(126 days)
No
The summary describes a robotic surgical navigation system based on pre-operative planning and intra-operative guidance using a 3D model derived from a CBCT scan. There is no mention of AI or ML being used for planning, guidance, image processing, or any other function. The system relies on pre-programmed navigation based on the user's plan.
No.
The device is a navigational system and powered surgical device that assists in planning and performing dental implantation surgery, rather than directly treating a disease or condition itself.
No.
The Yomi Robotic System is a surgical navigation and robotic assistance system, not a diagnostic device. It is used for planning and performing dental implantation procedures, providing guidance for surgical instruments and bone reduction, rather than for diagnosing conditions or diseases.
No
The device description explicitly states that the Yomi Robotic System includes hardware components such as a robotic arm, patient tracking linkages (Patient Splint, Tracker End Effector, Patient Tracker), and accessories like the YomiLink Arch and Probing Bit. While it includes software for planning and guidance, it is not solely software.
Based on the provided text, the Yomi Robotic System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Yomi Robotic System's Function: The Yomi Robotic System is a surgical planning and guidance system used during dental implantation surgery. It uses imaging data (CBCT scans) to create a 3D model and guide surgical instruments. It does not analyze biological specimens.
The device's intended use and description clearly focus on surgical assistance and navigation, not on diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Yomi Robotic System is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotional guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi Robotic System is intended for use in partially edentulous adult patients who qualify for dental implants.
When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.
Product codes (comma separated list FDA assigned to the subject device)
PLV, QRY
Device Description
Yomi Robotic System is a dental stereotaxic instrument and a powered surgical device for bone cutting. Yomi Robotic System is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The Yomi Robotic System is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
The Yomi Robotic System allows the user to plan the surgery virtually in YomiPlan, cleared for use alone on third-party PCs for preplanning. The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in the planning software. The plan is used for the system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The Yomi robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument.
The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Patient Splint (YomiLink Teeth or YomiLink Bone), Tracker End Effector (TEE), and the Patient Tracker (PT). In cases where YomiLink Teeth is utilized, it is attached to the contralateral side of the patient's mouth over stable teeth using on-label dental materials prior to the presurgical CBCT scan. In cases where YomiLink Bone is utilized, it is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required), or after the scan when using the subject YomiLink Arch device.
The subject of this submission is to introduce new accessories, the YomiLink Arch and Probing Bit. The YomiLink Arch allows for CBCT scan acquisition prior to YomiLink Bone placement and enables guided YomiLink Bone placement. This submission also introduces an update to the system planning software to enable use of the YomiLink Arch (YLA).
Following attachment of YomiLink Bone (YLB) to the patient, probing of the YLA is performed utilizing the YLA Probing Bit to transfer registration in the software from YLA to YLB and allow for tracking of the YLB throughout the remaining surgical procedure. The YLA Probing Bit is available in straight and contra-angle configurations corresponding to the handpiece to which they are attached.
All other aspects of the Yomi Robotic System remain unchanged from prior clearances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone beam computed tomography (CBCT)
Anatomical Site
mandible and/or maxilla (for guided bone reduction); dental (for implantation surgery)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing has been fully executed to ensure that the subject device functions as intended:
- Total System Accuracy Verification: to verify the accuracy of the full system with the additional YLA workflow
- Guided Splint Placement Verification: to verify the accuracy of guided splint placement as part of the YLA workflow
- Probing and Registration Verification: to verify the accuracy of probing the YLA
- Deflection and Repeatability Verification: to assess the stability and repeatability of attachment of the YLA
- Proximity Warnings Verification: to assess the proximity warnings generated in the user application throughout the YLA workflow
- Typical Run Through Verification: to assess the typical steps in the user application throughout the YLA workflow
- Human Factors Validation: to validate the human factors and design of the YLA
- Software End User Validation: to validate that the YLA user application meets the user requirements
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
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Neocis Inc. Joshua Davis Regulatory Affairs Manager 2800 Biscayne Blvd, Suite 600 Miami, Florida 33137
Re: K231018
Trade/Device Name: Yomi Robotic System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV, QRY Dated: July 13, 2023 Received: July 14, 2023
Dear Joshua Davis:
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.
1
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 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 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.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231018
Device Name Yomi Robotic System
Indications for Use (Describe)
Yomi Robotic System is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotional guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi Robotic System is intended for use in partially edentulous adult patients who qualify for dental implants.
When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.
| 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 K231018
I. Submitter
Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS
Contact Person: Joshua Davis, Regulatory Affairs Manager Date Prepared: August 14, 2023
II. Device
Trade Name: Yomi Robotic System Common Name: Dental Stereotaxic Instrument Classification Name: Bone cutting instrument and accessories (21 CFR 872.4120) Classification: Class II QRY, PLV Product Code:
III. Predicate and Reference Devices
Primary Predicate: Yomi Robotic System (K222750) Reference Device: Yomi Robotic System (K211129)
IV. Indications for Use
Yomi Robotic System is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi Robotic System is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.
