(38 days)
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 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:
- . Zimmer Persona™ Knee System
- . Corin Unity Knee System
- . Aesculap Columbus Knee System
- . DJO Surgical® EMPOWR 3D Knee® System
- . United U2 Knee System
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 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.
The provided text describes the TSolution One® Total Knee Application, a robotic surgical tool for total knee arthroplasty (TKA). The document is a 510(k) summary demonstrating substantial equivalence to a predicate device (K201255).
Here's a breakdown of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "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." And "All of this testing demonstrated that the TSolution One® Total Knee Application met the test criteria and specifications of the predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cutting Accuracy Verification | Passed (Met test criteria and specifications of the predicate device) |
| Cadaver Lab Validation Testing | Passed (Met test criteria and specifications of the predicate device) |
| Software Testing | Passed (Met test criteria and specifications of the predicate device) |
| Electromagnetic Compatibility and Electrical Safety | Passed (Met the requirements of applicable IEC standards and met test criteria and specifications of the predicate device) |
| Biocompatibility Testing on Changed Materials | Passed (Performed according to ISO 10993-1:2009 standard for any new patient contacting materials, and met test criteria and specifications of the predicate device) |
2. Sample Size for Test Set and Data Provenance:
The document mentions "simulated surgical testing in a cadaver model" for validation testing but does not specify the sample size for this test set (e.g., number of cadavers or knees).
Data provenance: The cadaver model suggests human anatomical data, likely from a biospecimen provider, but does not specify the country of origin. The study was prospective simulation.
3. Number of Experts and Qualifications for Ground Truth:
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.
4. Adjudication Method:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not explicitly mentioned or described in the provided text. The document focuses on the device's technical performance and substantial equivalence to a predicate, rather than human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
The testing described appears to be for the standalone device, as it focuses on verifying cutting accuracy, software performance, and other technical aspects of the TSolution One® Total Knee Application. While it operates "under the direction of the surgeon," the described performance tests (cutting accuracy, software, EMC) are inherently standalone assessments of the system's capabilities. There is no explicit mention of human-in-the-loop performance measurement in the reported tests.
7. Type of Ground Truth Used:
For cutting accuracy and cadaver lab validation, the ground truth would likely be based on direct measurements of the resected bone surfaces against the pre-surgical plan, using high-precision metrology tools. This is implied by the nature of "cutting accuracy verification" and "cadaver model validation."
8. Sample Size for Training Set:
The document does not provide any information about the sample size used for the training set. It describes the device's technological characteristics and performance testing but not its development or training data.
9. How Ground Truth for Training Set Was Established:
The document does not provide any information on how the ground truth for the training set was established.
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November 13, 2020
Image /page/0/Picture/1 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
THINK Surgical, Inc. Meliha Mulalic Director, Regulatory Affairs and Quality Assurance 47201 Lakeview Blvd Fremont, California 94538
Re: K203040
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: October 5, 2020 Received: October 6, 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
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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
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Indications for Use
510(k) Number (if known) K203040
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 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:
- . Zimmer Persona™ Knee System
- . Corin Unity Knee System
- . Aesculap Columbus Knee System
- . DJO Surgical® EMPOWR 3D Knee® System
- . United U2 Knee 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 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.
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: | 13 November 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 and Reference Devices:
The TSolution® One Total Knee Application is substantially equivalent in intended use, Indications for Use, design, materials, technology, operational principles and performance to the TSolution One® Total Knee Application cleared via K201255 (primary predicate) and supported with K191369 (reference device).
Device Modification:
The TSolution One Total Knee Application includes a series of incremental hardware and software changes from the previously cleared predicate. These changes have been implemented for the following reasons: to enhance system efficiency and consistency, to enhance the flexibility and ease of use of the system, and to improve the cybersecurity and aesthetics of the system.
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 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).
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Image /page/4/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" replaced by a blue, elongated triangle pointing upwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. A registered trademark symbol is located to the right of the letter "K".
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:
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 as safe and effective and where references to rigid anatomical structures mav 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, 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
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Image /page/5/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 triangle 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 triangle adds a touch of color and visual interest.
TSolution One® Total Knee Application Special 510(k) Submission
device and the predicates is that the new device incorporates a series of incremental changes in the hardware and software that enhance system efficiency and consistency, enhance the flexibility and ease of use of the system, and improve the cybersecurity and aesthetics of the system. None of these changes either individually or in the aggregate alter the intended use, indications for use, 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.
