(59 days)
TMIN® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMNI® Miniature Robotic System is to be used with the following knee replacement systems in accordance with the indications and contraindications:
- · Enovis™ EMPOWR Knee System®
- · Ortho Development® BKS® and BKS TriMax® Knee System
- · Total Joint Orthopedics Klassic® Knee System
- · United® U2™ Total Knee System
- · Medacta® GMK® Sphere / SpheriKA Knee Systems
- · Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- · Maxx Orthopedics Freedom® Total & Titan Knee
- · LINK® LinkSymphoKnee System
The TMINI® Miniature Robotic System like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical. Preoperative Planning Workstation (TPLAN Planning Station), an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components. In addition, this submission will add a web-based method for surgeons to review, approve and download approved surgical plans generated on the TPLAN Planning Station.
The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.
The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively.
The provided document, an FDA 510(k) summary for the TMINI® Miniature Robotic System, focuses on demonstrating substantial equivalence to a predicate device (K243285) rather than on presenting de novo acceptance criteria and a study proving the device meets those criteria.
The purpose of this 510(k) submission (K243481) is to introduce modifications to the TPLAN Planning station (specifically, an improved segmentation algorithm using a pre-trained and closed machine learning model, enhanced DICOM data importing, updated implant display and selection tools, and improved cybersecurity) and to add the THINK Case Manager (TCM) as a remote method for surgeon review, approval and downloading of approved surgical plans.
Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria and a study that proves the device meets them in the context of a new device's performance validation against novel criteria. Instead, it asserts that the modified device's performance is substantially equivalent to that of the predicate device, which presumably underwent its own performance validation to establish its safety and effectiveness.
However, based on the provided text, I can extract information related to performance testing that was conducted to support the substantial equivalence claim.
Here's an analysis based on the available information:
Key Takeaway from the Document:
The document argues for substantial equivalence to a predicate device (K243285), meaning it explicitly states that no new questions of safety or effectiveness were identified by the modifications, and thus, extensive de novo performance validation against new acceptance criteria was not required or presented. The performance testing mentioned serves to confirm that the modifications did not negatively impact the existing performance characteristics.
Attempt to answer your questions based on the provided 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of specific quantitative acceptance criteria or detailed reported device performance values. Instead, it generally states that performance testing was conducted using methods and acceptance criteria similar to those used for the predicate device, and that the device "met all test criteria and specifications."
Here's a summary of the performance testing mentions:
| Acceptance Criterion (Inferred from testing type) | Reported Device Performance |
|---|---|
| Full System Run Through Testing | Passed |
| Cutting Accuracy | Passed |
| Pin & Block Placement Accuracy | Passed |
| Cadaver Lab Validation Testing | Passed |
| System Gap Balance Accuracy | Passed |
| User Needs Validation Testing | Passed |
| Usability Testing | Passed |
| Software Testing | Passed |
| Biocompatibility Testing (for patient-contacting materials if changed) | Passed (No new testing required as no material changes) |
Note: The phrase "Passed" indicates that the device met the (unspecified) acceptance criteria for these tests. The document emphasizes that these tests used "similar test methods and acceptance criteria to those used for the predicate device."
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for any of the performance tests (e.g., number of test runs, number of cases in cadaver lab validation).
Data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be pre-clinical (e.g., cadaver lab) or in-house testing, not clinical studies involving patient data for the purpose of this 510(k). The mention of "preoperative CT scans of the operative leg to create 3D surface models" refers to the input data for the system's function, not necessarily the data used for testing its performance in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given that it's a 510(k) for device modifications and not a de novo clinical validation, the focus is on engineering and performance testing against internal specifications or predicate performance, rather than establishing clinical ground truth with human experts for an AI component. The software modification mentioned is an "improved segmentation algorithm using a pre-trained and closed machine learning model," which suggests it's an internal algorithm improvement, not a new diagnosis/decision-support AI requiring human expert consensus for ground truth comparison.
