Smith & Nephew's 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 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 Patient Matched Cutting Blocks are intended for single use only.

Device Description

The Patient Matched Cutting Blocks were previously cleared for market via premarket notification K082358. Subject of this premarket notification are modifications to the software components used to design and manufacture the Patient Matched Cutting Blocks. The Patient Matched Cutting Blocks are designed and manufactured from patient imaging data (MRJ, X-Ray).

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Resection Depth	Equivalent to conventional instrumentation OR within clinically acceptable parameters.	The patient-matched cutting blocks designed using the case processing applications perform equivalent to conventional instrumentation or within clinically acceptable parameters.
Coronal Alignment (Varus/Valgus)	Equivalent to conventional instrumentation OR within clinically acceptable parameters.	The patient-matched cutting blocks designed using the case processing applications perform equivalent to conventional instrumentation or within clinically acceptable parameters.
Rotation	Equivalent to conventional instrumentation OR within clinically acceptable parameters.	The patient-matched cutting blocks designed using the case processing applications perform equivalent to conventional instrumentation or within clinically acceptable parameters.
Tibial Posterior Slope	Equivalent to conventional instrumentation OR within clinically acceptable parameters.	The patient-matched cutting blocks designed using the case processing applications perform equivalent to conventional instrumentation or within clinically acceptable parameters.
Software Performance	Perform as intended, with no new issues related to safety and effectiveness.	A review of software verification and validation testing demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended.

2. Sample Size Used for the Test Set and Data Provenance

The provided text states that a cadaveric assessment was conducted. However, it does not specify the sample size (i.e., number of cadavers or knees tested) for this assessment.

Regarding data provenance, the test data comes from a cadaveric study. The country of origin of the data is not explicitly stated, but the submitting company is Smith & Nephew, Inc., located in Memphis, Tennessee, USA, suggesting the study was likely conducted in the US. The study is prospective in nature, as it involves physical testing of the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth in the cadaveric assessment. It only mentions the "cadaveric assessment" and its results.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. Given the nature of a cadaveric assessment for physical measurements (resection depth, alignment, rotation, slope), it's possible that measurements were taken directly by researchers or using precise instruments, rather than relying on expert consensus and adjudication in the typical sense applied to image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The study conducted was a cadaveric assessment comparing the patient-matched cutting blocks to conventional instrumentation. Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance. The device in question is a physical cutting block, not an AI for image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a physical patient-matched cutting block, which inherently requires human-in-the-loop for its application during surgery. The software components used to design these blocks were verified and validated. While this software operates "standalone" in its design function, the overall device performance (the cutting blocks) is evaluated in the context of their use by a surgeon. The cadaveric assessment tests the performance of the cutting blocks themselves, not just the underlying design software in isolation from their physical use. Hence, a standalone algorithmic performance of the cutting block itself is not applicable in the same way it would be for an AI diagnostic tool. However, the software validation for the design process demonstrates its standalone functionality in generating the block designs.

7. The Type of Ground Truth Used

For the cadaveric assessment, the ground truth was likely established through direct physical measurement of the resections, alignments, rotations, and slopes achieved by using the cutting blocks, and comparison to the known expected values or to the results from conventional instrumentation. This would fall under objective physical measurements rather than pathology or expert consensus on interpretation.

8. The Sample Size for the Training Set

The document states that the Patient Matched Cutting Blocks are designed and manufactured from "patient imaging data (MRJ, X-Ray)." This indicates that patient imaging data is used to design each individual cutting block for each patient. This is not a "training set" in the machine learning sense, but rather the input data for the design process.

If we interpret "training set" as the data used to develop and refine the software components that design these blocks, the document does not provide a specific sample size for such a development or training set. It only mentions that software verification and validation testing was completed.

9. How the Ground Truth for the Training Set Was Established

Given that the "training set" refers to patient-specific imaging data used for design rather than a dataset for machine learning algorithm training, the concept of "ground truth" for this data is inherent in the patient's anatomy as captured by the imaging. The software uses these images to identify "anatomic landmarks necessary for alignment and positioning of the implant." Therefore, the "ground truth" for the input data is the patient's anatomical features as depicted in the imaging scans (MRJ, X-Ray). The accuracy of these images and the subsequent identification of landmarks by the software determine the "ground truth" for the design process. The document does not detail how the accuracy of landmark identification from these images was established or verified during the software development process, beyond general software validation.

Summary

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> We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	January 10, 2014
Contact Person and Address:	Bradley HeilRegulatory Affairs SpecialistT (901) 399-6339F (901) 566-7831
Name of Device:	Smith & Nephew, Inc. Patient Matched Cutting Block
Common Name:	Knee Prosthesis
Device Classification Name andReference:	CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis21 CFR 888.3565 Knee joint patellofemorotibialmetal/polymer porous-coated uncemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	OOG, JWH, MBH

Device Description

Technological Characteristics

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. Clinical data was not needed to support the safety and effectiveness of the subject devices.

Intended Use

Smith & Nephew's Patient Matched Cutting Blocks are intended to be used as patientspecific 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 Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. knee systems and their cleared indications for use:

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Genesis 2 Knee System .
Legion Knee System o
O Journey BCS Knee System
. Journey II Knee System

The Patient Matched Cutting Blocks are intended for single use only.

Performance Data

Smith & Nephew conducted a cadaveric assessment of the subject devices. The results of this study show that the patient matched cutting blocks designed using the case processing applications perform equivalent to conventional instrumentation or within clinically acceptable parameters with respect to resection depth, coronal alignment (varus/valgus), rotation and tibial posterior slope.

Substantial Equivalence Information

The subject devices are identical in function, intended use, indications for use, and material composition, and very similar in overall design to the Patient Matched Cutting Blocks cleared via premarket notification K082358.

Table 1: Substantially equivalent predicates to the modified Patient Matched Cutting Blocks

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	Patient Matched Cutting Blocks	K082358	11/25/2008

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the modified Patient Matched Cutting Blocks. Based on the similarities to the predicate components, a cadaveric assessment, and a review of the software validation testing performed, the devices are substantially equivalent to above predicate Patient Matched Cutting Blocks.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and appear to be abstract representations of human faces. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 28, 2104

Smith & Nephew, Inc. Mr. Bradley Heil Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

Re: K130708

Trade/Device Name: Smith & Nephew Patient Matched Cutting Blocks 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: October 29, 2013 Received: October 30, 2013

Dear Mr. Heil:

This letter corrects our substantially equivalent letter of December 11, 2013.

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

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Page 2 - Mr. Bradley Heil

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Vincent J. Devlin -S

for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130708

Device Name: Smith & Nephew, Inc. Patient Matched Cutting Blocks

Indications for Use:

The 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 Patient Matched Cutting Blocks are intended for single use only.

Prescription Use X (Part 21 CFR 801 Subpart AND/OR D)

Over-The-Counter Use

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page _ 1 of _ 1

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.