(27 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 being used in the planning, execution, or any other part of the system. The focus is on 3D planning and robotic precision based on that plan.
No.
Explanation: The device is a surgical planning and implementation tool for total knee arthroplasty, assisting the physician in performing the procedure, rather than directly treating a disease or condition.
No
Explanation: The device is described as a preoperative planning workstation and an implementation tool for surgical procedures, focusing on guiding bone preparation for total knee arthroplasty. Its primary functions are planning and assisting in the execution of the surgical plan, not diagnosing a medical condition.
No
The device description explicitly states that the TSolution One® Total Knee Application "consists of TPLAN and TCAT," and TCAT includes "an electromechanical arm, an arm base including control electronics and computer, a 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TSolution One® Total Knee Application is a surgical planning and robotic assistance system. It uses patient imaging (CT scans) to plan and execute bone resections during total knee arthroplasty. It does not analyze biological specimens from the patient.
- Intended Use: The intended use clearly states its purpose is for preoperative planning and intraoperative assistance in surgical procedures, not for diagnostic testing of biological samples.
Therefore, the TSolution One® Total Knee Application falls under the category of a surgical planning and robotic assistance device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The TSolution One® Total Knee Application is intended for use as a device that uses 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:
- Aesculap Columbus Knee System
- · Corin Unity Knee
- DJO Surgical EMPOWR 3D Knee
- · DJO Surgical EMPOWR Knee System
- · Ortho Development Balanced Knee
- · Total Joint Orthopedics Klassic Knee System
- · United U2 Knee
- Zimmer Biomet Persona
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
Like its predicate, the TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planning workstation and implementation tool for treatment of patients who require total ioint 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; orthopedic surgical procedures
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)
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): 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.
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
April 1, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
THINK Surgical, Inc. Meliha Mulalic Director, Regulatory Affairs and Quality Assurance 47201 Lakeview Blvd Fremont, California 94538
Re: K210668
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: March 4, 2021 Received: March 5, 2021
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.
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 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, 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
2
Indications for Use
510(k) Number (if known)
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 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:
- Aesculap Columbus Knee System
- · Corin Unity Knee
- DJO Surgical EMPOWR 3D Knee
- · DJO Surgical EMPOWR Knee System
- · Ortho Development Balanced Knee
- · Total Joint Orthopedics Klassic Knee System
- · United U2 Knee
- Zimmer Biomet Persona
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/1 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. The logo is simple and modern, and the blue triangle 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: | 04 March 2021 |
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, Indications for Use, design, materials, technology, operational principles and performance to the predicate device cleared via K203040.
Device Modification:
The purpose of this submission is to add three more FDA cleared knee implant systems that are compatible with the TSolution® One Total Knee Application to the five knee systems that are already cleared for use with the device. The three new implant systems are: the Ortho Development Balanced Knee, the Total Joint Orthopedics Klassic Knee, and the DJO Surgical® EMPOWR Knee System®. As part of this change the labeling has been modified to show that the Indications for Use of the device has been updated to include compatibility with these three additional knee implant systems.
4
Image /page/4/Picture/1 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. The logo is simple and modern, and the blue triangle adds a touch of color and visual interest.
Device Description:
Like its predicate, the TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planning workstation and implementation tool for treatment of patients who require total ioint 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.
Intended Use / Indications for Use:
Like the predicate, 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 surqical 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 as 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:
- Aesculap Columbus Knee System
- Corin Unity Knee ●
- DJO Surgical EMPOWR 3D Knee ●
- DJO Surqical EMPOWR Knee System ●
- . Ortho Development Balanced Knee
- Total Joint Orthopedics Klassic Knee System ●
- United U2 Knee
- Zimmer Biomet Persona .
5
Image /page/5/Picture/1 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 replacing 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.
Substantial Equivalence:
Both the TSolution One® Total Knee Application, the subject of this submission, and the predicate device 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 surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The difference between the new device and the predicate is that the new device includes compatibility with three additional knee implant systems. None of these changes either individually or in the aggregate alter the intended use, indications for use (other than the addition of the three new implant systems), design, materials, technology or operational principles of the TSolution One Total Knee Application.
The Indications for Use of the new device and its predicate are identical except for the addition of the three new implant systems to the list of compatible implant systems.
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.
| Product | TSolution One Total Knee
Application | TSolution One Total Knee
Application | Substantial
Equivalence
Conclusion |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 510(k) number | Subject Device | K203040 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Technological
Characteristics | | | |
| -Patient Imaging | CT Scan | CT Scan | SAME |
| -User Controls | 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 | 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 | 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. | SAME |
| Product | TSolution One Total Knee
Application | TSolution One Total Knee
Application | Substantial
Equivalence
Conclusion |
| 510(k) number | Subject Device | K203040 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | SAME |
| -Surgical
Exposure | 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 | 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. | 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. | SAME |
| -Compatible Knee
Implant Systems | -Aesculap Columbus Knee
System
-Corin Unity Knee
-DJO Surgical EMPOWR
3D Knee
- DJO Surgical EMPOWR
Knee System
-Ortho Development
Balanced Knee
-Total Joint Orthopedics
Klassic Knee System
-United U2 Knee
-Zimmer Biomet Persona | -Zimmer Persona™ Knee
System
-Corin Unity Knee System
-Aesculap Columbus Knee
System
-DJO Surgical® EMPOWR
3D Knee® System
-United U2 Knee System | Substantially
Equivalent
(addition of
three new
implant
systems –
underlined) |
| Performance
Testing | | | |
| -Cutting Accuracy
Verification | Passed | Passed | SAME |
| -Cadaver Lab
Validation Testing | Passed | Passed | SAME |
| -Software Testing | Passed | Passed | SAME |
Substantial equivalence in technological characteristic and performance of the TSolution One® Total Knee Application to the predicate device is outlined in the table below:
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Image /page/6/Picture/1 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a sans-serif font, with the "I" replaced by a blue vertical line that tapers to a point at the bottom. Below the word "THINK" is the word "SURGICAL" in a smaller sans-serif font.
Risk assessment was performed on the device in accordance with ISO 14971:2007 and THINK Surgical Risk Management procedures. The risk assessment was comprised of analysis and mitigation of the risks associated with the addition of three compatible knee implant systems. The risk assessment resulted in the identification of no new clinical
7
Image /page/7/Picture/1 description: The image shows the logo for "Think Surgical". The word "THINK" is written in a bold, sans-serif font, with the "I" represented by a blue, elongated triangle pointing downwards. Below "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is clean and modern, with a focus on the company name.
hazards. Each of the clinical hazards identified through this risk assessment is a previously documented hazard associated with the use of the TSolution One® Total Knee Application. The addition of three new implant systems does not increase the likelihood or severity of these hazards; therefore, the risks associated with the use of the device remain unchanged as compared to the predicate.
Conclusion
The TSolution One® Total Knee Application is substantially equivalent to the predicate. TSolution One® Total Knee Application (K203040), in the following ways: it has the same intended use, the same technological characteristics and operating principles, and incorporates the same design and materials. Performance testing and risk analysis has demonstrated that the performance and risk profile of the TSolution One® Total Knee Application (the subject of this submission) are equivalent to those of the predicate device. The TSolution One® Total Knee Application is as safe and effective as the predicate device and does not raise any new questions of safety and effectiveness; therefore, a determination of Substantial Equivalence is supported.