IN ANATOMIC:
The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The AEQUALIS™ FLEX REVIVE™ Shoulder System 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 AEQUALIS™ FLEX REVIVE™ Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

Rheumatoid arthritis with pain
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of other devices if sufficient bone stock remains

IN REVERSE:
The AEQUALIS™ FLEX REVIVE™ Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:

Rheumatoid arthritis
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Massive and non-repairable rotator cuff tear
· Revision of the devices if sufficient bone stock remains

The reversed tray and polyethylene insert are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision with a functional deltoid muscle.

Device Description

AEQUALIS™ FLEX REVIVE™ Shoulder System (AFR) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. AFR includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts.

The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery.

The humeral length is measured to determine the overall humeral implant construct length. The length is assembled from 120 mm (using the short proximal body and stem) to 300 mm (using the standard proximal body, spacers, and stem) in 10 mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.

The proximal body, stem, and spacers are made from Ti6A14V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the AEQUALIS™ FLEX REVIVE™ Shoulder System. This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study or a clinical trial to establish the device's performance against specific acceptance criteria for diagnostic output.

Therefore, the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating the performance of an AI/diagnostic device, is not applicable to this document.

Here's why and what information can be extracted from the document:

Type of Device: The AEQUALIS™ FLEX REVIVE™ Shoulder System is a shoulder joint prosthesis, not a diagnostic device, AI software, or a device that produces a measurable output requiring a performance study against specific acceptance criteria like sensitivity, specificity, or accuracy.
Regulatory Pathway: The document is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves performance bench testing, biocompatibility, and sometimes design verification, but rarely requires large-scale clinical studies proving diagnostic or AI performance with clearly defined acceptance criteria in the way you've described.
"Non-clinical Performance Testing" Section: This section explicitly states the types of tests performed:
- Packaging Validation Testing
- Biocompatibility Evaluation
- Press-Fit Analysis
- Simulated Use Test
  These are engineering, material, and mechanical tests, not diagnostic performance evaluations.
"Clinical Testing" Section: This section explicitly states: "No clinical studies were performed." This is crucial as it directly answers point 5 and 6 of your prompt, indicating that no studies were done to assess human reader improvement with AI or standalone algorithm performance.

Based on the provided text, none of the specific details about acceptance criteria for AI/diagnostic performance studies, sample sizes for those studies, expert involvement, adjudication methods, MRMC studies, or specific ground truth for such studies can be extracted because they are not relevant to this type of device submission.

However, if we interpret "acceptance criteria" broadly in the context of this 510(k) submission, it refers to passing the non-clinical performance tests and demonstrating substantial equivalence to the predicate device.

Information that can be extracted or inferred from the document related to its regulatory acceptance is presented below, though it does not align with your specific questions about AI/diagnostic performance studies.

Acceptance Criteria and Device Performance (in the context of a 510(k) for a prosthesis):

Acceptance Criteria Category (as per 510(k) for a prosthesis)	Reported Device Performance / Assessment
Substantial Equivalence:	Demonstrated to be substantially equivalent to the predicate device (K181420).
Intended Use:	Identical to the predicate device.
Principles of Operation:	Identical to the predicate device.
Conditions for Use:	Identical to the predicate device.
Design Differences:	Differences (new distal stem components in additional lengths and a partially coated format) do not raise new issues of safety or effectiveness.
Material Composition:	Proximal body, stem, spacers: Ti6A14V per ASTM F-136. Assembly screw, locking cap: CoCr per ISO 5832-12. (Compared to predicate, implied to be acceptable).
Sterilization:	Gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10^-6. (Standard acceptance, implied).
Packaging Validation Testing:	Device passed all testing.
Biocompatibility Evaluation:	Device passed all testing.
Press-Fit Analysis:	Device passed all testing.
Simulated Use Test:	Device passed all testing.

Study Details (as they pertain to this 510(k) submission, not an AI/diagnostic study):

Sample sizes used for the test set and the data provenance: Not applicable in the context of AI/diagnostic performance. The document describes "non-clinical bench testing" and "process validations" for which specific sample sizes (e.g., number of components tested for strength, wear, etc.) are performed but not detailed in this summary document. There is no "test set" of patient data for diagnostic performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an implant, not a diagnostic tool requiring expert interpretation of images or data for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no "test set" of patient cases or diagnostic interpretations for adjudication.
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. The document explicitly states: "No clinical studies were performed." This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithmic performance study was done. This is not an AI/algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/diagnostic context. For the device itself, the "ground truth" for its performance would be engineering specifications, material standards, and mechanical test results (e.g., passing pre-defined load limits, wear rates, etc.).
The sample size for the training set: Not applicable. This device does not use a training set for an AI model.
How the ground truth for the training set was established: Not applicable. This device does not have a training set.

