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

· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
· Post-traumatic arthritis

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 and intended for cementless use.

The Tornier Perform Humeral System - Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.

Device Description

The Tornier Perform Humeral System - Stemless is metaphyseal humeral system intended for anatomic total shoulder arthroplasty. The Perform Humeral System - Stemless is implanted with existing Tornier anatomic glenoid systems.

The Tornier Perform Humeral System – Stemless includes new titanium nucleus components and previously-cleared modular humeral heads (K201315). The system also includes reusable instruments used to implant the shoulder prosthesis.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the Tornier Perform Humeral System - Stemless. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies proving acceptance criteria through device performance.

Therefore, the requested information on acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance, is largely not applicable to this document. The document explicitly states: "No clinical studies were performed."

However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose in the context of a 510(k) by showing the device performs comparably to an already cleared device.

Here's a breakdown of the available information based on your request:

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

Since no clinical studies were performed to establish performance against pre-defined acceptance criteria in terms of human-in-the-loop performance or diagnostic accuracy, such a table cannot be created from this document. The document focuses on demonstrating substantial equivalence to an existing predicate device through non-clinical performance testing.

The types of "performance" mentioned are related to mechanical and material properties:

Acceptance Criteria (Implied by equivalence to predicate)	Reported Device Performance (as demonstrated by non-clinical testing)
Fatigue Resistance (Comparable to predicate device)	Fatigue testing performed. (Specific results not detailed in this summary, but presumed to meet standards for equivalence.)
Displacement under load (Comparable to predicate device)	Displacement finite element analysis performed. (Specific results not detailed.)
Static Nucleus Strength (Comparable to predicate device)	Comparative static nucleus testing performed. (Specific results not detailed.)
Taper Integrity (Comparable to predicate device)	Static taper evaluation performed. (Specific results not detailed.)
Wear Properties (Comparable to predicate device; with caveat for titanium)	Wear and range of motion evaluations performed. (Specific results not detailed. Noted: "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.")
MRI Safety/Compatibility (Compatible with MRI)	MRI compatibility evaluation performed. (Specific protocol or limits not detailed.)
Particulate Release (Acceptable levels)	Particulate testing performed. (Specific results not detailed.)
Biocompatibility (Biocompatible)	Assessed in accordance with recognized consensus standards.
Sterilization Efficacy (Sterile)	Assessed in accordance with recognized consensus standards.
Cleaning Efficacy (Clean)	Assessed in accordance with recognized consensus standards.
Endotoxin Levels (Safe)	Assessed in accordance with recognized consensus standards.
Packaging Integrity (Maintains sterility/integrity)	Assessed in accordance with recognized consensus standards.
Shelf Life Stability (Stable over intended shelf life)	Assessed in accordance with recognized consensus standards.
Distribution Safety (Safe for distribution)	Assessed in accordance with recognized consensus standards.

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

Not applicable. No "test set" in the context of clinical or AI performance evaluation was used. The testing was non-clinical (laboratory/mechanical).

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

Not applicable. No "ground truth" for a test set based on expert review was established or required for this type of submission focused on mechanical device equivalence.

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

Not applicable. No "test set" requiring adjudication by experts was used.

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 mechanical orthopedic implant, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance in that context.

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

Not applicable. This is a mechanical orthopedic implant, not an algorithm or AI.

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

Not applicable. The "ground truth" for the non-clinical tests would have been established engineering specifications, material standards, and performance of the predicate device.

8. The sample size for the training set:

Not applicable. This is a mechanical orthopedic implant, not an AI or algorithm that requires a training set.

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

Not applicable.

Summary

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September 14, 2022

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

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

Re: K220418

Trade/Device Name: Tornier Perform Humeral System - Stemless Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PKC Dated: August 19, 2022 Received: August 19, 2022

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/cfpm/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 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

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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 (QS) 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/cdrl-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,

Victoria Lilling, M.D. 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)

K220418

Device Name Tornier Perform® Humeral System - Stemless

Indications for Use (Describe)

The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement.

· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
· Post-traumatic arthritis

All components are single use and intended for cementless use.

The Tornier Perform Humeral System - Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "TORNIER" in a serif font, with each letter 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 smaller hexagon shape in the middle.

Date Prepared: February 11, 2022

Administrative Information

Name:	Tornier, Inc.
Address:	10801 Nesbitt Avenue SouthBloomington, MN 55437United States of America
Contact Person:	Renee Stoffel
Title:	Principal Specialist, Regulatory Affairs
Phone:	952-683-7471
Fax:	952-426-7601

Device Information

Name of Device:	Tornier Perform® Humeral System - Stemless
Common Name (s):	Shoulder Prosthesis
Regulatory Class:	II
Regulation:	21 CFR 888.3660, Shoulder joint metal/polymer semi-constrained cementedprosthesis.
Product Codes:	PKC

Predicate Device Information

Primary Predicate:	Simpliciti Shoulder System, K143552
Additional Predicate:	Perform Humeral System – Stem, K201315
Reference Device:	Aequalis Perform Reversed Glenoid, Aequalis Perform + Reversed Glenoid,K161742 and K183696

Device Description

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Image /page/4/Picture/0 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 stylized letter "T" inside a hexagon. The logo is also colored in blue and has a modern, geometric design.

Indications for Use

The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement.

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

Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
Post-traumatic arthritis ●

Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of 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 and intended for cementless use.

The Tornier Perform Humeral System - Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.

Comparison to Predicate Device

The Tornier Perform Humeral System - Stemless and the primary predicate Simpliciti Shoulder System have the same intended use, same principle of operation, and similar technological features. Differences for the subject Tornier Perform Humeral System - Stemless system include nucleus components that are additively manufactured with a four-fin design and connection to modular humeral heads (previouslycleared in K201315).

Non-clinical Performance Testing

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

Fatigue testing ●
Displacement finite element analysis
Comparative static nucleus testing
Static taper evaluation ●
Wear and range of motion evaluations
MRI compatibility evaluation ●
o Particulate testing

Biocompatibility, sterilization, cleaning, endotoxin, packaging, shelf life, and distribution for the Tornier Perform Humeral System - Stemless components were also assessed in accordance with recognized consensus standards.

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Image /page/5/Picture/0 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 stylized letter "T" inside a hexagon. The logo is also colored in blue and appears to be a modern design.

Clinical Testing

No clinical studies were performed.

Conclusions

The Tornier Perform® Humeral System - Stemless does not raise different questions of safety or effectiveness. Differences in technological characteristics have been addressed with performance testing. The results of performance testing for the Tornier Perform® Humeral System - Stemless support substantial equivalence to the primary predicate Simpliciti Shoulder System (K143552, cleared March 4, 2015).

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.”