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 placement of knee implant components.

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® Mimiature Robotic System is to be used with the following knee replacement system(s) 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
· Medacta® GMK® Sphere / SpheriKA Knee Systems
· Zimmer Biomet Anterior & Posterior Referencing Persona® Knee

Device Description

Like its predicate, the TMIN® Miniature Robotic System (Additional Knee 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) available for use with the system. The surgeon can select an implant model from this library. The planner/surqeon 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 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 quides 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the TMINI Miniature Robotic System, focusing on adding compatibility with two new knee implant systems. It explicitly states that the subject device is substantially equivalent to a previously cleared predicate device (K241031) and that no new questions of safety or effectiveness have been raised. Therefore, the study described is not a primary clinical validation study of a novel device, but rather a verification and validation (V&V) exercise to demonstrate equivalence for an updated device.

The document does not describe an AI-driven diagnostic device that would typically involve establishing ground truth from expert consensus or pathology, or MRMC studies. Instead, it describes a surgical robotic system where "accuracy" refers to the robotic system's ability to precisely place instruments based on a pre-planned surgical model.

Based on the provided text, here's an analysis against your questions:

1. A table of acceptance criteria and the reported device performance:

The document mentions that "The verification and validation activities were successfully completed, and all pre-determined acceptance criteria were met." However, it does not provide a detailed table of quantitative acceptance criteria or corresponding reported device performance values for specific metrics like cutting accuracy, pin & block placement accuracy, or system gap balance accuracy. It only states "Passed" for these categories, implying that the predefined, but unstated, acceptance criteria were satisfied.

The table on page 5-6 lists various technological characteristics and performance testing categories, with the "Conclusion" indicating "SAME" or "Substantially Equivalent" for each.

Category	TMINI® Miniature Robotic System (Additional Knee System) Performance	TMINI™ Miniature Robotic System (Predicate) Performance	Conclusion
Full System Run	Passed	Passed	SAME
Cutting Accuracy	Passed	Passed	SAME
- Pin & Block Placement Accuracy	Passed	Passed	SAME
- Cadaver Lab Validation Testing	Passed	Passed	SAME
- System Gap Balance Accuracy	Passed	Passed	SAME
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity)	*Passed	Passed	SAME

Note: The asterisk on Biocompatibility indicates "There are no material changes to any of the direct patient contact components... therefore, no additional biocompatibility testing was required." The "Passed" refers to the predicate device's prior testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document states "Verification and validation activities were performed... Throughout all testing performed, test samples were representative of the production product." It explicitly mentions "Cadaver Lab Validation Testing."
However, the document does not specify the sample size (number of cadavers or test instances) used for the cadaver lab validation or other performance testing.
It also does not specify the country of origin of the data or whether the study was retrospective or prospective. Given it's a cadaver lab, it would inherently be a prospective experimental study, but details are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a surgical robotic system, not an AI diagnostic system. The "ground truth" for its performance testing (e.g., accuracy of cuts or pin placement) would be established by

Predefined surgical plans based on CT scans.
Precise metrology (measurement) of the physical results against those plans.
This is not a human expert interpretation task.

Therefore, the concept of "experts" establishing ground truth in the context of an AI diagnostic device (like radiologists interpreting images for disease presence) does not directly apply here.
The document does not mention experts being used to establish a subjective "ground truth" for the test set. The surgical plan is derived from CT data and the system's software, and its accuracy is measured against physical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

As the ground truth is based on physical measurements against a pre-planned surgical model, adjudication methods typically used for subjective clinical assessments in AI diagnostic studies (like 2+1 radiologist review) are not relevant here. The document does not describe any such adjudication method.

