(30 days)
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 TMINIM 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™ Knee Total Knee 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.
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 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 quide 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 describes the TMINI™ Miniature Robotic System (Additional Knee Systems) and its substantial equivalence to a predicate device (K230202) for total knee replacement (TKA) surgery. The primary modification in this submission is the addition of compatibility with three new knee implant systems.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in a table format with specific thresholds (e.g., "Accuracy must be within +/- X mm"). Instead, it states that performance testing was conducted and passed. The performance criteria are implicitly linked to the "cutting accuracy" and "cadaver lab validation testing."
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Cutting Accuracy Verification | Device must meet all test criteria and specifications for cutting accuracy, similar to the predicate. | Passed (All test criteria and specifications met) |
| Cadaver Lab Validation Testing | Device must meet all test criteria in simulated surgical testing in a cadaver model, similar to the predicate. | Passed (All test criteria met) |
| Biocompatibility | Materials must pass standard biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity). | Passed (All 5 tests passed the acceptance criteria of the test protocol) |
| Risk Assessment | The addition of new implant systems must not introduce new clinical hazards or increase the likelihood/severity of existing hazards. | Passed (No new clinical hazards identified; existing risks unchanged) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size for the "cutting accuracy verification" or the "cadaver lab validation testing." It mentions "simulated surgical testing in a cadaver model," implying a limited number of cadavers were used, but the exact count is not given.
- Data Provenance: The document does not specify the country of origin for the data. The "cadaver model" likely refers to ex vivo testing in a lab setting, not human clinical data. The review is for a 510(k) submission to the US FDA, so the data would have been submitted to support this application. It is implicitly a pre-market study, and given the nature of a 510(k) (seeking substantial equivalence), it would be considered prospective for the purpose of demonstrating the device's performance for this specific submission, even if the methods were established previously.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts, their qualifications, or how they established ground truth for the performance testing.
4. Adjudication Method for the Test Set
The document does not provide any information regarding an adjudication method for the test set. Given the "cutting accuracy" and "cadaver lab validation" descriptions, the "ground truth" likely involves precise physical measurements rather than subjective expert interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation of images is a key component, often comparing human readers with and without AI assistance. The TMINI™ Miniature Robotic System is a surgical assistance device, and the testing described focuses on its mechanical accuracy and safety, not diagnostic interpretation. Therefore, there is no mention of human readers or an effect size of AI assistance on their performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The performance testing described ("cutting accuracy verification" and "cadaver lab validation testing") can be interpreted as standalone performance of the robotic system in achieving its intended surgical goal. While the system "assists the surgeon," the testing focuses on the robot's precision in placing bone pins and enabling cuts, which is an intrinsic performance characteristic of the algorithm and hardware. It demonstrates the direct output of the robotic system.
7. The Type of Ground Truth Used
The ground truth for "cutting accuracy verification" would likely be:
- Precise Physical Measurements: Using highly accurate measurement tools (e.g., CMM, optical tracking systems, or specialized gauges) to quantify the deviation of the cuts or pin placements from the pre-planned surgical model.
The ground truth for "cadaver lab validation testing" would similarly involve:
- Physical Measurements Post-Procedure: Assessing the accuracy of implant component placement or bone cuts on the cadaveric specimens against the pre-operative plan. This might involve post-procedure imaging (e.g., CT scans) and subsequent measurement analysis.
The biocompatibility testing ground truth is based on standard chemical and biological assay results.
8. The Sample Size for the Training Set
The document does not directly address or mention a "training set" in the context of an AI/ML algorithm. The TMINI™ system uses "software-defined spatial boundaries" and "preoperative CT scans" for planning. While there's software involved, the description doesn't suggest a machine learning model that undergoes a training phase with a large dataset. It appears to be a deterministic robotic system guided by a surgical plan created from CT data.
9. How the Ground Truth for the Training Set Was Established
As no "training set" for an AI/ML algorithm is explicitly mentioned or seems applicable to this device as described, the question of how its ground truth was established is not relevant based on the provided text. The "TPLAN Planning Workstation" has a "library of 510(k) cleared knee replacement implant(s)," and surgeons use this to manipulate 3D representations for planning, which then guides the robot. This implies a rules-based or model-based system rather than a machine learning one requiring a distinct training phase.
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October 12, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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. Anand Patel Manager, Regulatory Affairs 47201 Lakeview Blvd. Fremont, California 94538
Re: K232802
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: September 8, 2023 Received: September 12, 2023
Dear Anand Patel:
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" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) 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 QS 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).
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.
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 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
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Indications for Use
510(k) Number (if known) K232802
Device Name TMINI™ 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 TMINIM 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™ Knee Total Knee System
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 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.
510(k) SUMMARY K232802
Applicant Information:
| Owner Name: | THINK Surgical, Inc. |
|---|---|
| Address: | 47201 Lakeview Blvd., Fremont, CA 94538 |
| Phone number: | 443-756-9392 |
| Fax number: | 510-249-2396 |
| Establishment Registration Number: | 3000719653 |
| Contact Person: | Anand Patel |
| Date Prepared: | 08 September 2023 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Trade Name: | TMINITM 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 (Additional Knee Systems) 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 K230202.
