specific acceptance criteria (e.g., SAL of 10^-6) and reported performance (e.g., dosimetric release, bioburden reduction) are not detailed.
Endotoxin testing	AAMI ST72	"Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the device met endotoxin limits (e.g., < 20 EU/device) as per AAMI ST72. Specific acceptance criteria and reported performance (e.g., measured endotoxin levels) are not detailed.

The following information cannot be determined from the provided text as it pertains to AI/ML or clinical studies, neither of which are described for this conventional medical device.

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 applicable as no clinical or AI/ML-related test set is described. The document refers to non-clinical testing of the physical device.

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)

Not applicable as this is not an AI/ML device and no expert-based ground truth for a test set is described.

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

Not applicable as no AI/ML test set 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

No MRMC study was done, as this is a physical implant and not an AI/ML-assisted diagnostic device. The document explicitly states: "No clinical studies were performed."

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

Not applicable, as this is a physical medical device and not an algorithm.

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

Not applicable, as this is a physical medical device and not an AI/ML model requiring ground truth for performance evaluation in the context of diagnostic or predictive tasks. The "ground truth" for the non-clinical tests would be the specific pass/fail criteria defined by the relevant ASTM/ISO standards.

8. The sample size for the training set

Not applicable, as this device does not involve a training set for an AI/ML algorithm.

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

Not applicable, for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 11, 2020

Tornier, Inc. Renee Stoffel Principal Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55437 USA

Re: K201315

Trade/Device Name: PERFORM Humeral System - Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PAO, KWT, KWS, HSD, PHX Dated: August 7, 2020 Received: August 12, 2020

Dear Renee Stoffel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201315

Device Name PERFORM™ Humeral System - Stem

Indications for Use (Describe)

In Anatomic:

The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.

The PERFORM™ Humeral System - Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, and to relieve pain. The PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder joints disabled by:

· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
· Correction of functional deformity
Post-traumatic arthritis
· Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

All components are single use. The humeral stems are intended for cementless use.

The PERFORM Humeral System - Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty.

In Reverse:

The PERFORM™ Humeral System - Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:

· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
· Pseudoparalysis or anterior superior escape
Rotator cuff tear arthropathy
· Correction of functional deformity
Post-traumatic arthritis
· Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System - Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/1 description: The image shows the word "TORNIER" in a large, sans-serif blue font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of it. The letter "T" is also blue and is made up of two smaller hexagons.

Date Prepared: August 7, 2020

Administrative Information

Name:	Tornier, Inc.
Address:	10801 Nesbitt Avenue SouthBloomington, MN 55437United States of America
Contact Person:	Renee Stoffel
Title:	Principal Regulatory Affairs Specialist
Phone:	952-683-7471

Device Information

Name of Device:	PERFORM™ Humeral System – Stem
Common Name (s):	Shoulder Prosthesis
Regulatory Class:	II
Regulation:	21 CFR 888.3650, Shoulder joint metal/polymer non-constrained cementedprosthesis.21 CFR 888.3660, Shoulder joint metal/polymer semi-constrained cementedprosthesis.21 CFR 888.3690, Shoulder joint humeral (hemi-shoulder) metallic uncementedprosthesis.
Product Codes:	KWT, KWS, HSD, PHX, PAO

Predicate Device Information

Predicate:	AEQUALIS ASCEND™ FLEX Shoulder System
510(k) Number:	K190521
Reference Device:	AEQUALIS™ REVERSED Shoulder System
510(k) Number:	K151293

Device Description

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Image /page/5/Picture/1 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a logo consisting of a hexagon shape, also in blue. Inside the hexagon is a stylized letter "T" with a smaller hexagon shape in the middle of the "T".

Indications for Use

In Anatomic:

Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis .
Correction of functional deformity
Post-traumatic arthritis 0
o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

All components are single use. The humeral stems are intended for cementless use.

The PERFORM Humeral System – Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty.

In Reverse:

o Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
Pseudoparalysis or anterior superior escape ●
Rotator cuff tear arthropathy
Correction of functional deformity
Post-traumatic arthritis
o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

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Image /page/6/Picture/1 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a blue hexagon containing a stylized letter "T" inside. The letter "T" is also blue and has a unique design, with a smaller "T" shape nested within the larger one.

Comparison to Predicate Device

The PERFORM Humeral System - Stem and the predicate AEQUALIS ASCEND FLEX Shoulder System have the same intended use, same principle of operation, and similar technological features. Differences for the subject PERFORM Humeral System – Stem include humeral stems with a modified connection mechanism, modular humeral heads, Vitamin E UHMWPE reverse inserts, and an optional humeral spacer instead of a required humeral tray.

Non-clinical Performance Testing

Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device.

Fatigue testing
Static taper evaluation to ASTM F2009 ●
Static Reversed Insert testing
Wear and range of motion evaluations
Vitamin E material characterization testing
MRI compatibility evaluation
o Biocompatibility evaluation to ISO 10993-1
Packaging and shelf life evaluations to ISO 11607-1. ISO 11607-2, ASTM F1980 ●
Distribution testing to ISTA Procedure 3A, ASTM D4169, ASTM F2096 o
Sterilization evaluation to ISO 11137-1 and ISO 11137-2 ●
Endotoxin testing to AAMI ST72 ●

Clinical Testing

No clinical studies were performed.

Conclusions

The PERFORM™ Humeral System - Stem does not raise new questions of safety or effectiveness. Differences in technological characteristics have been addressed with performance testing. The results of performance testing for the PERFORM Humeral System - Stem support substantial equivalence to the predicate AEQUALIS ASCEND™ FLEX Shoulder System (K190521, cleared on June 12, 2019).

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.”