V. Device Description
Yomi Robotic System is a dental stereotaxic instrument and a powered surgical device for bone cutting. Yomi Robotic System is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The Yomi Robotic System is intended
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Image /page/4/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font in a light orange color. Above the word is a gray horizontal line that extends to the left and right of the word. To the right of the word, there is a gray vertical line that intersects the horizontal line, forming a plus sign with a small circle in the center.
for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
The Yomi Robotic System allows the user to plan the surgery virtually in YomiPlan, cleared for use alone on third-party PCs for preplanning. The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in the planning software. The plan is used for the system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The Yomi robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument.
The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Patient Splint (YomiLink Teeth or YomiLink Bone), Tracker End Effector (TEE), and the Patient Tracker (PT). In cases where YomiLink Teeth is utilized, it is attached to the contralateral side of the patient's mouth over stable teeth using on-label dental materials prior to the presurgical CBCT scan. In cases where YomiLink Bone is utilized, it is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required), or after the scan when using the subject YomiLink Arch device.
The subject of this submission is to introduce new accessories, the YomiLink Arch and Probing Bit. The YomiLink Arch allows for CBCT scan acquisition prior to YomiLink Bone placement and enables guided YomiLink Bone placement. This submission also introduces an update to the system planning software to enable use of the YomiLink Arch (YLA).
Following attachment of YomiLink Bone (YLB) to the patient, probing of the YLA is performed utilizing the YLA Probing Bit to transfer registration in the software from YLA to YLB and allow for tracking of the YLB throughout the remaining surgical procedure. The YLA Probing Bit is available in straight and contra-angle configurations corresponding to the handpiece to which they are attached.
All other aspects of the Yomi Robotic System remain unchanged from prior clearances.
VI. Comparison of Technological Characteristics
The following Table 1 provides a summary of the subject Yomi Robotic System features compared to the predicate device, Yomi Robotic System (K222750), and reference device, Yomi Robotic System (K211129).
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Image /page/5/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray line that extends horizontally, and a gray vertical line intersects the horizontal line at the center of the word. There is a small circle at the intersection of the two lines.
Table 1: Comparison of technological characteristics to the predicate and reference devices.
| Technological
Characteristics | Subject Device: Yomi
Robotic System with
YomiLink Arch | Primary Predicate: Yomi
Robotic System with
Intraoral Fiducial Array
(K222750) & Reference
Device: Yomi Robotic
System (K211129) | Comparison |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use (IFU) | Yomi Robotic System is a
computerized robotic
navigational system intended to
provide assistance in both the
planning (pre-operative) and the
surgical (intra-operative) phases
of dental implantation surgery.
The system provides software
to preoperatively plan dental
implantation procedures and
provides robotic navigational
guidance of the surgical
instruments. The system can
also be used for planning and
performing guided bone
reduction (also known as
alveoplasty) of the mandible
and/or maxilla. Yomi Robotic
System is intended for use in
partially edentulous and fully
edentulous adult patients who
qualify for dental implants.
When YomiPlan software is
used for preplanning on third
party PCs, it is intended to
perform the planning (pre-
operative) phase of dental
implantation surgery. YomiPlan
provides pre-operative planning
for dental implantation
procedures using the Yomi
Robotic System. The output of
YomiPlan is to be used with the
Yomi Robotic System. | Yomi Robotic System is a
computerized robotic
navigational system intended
to provide assistance in both
the planning (pre-operative)
and the surgical (intra-
operative) phases of dental
implantation surgery. The
system provides software to
preoperatively plan dental
implantation procedures and
provides robotic navigational
guidance of the surgical
instruments. The system can
also be used for planning and
performing guided bone
reduction (also known as
alveoplasty) of the mandible
and/or maxilla. Yomi is
intended for use in partially
edentulous and fully
edentulous adult patients who
qualify for dental implants.
When YomiPlan software is
used for preplanning on third
party PCs, it is intended to
perform the planning (pre-
operative) phase of dental
implantation surgery. YomiPlan
provides pre-operative
planning for dental
implantation procedures using
the Yomi Robotic System. The
output of YomiPlan is to be
used with the Yomi Robotic
System. | Equivalent |
| Technological
Characteristics | Subject Device: Yomi
Robotic System with
YomiLink Arch | Primary Predicate: Yomi
Robotic System with
Intraoral Fiducial Array
(K22750) & Reference
Device: Yomi Robotic
System (K211129) | Comparison |
| Principles of
Operation | YomiLink Arch contains
fiducial markers that allow for
registration in CBCT scans
prior to surgery. The Tracker
End Effector is attached to
YomiLink Arch to provide a
connection between the patient
and the Patient Tracker arm of
the system. YomiLink Arch
contains divots that can then be
probed with the robot to match
to known locations in the CBCT
scan image space based on the
fiducial markers | The Intraoral Fiducial Array
contains fiducial markers that
allow for registration in CBCT
scans prior to surgery. The
Intraoral Fiducial Array
mounts to the YomiLink Teeth
patient splint | Equivalent |
| Robotic Guide
Arm | Guided robotic arm | Guided robotic arm | Equivalent |
| Movement
Direction | Guided Robotic Arm holds a
surgical instrument and
provides haptic feedback on
position with respect to the plan
restricting movement outside of
volume predefined during
planning.