4. Adjudication method for the test set
This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done or mentioned. This type of study is typically performed for AI-driven diagnostic or decision-support tools where human interpretation is involved. The device here is a robotic system for total knee replacement, where the AI component mentioned is an "improved segmentation algorithm" for planning, not a diagnostic imaging AI that assists radiologists.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions an "improved segmentation algorithm using a pre-trained and closed machine learning model." While it implies standalone performance would be measured for such an algorithm (e.g., against ground truth segmentations), the document does not detail the specific standalone performance metrics, acceptance criteria, or results for this algorithm. The overall "Software Testing" passed, but these details are not exposed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the tests it lists. For "Cutting Accuracy," "Pin & Block Placement Accuracy," and "System Gap Balance Accuracy," it's highly likely that engineering measurements against a known or measured truth (e.g., precise physical measurements in a cadaver lab or benchtop setting) served as the ground truth. For "Software Testing" related to the segmentation algorithm, the ground truth would typically be manually segmented CT scans by experts, but this is not confirmed in the text.
8. The sample size for the training set
This information is not provided. The document states the segmentation algorithm uses a "pre-trained and closed machine learning model," meaning the training was completed before this submission and the model is static. The size and nature of the training data are not disclosed.
9. How the ground truth for the training set was established
This information is not provided. For a segmentation algorithm, the ground truth for training would typically involve manual segmentation annotations performed by qualified experts (e.g., orthopedic surgeons or trained annotators with anatomical expertise) on a dataset of CT scans.
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Image /page/0/Picture/0 description: The image contains 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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
January 6, 2025
THINK Surgical, Inc. Denise Duchene Director, Regulatory Affairs 47201 Lakeview Blvd Fremont, California 94538
Re: K243481
Trade/Device Name: TMINI Miniature Robotic System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 7, 2024 Received: November 8, 2024
Dear Denise Duchene:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
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
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Indications for Use
510(k) Number (if known) K243481
Device Name TMINI® Miniature Robotic System
Indications for Use (Describe)
TMIN® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMNI® Miniature Robotic System is to be used with the following knee replacement systems in accordance with the indications and contraindications:
- · Enovis™ EMPOWR Knee System®
- · Ortho Development® BKS® and BKS TriMax® Knee System
- · Total Joint Orthopedics Klassic® Knee System
- · United® U2™ Total Knee System
- · Medacta® GMK® Sphere / SpheriKA Knee Systems
- · Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- · Maxx Orthopedics Freedom® Total & Titan Knee
- · LINK® LinkSymphoKnee 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/4/Picture/0 description: The image shows the logo for Think Surgical. The logo features the word "THINK" in bold, sans-serif font, with the "I" replaced by a blue, three-dimensional sphere with a white "T" shape on it. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
510(k) SUMMARY
Applicant Information:
| Owner Name: | THINK Surgical, Inc. |
|---|---|
| Address: | 47201 Lakeview Blvd., Fremont, CA 94538 |
| Phone number: | 408-921-5648 |
| Fax number: | 510-249-2396 |
| Establishment Registration Number: | 3000719653 |
| Contact Person: | Denise Duchene |
| Date Prepared: | 15 November 2024 |
| Device Information: |
| Device Classification: | Class II |
|---|---|
| Trade Name: | TMINI® Miniature Robotic System |
| Common name: | Orthopedic Stereotaxic Instrument |
| Classification name: | Stereotaxic Instrument |
| Regulation number: | 882.4560 |
| Product Code: | OLO |
Predicate Device:
The TMINI® Miniature Robotic System (TPLAN® Planning Station and THINK Case Manager (TCM)) is substantially equivalent in intended use. Indications for Use, design. materials, technology, operational principles and performance to the predicate, TMINI® Miniature Robotic System, cleared via K243285.
Device Modification:
The purpose of this submission is to introduce modifications to the TPLAN Planning station used with the TMIN® Miniature Robotic System to enhance efficiency and consistency. The TPLAN® Planning Station component of the TMINI® Miniature Robotic System has been modified to improve the segmentation algorithm using a pre-trained and closed machine learning model during the development, enhance DICOM data importing, update the implant display and selection tools, and improve cybersecurity. In addition, we have added the THINK Case Manager (TCM) as a remote method for surgeon review, approval and downloading of approved surgical plans.
