(21 days)
The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.
Truliant femoral components are for use in resurfacing femoral bone as part of tricompartmental total knee arthroplasty employing modular components from the Optetrak / Optetrak Logic and Truliant device families.
Proposed Truliant femoral components represent modifications to Truliant femoral components cleared per 510(k) K170240. The proposed Truliant femoral components are identical to cited predicate femoral components except for dimensional modifications representing new additions to the product scope.
Proposed Truliant tibial trays represent modifications to One Logic tibial trays cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant trays are identical to cited predicate trays except for dimensional modifications representing new additions to the product scope.
Proposed Truliant tibial inserts represent modifications to One Logic tibial inserts cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant inserts are identical to cited predicate inserts except for dimensional modifications representing new additions to the product scope.
The proposed devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction. are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation. The only modifications proposed by this submission are dimensional.
Based on the provided text, the device in question is the Exactech® Truliant™ Line Extensions, which are knee prosthesis components (Femoral Components, Tibial Inserts, and Tibial Trays). This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study to prove the device meets specific acceptance criteria in terms of performance in patients.
Therefore, many of the requested criteria for an AI/device performance study (like MRMC studies, ground truth establishment, training set details, and specific acceptance metrics like AUC, sensitivity, specificity) are not applicable to this type of submission. This document describes a substantial equivalence determination for a medical device based on engineering and mechanical testing, not a study evaluating human-in-the-loop performance or standalone AI algorithm performance.
Here's a breakdown based on the provided text, addressing the points where information is available or explaining why it's not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria in numerical terms for clinical performance (e.g., a certain percentage improvement). Instead, it states that the testing "conclude[s] the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact, insert / tray assembly properties, or biocompatibility." This implies that the acceptance criterion was non-inferiority or equivalency to the predicate devices in these mechanical and biocompatibility aspects.
The reported performance is described qualitatively:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Patellofemoral constraint (Mechanical) | "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact..." |
| Patellofemoral contact pressure (Mechanical) | "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact..." |
| Insert / tray assembly micromotion (Mechanical) | "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with... insert / tray assembly properties..." |
| Insert / tray locking strength (Mechanical) | "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with... insert / tray assembly properties..." |
| Biocompatibility | "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with... biocompatibility." |
| Pyrogenicity / Sterility (USP <161>, <85>, ANSI/AAMI ST72) | "Pyrogen testing was conducted in accordance with USP <161>. USP <85>, and ANSI/AAMI ST72 to ensure the proposed Truliant components meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information..." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document refers to "engineering studies" and "mechanical testing." These typically involve a limited number of physical prototypes for testing the stated properties. The specific number of components or test specimens for each mechanical test (e.g., number of inserts, trays, or femurs tested for micromotion or strength) is not specified in this summary.
- Data Provenance: Not applicable in the sense of clinical patient data. The data comes from in vitro mechanical and biocompatibility testing of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring human expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human expert interpretation or adjudication.
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 knee prosthesis, not an AI imaging analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI algorithm. Its performance is evaluated through mechanical and materials testing.
7. The type of ground truth used
For mechanical and biocompatibility testing, the "ground truth" is established by engineering specifications, material science standards, and recognized test methods (e.g., ASTM standards for mechanical properties, ISO standards for biocompatibility, USP for pyrogenicity). The device's performance is compared against these predefined physical and chemical limits or against the performance of predicate devices.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. There is no concept of a "training set" for this type of device submission.
{0}------------------------------------------------
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2017
Exactech. Inc. Patrick Hughes Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K171045
Trade/Device Name: Exactech® Truliant™ Line Extensions Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: April 6, 2017 Received: April 7, 2017
Dear Mr. Hughes:
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
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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" (21 CFR 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.
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K171045
Device Name Exactech® Truliant™ Line Extensions
Indications for Use (Describe)
The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present.
The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Exactech® Truliant™ Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness
| Sponsor: | Exactech, Inc.2320 N.W. 66th CourtGainesville, FL 32653 |
|---|---|
| Phone: (352) 377-1140Fax: (352) 378-2617 | |
| FDA Establishment Number 1038671 | |
| Contact: | Patrick HughesSenior Regulatory Affairs Specialist |
Date: April 6, 2017
Trade or Proprietary or Model Name(s): Exactech® Truliant™ Line Extensions
Common Name: Cemented Total Knee Prosthesis
Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product Code: JWH
Classification Panel: Orthopedic
Regulation Number 888.3560
Device Class II
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K170240 | Exactech Truliant Femoral Components | Exactech, Inc |
| K152170 | Exactech One Logic Tibial Assembly | Exactech, Inc |
Indications for Use:
The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-
{4}------------------------------------------------
Exactech® Truliant™ Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness
traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.
Device Description:
Truliant femoral components are for use in resurfacing femoral bone as part of tricompartmental total knee arthroplasty employing modular components from the Optetrak / Optetrak Logic and Truliant device families.
Proposed Truliant femoral components represent modifications to Truliant femoral components cleared per 510(k) K170240. The proposed Truliant femoral components are identical to cited predicate femoral components except for dimensional modifications representing new additions to the product scope.
Proposed Truliant tibial trays represent modifications to One Logic tibial trays cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant trays are identical to cited predicate trays except for dimensional modifications representing new additions to the product scope.
Proposed Truliant tibial inserts represent modifications to One Logic tibial inserts cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant inserts are identical to cited predicate inserts except for dimensional modifications representing new additions to the product scope.
The proposed devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction. are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation. The only modifications proposed by this submission are dimensional.
{5}------------------------------------------------
Exactech® Truliant™ Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness
Testing Description:
This submission references results for mechanical patellofemoral constraint, patellofemoral contact pressure testing, mechanical insert / tray assembly micromotion, mechanical insert / tray locking strength, and device biocompatibility. Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact, insert / tray assembly properties, or biocompatibility.
Pyrogen testing was conducted in accordance with USP <161>. USP <85>, and ANSI/AAMI ST72 to ensure the proposed Truliant components meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate proposed Truliant line extensions are substantially equivalent to cited cleared predicate Truliant femoral components and One Logic / Truliant tibial inserts and tibial trays.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.