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:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI diagnostic systems where human readers interpret medical images. The TMINI Miniature Robotic System is a surgical robot that assists the surgeon in the physical execution of a total knee replacement, it does not interpret images for diagnosis or assist human readers in making diagnostic decisions. The document focuses on the validated accuracy of the robotic system itself in performing physical tasks (e.g., placing pins, guiding cuts) based on the surgical plan.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a "robotically controlled hand-held tool" that "assists the surgeon." Its operation inherently involves a human surgeon. The performance metrics listed (cutting accuracy, pin & block placement accuracy, cadaver lab validation testing, system gap balance accuracy) relate to the system's ability to achieve predefined surgical parameters, which implies a standalone assessment of the system's mechanical and software precision. The document doesn't explicitly separate "algorithm only" performance from system performance with the surgeon as an operator, but the tests performed (e.g., cadaver lab) would evaluate the combined system's precision in accurately executing the surgical plan.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance testing of this robotic surgical system would be:

The preoperatively determined surgical plan: Based on CT scans and software templating, defining the precise locations and orientations for cuts and implant placement.
Precise metrological measurements: Physical measurements taken on the cadaver (or test jig) after the robotic assistance to determine how closely the actual executed actions (e.g., pin placement, cut planes) match the planned actions. This is an engineering/physical measurement ground truth, not a clinical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set:

The document does not refer to "training sets" in the context of machine learning. The device described appears to be a deterministic robotic system based on pre-programmed algorithms and optical tracking, not a machine learning model that learns from large datasets. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here and is not mentioned.

9. How the ground truth for the training set was established:

Since the document does not mention "training sets" or machine learning, this question is not applicable. The system's functionality is based on engineering principles and pre-programmed surgical planning, not on learning from a labeled training dataset.

Summary

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August 23, 2024

Think Surgical, Inc. Anand Patel Manager, Regulatory Affairs 47201 Lakeview Blvd Fremont, California 94528

Re: K242264

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: July 31, 2024 Received: August 1, 2024

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"

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K242264 - Anand Patel

(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).

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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/7 description: The image shows the name "Shumaya Ali-S" in a large, clear font. The text is horizontally aligned and appears to be the primary focus of the image. The background is a light color, possibly white or a very pale blue, with a faint watermark-like design that is barely visible behind the text.

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) K242264

Device Name TMINI® Miniature Robotic System

Indications for Use (Describe)

· Enovis™ EMPOWR Knee System®
· Ortho Development® BKS® and BKS TriMax® Knee System
· Total Joint Orthopedics Klassic® Knee System
· United® U2™ Knee Total Knee System
· Medacta® GMK® Sphere / SpheriKA Knee Systems
· Zimmer Biomet Anterior & Posterior Referencing Persona® Knee

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 features a stylized letter "T" with a blue sphere at the top and a blue, elongated 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.

510(k) SUMMARY

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:	21 August 2024
Device Information:
Device Classification:	Class II
Trade Name:	TMINI® Miniature Robotic System
Common name:	Orthopedic Stereotaxic Instrument
Classification name:	Stereotaxic Instrument

Requlation number:

Product Code:

Predicate Device:
The TMINI® Miniature Robotic System (Additional Knee System) is substantially equivalentin intended use, Indications for Use, design, materials, technology, operational principlesand performance to the predicate, TMINI® Miniature Robotic System, cleared viaK241031.

882.4560

OLO

Device Modification:

The purpose of this submission is to add two additional FDA cleared knee implant systems that are compatible with the TMIN® Miniature Robotic System to the Enovis™ EMPOWR Knee System®, Ortho Development® BKS® and BKS TriMax® Knee System, the Total Joint Orthopedics Klassic® Knee System, and the United® U2™ Knee System that is already cleared for use with the device. The two new implant systems are: the Medacta® GMK® Sphere / SpheriKA Knee Systems, and the Zimmer Biomet Anterior & Posterior Referencing Persona® Knee. 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 two additional knee implant systems.

Device Description:

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Image /page/4/Picture/1 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 teardrop shape. Above the word "THINK" is the trademark symbol, and below it is the word "SURGICAL" in a smaller font. To the right of the word "THINK" is the registered trademark symbol.

and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components.

Intended Use:

Like the predicate, the TMIN® Miniature Robotic System (Additional Knee 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 differences between the indications for use of the current device and the predicate are the addition of the two additional knee systems and the removal of the sentence listing the system components. See Table-1 below.