Device Description:
The TMINI® Miniature Robotic System like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical. Preoperative Planning Workstation (TPLAN Planning Station), an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that
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Image /page/5/Picture/1 description: The image is a logo for Think Surgical. The logo features a blue circle with a white "T" inside of it. The word "THINK" is written in bold, black letters below the circle. The word "SURGICAL" is written in smaller, black letters below the word "THINK".
assists the surgeon in preparing the bone for implantation of TKA components. In addition, this submission will add a web-based method for surgeons to review, approve and download approved surgical plans generated on the TPLAN Planning Station.
The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.
The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively.
Intended Use:
The TMINI System (TPLAN Planning Station and TCM) like the predicate TMINI Miniature Robotic System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Indications for Use:
The Indications for Use of the TMINI® Miniature Robotic System (TPLAN Planning Station and TCM) and the predicate are the same (See Table 1), Both describe the use of a system that uses diagnostic imaging of the patient to allow a surgeon to plan and execute orthopedic total knee procedures. The only difference is that the device, that is the subject of this 510(k) submission, implements a series of incremental modifications to the TPLAN Planning Station and introduces a web-based method for surgeon review, approval and download of surqical plans to enhance system efficiency, consistency and ease of use.
None of the changes made to the predicate, nor the aggregate of all changes, have altered the indications for use, nor have they raised new type of safety or effectiveness questions.
Tables 1 and 2, below identify the substantial equivalence of the TMINI® Miniature Robotic System (TPLAN Planning Station and TCM) to the predicate, TMINI® Miniature Robotic System cleared via K243285.
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Image /page/6/Picture/0 description: The image shows the logo for Think Surgical. The logo features a stylized letter 'T' with a blue sphere at the top and a blue triangle extending downwards. Below the 'T', the word 'THINK' is written in a bold, sans-serif font, and below that, the word 'SURGICAL' is written in a smaller, sans-serif font.
| Product | TMINI® Miniature RoboticSystem (TPLAN PlanningStation and TCM) | TMINI® Miniature RoboticSystem | Conclusion |
|---|---|---|---|
| 510(k) number | K243481 | K243285 | |
| Manufacturer | THINK Surgical, Inc | THINK Surgical, Inc | |
| Product Code | OLO | OLO | SAME |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | SAME |
| Intended Use | Intended to assist the surgeonin providing software definedspatial boundaries fororientation and referenceinformation to anatomicalstructures during orthopedicprocedures. | Intended to assist the surgeonin providing software definedspatial boundaries fororientation and referenceinformation to anatomicalstructures during orthopedicprocedures. | SAME |
| Indications for Use | The TMINI® Miniature RoboticSystem is indicated as astereotaxic instrumentationsystem for total kneereplacement (TKA) surgery. It isto assist the surgeon byproviding software-definedspatial boundaries fororientation and referenceinformation to identifiableanatomical structures for theaccurate placement of kneeimplant components.The robotic device placement isperformed relative toanatomical landmarks asrecorded using the systemintraoperatively and based on asurgical plan-determinedpreoperatively using CT basedsurgical planning tools.The targeted population has thesame characteristics as thepopulation that is suitable forthe implant(s) compatible withthe TMINI® Miniature RoboticSystem.The TMINI® Miniature RoboticSystem is to be used with thefollowing knee replacementsystem(s) in accordance withthe indications andcontraindications:- Enovis™ EMPOWR KneeSystem®- Ortho Development BKS®and BKS TriMax® KneeSystemTotal Joint Orthopedics | The TMINI® Miniature RoboticSystem is indicated as astereotaxic instrumentationsystem for total kneereplacement (TKA) surgery. It isto assist the surgeon byproviding