Device Modification:
The purpose of this submission is to add three additional FDA cleared knee implant systems that are compatible with the TMINI™ Miniature Robotic System to the Enovis™ EMPOWR Knee System® that is already cleared for use with the device. The three new implant systems are: the Ortho Development® BKS® and BKS TriMax® Knee System, the Total Joint Orthopedics Klassic® Knee System, and the United® U2™ Knee System. As part of this change the labeling has been modified to show that the Indications for Use of the device has been updated to include compatibility with these three additional knee implant systems.
Device Description:
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
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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" represented by a blue, elongated triangle pointing downwards. 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.
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 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 quide 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:
Like the predicate, 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:
The only difference between the indications for use of the current device and the predicate is the addition of the three additional knee systems. See Table-1 below.
| Product | TMINI™ Miniature RoboticSystem (Additional KneeSystems) | TMINI™ Miniature RoboticSystem | Conclusion |
|---|---|---|---|
| 510(k) number | Subject Device | K230202 | |
| 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™ MiniatureRobotic System is indicatedas a stereotaxicinstrumentation system fortotal knee replacement (TKA)surgery. It is to assist thesurgeon by providing | The TMINI™ MiniatureRobotic System is indicatedas a stereotaxicinstrumentation system fortotal knee replacement (TKA)surgery. It is to assist thesurgeon by providing | SubstantiallyEquivalent(AddsCompatibility withthree additionaltotal knee implantsystems) |
| Product | TMINI™ Miniature RoboticSystem (Additional KneeSystems) | TMINI™ Miniature RoboticSystem | Conclusion |
| software-defined spatialboundaries for orientation andreference information toidentifiable anatomicalstructures for the accurateplacement of knee implantcomponents. | software-defined spatialboundaries for orientation andreference information toidentifiable anatomicalstructures for the accurateplacement of knee implantcomponents. | ||
| The robotic device placementis performed relative toanatomical landmarks asrecorded using the systemintraoperatively and based ona surgical plan-determinedpreoperatively using CTbased surgical planning tools. | The robotic device placementis performed relative toanatomical landmarks asrecorded using the systemintraoperatively and based ona surgical plan-determinedpreoperatively using CTbased surgical planning tools. | ||
| It includes a handheld roboticdevice, an optical sensornavigation system andaccessories, software system,surgical instruments andaccessories. | It includes a handheld roboticdevice, an optical sensornavigation system andaccessories, software system,surgical instruments andaccessories. | ||
| The targeted population hasthe same characteristics asthe population that is suitablefor the implant(s) compatiblewith the TMINI™ MiniatureRobotic System. | The targeted population hasthe same characteristics asthe population that is suitablefor the implant(s) compatiblewith the TMINI™ MiniatureRobotic System. | ||
| The TMINI™ MiniatureRobotic System is to be usedwith the following kneereplacement system(s) inaccordance with theindications andcontraindications:- Enovis™ EMPOWRKnee System®-Ortho Development BKS®and BKS TriMax® KneeSystem-Total Joint OrthopedicsKlassic® Knee System-United U2™ Knee TotalKnee System | The TMINI™ MiniatureRobotic System is to be usedwith the following kneereplacement system(s) inaccordance with theindications andcontraindications:- Enovis™ EMPOWRKnee System® |
Table 1: Comparison of Intended Use and Indications for Use
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TMINI™ Miniature Robotic System Special 510(k) Submission
Substantial Equivalence:
Both the TMINI™ Miniature Robotic System (Additional Knee Systems), 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
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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 includes compatibility with three additional knee implant systems. None of these changes either individually or in the aggregate alter the intended use, indications for use (other than the addition of the three new implant systems), design, materials, technology, or operational principles of the TMINI™ Miniature Robotic System.
The Indications for Use of the new device and its predicate are identical except for the addition of the three new implant systems to the list of compatible implant systems.
Performance testing to verify the cutting accuracy of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device. This testing demonstrated that the TMINI™ Miniature Robotic System met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted using simulated surgical testing in a cadaver model and all test criteria were met.
Biocompatibility information for patient contacting materials and testing for the TMINI™ Miniature Robotic System were presented in predicate device submission K230202. There are no material changes to any of the direct patient contact components of the TMINI Miniature Robotic System.
All four of the Guide Blocks for the TMINI™ Miniature Robotic System (Additional Knee Systems) have text printed on the Indirect Patient Contact Surface of the blocks using Pad printing ink. Biocompatibility testing was provided to assess these materials and included: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity and Pyrogenicity. All 5 tests passed the acceptance criteria of the test protocol.
