(90 days)
The TMINI™ 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 placement 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.
It includes a handheld robotic device, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
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 TMINI™ Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications: Enovis™ EMPOWR Knee System®.
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.
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). The surgeon can select an implant model from this library and manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. Once the surgeon is satisfied with the implant location and orientation, the data is written to a file that is used to guide the robotically controlled hand-held tool.
The handheld 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.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way described in the prompt. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Rosa Knee System) for FDA clearance.
However, I can extract the information related to performance testing that is mentioned as part of the substantial equivalence claim.
Here's an attempt to answer based on the available information, highlighting where details are missing:
The TMINI™ Miniature Robotic System (K230202) underwent performance testing to support its substantial equivalence to the legally marketed predicate, Rosa Knee System (K182964).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate) | Reported Device Performance (TMINI™) |
|---|---|---|
| Biocompatibility | Passed | Passed |
| Cutting Accuracy | < 0.75mm RMSE | Equivalent or better than manual instrumentation (< 0.5mm RMSE) |
| Cadaver Lab Validation Testing | Passed | Passed |
| Software Testing | Passed | Passed |
| Electromagnetic Compatibility and Electrical Safety | Meets IEC Requirements | Meets IEC Requirements |
2. Sample size used for the test set and the data provenance:
- Cutting Accuracy: The text states "< 0.5mm RMSE" as the reported device performance. It also mentions "See Section 19 for Details" regarding Cutting Accuracy and Cadaver Lab Validation. Without access to Section 19, the specific sample size, data provenance (e.g., country of origin, retrospective/prospective), and whether this refers to a test set in the context of an AI study are not available in this document. This typically refers to a performance study on cadavers or simulated bone, not an AI test set with "data provenance" in the usual imaging sense.
- For Biocompatibility, Software, EMC/Electrical Safety, and Cadaver Lab Validation, specific sample sizes and data provenance are not detailed in this summary.
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. The performance tests mentioned (Biocompatibility, Cutting Accuracy, Cadaver Lab Validation, Software, EMC/Electrical Safety) are typically engineering and clinical performance evaluations, not diagnostic accuracy studies involving expert interpretation of data.
4. Adjudication method for the test set:
This information is not provided because the performance tests described do not involve adjudication by experts in the context of a diagnostic AI study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is irrelevant for this submission. The TMINI™ Miniature Robotic System is described as a stereotaxic instrumentation system to assist surgeons in total knee replacement surgery by providing software-defined spatial boundaries and orientation/reference information. It is not an AI-powered diagnostic tool that assists human readers (e.g., radiologists) in interpreting images. Therefore, an MRMC study is not applicable to this device type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device description indicates human-in-the-loop operation, as it "assists the surgeon" and involves a "handheld robotic device" and a "surgical plan determined preoperatively using CT based surgical planning tools." The performance claim for cutting accuracy is for the robotic system, implying its standalone mechanical accuracy, but it's always in the context of assisting a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For Cutting Accuracy, the ground truth would likely be a precise physical measurement of the achieved cut planes/pin placements compared to the pre-planned positions and orientations. This would be established through metrology or other highly accurate measurement techniques in a laboratory or cadaveric setting. For other tests like Biocompatibility, Software, EMC/Electrical Safety, and Cadaver Lab Validation, the ground truth would be adherence to established standards or clinical protocols.
8. The sample size for the training set:
This information is not provided. The TMINI™ system uses CT-based surgical planning tools. While software is involved, the primary focus of the performance testing presented is on the accuracy and safety of the robotic system's physical actions rather than a machine learning model's training data.
9. How the ground truth for the training set was established:
This information is not provided. If there is a machine learning component, details of its training data and ground truth establishment are not included in this summary. However, given the nature of the device (robotic surgical assistance), "training set" might refer to data used to develop the planning algorithms or robotic control, which would have different ground truth establishment methods than, for example, an image classification AI.
