(30 days)
Not Found
No
The summary describes a robotic surgical system for total knee arthroplasty that uses preoperative planning software and a robotic arm for precise bone preparation. There is no mention of AI or ML in the intended use, device description, or performance studies. The system appears to be based on pre-programmed plans and precise execution rather than adaptive or learning algorithms.
No.
The document describes a surgical planning and implementation tool for total knee arthroplasty, not a device that directly treats a disease or condition.
No
The device is described as a preoperative planning workstation and implementation tool that uses diagnostic images to assist with planning and provide orientation during surgery. Its primary function is to assist in surgical procedures (resecting techniques and implant positioning) rather than to diagnose a medical condition.
No
The device description explicitly states that the TSolution One® Total Knee Application consists of both TPLAN (software) and TCAT, which includes an electromechanical arm, arm base, control electronics, computer, display monitor, operating software, pendant control, and tools and accessories. This clearly indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The TSolution One® Total Knee Application is a surgical planning and robotic assistance system. It uses diagnostic images (CT scans) to plan a surgical procedure and then assists the surgeon in executing that plan by preparing bone.
- Intended Use: The intended use is for preoperative planning and intraoperative assistance during total knee arthroplasty. It is a tool for surgical intervention, not for analyzing biological specimens to diagnose or monitor a condition.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The TSolution One® Total Knee Application is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.
The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA).
The TSolution One® Total Knee Application is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made.
The TSolution One® Total Knee Application is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Total Knee Application facilitates accurate positioning of TKA implants, relative to these alignment axes.
The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:
- Zimmer Persona™ Knee System
- Corin Unity Knee System
- Aesculap Columbus Knee System
- DJO Surgical® EMPOWR 3D Knee® System
- United U2 Knee System
Product codes
OLO
Device Description
The TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planning workstation and implementation tool for treatment of patients who require total joint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).
The TSolution One® Total Knee Application consists of TPLAN and TCAT. TPLAN is a three-dimensional (3D) preoperative planning workstation that aids a surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy. TCAT consists of an electromechanical arm, an arm base including control electronics and computer, a display monitor, operating software, pendant control, and tools and accessories, for the implementation of the preoperative plan. TCAT and TPLAN when used according to the instructions for use, make submillimeter precision bone preparation possible before and during TKA surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Scan
Anatomical Site
distal femur and proximal tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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
Cadaver Lab Validation Testing
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing to verify the cutting accuracy of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device. This testing demonstrated that the TSolution One® Total Knee Application met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted using simulated surgical testing in a cadaver model and all test criteria were met.
- Cutting Accuracy Verification: Passed
- Cadaver Lab Validation Testing: Passed
- Software Testing: Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
§ 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).
0
June 10, 2020
Image /page/0/Picture/1 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
THINK Surgical, Inc. Meliha Mulalic Director, Regulatory Affairs and Quality Assurance 47201 Lakeview Blvd Fremont, California 94538
Re: K201255
Trade/Device Name: TSolution One Total Knee Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 8, 2020 Received: May 11, 2020
Dear Meliha Mulalic:
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
1
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 medical devices and radiation-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, MPH 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
2
Indications for Use
510(k) Number (if known) K201255
Device Name TSolution One® Total Knee Application
Indications for Use (Describe)
The TSolution One® Total Knee Application is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.
The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA).
The TSolution One® Total Knee Application is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made.
The TSolution One® Total Knee Application is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Total Knee Application facilitates accurate positioning of TKA implants, relative to these alignment axes.
The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:
- · Zimmer Persona™ Knee System
- · Corin Unity Knee System
- Aesculap Columbus Knee System
- · DJO Surgical® EMPOWR 3D Knee® System
- United U2 Knee System
| Type or 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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3
Image /page/3/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a bold, sans-serif font, with a blue vertical line in place of the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue line adds a touch of color and visual interest.