software-definedspatial boundaries fororientation and referenceinformation to identifiableanatomical structures for theaccurate placement of kneeimplant components.The robotic device placement isperformed relative toanatomical landmarks asrecorded using the systemintraoperatively and based on asurgical plan-determinedpreoperatively using CT basedsurgical planning tools.The targeted population has thesame characteristics as thepopulation that is suitable forthe implant(s) compatible withthe TMINI® Miniature RoboticSystem.The TMINI® Miniature RoboticSystem is to be used with thefollowing knee replacementsystem(s) in accordance withthe indications andcontraindications:- Enovis™ EMPOWR KneeSystem®- Ortho Development BKS®and BKS TriMax® KneeSystem- Total Joint Orthopedics | SAME |
| Product | TMINI® Miniature RoboticSystem (TPLAN PlanningStation and TCM) | TMINI® Miniature RoboticSystem | Conclusion |
| - United U2™ Knee TotalKnee System- Medacta® GMK® Sphere /SpheriKA Knee Systems- Zimmer Biomet Anterior &Posterior Referencing- Persona® Knee- b-ONE MOBIO® TotalKnee System- Maxx Orthopedics- Freedom® Total & TitanKnee- LINK® LinkSymphoKneeSystem | - United U2™ Knee TotalKnee System- Medacta® GMK® Sphere /SpheriKA Knee Systems- Zimmer Biomet Anterior &Posterior Referencing- Persona® Knee- b-ONE MOBIO® TotalKnee System- Maxx Orthopedics- Freedom® Total & TitanKnee- LINK® LinkSymphoKneeSystem |
Table 1: Comparison of Intended Use and Indications for Use
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Image /page/7/Picture/0 description: The image is a logo for "Think Surgical". The logo features a stylized letter "T" with a blue sphere at the top, resembling a head. The word "THINK" is written in bold, dark gray letters below the "T", and the word "SURGICAL" is written in smaller letters below "THINK".
Substantial Equivalence:
Both the TMINI® Miniature Robotic System (TPLAN Planning Station and TCM), the subject of this submission, and the predicate device have the same intended use. Both are indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components during orthopedic procedures.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools. The difference between the new device and the predicate is that the new device incorporates a series of incremental changes to the TPLAN Planning Station component and adds a web-based tool for review of surgical plans to enhance system efficiency, consistency and ease of use. 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 TMIN® Miniature Robotic System and no new questions of safety or effectiveness resulted from the changes.
The Indications for Use of the TMINI® Miniature Robotic System (TPLAN Planning Station and TCM) and the predicate are the same (See Table 1). Both describe the use of a system that uses diagnostic imaging of the patient to allow a surgeon to plan and execute orthopedic total knee procedures. The only difference is that the device, that is the subject of the 510(k) submission, implements a series of incremental modifications to the TPLAN Planning Station and add a web-based application for review, approval and download of approved surgical plans to enhance system efficiency, consistency and ease of use.
Performance testing to verify the function 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 TMIN® Miniature Robotic System (TPLAN Planning Station and TCM) met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted and all test criteria were met.
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Image /page/8/Picture/0 description: The image shows the logo for Think Surgical. The logo features a stylized letter 'T' with a blue sphere at the top, resembling a head. Below the 'T', the word 'THINK' is written in bold, sans-serif font, with the 'I' replaced by a blue, elongated triangle pointing downwards. Underneath 'THINK', the word 'SURGICAL' is written in a smaller, sans-serif font.
Biocompatibility information for patient contacting materials and testing for the TMINI® Miniature Robotic System were presented in predicate device submission K232802. There are no material changes to any of the direct patient contact components of the TMINI® Miniature Robotic System as a result of TPLAN Planning Station and TCM modifications included in this submission; therefore, no additional biocompatibility testing was required.
