(125 days)
Smith & Nephew's VISIONAIRE UK Patient Matched Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of 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 UK Patient Matched Cutting Guides are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
- JOURNEY II Unicompartmental Knee (JOURNEY II UK) System
The Smith & Nephew VISIONAIRE UK Patient Matched Cutting Guides are intended for single use only.
The VISIONAIRE Unicompartmental Knee (UK) Patient Matched Cutting Guides are to be used as patient-specific surgical instrumentation to assist in the positioning of partial knee replacement implant components intra-operatively and in guiding the marking of bone before cutting. The subject device is designed and manufactured from patient imaging data (i.e. MRI, X-Ray) using additive manufacturing of Nylon 12 material to create the patientmatched guides. The blocks achieve mechanical alignment via an intimate fit with the patient's proximal tibia or distal femur. This fit is achieved by reconstructing the patient's bony and cartilaginous anatomy from the MRI scans of the patient's knee. The VISIONAIRE UK Patient Matched Cutting Guides are intended to be used for medial femoral and tibia resections in conjunction with previously cleared Smith & Nephew JOURNEY II Unicompartmental Knee (JOURNEY II UK) System (K190085).
The provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or other similar quantitative measures typically associated with AI/ML diagnostic or measurement devices.
The document is a 510(k) summary for the "VISIONAIRE UK Patient Matched Cutting Guides," which are patient-specific surgical instruments. The assessment for this type of device focuses on substantial equivalence to existing predicate devices, functional performance in a surgical context, and safety.
Here's a breakdown of the information that is available in the document, framed against your requested points:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document in the format of quantitative performance metrics for AI/ML. The device is a physical surgical guide, not a diagnostic AI.
The document states: "Smith & Nephew conducted cadaveric testing of the VISIONAIRE UK Patient Matched Cutting Guides. The results of this testing demonstrated that the patient matched cutting blocks/guides designed using the case processing applications perform equivalent to the predicate devices listed in the Table 5.1 below."
This implies that the acceptance criteria for the cadaveric testing would have been equivalence to the predicate devices in guiding bone cuts, likely in terms of accuracy of bone resection or component positioning. However, the specific criteria (e.g., "within X degrees of alignment," "within Y mm of cut depth") and the actual performance results (e.g., "average deviation was Z mm/degrees") are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "cadaveric testing," which serves as the "test set" for the physical guides.
- Sample size for the test set: Not specified.
- Data provenance: Cadaveric testing. Country of origin not specified, but typically conducted in-house or at a specialized lab. This is a prospective test, as the testing was conducted specifically for this submission.
The patient imaging data (MRI, X-Ray) used to design the guides for this testing would have been retrospective if taken from existing cadaveric scans or prospective if new scans were performed. This detail is not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For cadaveric testing of surgical guides, ground truth would likely be established by direct measurement of the bone cuts or implant placement by qualified engineers or surgeons, but the specific details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 and not done. This device is a surgical cutting guide, not an AI/ML diagnostic or measurement tool that assists human readers in interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical cutting guide, designed using "VISIONAIRE Patient Matched Technology" (which involves software applications, not a standalone AI for diagnosis). The performance evaluation focuses on the physical guide's ability to facilitate accurate surgical cuts, assisted by human surgeons. The software itself is assessed for safety and effectiveness in its role of manufacturing the guide, not as a standalone diagnostic algorithm. The document states: "All changes are made to the non-medical device software as part of the subject device submission. There are no changes required to the previously cleared VISIONAIRE Patient Matched Cutting Blocks software (Secondary Predicate - K200826) that are involved in creating the VISIONAIRE UK Patient Matched Cutting Guides."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the cadaveric testing, the ground truth would likely be physical measurements of the achieved bone resection or implant alignment compared to the planned resection/alignment, performed by engineers or surgeons after the cuts were made using the guides. The document does not specify how this ground truth was measured or established.