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April 25, 2023
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
THINK Surgical, Inc. Meliha Mulalic VP, Regulatory Affairs and Quality Assurance 47201 Lakeview Boulevard Fremont, California 94538
Re: K230202
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: January 24, 2023 Received: January 25, 2023
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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)
K230202
Device Name TMINITM Miniature Robotic System
Indications for Use (Describe)
TMINI™ 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 placement 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.
It includes a handheld robotic device, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
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 TMINI™ Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications: Enovis™ EMPOWR 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 the middle of the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue line adds a touch of color and visual interest.
510(k) SUMMARY
Applicant Information:
| Owner Name: | THINK Surgical, Inc. |
|---|---|
| Address: | 47201 Lakeview Blvd., Fremont, CA 94538 |
| Phone number: | 510-249-2337 |
| Fax number: | 510-249-2396 |
| Establishment Registration Number: | 3000719653 |
| Contact Person: | Meliha Mulalic |
| Date Prepared: | January 24, 2023 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Trade Name: | TMINI™ Miniature Robotic System |
| Common name: | Orthopedic Stereotaxic Instrument |
| Classification name: | Stereotaxic Instrument |
| Regulation number: | 21 CFR 882.4560 |
| Product Code: | OLO |
Predicate Device:
The TMINI™ Miniature Robotic System is substantially equivalent in intended use, fundamental scientific technology and performance to the following legally marketed device in commercial distribution: Rosa Knee System cleared by the FDA through K182964.
Device Description:
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.
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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. 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.
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). The surgeon can select an implant model from this library and manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. Once the surgeon is satisfied with the implant location and orientation, the data is written to a file that is used to guide the robotically controlled hand-held tool.
The handheld 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.
Intended Use
The 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
he TMINI™ 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 placement 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.
It includes a handheld robotic device, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
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 TMINI™ Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with their indications and contraindications: Enovis™ EMPOWR Knee System®.
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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 sans-serif font, with the "I" in "THINK" being a blue vertical line. Below the word "THINK" is the word "SURGICAL" in a smaller sans-serif font.
Substantial Equivalence:
The TMINI™ Miniature Robotic System, is substantially equivalent to the predicate Rosa Knee System cleared by FDA through K182964. The subject device has the same intended use as the predicate device and substantially equivalent indications for use, materials, technology and operational principles.
Both the TMINI™ Miniature Robotic System and the predicate, Rosa Knee System, consist of three primary components; a planning workstation or online planning application, an optical tracking system and a robotically controlled device that assists the surgeon in preparing the bone for implantation of the TKA components. Both Systems use three-dimensional (3D) preoperative planning software that aids the surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy. Both the TMINI™ Miniature Robotic System and the predicate, Rosa Knee System, use a robotic device with a tracking array that guides the surgeon in preparing the bone for implantation of the total knee components consistent with the planned surgical procedure.
The tools and accessories that are used to accomplish total knee arthroplasty are the same or substantially equivalent to those used for conventional TKA procedures without robotic control. These include various instrumentation both reusable and disposable: surgical drapes, drills, saw blades, probes, bone pins, and cut and drill guides.
The substantial equivalence of the TMINI™ Miniature Robotic System is supported by equivalence in materials, technology and operational principals, and performance testing which supports the safety and substantial equivalence of the device for use in TKA.
