(91 days)
Signature™ Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Signature™ Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ M Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, and AGC™ Complete Knee system.
The Signature™ guides are intended for single use only.
The Signature™ Personalized Patient Care System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the placement of Biomet total and partial knee replacement components.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software Accuracy | "The Signature™ Planner software has been validated for its intended use..." and "...verified that the accuracy and performance of the system is adequate to perform as intended." |
| Accuracy of Surgical Guidance | "...accuracy performance testing by means of cadaveric trials...verified that the accuracy and performance of the system is adequate to perform as intended." |
| Guide Deformation after Sterilization | "...guide deformation verification after sterilization was performed...verified that the accuracy and performance of the system is adequate to perform as intended." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size for the test set. It mentions "cadaveric trials" for accuracy performance testing.
The data provenance is from cadaveric trials, which implies a pre-clinical, non-human source. The country of origin is not specified. It is a retrospective study in the sense that cadavers are used for testing, but given the nature of the device (surgical planning and guidance), it implies a pre-clinical evaluation phase.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided text does not specify the number of experts used to establish ground truth or their qualifications for the test set.
4. Adjudication Method for the Test Set
The provided text does not specify an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on the device's standalone accuracy and performance, not on its impact on human reader performance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was done for the algorithm. The text states: "The Signature™ Planner software has been validated for its intended use to determine substantial equivalence to the predicate devices." and "...accuracy performance testing by means of cadaveric trials...was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended." This indicates the software and guides were tested for their inherent accuracy and performance.
7. Type of Ground Truth Used
The ground truth for the in-vitro performance was established through cadaveric trials for the surgical guidance accuracy. For the software validation, it's implicitly against established engineering and computational standards for accuracy, though the exact method isn't detailed.
8. Sample Size for the Training Set
The provided text does not specify the sample size for the training set. The device description points to it being a software that generates plans based on MRI imaging data, implying an underlying algorithm that would likely have been trained, but no details are given.
9. How the Ground Truth for the Training Set Was Established
The provided text does not describe how the ground truth for the training set was established.
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510(k) Summary
Submitter information
| Company name | Materialise N.V. |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | +32 16 39 62 80 |
| Fax number | +32 16 39 66 06 |
| Contact name | Alexandra Razzhivina |
| Contact title | Regulatory affairs officer |
| Contact e-mail address | alexandra.razzhivina@materialise.be |
Submission date
The date of the Traditional 510(k) submission is 11th of February.
Submission information
| Trade Name | Signature™ PlannerSignature™ guides |
|---|---|
| Common Name | Knee prosthesis |
| Classification Name | - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.-Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis- Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis |
| Product code | JWH/OIY (21 CFR § 888.3560), MBH (21 CFR § 888.3565),HRY (21 CFR § 888.3530), OOG |
Predicate devices
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Signature™ Personalized Patient Care System |
| 510(k) number | K102795 |
| Decision date | 02/02/2011 |
| Product code | JWH/OIY, MBH, OOG |
| Manufacturer | Materialise N.V. |
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Patient Matched Cutting Blocks |
| 510(k) number | K082358 |
| Decision date | 11/25/2008 |
| Product code | JWH, MBH |
| Manufacturer | Smith and Nephew, Inc. |
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Device Information
Description of the device
The Signature™ Personalized Patient Care System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the placement of Biomet total and partial knee replacement components.
Functioning of the device
The Signature™ Personalized Patient Care System generates a pre-surgical plan based on MRI imaging data using the Signature™ Planner (software component). The software is then used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the presurgical plan. Next, Signature™ guides are designed and manufactured based on the approved pre-surgical plan. Signature™ guides are patient specific templates that transfer the pre-operatively determined cut planes for positioning of the total and partial knee replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual total and partial knee replacement components by guiding and marking drill and/or cut locations.
Intended use
Signature™ Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ M Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, and AGC™ Complete Knee system.
The Signature™ guides are intended for single use only.
Summary of technological characteristics
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices.
Performance data
Non-clinical tests
The Signature"" Planner software has been validated for its intended use to determine substantial equivalence to the predicate devices.
Accuracy performance testing by means of cadaveric trials, and guide deformation verification after sterilization was performed to determine substantial equivalence. Testing
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verified that the accuracy and performance of the system is adequate to perform as intended.
Clinical data Not applicable.
. · ..
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Materialise N.V. % Ms. Alexandra Razzhivina Technologielaan 15 3001 Leuven Belgium
MAY 16 2011
Re: K110415 Trade/Device Name: Signature guides™, Signature™ Planner Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY, JWH, OIY, MBH, OOG Dated: May 4, 2011 Received: May 6, 2011
Dear Ms. Razzhivina:
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 10 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Alexandra Razzhivina
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Aty B. Rh
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K | 041 | کا
Device Name: The Signature™ Personalized Patient Care System (Signature™ guides, Signature™ Planner)
Indications for Use:
Signature™ Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Signature™ Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ M Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, and AGC™ Complete Knee system.
The Signature™ guides are intended for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110415
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.