8. The sample size for the training set
Not applicable for a typical AI/ML training set. The "training" for this device involves the design and manufacturing process based on patient imaging data. The document mentions "patient imaging data (i.e. MRI, X-Ray)" being used to design and manufacture the guides. There isn't a "training set" in the sense of a machine learning model learning from a dataset. The software uses these scans to generate a patient-specific guide.
9. How the ground truth for the training set was established
Not applicable. There isn't a "training set" in the AI/ML context. The patient's own anatomy, as captured by the MRI scans, serves as the basis for the design of their individual guide. The "ground truth" here is the patient's actual anatomical features.
In summary, the provided document is a regulatory submission for a physical medical device (surgical guide), not an AI/ML software as a medical device. Therefore, many of the requested criteria related to AI/ML performance studies are not relevant or addressed in the document. The key study mentioned is "cadaveric testing" to demonstrate equivalence to predicate devices in the context of guiding surgical cuts.
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October 29, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Smith & Nephew, Inc. Leah Andre Regulatory Affairs Specialist II 7135 Goodlett Farms Parkway Cordova. Tennessee 38016
Re: K211512
Trade/Device Name: VISIONAIRE UK Patient Matched Cutting Guides Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX, OOG, MBH, JWH
Dear Leah Andre:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 16, 2021. Specifically, FDA is updating this SE Letter as an administrative correction. The 510(k) summary that was included in the SE package included the VISIONAIRE lateral cutting guides; however, the VISIONAIRE lateral cutting guides have been removed from the submission. The updated 510(k) summary does not include the lateral cutting guides and will be included in the SE Package.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ting Song, Ph.D., R.A.C., OHT6: Office of Orthopedic Devices, (301) 769-7677.
Sincerely,
Ting Song-S
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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September 16, 2021
Image /page/1/Picture/1 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 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.
Smith & Nephew, Inc. Leah Hawkins Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova. Tennessee 38016
Re: K211512
Trade/Device Name: VISIONAIRE UK Patient Matched Cutting Guides Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX, OOG, MBH, JWH Dated: August 19, 2021 Received: August 20, 2021
Dear Leah Hawkins:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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 medical devices and radiation-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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song -S
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K211512
Device Name VISIONAIRE UK Patient Matched Cutting Guides
Indications for Use (Describe)
Smith & Nephew's VISIONAIRE UK Patient Matched Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of 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 UK Patient Matched Cutting Guides are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
- JOURNEY II Unicompartmental Knee (JOURNEY II UK) System
The Smith & Nephew VISIONAIRE UK Patient Matched Cutting Guides are intended for single use only.
| 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 Submitted by: | Smith & Nephew, Inc.Orthopaedic Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016 |
|---|---|
| Date of Submission: | May 13, 2021 |
| Primary Contact Person: | Leah Hawkins, Regulatory Affairs Specialist II |
| T (901) 800-3355 | |
| M (901) 463-8447 | |
| Secondary Contact Person: | Michelle Huettner, Director, Regulatory Affairs |
| T (901) 800-3241 | |
| M (765) 426-6070 | |
| Name of Device: | VISIONAIRE UK Patient Matched Cutting Guides |
| Common Name: | Knee Prosthesis |
| Device Classification Name andReference: | 21 CFR 888.3520 - Knee Joint femorotibialmetal/polymer non-constrained cementedprosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HSX - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis |
| OOG - Knee joint patellofemorotibialpolymer/metal/polymer semi-constrainedcemented prosthesis. | |
| MBH - Knee joint patellofemorotibialmetal/polymer porous-coated uncementedprosthesis. | |
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JWH - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Predicate Device:
Primary Predicate: Materialise PKA Guide System - K173970 (S.E. 7/6/2018) HSX, OOG
Secondary Predicate: VISIONAIRE Patient Matched Cutting Blocks - K200826 (S.E. 4/24/2020) JWH, MBH, OOG
Reference Device: VISIONAIRE Adaptive Guides - K170282 (S.E. 5/22/2017) JWH, MBH, OOG
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Device Description
The purpose of this Traditional 510(k) is to notify the FDA of our intent to market the Smith & Nephew VISIONAIRE UK Patient Matched Cutting Guides with the VISIONAIRE Patient Matched Technology. The VISIONAIRE Unicompartmental Knee (UK) Patient Matched Cutting Guides are to be used as patient-specific surgical instrumentation to assist in the positioning of partial knee replacement implant components intra-operatively and in guiding the marking of bone before cutting. The subject device is designed and manufactured from patient imaging data (i.e. MRI, X-Ray) using additive manufacturing of Nylon 12 material to create the patientmatched guides. The blocks achieve mechanical alignment via an intimate fit with the patient's proximal tibia or distal femur. This fit is achieved by reconstructing the patient's bony and cartilaginous anatomy from the MRI scans of the patient's knee. The VISIONAIRE UK Patient Matched Cutting Guides are intended to be used for medial femoral and tibia resections in conjunction with previously cleared Smith & Nephew JOURNEY II Unicompartmental Knee (JOURNEY II UK) System (K190085). Similar unicompartmental knee patient-specific surgical instrumentation used with JOURNEY II UK System has been previously cleared as Materialise PKA Guide System (Primary Predicate - K173970).