| Product | TMINI™ Miniature Robotic System | Rosa Knee System | Conclusion |
|---|---|---|---|
| 510(k) number | PENDING | K182964 | |
| Manufacturer | Think Surgical, Inc | Orthosoft Inc. (d/b/a Zimmer CAS) | |
| Product Code | OLO | OLO | SAME |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | SAME |
| Intended Use | Intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | Intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | SAME |
| Product510(k)number | TMINI™ Miniature RoboticSystem | Rosa Knee System | Conclusion |
| Manufacturer | Think Surgical, Inc | Orthosoft Inc. (d/b/a ZimmerCAS) | |
| Indicationsfor 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 to anatomicallandmarks as recorded usingthe system intraoperatively andbased on a surgical plan,determined preoperatively usingCT based surgical planningtools.It includes a handheld roboticdevice, an optical sensornavigation system andaccessories, software system,surgical instruments andaccessories.The targeted population has thesame characteristics as thepopulation that is suitable for theimplant(s) compatible with theTMINI™ Miniature RoboticSystem. The TMINI™ MiniatureRobotic System is to be usedwith the following kneereplacement system(s) inaccordance with their indicationsand contraindications: Enovis TMEMPOWR Knee System®. | The Rosa® System is indicatedas a stereotaxic 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 to anatomicallandmarks as recorded usingthe system intraoperatively andbased on a surgical plan,optionally determinedpreoperatively using compatibleX-ray or MRI based surgicalplanning tools.It includes a robotic arm, anoptical sensor navigationsystem and accessories,software system, surgicalinstruments and accessories.The targeted population has thesame characteristics as thepopulation that is suitable forthe implant(s) compatible withthe Rosa® Knee System. TheRosa Knee System is to beused with the following fixedbearing knee replacementsystems in accordance withtheir indications andcontraindication: NexGen® CR,NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS,NexGen LPS-Flex, NexGenLPS-Flex Gender, Persona CR,Persona® CR, Persona PS,Vanguard® CR and VanguardCR | SubstantiallyEquivalent(1) Both systemshave a pre-surgical planningmodule – whileRosa can alsobe usedintraoperativelywithout a pre-surgical plan.(2) Both systemsuse radiographicimaging — TMINIuses CT imagingwhile Rosa useseither X-ray orMRI imaging.(3) Both systemshave a roboticdevice thatassists withsurgicalpreparation - theTMIN roboticdevice ishandheld whilethe Rosa has arobotic arm.(4) Both devicesare used onlywith their statedcompatibleimplant systems |
| Product | TMINI™ Miniature Robotic System | Rosa Knee System | Conclusion |
| 510(k) number | Pending | K182964 | |
| Manufacturer | Think Surgical Inc | Orthosoft Inc. (d/b/aZimmer CAS) | |
| Materials | |||
| -Materials Used | Uses materials with along history of use inorthopedic procedures. | Uses materials with along history of use inorthopedic procedures. | SAME |
| Technological Characteristics | |||
| -Major System Components | Planning and robotcontrol software, roboticpositioning device,navigation system,reusable and disposableinstrumentation | Planning and robotcontrol software, roboticpositioning device,navigation system,reusable and disposableinstrumentation | SAME |
| -Surgical planning system | Technician guidedsurgical planning withsurgeon review andapproval on a desktopplanning station | Technician guidedsurgical planning withsurgeon review andapproval via an onlinereview application | SubstantiallyEquivalent(Both systems have asurgical planning system– TMINI has a desktopplanning station, whileRosa uses an onlineapplication) |
| -Pre-surgical Imaging | CT images used tocreate a 3D model of thebone for surgicalplanning | MRI or X-ray used tocreate 3D model of thebone for pre-operativeplanning | SubstantiallyEquivalent(Both systems useradiographic imaging tocreate 3D bone models -TMINI uses CT and Rosauses X-ray or MRI) |
| -Surgical Exposure | Similar to traditionalsurgical exposure | Similar to traditionalsurgical exposure | SAME |
| -Bone Marker Arrays for boneregistration and tracking | Active markers on femurand tibia mounted ontothe bones via anattachment assembly. | Passive reflectivemarkers on femur andtibia mounted onto thebones via an attachmentassembly. | SubstantiallyEquivalent(Both systems use bonemarkers for registrationand tracking of motionTMINI uses activemarkers, while Rosauses passive markers) |
| -Patient/Robot Registration | Preoperativelydetermined landmarksare compared tointraoperatively identifiedlandmarks to completepatient bone registration. | Preoperativelydetermined landmarksare compared tointraoperatively identifiedlandmarks to completepatient bone registration. | SAME |
