Smith & Nephew's VISIONAIRE Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement 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 Patient Matched Cutting Blocks 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 Patient Matched Cutting Blocks are intended for single use only.

Device Description

The subject of this premarket notification is to seek FDA clearance of software components to be used in the design and manufacture of the VISIONAIRE Patient Matched Cutting Blocks. Patient Matched Cutting Blocks were previously cleared for market via premarket notifications- K183010. The blocks are designed utilizing the VISIONAIRE Patient Matched Technology software components and patient imaging data (MRI, X-Ray). The blocks are intended to be used as patient-specific surgical instruments to assist in the positioning of total knee replacement implant components intra-operatively and in guiding the marking of bone before cutting.

AI/ML Overview

The provided document, K200826, describes a 510(k) premarket notification for the "Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks." This submission focuses on seeking FDA clearance for software components used in the design and manufacture of these cutting blocks, rather than the blocks themselves or a new AI algorithm for medical image analysis.

The document explicitly states:

"No new mechanical testing was performed. No implants or new blocks are being introduced in this premarket notification." (Page 4)
"There are no changes to the block design, packaging, material composition or manufacturing of Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks as a result of these changes described in the premarket notification." (Page 4)
"Clinical data was not needed to support the safety and effectiveness of the subject device(s)." (Page 4)
"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." (Page 4)

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning the performance of an AI-powered diagnostic or decision-support system. The information requested (e.g., acceptance criteria tables, sample sizes for test sets, expert qualifications, MRMC studies, standalone performance, ground truth types) is typical for the validation of AI/ML medical devices that perform tasks like image analysis or diagnosis.

This 510(k) submission is for software changes related to the design and manufacturing process of previously cleared devices (K183010), not for a new AI algorithm that uses medical imaging directly for diagnostic or assistance purposes in the way implied by the questions. The software validation mentioned is general software validation (e.g., unit testing, integration testing, system testing) to ensure the software performs its intended function in designing the blocks correctly, not a clinical performance study with human readers or an AI-only performance study against ground truth established by experts.

To answer your request, if this were an AI medical device, the following information would be expected:

A table of acceptance criteria and the reported device performance: This would typically define metrics like sensitivity, specificity, AUC, or accuracy, along with objective thresholds that the device's performance must meet.
Sample sizes used for the test set and the data provenance: Details on the number of cases (e.g., scans, patients) in the test set, where the data came from (e.g., specific hospitals, demographics), and whether it was retrospectively collected or prospectively collected.
Number of experts used to establish the ground truth for the test set and the qualifications: How many domain experts (e.g., board-certified radiologists) reviewed the test cases to establish the definitive diagnosis or finding, and their experience levels.
Adjudication method for the test set: How disagreements among experts in establishing ground truth were resolved (e.g., majority vote, consensus meeting, senior expert review).
If a multi reader multi case (MRMC) comparative effectiveness study was done: Whether human readers were evaluated with and without the AI assistance, and the statistical significance of any improvement in their performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The performance metrics of the AI algorithm operating independently of human review.
The type of ground truth used: Whether ground truth was derived from expert consensus, histopathology, long-term patient outcomes, or another definitive method.
The sample size for the training set: The number of cases used to train the AI model.
How the ground truth for the training set was established: The process by which the training data was labeled and verified.

Since the provided document is not for an AI diagnostic device in the traditional sense, it lacks these specific details. The software in question essentially aids in the manufacturing design of a physical device, based on patient imaging data, rather than performing an interpretive or diagnostic function on the imaging itself.

Summary

{0}------------------------------------------------

April 24, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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. Brad Sheals Regulatory Affairs Manager 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K200826

Trade/Device Name: Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OOG Dated: March 27, 2020 Received: March 30, 2020

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. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song, PhD, RAC Acting 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K200826

Device Name

Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks

Indications for Use (Describe)

The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks 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 Patient Matched Cutting Blocks 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)

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}------------------------------------------------

Image /page/3/Picture/1 description: The image features the Smith & Nephew logo. The logo consists of a stylized orange flower-like symbol on the left, followed by the text "We are" in gray. To the right of this text is "smith&nephew" in orange.

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	04/07/2020
Contact Person and Address:	Brad ShealsRegulatory Affairs ManagerT 901-399-6897F 901-566-7911
Name of Device:	Smith & Nephew VISIONAIRE Patient Matched CuttingBlocks
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

Intended Use

Smith & Nephew's VISIONAIRE Patient Matched Cutting Blocks 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 Patient Matched Cutting Blocks 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

{4}------------------------------------------------

The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for single use only.

Technological Characteristics

No new mechanical testing was performed. No implants or new blocks are being introduced in this premarket notification. There are no changes to the block design, packaging, material composition or manufacturing of Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks as a result of these changes described in the premarket notification. Clinical data was not needed to support the safety and effectiveness of the subject device(s). The following technological difference exists between the subject device and predicate device, which is related to the manufacturing and design process (e.g. The use of an additional X-ray measurement tool and removal of MDDS-Non Devices as defined in Section 520 (o)(1)(D)).

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. Per the FDA's recommendations, the VISIONAIRE Patient Matched Technology software components for this device were considered as a "major" level of concern, since a failure in the software could directly result in serious injury or death to the patient or operator.

Based on the documentation 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 Patient Matched Cutting Blocks 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 (K183010, S.E. 11/28/2018).

Conclusion

This premarket notification is being submitted to request clearance of the subject Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks. Based on the similarities to the predicate cutting blocks and a review of the software testing performed, the subject device is substantially equivalent to the predicate device- Patient Matched Cutting Blocks (K183010, S.E. 11/28/2018).

Regulation Number and Section

§ 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.