The VELYS Robotic-Assisted Solution is intended for stereotaxic surgery to aid the surgeon in identifying the relative position and orientation of anatomical structures, planning the position of the femoral and tibial implant components intraoperatively, and preparing the bones during unicompartmental knee arthroplasty.

When indicated for unicompartmental knee arthroplasty, the VELYS Robotic-Assisted Solution is indicated for use with the SIGMA HP Partial Knee Implants and INTUITION Instruments for SIGMA HP Partial Knee and their cleared indications for use.

Device Description

The VELYS™ Robotic-Assisted Solution is an image-free robotic-assisted surgery system. It is intended for stereotaxic surgery to aid the surgeon in identifying the relative position and orientation of anatomical structures and landmarks, planning the position of the femoral and tibial implant components intraoperatively, and preparing the bones during total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA).

The image-free system uses a dedicated optical tracking device to acquire anatomical landmarks intra-operatively. These landmarks are then used to plan the femoral and tibial implant locations based on the surgeon's preferred surgical technique and placement preferences. Following the planning step, the VELYS™ Robotic-Assisted Solution helps the surgeon to execute the bone preparation according to the plan.

The system includes a Robotic-Assisted Device that constrion and orientation of the saw handpiece and blade inside each resection plane on the patient's femur and tibia. The surgeon actuates and manipulates the saw handpiece, within the planned resection plane, to execute the bone resection. This is analogous to using manual instruments in TKA or UKA. If the patient's leg moves during the resection, the Robotic-Assisted Device compensates for such movement in real-time.

The Robotic-Assisted Device is assembled with a Robotic-Assisted Device arm, mounted on the Operating Room (OR) bed rail, for a minimal footprint

The VELYS® Robotic-Assisted Solution incorporates several software subsystems, including applications responsible for general operation of the system and clinical applications dedicated to the surgery workflow.

The users interact with the clinical applications via a touchscreen and footswitch to navigate through the surgery steps. Case Reports including key surgical procedure information are stored on the system and can be retrieved by the surgeon for future use. Cases Reports including PHI are only available to the surgeon who performed the procedure.

AI/ML Overview

The provided text describes a 510(k) submission for the VELYS Robotic-Assisted Solution, primarily focusing on its expanded indication for unicompartmental knee arthroplasty (UKA). The document outlines the device's intended use, technological characteristics, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Based on the provided document, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document mentions "Performance testing activity included," followed by a list. However, it does not explicitly state specific quantifiable acceptance criteria or the numerical results for these tests. It only lists the types of tests performed.

Test Category	Acceptance Criteria (Not explicitly stated in the document)	Reported Device Performance (Not explicitly stated in the document)
Sagittal Border Guard Evaluation	(e.g., maintain specified distance from bone)	(e.g., Met 99% accuracy within X mm)
Dynamic Compensation Performance Test	(e.g., maintain alignment during specified movement)	(e.g., Successfully compensated for Y mm of movement)
Cadaveric Resection Accuracy and Soft Tissue Study	(e.g., resection within X mm/degree of plan)	(e.g., Achieved an average resection accuracy of Z mm)
Summative Usability Evaluation	(e.g., completion of tasks within time, low error rate)	(e.g., Usability metrics within acceptable range)
Design Validation	(e.g., meeting all design requirements)	(e.g., All design requirements validated)

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 states:

"Bench testing was performed on the subject device, VELYS™ Robotic-Assisted Solution for Unicompartmental Knee Arthroplasty (UKA)..."
"Cadaveric Resection Accuracy and Soft Tissue Study" was performed.

The sample sizes for the test sets (e.g., number of cadavers, number of test runs) are not specified in the provided text.
The data provenance is generally "Bench testing" and "Cadaveric Study," implying a controlled laboratory environment. The country of origin of the data and whether it was retrospective or prospective is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not provide information on the number of experts used or their qualifications to establish ground truth for any of the performance tests. The focus is on technical performance rather than clinical interpretability requiring expert adjudication.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Given that the performance tests are largely technical (e.g., robotic alignment, resection accuracy), rather than diagnostic interpretations, adjudication methods like 2+1 or 3+1 are not applicable and are not mentioned in the document.

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

The document explicitly states: "No clinical data was necessary to support the determination of substantial equivalence."
Therefore, an MRMC comparative effectiveness study was not performed for this submission. The device is a robotic-assisted surgical tool, not an AI-powered diagnostic imaging tool that would typically involve human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as a "Robotic-Assisted Device" where "The surgeon actuates and manipulates the saw handpiece, within the planned resection plane, to execute the bone resection." While the system has "Robotic-Assisted Device" that "compensates for such movement in real-time," it is fundamentally a human-in-the-loop system. The tests mentioned (e.g., resection accuracy, dynamic compensation) assess the integrated human-robot system's performance, rather than a standalone AI algorithm without human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Cadaveric Resection Accuracy and Soft Tissue Study," the ground truth for resection accuracy would likely be precise measurements of the actual bone cuts compared to the planned cuts post-resection using highly accurate metrology (e.g., CMM, 3D scanning). For other tests like "Sagittal Border Guard Evaluation" and "Dynamic Compensation Performance Test," the ground truth would be engineering specifications and measurements of the robot's or system's physical behavior against those specifications. The document doesn't specify the exact methods for ground truth establishment, but it is implied to be based on physical measurements against design specifications.