Substantial equivalence in technological characteristic and performance of the TMINI® Miniature Robotic System to the predicate device is outlined in Table-2 below:
| Product | TMINI® Miniature RoboticSystem (TPLAN PlanningStation and TCM) | TMINI® Miniature RoboticSystem | Conclusion |
|---|---|---|---|
| 510(k) number | K243481 | K243285 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Materials | |||
| Materials Used | Uses materials with a longhistory of use in orthopedicprocedures or providedbiocompatibility dataconsistent with ISO 10993requirements | Uses materials with a longhistory of use in orthopedicprocedures or providedbiocompatibility dataconsistent with ISO 10993requirements | SAME |
| TechnologicalCharacteristics | |||
| Major System Components | Planning, web-based planreview, and robot controlsoftware, robotic positioningdevice, navigation system,reusable and disposableinstrumentation | Planning and robot controlsoftware, robotic positioningdevice, navigation system,reusable and disposableinstrumentation | Substantiallyequivalent |
| Patient Imaging | CT images used to create a3D model of the bone forsurgical planning | CT images used to create a3D model of the bone forsurgical planning | SAME |
| Preoperative planning workstation | TPLAN three-dimensionalpreoperative planningworkstation | TPLAN three-dimensionalpreoperative planningworkstation | SAME |
| Surgical planning system | Technician guided surgicalplanning with surgeonreview and approval on adesktop planning station | Technician guided surgicalplanning with surgeonreview and approval on adesktop planning station | SAME |
| Surgical planning review, approval, and approved plan export or download | Performed by surgeon oneither the TPLAN PlanningStation or the THINK CaseManager (TCM) | Performed by the surgeonon the TPLAN PlanningStation | Substantiallyequivalent |
| Bone Marker Arrays for bone registration and tracking | Active markers on femurand tibia mounted onto thebones via an attachmentassembly | Active markers on femurand tibia mounted onto thebones via an attachmentassembly | SAME |
| Surgical Exposure | Similar to traditional surgicalexposure | Similar to traditional surgicalexposure | SAME |
| Patient/Robot Registration | Preoperatively determinedlandmarks are compared tointraoperatively identifiedlandmarks to complete | Preoperatively determinedlandmarks are compared tointraoperatively identifiedlandmarks to complete | SAME |
Table-2: Substantial Equivalence
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Image /page/9/Picture/0 description: The image shows the logo for Think Surgical. The logo features a blue circle with a white "T" inside, and the word "THINK" in black, sans-serif font below the circle. The word "SURGICAL" is in smaller, gray, sans-serif font below the word "THINK".
| Product | TMINI® Miniature RoboticSystem (TPLAN PlanningStation and TCM) | TMINI® Miniature RoboticSystem | Conclusion | |
|---|---|---|---|---|
| 510(k) number | K243481 | K243285 | ||
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | ||
| ● | Camera Tracking | Six camera overhead | Six camera overhead | SAME |
| Technology | tracking with a wide-anglefield of view | tracking with a wide-anglefield of view | ||
| ● | Cut guidepositioning | Robotic device places bonepins in the correct plane,then cutguide or drill block isattached to the pins andbone | Robotic device places bonepins in the correct plane,then cutguide or drill block isattached to the pins andbone | SAME |
| ● | Intraoperativeplanning changes | Implant position can be fullyadjusted, allowing deviationfrom the intended implantpositioning philosophy andimplant size | Implant position can be fullyadjusted, allowing deviationfrom the intended implantpositioning philosophy andimplant size | SAME |
| ● | Bone PreparationTechnique | A surgical saw is used to cutthe bone through a cutguide | A surgical saw is used to cutthe bone through a cutguide | SAME |
| ● | IntraoperativeAnatomicMeasurements | The tracked bone arraysand bone registration dataare used to determine theknee flexion angle andvarus/valgus laxity | The tracked bone arraysand bone registration dataare used to determine theknee flexion angle andvarus/valgus laxity | SAME |
| ● | Gap Balancing | Displays the maximumspace in the medial andlateral compartments inmillimeters with the knee inextension and in flexionallowing the surgeon toperform gap balancing, ifdesired | Displays the maximumspace in the medial andlateral compartments inmillimeters with the knee inextension and in flexionallowing the surgeon toperform gap balancing, ifdesired | SAME |