| Product | TMINI™ Miniature Robotic System | Rosa Knee System | Conclusion |
| 510(k) number | Pending | K182964 | |
| Manufacturer | Think Surgical Inc | Orthosoft Inc. (d/b/a Zimmer CAS) | |
| Camera Tracking Technology | Six camera overhead tracking with a wide angle field of view | Two camera sideways tracking with traditional field of view | Substantially Equivalent(Both systems provide intraoperative tracking required for robotic control and patient tracking) |
| -Cut guide positioning | Robotic device places bone pins in the correct plane, then cutguide or drill block is attached to the pins and bone. | Robotic device places a cut guide or drill block in the correct plane, then bone pins are used to secure the guide or block to the bone. | Substantially Equivalent(Both systems use robotic control to place the cut guides to execute the TKA procedure - TMINI places the bone pins under robot control and then attaches the cut guide to the pins, while Rosa places the cut guide in the correct plane using the robot arm and then drills the pins to secure the guide) |
| - Intraoperative planning changes | Implant position can be adjusted along bone axis only, preserving the intended implant positioning philosophy. | Implant position can be fully adjusted, allowing deviation from the intended implant positioning philosophy. | Substantially Equivalent(Both systems allow for some degree of intraoperative adjustment of the surgical plan) |
| -Bone Preparation Technique | A surgical saw is used to cut the bone through a cut guide. | A surgical saw is used to cut the bone through a cut guide. | SAME |
| -Intraoperative Anatomic Measurements | The tracked bone arrays and bone registration data are used to determine the knee flexion angle and varus/valgus laxity. | The tracked bone arrays and bone registration data are used to determine the knee flexion angle and varus/valgus laxity. | SAME |
| -TKA Component Implantation Technique | Implants are secured to the bone, either with or without cement using standard surgical technique provided by the implant manufacturer. | Implants are secured to the bone, either with or without cement using standard surgical technique provided by the implant manufacturer. | SAME |
| Product | TMINI™ MiniatureRobotic System | Rosa Knee System | Conclusion |
| 510(k) number | Pending | K182964 | |
| Manufacturer | Think Surgical Inc | Orthosoft Inc. (d/b/aZimmer CAS) | |
| PerformanceTesting | |||
| -Biocompatibility | Passed | Passed | SAME |
| -Cutting Accuracy | Equivalent or better thanmanual instrumentation< 0.5mm RMSE | Equivalent or better thanmanual instrumentation< 0.75mm RMSE | SubstantiallyEquivalent(See Section 19 forDetails) |
| -Cadaver LabValidation Testing | Passed | Passed | SAME(See Section 19 forDetails) |
| -Software Testing | Passed | Passed | SAME(See Section 17 forDetails) |
| -ElectromagneticCompatibility andElectrical Safety | Meets IEC Requirements | Meets IEC Requirements | SAME(See Section 18 forDetails) |
Comparison of Intended Use and Indications for Use
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Image /page/6/Picture/1 description: The image shows the logo for Think Surgical. The logo is composed of the word "THINK" in a 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.
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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 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, with a focus on the company name.
Comparison of Materials, Technological Characteristics and Performance Testing
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Image /page/8/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a sans-serif font, with the "I" represented by a blue triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller sans-serif font.
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Image /page/9/Picture/0 description: The image shows the logo for Think Surgical. The logo is composed of the word "THINK" in a bold, sans-serif font, with the "I" represented by a blue, elongated triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
Conclusion
The TMINI™ Miniature Robotic System is substantially equivalent to the legally marketed predicate, Rosa Knee System (K182964) in the following ways:
- . has the same intended use,
- has substantially equivalent Indications for Use,
- . has the same or substantially equivalent materials, technological characteristics and operational principles.
Think Surgical Inc. respectfully submits that this filing contains adequate information and data to demonstrate the substantial equivalence of the TMINI ™ Miniature Robotic System to the legally marketed Rosa Knee System (cleared by K182964).
§ 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).