8. The sample size for the training set

This device is not an AI/ML device in the sense that it performs a diagnostic or predictive function learned from a large dataset. It is a robotic-assisted surgical system with software that aids in planning and execution. Therefore, the concept of a "training set" in the context of machine learning model development is not applicable to the information provided. The system's "training" would be its engineering design, calibration, and validation rather than statistical learning from a dataset.

9. How the ground truth for the training set was established

As the concept of a "training set" in the AI/ML context is not applicable here, the method for establishing its ground truth is also not relevant/described. The "ground truth" for the device's functionality would be its design specifications and physical principles.

Summary

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June 5, 2024

DePuy Ireland UC Camille Chua Regulatory Affairs Manager Loughbeg Ringaskiddy Ireland

Re: K240211

Trade/Device Name: VELYS Robotic-Assisted Solution Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: May 6, 2024 Received: May 6, 2024

Dear Camille Chua:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Shumaya Ali -S Shumaya Ali, M.P.H. Assistant Director

DHT6C: Division of Restorative, Repair and Trauma 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

Submission Number (if known)

K240211

Device Name

VELYS Robotic-Assisted Solution

Indications for Use (Describe)

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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510(k) #: K240211

510(k) Summary

Prepared on: 2024-06-05

Contact Details

21 CFR 807.92(a)(1)

Applicant Name		DePuy Ireland UC
Applicant Address		Loughbeg Ringaskiddy Ireland
Applicant Contact Telephone		+1 949-795-6191
Applicant Contact		Ms. Camille Chua
Applicant Contact Email		vchua1@its.jnj.com
Correspondent Name			DePuy Ireland UC
Correspondent Address			Loughbeg Ringaskiddy Ireland
Correspondent Contact Telephone			+1 949-795-6191
Correspondent Contact			Ms. Camille Chua
Correspondent Contact Email			vchua1@its.jnj.com
Device Name				21 CFR 807.92(a)(2)
Device Trade Name		VELYS Robotic-Assisted Solution
Common Name		Stereotaxic instrument
Classification Name		Orthopedic Stereotaxic Instrument
Regulation Number		882.4560
Product Code(s)		OLO
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)				Product Code
K172301	Mako Partial Knee Application				OLO
K233227	VELYS Robotic-Assisted Solution				OLO
Device Description Summary				21 CFR 807.92(a)(4)
The VELYS™ Robotic-Assisted Solution is an image-free robotic-assisted surgery system. It is intended for stereotaxic surgery to aid thesurgeon in identifying the relative position and orientation of anatomical structures and landmarks, planning the position of the femoraland tibial implant components intraoperatively, and preparing the bones during total knee arthroplasty (TKA) and unicompartmentalknee arthroplasty (UKA).

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K240211 510(k) #:

according to the plan.

The Robotic-Assisted Device is assembled with a Robotic-Assisted Device arm, mounted on the Operating Room (OR) bed rail, for a minimal footprint

Intended Use/Indications for Use

The VELYS Robotic-Assisted Solution is intended for stereotaxic surgery to aid the surgeon in identifying the relative position and orientation of anatomical structures, planning the femoral and tibial implant components intraoperatively, and preparing the bones during unicompartmental knee arthroplasty.

Indications for Use Comparison

The subject device has the same indications for use as the predicate device.

Technological Comparison

The subject device and the predicate device have similar technological characteristics with respect to principles of operation, system design, and performance. The subject and predict device achieve the same outcomes, however the main design differences of the subject device include: image-free planning and patient anatomy assessment, robotic-assisted bone resection, and surgeon control. Performance testing on the subject device and comparison to the reference device, VELYS™ Robotic-Assisted Solution with TKA, support that there are no new questions of safety or effectiveness.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Bench testing was performed on the subject device, VELYS™ Robotic-Assisted Solution for Unicompartmental Knee Arthroplasty (UKA), in accordance with the product risk analysis and product requirements, in line with FDA 21 CFR Part 820, and to demonstrate substantial equivalence with the predicate device. Where available, FDA-consensus standards and/or guidance documents were used. New bench testing specific to the expanded indication to include UKA and leveraged testing from the VELYS™ Robetic-Assisted Solution Total Knee Arthroplasty (TKA) reference device were performed for assessing device performance.

Performance testing activity included

· Sagittal Border Guard Evaluation
· Dynamic Compensation Performance Test
· Cadaveric Resection Accuracy and Soft Tissue Study
· Summative Usability Evaluation
· Design Validation

No clinical data was necessary to support the determination of substantial equivalence

Both the subject device and predicate device have intended use, same indications for use, and similar technological characteristics. Where there are technological differences, performance testing was conducted on the subject device and VELYS™ Robotic-Assisted Solution with TKA was utilized as a reference device to show that no new questions of safety or effectiveness were raised; therefore DePuy Synthes concludes that the subject and predicate devices are substantially equivalent.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).