The table below identifies the substantial equivalence of TMIN® Miniature Robotic System (Additional Knee System) to the predicate, TMINI™ Miniature Robotic System cleared via K241031.

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Image /page/5/Picture/0 description: The image is a logo for Think Surgical. The logo features a stylized letter "T" with a blue circle behind it. The words "THINK" and "SURGICAL" are written below the "T" in a sans-serif font. The word "THINK" is in a larger font size than the word "SURGICAL."

Product	TMINI® Miniature RoboticSystem (Additional KneeSystem)	TMINI™ Miniature RoboticSystem	Conclusion
510(k) number	Subject Device	K241031
Manufacturer	THINK Surgical, Inc	THINK Surgical, Inc	SAME
Product Code	OLO	OLO
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. Itis to assist the surgeon byproviding software-definedspatial boundaries fororientation and referenceinformation to identifiableanatomical structures for theaccurate placement of kneeimplant components.The robotic device placementis performed relative toanatomical landmarks asrecorded using the systemintraoperatively and based ona surgical plan-determinedpreoperatively using CT basedsurgical planning tools.The targeted population hasthe same characteristics asthe population that is suitablefor the implant(s) compatiblewith the TMINI® MiniatureRobotic System.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® Knee	The TMINI™ Miniature RoboticSystem is indicated as astereotaxic instrumentationsystem for total kneereplacement (TKA) surgery. Itis to assist the surgeon byproviding software-definedspatial boundaries fororientation and referenceinformation to identifiableanatomical structures for theaccurate placement of kneeimplant components.The robotic device placementis performed relative toanatomical landmarks asrecorded using the systemintraoperatively and based ona surgical plan-determinedpreoperatively using CT basedsurgical planning tools.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 TMINI™ Miniature RoboticSystem is to be used with thefollowing knee replacementsystem(s) in accordance with	SubstantiallyEquivalent(AddsCompatibilitywith twoadditional totalknee implantsystems andthe removal ofthe sentencelisting thesystemcomponents)
Product	TMINI® Miniature RoboticSystem (Additional KneeSystem)	TMINI™ Miniature RoboticSystem	Conclusion
	- Total Joint OrthopedicsKlassic® Knee System- United U2™ Knee TotalKnee System- Medacta® GMK® Sphere/ SpheriKA Knee Systems- Zimmer Biomet Anterior &Posterior ReferencingPersona® Knee	the indications andcontraindications:- Enovis™ EMPOWR KneeSystem®- Ortho Development BKS®and BKS TriMax® KneeSystem- Total Joint OrthopedicsKlassic® Knee System- United U2™ Knee TotalKnee System
Product	TMINI® Miniature RoboticSystem (Additional KneeSystem)	TMINI™ Miniature RoboticSystem (TMINI 1.1)	SubstantialEquivalenceConclusion
510(k) number	Subject Device	K241031
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 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 a3D model of the bone forsurgical planning	CT images used to create a3D model of the bone forsurgical planning	SAME
-Preoperative planningworkstation	TPLAN three-dimensionalpreoperative planningworkstation	TPLAN three-dimensionalpreoperative planningworkstation	SAME
-Surgical planningsystem	Technician guided surgicalplanning with surgeonreview and approval on adesktop planning station	Technician guided surgicalplanning with surgeonreview and approval on adesktop planning station	SAME
-Bone Marker Arrays forbone registration andtracking	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 traditionalsurgical exposure	Similar to traditionalsurgical exposure	SAME
-Patient/RobotRegistration	Preoperatively determinedlandmarks are compared tointraoperatively identifiedlandmarks to completepatient bone registration	Preoperatively determinedlandmarks are compared tointraoperatively identifiedlandmarks to completepatient bone registration	SAME
-Camera TrackingTechnology	Six camera overheadtracking with a wide-anglefield of view	Six camera overheadtracking with a wide-anglefield of view	SAME
-Cut guide positioning	Robotic device places bonepins in the correct plane,then cutguide or drill blockis attached to the pins andbone	Robotic device places bonepins in the correct plane,then cutguide or drill blockis attached to the pins andbone	SAME
Product	TMINI® Miniature RoboticSystem (Additional KneeSystem)	TMINI™ Miniature RoboticSystem (TMINI 1.1)	SubstantialEquivalenceConclusion
510(k) number	Subject Device	K241031
Manufacturer	THINK Surgical Inc.	THINK Surgical Inc.
-Intraoperative planningchanges	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 tocut the bone through a cutguide	A surgical saw is used tocut the bone through a cutguide	SAME
-Intraoperative AnatomicMeasurements	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 ComponentImplantation Technique	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
-Compatible KneeImplant Systems	- Enovis™ EMPOWR KneeSystem®-Ortho Development® BKS®and BKS TriMax® KneeSystem-Total Joint OrthopedicsKlassic® Knee System-United® U2TM KneeSystem-Medacta® GMK® Sphere /SpheriKA Knee Systems-Zimmer Biomet Anterior &Posterior ReferencingPersona® Knee	- Enovis™ EMPOWR KneeSystem®-Ortho Development® BKS®and BKS TriMax® KneeSystem-Total Joint OrthopedicsKlassic® Knee System-United® U2TM KneeSystem	SubstantiallyEquivalent(addition of twonew implantsystems)
Performance Testing
-Full System Run	Passed	Passed	SAME
Product	TMINI® Miniature RoboticSystem (Additional KneeSystem)	TMINI™ Miniature RoboticSystem (TMINI 1.1)	SubstantialEquivalenceConclusion
510(k) number	Subject Device	K241031
Manufacturer	THINK Surgical Inc.	THINK Surgical Inc.
Cutting Accuracy-Pin & Block PlacementAccuracy-Cadaver Lab ValidationTesting-System Gap BalanceAccuracy	Passed	Passed	SAME
*BiocompatibilityTesting
-Cytotoxicity	*Passed	Passed	SAME
-Sensitization	*Passed	Passed	SAME
-IntracutaneousReactivity	*Passed	Passed	SAME
-Acute Systemic Toxicity	*Passed	Passed	SAME
-Pyrogenicity	*Passed	Passed	SAME