510(k) SUMMARY
Applicant Information:
| Owner Name: | THINK Surgical, Inc. |
|---|---|
| Address: | 47201 Lakeview Blvd., Fremont, CA 94538 |
| Phone number: | 510-249-2337 |
| Fax number: | 510-249-2396 |
| Establishment Registration Number: | 3000719653 |
| Contact Person: | Meliha Mulalic |
| Date Prepared: | 10 June 2020 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Trade Name: | TSolution® One Total Knee Application |
| Common name: | Orthopedic Stereotaxic Instrument |
| Classification name: | Stereotaxic Instrument |
| Regulation number: | 882.4560 |
| Product Code: | OLO |
Predicate Device:
The TSolution® One Total Knee Application is substantially equivalent in intended use, fundamental scientific technology and performance to TSolution One® Total Knee Application cleared via K191369 (primary predicate) and K193135.
Device Modification:
The following changes have been made to the TSolution® One Total Knee Application:
- . Compatible implants - Addition of the United U2 Knee System.
- Labeling - Implant compatibility has been modified in the Indications for Use.
Device Description:
The TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planning workstation and implementation tool for treatment of patients who require total joint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).
The TSolution One® Total Knee Application consists of TPLAN and TCAT. TPLAN is a three-dimensional (3D) preoperative planning workstation that aids a surgeon in
4
Image /page/4/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in large, bold, sans-serif letters, with the "I" in "THINK" being a blue, elongated triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in smaller, sans-serif letters. A registered trademark symbol is located to the right of the letter "K".
TSolution One® Total Knee Application Special 510(k) Submission
planning the position and orientation of the implant components relative to 3D models of the patient's anatomy. TCAT consists of an electromechanical arm, an arm base including control electronics and computer, a display monitor, operating software, pendant control, and tools and accessories, for the implementation of the preoperative plan. TCAT and TPLAN when used according to the instructions for use, make submillimeter precision bone preparation possible before and during TKA surgical procedures.
Intended Use / Indications for Use:
The TSolution One® Total Knee Application is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.
The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA).
The TSolution One® Total Knee Application is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made.
The TSolution One® Total Knee Application is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Total Knee Application facilitates accurate positioning of TKA implants, relative to these alignment axes.
The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:
- Zimmer Persona™ Knee System .
- Corin Unity Knee System
- Aesculap Columbus Knee System ●
- DJO Surgical® EMPOWR 3D Knee® System
- United U2 Knee System .
Substantial Equivalence:
Both the TSolution One® Total Knee Application, and the predicate devices have the same intended use. Both are intended for use as devices that use diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surqical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The difference between the new device and the predicates is that the new device provides an additional compatible total knee implant system to those previously cleared.
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Image /page/5/Picture/0 description: The image shows the logo for Think Surgical. The logo is composed of the word "THINK" in a sans-serif font, with a blue vertical line in the middle of the "I". Below the word "THINK" is the word "SURGICAL" in a smaller font.
The indications for use of the new device adds one new total knee implant systems that is compatible with the TSolution One® Total Knee Application.
Performance testing to verify the cutting accuracy of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device. This testing demonstrated that the TSolution One® Total Knee Application met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted using simulated surgical testing in a cadaver model and all test criteria were met.
Substantial equivalence in technological characteristic and performance of the TSolution One® Total Knee Application to the predicate device is outlined in the table below:
| Product | TSolution One
Total Knee
Application | TSolution One
Total Knee
Application | TSolution One
Total Knee
Application | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Subject Device | K191369 | K193135 | |
| Manufacturer | THINK Surgical
Inc. | THINK Surgical
Inc. | THINK Surgical
Inc. | Conclusion |
| Technological
Characteristics | | | | |
| -Patient Imaging | CT Scan | CT Scan | CT Scan | SAME |
| -User Controls | Keyboard,
mouse, Pendant
with mechanically
latched Stop