6 degrees of freedom | Guided Robotic Arm holds a
surgical instrument and
provides haptic feedback on
position with respect to the
plan restricting movement
outside of volume predefined
during planning.
6 degrees of freedom | Equivalent |
| Patient affixed
tracking parts | YomiLink Arch
Splints | Splints with arrays | Equivalent |
| Patient Tracking
Mechanism | Physical linkage to patient via
Patient Tracker (PT), Kinematic
Mount (KM), and Tracker End
Effector (TEE) | Physical linkage to patient via
Patient Tracker (PT),
Kinematic Mount (KM), and
Tracker End Effector (TEE) | Equivalent |
| Fiducials for CT
scan | YomiLink Arch contains
fiducial beads and is placed
directly on patient arch during
the CT scan to provide a
reference in the image | Intraoral Fiducial Array
contains fiducial beads and is
attached to patient splint
during the CT scan to provide
a reference in the image | Equivalent |
| Technological
Characteristics | Subject Device: Yomi
Robotic System with
YomiLink Arch | Primary Predicate: Yomi
Robotic System with
Intraoral Fiducial Array
(K222750) & Reference
Device: Yomi Robotic
System (K211129) | Comparison |
| Probing Bit | YLB is registered by probing
the YLA divots | N/A. YLB is registered via
CT scan | Equivalent |
| Patient Contact | Surface device
Limited duration | Surface device
Limited duration | Equivalent |
| Biocompatibility | Mucosal membrane, tissue, bone,
dentin contact | Mucosal membrane, tissue,
bone, dentin contact | Equivalent |
| Reprocessing
Classification | N/A. Single use only | Non-critical reusable | Equivalent |
| Reprocessing
Method | N/A. Single use only.
Sterilized by the end user prior to
use | Cleaning & Sterilization | Equivalent |
| Sterilization
Method | Provided unsterile, end user
moist heat sterilized | Provided unsterile, end user
moist heat sterilized | Equivalent |
| Mating
Component
Design | Kinematic Mount | Kinematic Mount | Equivalent |
| Materials | Main body: Avaspire AV-651
CF30
Fiducial Beads: Silicon Nitride
Epoxy: EA M-31CL epoxy
Probing Bit: 17-4 Stainless Steel,
Precipitation Hardened (PH) | Main body: Avaspire AV-651
CF30
Fiducial Beads: Silicon Nitride
Epoxy: EA M-31CL epoxy | Equivalent |
| Performance
Testing | Total System Accuracy
• Verification
Probing and Registration
• Verification
Deflection and
• Repeatability Verification
Guided Splint Placement
• Verification
Proximity Warnings
• Verification
Typical Run Through
• Verification
Human Factors
• Validation
Software End User
• Validation | Total System Accuracy
• Verification
Registration Verification
• Deflection and
• Repeatability Verification
Human Factors
• Validation | Equivalent |
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Image /page/7/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a light orange color. Above the word is a thin gray line that extends horizontally. To the right of the word is a gray crosshair symbol with a small circle at the intersection.
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Image /page/8/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a light golden color. A gray line extends horizontally above the word, and a gray crosshair-like symbol is positioned to the right of the word, with a small circle at the intersection of the lines.
VII. Performance Testing
The following testing has been fully executed to ensure that the subject device functions as intended:
- . Total System Accuracy Verification: to verify the accuracy of the full system with the additional YLA workflow
- Guided Splint Placement Verification: to verify the accuracy of guided splint placement as part of the YLA workflow
- Probing and Registration Verification: to verify the accuracy of probing the YLA ●
- Deflection and Repeatability Verification: to assess the stability and repeatability of attachment of the YLA
- Proximity Warnings Verification: to assess the proximity warnings generated in the user application throughout the YLA workflow
- Typical Run Through Verification: to assess the typical steps in the user application ● throughout the YLA workflow
- Human Factors Validation: to validate the human factors and design of the YLA ●
- Software End User Validation: to validate that the YLA user application meets the user ● requirements
Non-clinical data referenced or relied upon for the subject YomiLink Arch and Probing Bit from the predicate, K222750, to demonstrate substantial equivalence include: Biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and validated cleaning & sterilization instructions per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17665-1 and ISO 17665-2.
VIII. Conclusion
The subject of this submission is to introduce new accessories, the YomiLink Arch and Probing Bit. which allow for CBCT scan acquisition prior to YomiLink Bone placement and enables guided YomiLink Bone placement. This submission also introduces an update to the system planning software to enable use of the YomiLink Arch. There are no changes to the intended use compared to the predicate device. There are no fundamental changes to the technology. The performance testing demonstrates substantially equivalent performance of the subject device as compared to the predicate.