(64 days)
Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:
- · Degenerative pathologies: arthrosis, rheumatoid arthrosis, post traumatic arthrosis
- · Primary and secondary necrosis of the humeral head
- · Displaced 4-part upper humeral fracture
- · Humeral head fracture
- · Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
- · Revision surgery when other treatments or devices have failed
- The Aequalis PerFORM+ glenoids are intended for cemented use only.
The Aequalis monobloc stem is for cemented use
The Aequalis Press-Fit is for uncemented use
The Aequalis PerFORM+ Shoulder System is a modular system consisting of a metaphyseal humeral stem component, anatomic humeral heads and glenoid for a total shoulder athroplasty. Surgical instruments are designed to facilitate proper implantation of the system.
The provided text describes a 510(k) premarket notification for the "Aequalis PerFORM+ Shoulder System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria related to AI/software performance.
Therefore, the requested information regarding acceptance criteria and studies (especially those related to AI/software performance, such as sample size, ground truth, expert involvement, MRMC studies, or standalone algorithm performance) is not applicable or cannot be extracted from this document, as it pertains to a traditional orthopedic implant rather than an AI/software-based medical device.
The "studies" mentioned are non-clinical performance data for the physical device, mainly mechanical and biocompatibility testing.
Here's a breakdown of the information that can be extracted or clarified as "not applicable" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Validation and / or Verification Method | Acceptance Value / Criteria | Results |
|---|---|---|
| Loosening Test | No Loosening detected at completion of test. | Acceptable |
| Shear testing | Comparable to the predicate device design. | Acceptable |
| Tensile (pull out) testing | Comparable to the predicate device design. | Acceptable |
| Endotoxin | $\le 20\ EU / device$ | Acceptable |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical and biocompatibility tests of the physical shoulder implant components, not a dataset for an AI/software. No information on the number of samples for these tests or data provenance is provided beyond the "results" column being "Acceptable."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/software (e.g., expert consensus on medical images) is not relevant to the non-clinical performance tests of an orthopedic implant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for resolving discrepancies in expert labeling of data, which is not part of the described testing.
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 device is a physical shoulder implant, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical shoulder implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the non-clinical tests performed. The "ground truth" for mechanical testing is based on engineering standards and measurements, and for endotoxin, it's a quantitative lab result compared to a threshold.
8. The sample size for the training set: Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is for a traditional medical device (shoulder implant) and therefore lacks the information requested about AI/software performance studies and related aspects.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2016
Tornier, Incorporated Ms. Loucinda Biorklund Manager, Regulatory Affairs 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K160975
Trade/Device Name: Aequalis PerFORM+ 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 Dated: May 10, 2016 Received: May 11, 2016
Dear Ms. Bjorklund:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160975
Device Name
Aequalis PerFORM+ Shoulder System
Indications for Use (Describe)
Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:
- · Degenerative pathologies: arthrosis, rheumatoid arthrosis, post traumatic arthrosis
- · Primary and secondary necrosis of the humeral head
- · Displaced 4-part upper humeral fracture
- · Humeral head fracture
- · Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
- · Revision surgery when other treatments or devices have failed
- The Aequalis PerFORM+ glenoids are intended for cemented use only.
The Aequalis monobloc stem is for cemented use
The Aequalis Press-Fit is for uncemented use
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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510(k) Summary K160975
I. Submitter
Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437
| Date Prepared: | June 8, 2016 |
|---|---|
| Contact Person: | Loucinda Bjorklund |
| Manager, Regulatory Affairs | |
| Phone: | 952-683-7491 |
| Fax: | 952-426-7601 |
| II. | Device |
| Name of Device: | Aequalis PerFORM+ Shoulder System |
| Common or Usual Name: | Shoulder Prosthesis, humeral head |
| Classification Name: | 21 CFR 888.3660, shoulder joint metal/polymer semi-constrainedcemented prosthesis |
| Regulatory Class: | Class II |
| Product Code: | KWS |
III. Predicate Device
Aequalis PerFORM+ Shoulder System, K150583
IV. Device Description
The Aequalis PerFORM+ Shoulder System is a modular system consisting of a metaphyseal humeral stem component, anatomic humeral heads and glenoid for a total shoulder athroplasty. Surgical instruments are designed to facilitate proper implantation of the system.
V. Intended Use
The Tornier shoulder prostheses are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
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Indications For Use VI.
Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:
- . Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis.
- Primary or secondary necrosis of the humeral head. ●
- Displaced 4-part upper humeral fracture ●
- . Humeral head fracture
- Other pathologies where arthrodesis or resectional arthroplasty of the humeral head ● are not acceptable.
- Revision surgery when other treatments or devices have failed. .
The Aequalis PerFORM+ glenoids are intended for cemented use only.
The Aequalis monbloc stem is for cemented use
The Aequalis press-fit is for uncemented use
VII. Comparison of Technological Characteristics with the Predicate Device
The Aequalis PerFORM+ Shoulder System has the same intended use and fundamental scientific technology as the predicate device. The design differences do not affect safety or effectiveness or raise new issues of safety or effectiveness.
Non-Clinical Performance Data VIII.
The following performance data were provided in support of the substantial equivalence determination.
| Validation and / orVerification Method | Acceptance Value / Criteria | Results |
|---|---|---|
| Loosening Test | No Loosening detected at completion of test. | Acceptable |
| Shear testing | Comparable to the predicate device design. | Acceptable |
| Tensile (pull out) testing | Comparable to the predicate device design. | Acceptable |
| Endotoxin | $ ≤ 20 EU / device $ | Acceptable |
Performance Data
IX. Clinical Study
Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.
X. Conclusions
The Aequalis PerFORM+ Shoulder System described in this section has the same intended use and the same fundamental scientific technology as the cleared Aequalis Shoulder System. Based on the testing presented for the design differences between the subject and predicate devices, Tornier concludes that subject device is substantially equivalent to the predicate device.
§ 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.”