(115 days)
No
The summary describes a robotic surgical navigation system that uses pre-operative planning based on CBCT scans and provides physical, visual, and audible guidance during surgery. It does not mention or describe any components or functionalities that explicitly utilize AI or ML algorithms for tasks like image analysis, decision support, or adaptive control. The system appears to be based on pre-programmed navigation and guidance rather than learning or intelligent processing.
No
The device is a navigational system and robotic arm that assists surgeons during dental implantation and bone reduction procedures by guiding surgical instruments. It does not directly treat or cure a disease or condition.
No
Explanation: The device is described as 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, and for guided bone reduction. Its function is to guide surgical instruments and assist in performing procedures, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is a "computerized robotic navigational system" and includes physical components like a robotic arm, patient tracking linkages (splints, end effector, patient tracker), and guides a bone cutting instrument. While it includes software for planning, it is not solely software.
Based on the provided text, the Yomi Robotic System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening.
- Yomi's Function: The Yomi Robotic System is a surgical guidance system. It uses imaging data (CBCT scans) to plan and guide surgical procedures (dental implant placement and bone reduction) directly on the patient's body. It does not analyze samples taken from the body.
- Device Classification: The text explicitly states the Yomi Robotic System is classified as a dental stereotaxic instrument and a powered surgical device for bone cutting. These classifications fall under surgical and dental device categories, not IVD.
Therefore, the Yomi Robotic System is a surgical device, not an IVD.
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 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 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. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.
Product codes (comma separated list FDA assigned to the subject device)
QRY, PLV
Device Description
In terms of FDA regulations, the Yomi Robotic System is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). In terms of previously FDA-cleared indications for use (K210711), the 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 System allows the user to plan the surgery virtually in Yomi Plan, 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 our 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 Chairside Patient Splint (CPS) or Edentulous Patient Splint (EPS), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials prior to the presurgical CBCT scan. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required).
The subject of this submission is introducing a feature to allow the system to be used for planning and performing guided bone reduction (also known as alveoplasty). The bone reduction feature is intended for use during dental implant procedures to flatten the surface of the bone intended for dental implant placement. The device is used with compatible bone cutting tool secured to the guidance arm for the bone reduction. The bone reduction feature is intended to be performed on full arch or partially edentulous patients. During preoperative planning, the surgeon identifies the area of the bone to be reduced. Real-time visualization of the bone reduction is visualized on the graphic user interface. The guidance arm constrains the movement of the cutting tool to the planned location, boundaries, and depth. After the bone reduction, the implant procedure continues with the Yomi Robotic System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cone beam computed tomography (CBCT) scan
Anatomical Site
Mandible and/or maxilla (dental 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)
Software verification testing has been fully executed to ensure that the software user interface functions as intended.
Verification testing for new instruments used in bone reduction procedures has been performed with the Yomi System along with validation testing, including cadaveric Human Factors Validation for Bone Reduction and Software End User Validation of Bone Reduction.
The performance testing demonstrates substantially equivalent performance of the subject device as compared to the predicate.
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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Image /page/0/Picture/0 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 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.
November 4, 2022
Neocis Inc. Olga Lewis Regulatory Affairs Director 2800 Biscayne Blvd Suite 600 Miami, Florida 33137
Re: K222049
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: QRY, PLV Dated: October 13, 2022 Received: October 17, 2022
Dear Olga Lewis:
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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222049
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 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 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. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan 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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Image /page/3/Picture/0 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a horizontal gray line, and to the right of the word is a gray crosshair symbol. The crosshair is positioned such that the horizontal line aligns with the top of the word, and the vertical line extends above and below the horizontal line.
510(k) Summary
K222049
l. Submitter
Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS
| Contact Person: | Olga Lewis, Director of Regulatory Affairs |
|---|---|
| Date Prepared: | November 3, 2022 |
II. Device
| Trade Name: | Yomi Robotic System |
|---|---|
| Common Name: | Dental Stereotaxic Instrument |
| Classification Name: | Bone cutting instrument and accessories (21 CFR) |
| Classification: | 872.4120) Class II |
| Product Code: | QRY, PLV |
III. Predicate Devices
Primary Predicate: Neocis Guidance System (NGS) with Yomi Plan v2.0.1 K210711 Reference Device: Mako Partial Knee Application K142530
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 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. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.