In summary, the provided document is a regulatory communication for a medical device (a shoulder prosthesis) seeking 510(k) clearance based on substantial equivalence, not a study evaluating the performance of an AI or diagnostic device against specific clinical or imaging acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

June 14, 2019

Tornier, Inc. Katie Molland, PhD, RAC Senior Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55340

Re: K191318

Trade/Device Name: AEQUALISTM FLEX REVIVE™ 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, PHX, HSD Dated: May 14, 2019 Received: May 15, 2019

Dear Dr. Katie Molland:

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 CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191318

Device Name AEQUALISTM FLEX REVIVE™ Shoulder System

Indications for Use (Describe) IN ANATOMIC:

The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

Rheumatoid arthritis with pain
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of other devices if sufficient bone stock remains

IN REVERSE:

The AEQUALIS™ FLEX REVIVE™ Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:

Rheumatoid arthritis
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Massive and non-repairable rotator cuff tear
· Revision of the devices if sufficient bone stock remains

Notes:

· All components are single use.
· The coated humeral stem is intended for cemented or cementless use.
· The all-poly glenoid components are intended for cemented use only
· The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.

• Titanium humeral heads are intents 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 who lack a suspected material sensitivity to cobalt alloy.

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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)

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Image /page/4/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 hexagonal logo, also in blue, containing a stylized letter "T" within it. The logo appears to be a symbol or trademark associated with the word "TORNIER".

Date Prepared: June 12, 2019

Administrative Information

Name:	Tornier, Inc.
Address:	10801 Nesbitt Avenue SouthBloomington, MN 55437United States of America
Contact Person:	Katie Molland, Ph.D.
Title:	Senior Regulatory Affairs Specialist
Phone:	952-683-7446
Fax:	952-426-7601

Device Information

Name of Device:	AEQUALIST™ FLEX REVIVE™ Shoulder System
Common Name (s):	Shoulder Prosthesis
Classification Name:	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Regulatory Class:	II
Regulation Number:	21 CFR 888.3660, 888.3690
Product Codes:	KWS, PHX, HSD

Predicate Device Information

AEQUALIS™ FLEX REVIVE™ Shoulder System Predicate: K181420 510(k) Number:

Reference Device Information

Reference Device:	Biomet Comprehensive Segmental Revision System
510(k) Number:	K173411

Device Description

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Image /page/5/Picture/1 description: The image shows the word "TORNIER" in large, blue, sans-serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of a smaller hexagon. The logo is simple and modern, and the blue color gives it a professional look.

Intended Use

The AEOUALIS™ FLEX REVIVE™ Shoulder System is intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.

Indications for Use

IN ANATOMIC:

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

Rheumatoid arthritis with pain
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) ●
0 Correction of functional deformity
Fractures of the humeral head
o Traumatic arthritis

Tornier, Inc.

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Image /page/6/Picture/1 description: The image shows the word "TORNIER" in large, blue, sans-serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of a smaller hexagon. The logo is simple and modern, and the blue color gives it a professional look.

Revision of other devices if sufficient bone stock remains . IN REVERSE:
The AEQUALIS™ FLEX REVIVE™ Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:
Rheumatoid arthritis o
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
Correction of functional deformity ●
Fractures of the humeral head ●
Traumatic arthritis
. Massive and non-repairable rotator cuff tear
o Revision of the devices if sufficient bone stock remains

The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.

Notes:

o All components are single use.
The coated humeral stem is intended for cemented or cementless use. ●
The all-poly glenoid components are intended for cemented use only.
The glenoid sphere implant is anchored to the bone with screws and is for non-cemented o fixation.
0 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 who lack a suspected material sensitivity to cobalt alloy.

Comparison of Technological Characteristics with the Predicate Device

New Distal Stem components will be offered in additional lengths and a partially coated format for the same intended use as the predicate device. The new stems are compatible with all existing components of the predicate AFR Shoulder System. The design differences do not raise new issues of safety or effectiveness and are supported by performance testing and process validations.

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Image /page/7/Picture/1 description: The image shows the word "TORNIER" in large, blue, serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of it. The letter "T" is also in blue.

Non-clinical Performance Testing

To demonstrate substantial equivalence to the predicate device, the following non-clinical bench testing and process validations were performed as indicated by risk analysis:

Packaging Validation Testing o
Biocompatibility Evaluation o
Press-Fit Analysis ●
o Simulated Use Test

The subject device passed all testing with the same acceptance criteria as the predicate device.

Clinical Testing

No clinical studies were performed.

Conclusions

The subject device is identical to the predicate device with respect to intended use, principles of operation, and conditions for use. The AEQUALIS™ FLEX REVIVE™ Shoulder System does not raise new questions of safety or effectiveness. Differences in technological characteristics that pose new potential risks as identified by risk analyses have been addressed with verification and validation testing. The results of testing for the modified AEQUALISTM FLEX REVIVE™ Shoulder System support substantial equivalence to the current AEQUALIS™ FLEX REVIVE™ Shoulder System (K181420).

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.”