(112 days)
Smith & Nephew's VISIONAIRE Adaptive Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Smith & Nephew VISIONAIRE Adaptive Guides are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
- Genesis II Knee System
- Legion Knee System
- Journey BCS Knee System
- Journey II Knee System
The Smith & Nephew VISIONAIRE Adaptive Guides are intended for single use only.
The subject of this premarket notification is to seek FDA clearance of the Smith & Nephew VISIONAIRE Adaptive Guides and the modifications to the software components used to design and manufacture the VISIONAIRE Patient Matched Cutting Blocks. The subject guides are designed, manufactured from patient imaging data (i.e. MRI, X-Ray) and offered in various femur/tibia options and features requested by the surgeon: a tibia-cut-first guide and options for removable tabs. Also within this notification are surgical alignment instruments to evaluate guide position. Patient Matched Cutting Blocks were previously cleared for market via premarket notification K130708.
This document is a 510(k) premarket notification for the "Smith & Nephew VISIONAIRE Adaptive Guides". It states that the device is substantially equivalent to a predicate device and includes information about its intended use and technological characteristics.
Here’s an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a tabular format, nor does it detail specific quantitative performance metrics beyond stating equivalency. Instead, it relies on demonstrating equivalency to a predicate device and positive results from cadaveric testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: The device should perform in a manner similar to the predicate Patient Matched Cutting Blocks (K130708). | "The results of this testing demonstrated that the patient matched cutting blocks/guides designed using the case processing applications perform equivalent to the predicate cutting blocks." "The Smith & Nephew VISIONAIRE Adaptive Guides are identical in function, equivalent design features, intended use, indications for use, operational principles, manufacturing processes, and materials as the predicate device- Patient Matched Cutting Blocks (K130708, S.E. 02/28/2014)." |
| Software performs as intended and introduces no new safety/effectiveness issues. | "Software verification and validation testing was completed... A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended." |
| No new issues related to safety and effectiveness. | "Based on the testing within this premarket notification, there are no new issues related to the safety and effectiveness of the subject device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "cadaveric testing" for the subject device but does not specify the sample size (i.e., number of cadavers or knees tested).
- Data Provenance: The cadaveric testing implies the data is prospective (generated for this specific study). The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the cadaveric testing.
4. Adjudication Method for the Test Set
The document does not provide information on any adjudication method used for the test set.
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
- MRMC Study: The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- AI Assistance: The device described (VISIONAIRE Adaptive Guides) is a patient-specific surgical instrumentation that uses patient imaging data (MRI, X-Ray) for design and manufacturing, assisting in positioning and guiding bone marking. While it uses software, the submission focuses on its physical guidance function and comparison to predicate physical cutting blocks, not on evaluating human reader improvement with AI assistance in image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document does not explicitly describe a standalone algorithm-only performance study. The "software verification and validation testing" refers to ensuring the software components that design and manufacture the guides perform as intended, but it's not a standalone diagnostic or interpretive algorithm performance study in the context of typical AI/ML submissions. The device is an aid to surgery, not a standalone diagnostic tool.
7. The Type of Ground Truth Used
For the cadaveric testing, the ground truth would likely be established through direct measurement of anatomical alignment and component positioning on the cadaveric specimens after using the guides, potentially validated against surgical planning or anatomical landmarks. However, the document does not explicitly state the type of ground truth used.
8. The Sample Size for the Training Set
The document refers to the device being designed and manufactured from "patient imaging data (i.e. MRI, X-Ray)". However, it does not specify any sample size for a training set in the context of an AI/ML algorithm development. The software capabilities are about designing and manufacturing physical guides based on existing imaging, rather than learning from a vast dataset.
9. How the Ground Truth for the Training Set was Established
Since no specific "training set" for an AI/ML model is described, there's no information on how ground truth for such a set would have been established. The ground truth for the design and manufacturing process would be the accuracy of the physical guides in matching the patient's anatomy and desired surgical plan, which is implicitly validated by the cadaveric testing.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2017
Smith & Nephew, Inc Brad Sheals Principal Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K170282
Trade/Device Name: Smith & Nephew VISIONAIRE Adaptive Guides 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, MBH, OOG Dated: January 27, 2017 Received: January 30, 2017
Dear Brad Sheals:
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
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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.
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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| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K170282 |
|---|---|
| Device Name | Smith & Nephew VISIONAIRE Adaptive Guides |
| Indications for Use (Describe) | Smith & Nephew's VISIONAIRE Adaptive Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. |
The Smith & Nephew VISIONAIRE Adaptive Guides are intended for use with the following existing Smith & Nephew,
Inc. Knee Systems and their cleared indications for use:
- Genesis II Knee System
- Legion Knee System
- Journey BCS Knee System
- Journey II Knee System
The Smith & Nephew VISIONAIRE Adaptive Guides are intended for single 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) |
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Image /page/3/Picture/1 description: The image shows the Smith & Nephew logo. The words "We are" are in gray, while "smith&nephew" is in orange. To the left of the text is an orange star-like symbol.
| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116 |
|---|---|
| Date of Summary: | May 18, 2017 |
| Contact Person and Address: | Brad ShealsPrincipal Regulatory Affairs SpecialistT 901-399-6897F 901-566-7911 |
| Name of Device: | Smith & Nephew VISIONAIRE Adaptive Guides |
| Common Name: | Knee Prosthesis |
| Device Classification Name andReference: | 21 CFR 888.3560- Knee joint patellofemorotibialpolymer/metal/polymer non-constrained cementedprosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH, MBH, OOG |
Device Description
The subject of this premarket notification is to seek FDA clearance of the Smith & Nephew VISIONAIRE Adaptive Guides and the modifications to the software components used to design and manufacture the VISIONAIRE Patient Matched Cutting Blocks. The subject guides are designed, manufactured from patient imaging data (i.e. MRI, X-Ray) and offered in various femur/tibia options and features requested by the surgeon: a tibia-cut-first guide and options for removable tabs. Also within this notification are surgical alignment instruments to evaluate guide position. Patient Matched Cutting Blocks were previously cleared for market via premarket notification K130708.
Intended Use
Smith & Nephew's VISIONAIRE Adaptive Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Smith & Nephew VISIONAIRE Adaptive Guides are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
-
Genesis II Knee System
-
Legion Knee System
-
Journey BCS Knee System
-
Journey II Knee System
The Smith & Nephew VISIONAIRE Adaptive Guides are intended for single use only.
Page 1 of 2.
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Technological Characteristics
Smith & Nephew conducted cadaveric testing of the subject device. The results of this testing demonstrated that the patient matched cutting blocks/guides designed using the case processing applications perform equivalent to the predicate cutting blocks.
Software verification and validation testing was completed in line with FDA's guidance document entitled, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff," dated January 11, 2002. A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended.
Based on the testing within this premarket notification, there are no new issues related to the safety and effectiveness of the subject device. Clinical data was not needed to support the safety and effectiveness of the subject device.
Substantial Equivalence Information
The Smith & Nephew VISIONAIRE Adaptive Guides are identical in function, equivalent design features, intended use, indications for use, operational principles, manufacturing processes, and materials as the predicate device- Patient Matched Cutting Blocks (K130708, S.E. 02/28/2014).
Conclusion
This premarket notification is being submitted to request clearance for the Smith & Nephew VISIONAIRE Adaptive Guides. Based on the similarities to the predicate cutting blocks, cadaveric testing, and a review of the software validation testing performed, the subject device is substantially equivalent to the predicate device- Patient Matched Cutting Blocks (K130708, S.E. 02/28/2014).
§ 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.