V. Device Description
In terms of FDA regulations, the Yomi Robotic System is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). In terms of previously FDAcleared indications for use (K210711), the 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.
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Image /page/4/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 horizontal gray line that extends from the left of the "n" to the right of the "s". A vertical gray line intersects the horizontal line above the "o", forming a cross shape with a small circle at the intersection.
The Yomi System allows the user to plan the surgery virtually in Yomi Plan, 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 our 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 FDAcleared third party powered bone cutting instrument.
The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Chairside Patient Splint (CPS) or Edentulous Patient Splint (EPS), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials prior to the presurgical CBCT scan. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required).
The subject of this submission is introducing a feature to allow the system to be used for planning and performing guided bone reduction (also known as alveoplasty). The bone reduction feature is intended for use during dental implant procedures to flatten the surface of the bone intended for dental implant placement. The device is used with compatible bone cutting tool secured to the guidance arm for the bone reduction. The bone reduction feature is intended to be performed on full arch or partially edentulous patients. During preoperative planning, the surgeon identifies the area of the bone to be reduced. Real-time visualization of the bone reduction is visualized on the graphic user interface. The guidance arm constrains the movement of the cutting tool to the planned location, boundaries, and depth. After the bone reduction, the implant procedure continues with the Yomi Robotic System.
VI. Comparison of Technological Characteristics
The following Table 1 provides a summary of the subject Yomi System features compared to the predicate device, Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (K210711), and a reference device, Mako Partial Knee Application (K142530). The MAKO device was chosen as the reference device since the visualization method during bone removal with the MAKO system for PKA is essentially the same as the subject device. Although the indications for use are different, the implementation of the visualization of the bone removal process is equivalent with both, the reference device as well as the predicate device.
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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 light orange color. Above the word is a gray line that extends horizontally, and a gray line that extends vertically, intersecting at a small circle.
Table 1: Comparison of technological characteristics to the predicates
| Technological
Characteristics | Subject Device: Yomi Robotic
System with Yomi Robotic
Guided Bone Reduction | Primary Predicate: Neocis
Guidance System (NGS) with
Yomi Plan v2.0.1 K210711 | Reference Device: Mako
Partial Knee Application
K142530 | 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 is intended
for use in partially edentulous and
for 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. Yomi
Plan provides pre-operative
planning for dental implantation
procedures using the Yomi
Robotic System. The output of
Yomi Plan is to be used with the
Yomi Robotic System. | Neocis Guidance System (NGS) 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 NGS 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 NGS. The
output of Yomi Plan is to be used
with the NGS. | The Partial Knee Application (PKA),
for use with the Robotic Arm
Interactive Orthopedic System
(RIO), is intended to assist the
surgeon in providing software
defined spatial boundaries for
orientation and reference
information to anatomical
structures during orthopedic
procedures.
The Partial Knee Application
(PKA), for use with the Robotic
Arm Interactive Orthopedic
System (RIO), is indicated for use
in surgical knee procedures in
which the use of stereotactic
surgery may be appropriate, and
where reference to rigid
anatomical bony structures can be
identified relative to a CT based
model of the anatomy. These
procedures include unicondylar
knee replacement and/or
patellofemoral knee replacement.
The Implant systems with which
the system is compatible:
-Restoris Multicompartmental
Knee System
-Restoris Porous Partial Knee
System | When compared to
the primary predicate
device, K210711,
added text specific to
bone reduction.