| ● | TKA ComponentImplantationTechnique | Implants are secured to thebone, either with or withoutcement using standardsurgical technique providedby the implant manufacturer | Implants are secured to thebone, either with or withoutcement using standardsurgical technique providedby the implant manufacturer | SAME |
| Product | TMINI® Miniature RoboticSystem (TPLAN PlanningStation and TCM) | TMINI® Miniature RoboticSystem | Conclusion | |
| 510(k) number | K243481 | K243285 | ||
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | SAME | |
| Compatible KneeImplant Systems | - Enovis™ EMPOWRKnee System®- Ortho Development®BKS® and BKS TriMax®Knee System- Total Joint OrthopedicsKlassic® Knee System- United® U2™ KneeSystem- Medacta® GMK®Sphere / SpheriKAKnee Systems- Zimmer Biomet Anterior& Posterior Referencing- Persona® Knee- b-ONE MOBIO® TotalKnee System- Maxx OrthopedicsFreedom® Total &Titan Knee- LINK®- LinkSymphoKneeSystem | - Enovis™ EMPOWRKnee System®- Ortho Development®BKS® and BKS TriMax®Knee System- Total Joint OrthopedicsKlassic® Knee System- United® U2™ KneeSystem- Medacta® GMK®Sphere / SpheriKAKnee Systems- Zimmer Biomet Anterior& Posterior Referencing- Persona® Knee- b-ONE MOBIO® TotalKnee System- Maxx OrthopedicsFreedom® Total &Titan Knee- LINK®- LinkSymphoKneeSystem | SAME | |
| Performance Testing | ||||
| Full System RunThrough Testing | Passed | Passed | SAME | |
| Cutting AccuracyPin & BlockPlacementAccuracyCadaver LabValidation TestingSystem GapBalance Accuracy | Passed | Passed | SAME | |
| User Needs ValidationTesting | Passed | Passed | SAME | |
| Usability Testing | Passed | Passed | SAME | |
| Software Testing | Passed | Passed | SAME | |
| *BiocompatibilityTesting | ||||
| Cytotoxicity | *Passed | Passed | SAME | |
| Sensitization | *Passed | Passed | SAME | |
| IntracutaneousReactivity | *Passed | Passed | SAME | |
| Acute SystemicToxicity | *Passed | Passed | SAME | |
| Pyrogenicity | *Passed | Passed | SAME |
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Image /page/10/Picture/0 description: The image shows the logo for Think Surgical. The logo features a blue sphere with a white reflection on top, resembling a stylized "T". Below the sphere, the word "THINK" is written in a bold, sans-serif font, with the "I" replaced by a thin, vertical line that extends upwards to touch the sphere. Below the word "THINK", the word "SURGICAL" is written in a smaller, sans-serif font.
- There are no material changes to any of the direct patient contact components of the TMIN® Miniature Robotic System as a result of TPLAN Planning Station and TCM modifications included in this submission; therefore, no additional biocompatibility testing was required.
Risk assessment was performed on the device in accordance with ISO 14971:2019 and THINK Surgical Risk Management procedures. Each change was assessed separately and in the aggregate through risk analysis and appropriate performance testing to
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Image /page/11/Picture/0 description: The image shows the logo for Think Surgical. The logo features the word "THINK" in bold, sans-serif font, with the "I" replaced by a blue, downward-pointing triangle. Above the word "THINK" is a blue circle with a white highlight, and the letters "TM" are to the right of the circle.
evaluate the impact of the change. Risk analysis resulted in the identification of new instances of risk; however, no new clinical hazards were identified, and no new questions of safety or effectiveness were identified as a result of these changes. The risks identified have been mitigated to acceptable levels and there is no change in the overall risk profile of the device compared to the predicate cleared in K243285.
Conclusion
The TMINI® Miniature Robotic System (TPLAN Planning Station and TCM) is substantially equivalent to the predicate, TMIN® Miniature Robotic System (K243285), in the following ways:
- it has the same intended use,
- . it has the same Indication for Use,
- it has 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 TMINI® Miniature Robotic System (TPLAN Planning Station and TCM) is substantially equivalent to that of the predicate device and does not raise any new question of safety and effectiveness.
THINK Surgical Inc. respectfully submits that this filing contains adequate information and data to demonstrate the substantial equivalence of the TMIN® Miniature Robotic System (TPLAN Planning Station and TCM) to the legally marketed TMINI® Miniature Robotic System cleared via K243285.
§ 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).