The results of the analysis demonstrate that any risks identified have been mitigated to acceptable levels and no new clinical hazards arise as a result of the changes. Additionally, the modifications made to the predicate device do not raise any new questions of safety or effectiveness or increase the overall risk profile of the device.
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. Electromagnetic Compatibility and Electrical Safety testing met the requirements of applicable IEC standards. 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. Biocompatibility Testing performed according to the ISO 10993-1:2009 standard was completed on any new patient contacting materials. All of this testing demonstrated that the TSolution One® Total Knee Application met the test criteria and specifications of the predicate device.
| Product | TSolution One TotalKnee Application | TSolution One TotalKnee Application | SubstantialEquivalenceConclusion |
|---|---|---|---|
| 510(k) number | Subject Device | K201255 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| TechnologicalCharacteristics | |||
| -Patient Imaging | CT Scan | CT Scan | SAME |
| -User Controls | Keyboard, mouse,Pendant withmechanically latched StopButton | Keyboard, mouse,Pendant withmechanically latchedStop Button | SAME |
| -Preoperativeplanningworkstation | TPLAN three-dimensionalpreoperative planningworkstation | TPLAN three-dimensionalpreoperative planningworkstation | SAME |
| -Pre-surgical Plan | CT images used to createa 3D model of the bone,library of FDA clearedcomponents used todevelop optimal implantsize and location | CT images used to createa 3D model of the bone,library of FDA clearedcomponents used todevelop optimal implantsize and location | SAME |
| Product | TSolution One TotalKnee Application | TSolution One TotalKnee Application | SubstantialEquivalenceConclusion |
| K201255 | |||
| 510(k) number | Subject Device | K201255 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| -Surgical PlanData | High level operative planbased on preoperativeplan with predeterminedcontrol file developed tocontrol the robotic arm. | High level operative planbased on preoperativeplan with predeterminedcontrol file developed tocontrol the robotic arm. | SAME |
| -SurgicalExposure | Similar to traditionalsurgical exposure for theanatomic site | Similar to traditionalsurgical exposure for theanatomic site | SAME |
| Electromechanicalarm to implementpre-surgical plan | TCAT electromechanicalarm system implementspre-surgical plan | TCAT electromechanicalarm system implementspre-surgical plan | SAME |
| -Patient/RobotRegistration | Pinless point to surfaceregistration withmechanical tracking.Percutaneous probe thinenough to make contactvia direct puncturethrough skin. | Pinless point to surfaceregistration withmechanical tracking.Percutaneous probe thinenough to make contactvia direct puncturethrough skin. | SAME |
| -Bone MotionRecovery | Two bone motionrecovery markers areused to recoverregistration after bonemotion. | Two bone motionrecovery markers areused to recoverregistration after bonemotion. | SAME |
| -Compatible KneeImplant Systems | -Zimmer Persona™ KneeSystem-Corin Unity Knee System-AesculapColumbus Knee System-DJO Surgical® EMPOWR3D Knee® System-United U2 Knee System | -Zimmer Persona™ KneeSystem-Corin Unity Knee System-AesculapColumbus Knee System-DJO Surgical®EMPOWR 3D Knee®System-United U2 Knee System | SAME |
| PerformanceTesting | |||
| -Cutting AccuracyVerification | Passed | Passed | SAME |
| -Cadaver LabValidation Testing | Passed | Passed | SAME |
| -Software Testing | Passed | Passed | SAME |
| -ElectromagneticCompatibility andElectrical Safety | Passed | Passed | SAME |
| Product | TSolution One Total Knee Application | TSolution One Total Knee Application | SubstantialEquivalenceConclusion |
| 510(k) number | Subject Device | K201255 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| _BiocompatibilityTesting onChangedMaterials | Passed | N/A | 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/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 a blue triangle 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 triangle adds a touch of color and visual interest.
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Image /page/7/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with the "I" replaced by a blue, downward-pointing triangle. 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 substantially equivalent to the predicate, TSolution One® Total Knee Application (K201255), 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 and risk analysis has demonstrated that the acceptance criteria of the TSolution One® Total Knee Application are equivalent to 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.
§ 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).