The VISIONAIRE UK Patient Matched Cutting Guides utilizes VISIONAIRE Patient Matched Technology to design and manufacture the patient-matched guides. As a result of this submission, the subject device will use the VISIONAIRE Patient Matched Technology process in previously cleared VISIONAIRE Patient Matched Cutting Blocks (Secondary Predicate -K200826). The only modification to the VISIONAIRE Patient Matched Technology process is the addition of VISIONAIRE UK implant options.
The VISIONAIRE UK Patient Matched Cutting Guides are a line extension to the currently marketed VISIONAIRE Adaptive Guides (Reference Device – K170282) and will utilize similar manufacturing and technological processes.
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Indications for Use
Smith & Nephew's VISIONAIRE UK Patient Matched Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of 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 UK Patient Matched Cutting Guides are intended for use with the following existing Smith & Nephew. Inc. Knee Systems and their cleared indications for use:
- JOURNEY II Unicompartmental Knee (JOURNEY II UK) System (K190085)
The Smith & Nephew VISIONAIRE UK Patient Matched Cutting Guides are intended for single use only.
Technological Characteristics
Smith & Nephew conducted cadaveric testing of the VISIONAIRE UK Patient Matched Cutting Guides. The results of this testing demonstrated that the patient matched cutting blocks/guides designed using the case processing applications perform equivalent to the predicate devices listed in the Table 5.1 below.
The associated software in order to manufacture the subject device demonstrate that there are no new issues related to the safety and effectiveness of the predicate device and the software will perform as intended. All changes are made to the non-medical device software as part of the subject device submission. There are no changes required to the previously cleared VISIONAIRE Patient Matched Cutting Blocks software (Secondary Predicate - K200826) that are involved in creating the VISIONAIRE UK Patient Matched Cutting Guides. Additional details related to the software are provided in Section 16.
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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 UK Patient Matched Cutting Guides are substantially equivalent in function, equivalent design features, intended use, indications for use, operational principles, manufacturing processes, and materials as the commercially available predicate devices listed below in Table 5.1.
Table 5.1: Predicate Devices
| Predicate Type | Manufacturer | Description | SubmissionNumber | ClearanceDate |
|---|---|---|---|---|
| Primary Predicate | Materialise N.V. | Materialise PKA Guide System | K173970 | 07/06/2018 |
| Secondary Predicate | Smith & Nephew, Inc. | VISIONAIRE Patient Matched Cutting Blocks | K200826 | 4/24/2020 |
| Reference Device | Smith & Nephew, Inc. | VISIONAIRE Adaptive Guides | K170282 | 05/22/2017 |
Conclusion
As previously noted. this 510(k) Premarket Notification is being submitted to request clearance for the VISIONAIRE UK Patient Matched Cutting Guides. Based on the similarities to the predicate cutting blocks and guide system, cadaveric testing, and a review of the software validation testing performed, the subject device is substantially equivalent to the commercially available predicate devices listed above.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.