Reference device has
different indications
but overall is
equivalent since it
offers power tools
and software
modifications for
bone cutting. |
| Technological
Characteristics | Subject Device: Yomi Robotic
System with Yomi Robotic
Guided Bone Reduction | Primary Predicate: Neocis
Guidance System (NGS) with
Yomi Plan v2.0.1 K210711 | Reference Device:
Partial Knee Application
K142530 | Comparison |
| Robotic
Guide
Arm | Guided robotic 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 | 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 | Splints with arrays | Splints with arrays | Femoral and tibial tracking
arrays affixed to bones during
surgery | Equivalent |
| Patient Tracking
Mechanism | Physical linkage to patient via
Patient Tracker (PT), Kinematic
Mount (KM), and End Effector
(EE) connected to splints | Physical linkage to patient via
Patient Tracker (PT),
Kinematic Mount (KM), and
End Effector (EE) connected to
splints | Optical IR camera used for
tracking femoral and tibial
arrays | Equivalent |
| Fiducials for CT
scan | Fiducial Array (FA) attached to
splint | Fiducial Array (FA) attached to
splint | Fiducials | Equivalent |
| Powered
Handpiece | Handpiece and drills | Handpiece and drills | Anspach Black Max bone
cutting system | Equivalent |
| Cutting tools | Burs and drills | Drills and burs | Burs | Equivalent |
| Planning
and
Guidance
Software | Updated Yomi Plan and NeoK
software to support bone
reduction feature (Windows-
based) | Yomi Plan software used for
planning and osteotomy
(Windows-based) | Linux-based software
application used for planning
and bone preparation | Equivalent |
| Workflow | Surgeon plans bone reduction
and implant placement and
executes according to the plan
following steps displayed on | Surgeon plans implant
placement and executes
according to the plan
following steps displayed on | Surgeon plans surgical
procedure, including bone
cutting and implant placement,
and executes according to the | Equivalent |
| Technological
Characteristics | Subject Device: Yomi Robotic
System with Yomi Robotic
Guided Bone Reduction | Primary Predicate: Neocis
Guidance System (NGS) with
Yomi Plan v2.0.1 K210711 | Reference Device: Mako
Partial Knee Application
K142530 | Comparison |
| | the GUI | the GUI | plan following steps displayed
on the GUI | |
| Visualization of
Bone Removal | Bone to be removed is colored
and during removal, the color
of the bone on the screen is
updated (in real time) to
another color to reflect bone
removal. | N/A | Bone to be removed is colored
and during removal, the color
of the bone on the screen is
updated (in real time) to
another color to reflect bone
removal. | Equivalent |
| Performance
Testing | Unit Level Testing
Integration and regression
testing
Verification testing of the new
handpiece and bur
Verification of bone reduction
planning, visualization, and
performance
Bone reduction accuracy
verification
Full system cadaver validation | Unit Level Testing
Integration and regression
testing
Verification testing of
compatible instrumentation
Verification of osteotomy
planning, visualization, and
performance
Osteotomy accuracy
verification
Full system cadaver validation | Sub-system level software
functional testing of Setup and
Bone Preparation
Implant visuals, boundaries and
stereotactic verification
Resection accuracy verification
Full system mock procedure
run-through verification
Full system cadaver validation | Equivalent |
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Image /page/6/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the letters in gold. Above the word is a gray horizontal line, and to the right of the word is a gray crosshair symbol with a circle in the center.
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Image /page/7/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font in a golden color. Above the word is a gray horizontal line that extends beyond the word on both sides. There is a small circle above the "i" with a vertical line extending above it, creating a crosshair-like design.
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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 orange color. A thin gray line runs above the word. To the right of the word, there is a gray symbol that looks like a plus sign with a small circle in the center.
VII. Performance Testing
Software verification testing has been fully executed to ensure that the software user interface functions as intended according to the following:
- ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices
- . ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
- Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions ● for Software Contained in Medical Devices Document issued on: May 11, 2005
- Guidance for Industry and FDA Staff General Principles of Software Validation Document ● issued on: January 11, 2002
Additionally, verification testing for new instruments used in bone reduction procedures has been performed with the Yomi System along with validation testing, including cadaveric Human Factors Validation for Bone Reduction and Software End User Validation of Bone Reduction.
VIII. Conclusion
This submission introduces a bone reduction feature to the Yomi Robotic System. 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.