Substantial equivalence in technological characteristic and performance of the TMINI™ Miniature Robotic System to the predicate device is outlined in Table-2 below:
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| Product | TMINI™ Miniature RoboticSystem (Additional KneeSystems) | TMINI™ Miniature RoboticSystem | SubstantialEquivalenceConclusion |
|---|---|---|---|
| 510(k) number | Subject Device | K230202 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Materials | |||
| -Materials Used | Uses materials with a longhistory of use in orthopedicprocedures or providedbiocompatibility data consistentwith ISO 10993 requirements. | Uses materials with a longhistory of use in orthopedicprocedures or providedbiocompatibility data consistentwith ISO 10993 requirements. | SAME |
| TechnologicalCharacteristics | |||
| -Major SystemComponents | Planning and robot controlsoftware, robotic positioningdevice, navigation system,reusable and disposableinstrumentation | Planning and robot controlsoftware, robotic positioningdevice, navigation system,reusable and disposableinstrumentation | SAME |
| -Patient Imaging | CT images used to create a 3Dmodel of the bone for surgicalplanning | CT images used to create a 3Dmodel of the bone for surgicalplanning | SAME |
| -Preoperativeplanningworkstation | TPLAN three-dimensionalpreoperative planningworkstation | TPLAN three-dimensionalpreoperative planningworkstation | SAME |
| -Surgical planningsystem | Technician guided surgicalplanning with surgeon reviewand approval on a desktopplanning station | Technician guided surgicalplanning with surgeon reviewand approval on a desktopplanning station | SAME |
| -Bone Marker Arraysfor bone registrationand tracking | Active markers on femur andtibia mounted onto the bonesvia an attachment assembly. | Active markers on femur andtibia mounted onto the bonesvia an attachment assembly. | SAME |
| -Surgical Exposure | Similar to traditional surgicalexposure | Similar to traditional surgicalexposure | SAME |
| -Patient/RobotRegistration | Preoperatively determinedlandmarks are compared tointraoperatively identifiedlandmarks to complete patientbone registration. | Preoperatively determinedlandmarks are compared tointraoperatively identifiedlandmarks to complete patientbone registration. | SAME |
| -Camera TrackingTechnology | Six camera overhead trackingwith a wide-angle field of view | Six camera overhead trackingwith a wide-angle field of view | SAME |
| -Cut guidepositioning | Robotic device places bonepins in the correct plane, thencutguide or drill block isattached to the pins and bone. | Robotic device places bonepins in the correct plane, thencutguide or drill block isattached to the pins and bone. | SAME |
| -Intraoperativeplanning changes | Implant position can beadjusted along bone axis only,preserving the intended implantpositioning philosophy. | Implant position can beadjusted along bone axis only,preserving the intended implantpositioning philosophy. | SAME |
| -Bone PreparationTechnique | A surgical saw is used to cutthe bone through a cut guide. | A surgical saw is used to cutthe bone through a cut guide. | SAME |
| -IntraoperativeAnatomicMeasurements | The tracked bone arrays andbone registration data are usedto determine the knee flexionangle and varus/valgus laxity. | The tracked bone arrays andbone registration data are usedto determine the knee flexionangle and varus/valgus laxity. | SAME |
| Product | TMINI™ Miniature Robotic System (Additional Knee Systems) | TMINI™ Miniature Robotic System | Substantial Equivalence Conclusion |
| 510(k) number | Subject Device | K230202 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| -TKA ComponentImplantationTechnique | 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 |
| -Compatible KneeImplant Systems | - Enovis ™ EMPOWR Knee System®-Ortho Development® BKS® and BKS TriMax® Knee System-Total Joint Orthopedics Klassic® Knee System-United® U2™ Knee System | - Enovis ™ EMPOWR Knee System® | Substantially Equivalent(addition of three newimplantsystems) |
| PerformanceTesting-Cutting AccuracyVerification | Passed | Passed | SAME |
| -Cadaver LabValidation 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 |
Table-2: Substantial Equivalence
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Risk assessment was performed on the device in accordance with ISO 14971:2019 and THINK Surgical Risk Management procedures. The risk assessment was comprised of analysis and mitigation of the risks associated with the addition of three compatible knee implant systems. The risk assessment resulted in the identification of no new clinical hazards. Each of the clinical hazards identified through this risk assessment is a previously documented hazard associated with the use of the TMINI™ Miniature Robotic System. The addition of three new implant systems does not increase the likelihood or severity of these hazards; therefore, the risks associated with the use of the device remain unchanged as compared to the predicate.
Conclusion
The TMINI™ Miniature Robotic System (Additional Knee Systems) is substantially equivalent to the predicate, TMINI™ Miniature Robotic System (K230202), in the following ways: it has the same intended use, the same technological characteristics and operating principles, and incorporates the same design and materials. Performance testing and risk analysis has demonstrated that the performance and risk profile of the TMINI™ Miniature Robotic System (Additional Knee Systems) is equivalent to that of the predicate device. The
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Image /page/9/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 downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
TMINI™ Miniature Robotic System (Additional Knee Systems) 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).