Button | Keyboard,
mouse, Pendant
with mechanically
latched Stop
Button | Keyboard,
mouse, Pendant
with mechanically
latched Stop
Button | SAME |
| -Preoperative
planning
workstation | TPLAN three-
dimensional
preoperative
planning
workstation | TPLAN three-
dimensional
preoperative
planning
workstation | TPLAN three-
dimensional
preoperative
planning
workstation | SAME |
| -Pre-surgical Plan | CT images used
to create a 3D
model of the
bone, library of
FDA cleared
components used
to develop
optimal implant
size and location | CT images used
to create a 3D
model of the
bone, library of
FDA cleared
components used
to develop
optimal implant
size and location | CT images used
to create a 3D
model of the
bone, library of
FDA cleared
components used
to develop
optimal implant
size and location | SAME |
| -Surgical Plan
Data | High level
operative plan
based on
preoperative plan
with
predetermined
control file
developed to
control the robotic
arm | High level
operative plan
based on
preoperative plan
with
predetermined
control file
developed to
control the robotic
arm | High level
operative plan
based on
preoperative plan
with
predetermined
control file
developed to
control the robotic
arm | SAME |
| Product | TSolution One
Total Knee
Application | TSolution One
Total Knee
Application | TSolution One
Total Knee
Application | |
| 510(k) number | Subject Device | K191369 | K193135 | |
| Manufacturer | THINK Surgical
Inc. | THINK Surgical
Inc. | THINK Surgical
Inc. | Conclusion |
| -Surgical
Exposure | Similar to
traditional surgical
exposure for the
anatomic site | Similar to
traditional surgical
exposure for the
anatomic site | Similar to
traditional surgical
exposure for the
anatomic site | SAME |
| Electromechanical
arm to implement
pre-surgical plan | TCAT
electromechanical
arm system
implements pre-
surgical plan | TCAT
electromechanical
arm system
implements pre-
surgical plan | TCAT
electromechanical
arm system
implements pre-
surgical plan | SAME |
| -Patient/Robot
Registration | Pinless point to
surface
registration with
mechanical
tracking.
Percutaneous
probe thin
enough to make
contact via direct
puncture through
skin. | Pinless point to
surface
registration with
mechanical
tracking.
Percutaneous
probe thin
enough to make
contact via direct
puncture through
skin. | Pinless point to
surface
registration with
mechanical
tracking.
Percutaneous
probe thin
enough to make
contact via direct
puncture through
skin. | SAME |
| -Bone Motion
Recovery | Two bone motion
recovery markers
are used to
recover
registration after
bone motion. | Two bone motion
recovery markers
are used to
recover
registration after
bone motion. | Two bone motion
recovery markers
are used to
recover
registration after
bone motion. | SAME |
| -Compatible Knee
Implant Systems | -Zimmer
Persona™ Knee
System
-Corin Unity Knee
System
-Aesculap
Columbus Knee
System
-DJO Surgical®
EMPOWR 3D
Knee® System
-United U2 Knee
System | -Zimmer
Persona™ Knee
System | -Zimmer
Persona™ Knee
System
-Corin Unity Knee
System
-Aesculap
Columbus Knee
System
-DJO Surgical®
EMPOWR 3D
Knee® System | Substantially
Equivalent
(Adds
Compatibility
with one
additional total
knee implant
system) |
| Performance
Testing | | | | |
| -Cutting Accuracy
Verification | Passed | Passed | Passed | SAME |
| Product | TSolution One
Total Knee
Application | TSolution One
Total Knee
Application | TSolution One
Total Knee
Application | |
| 510(k) number | Subject Device | K191369 | K193135 | |
| Manufacturer | THINK Surgical
Inc. | THINK Surgical
Inc. | THINK Surgical
Inc. | Conclusion |
| -Cadaver Lab
Validation Testing | Passed | Passed | Passed | SAME |
| -Software Testing | Passed | Passed | Passed | SAME |
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Image /page/6/Picture/0 description: The image shows the logo for Think Surgical. The logo is composed of the word "THINK" in a bold, sans-serif font, with the "I" represented by a blue, elongated triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
TSolution One® Total Knee Application Special 510(k) Submission
7
Image /page/7/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a bold, sans-serif font, with the "I" represented by a blue, elongated triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
TSolution One® Total Knee Application Special 510(k) Submission
Conclusion
The TSolution One® Total Knee Application is equivalent to the predicates, TSolution One® Total Knee Application (K191369 and K193135), in the following ways: it has the same intended use, the same technological characteristics and operating principles, incorporates the same design and materials. Performance testing has demonstrated that the characteristics of the TSolution One® Total Knee Application are equivalent to the predicate devices, and that the device is as safe and effective as the predicate devices and does not raise any new questions of safety and effectiveness; therefore, a determination of Substantial Equivalence is supported.