Table 1: 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 features a stylized letter 'T' in blue, with the top part of the 'T' forming a semi-circle. Below the 'T', the word 'THINK' is written in a bold, sans-serif font, with the 'I' replaced by a vertical line. Underneath 'THINK', the word 'SURGICAL' is written in a smaller, sans-serif font.

Substantial Equivalence:

Both the TMINI® Miniature Robotic System (Additional Knee System), 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 includes compatibility with two additional knee systems. The addition of the two knee systems do not alter the intended use, Indications for Use (other than the addition of the two new implant systems), design, materials, technology, or operational principles of the TMINI® Miniature Robotic System and no new questions of safety or effectiveness resulted from the changes.

The Indications for Use of the new device and its predicate are identical except for the addition of the two new implant systems to the list of compatible implant systems and the removal of the sentence listing the system components.

Verification and validation activities were performed to ensure that the TMINI® Miniature Robotic System (Additional Knee System) fulfilled system requirements, ensure that the product design conforms to the user needs and intended uses and performs substantially equivalent to the predicate, TMINI™ Miniature Robotic System, cleared via K241031. Throughout all testing performed, test samples were representative of the production product. The verification and validation activities for the TMINI® Miniature Robotic System (Additional Knee System) followed test protocols that were previously established and reviewed in the 510(k) submissions for the predicate device. The verification and validation activities were successfully completed, and all pre-determined acceptance criteria were met.

Biocompatibility information for patient contacting materials and testing for the TMINI® Miniature Robotic System were presented in submission K232802. There are no material changes to any of the direct patient contact components of the TMINI® Miniature Robotic

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Image /page/7/Picture/0 description: The image shows the logo for Think Surgical. The logo features a stylized letter 'T' with a blue circle at the top, resembling a surgical tool. Below the 'T', the word 'THINK' is written in bold, dark gray letters, and below that, the word 'SURGICAL' is written in smaller, lighter gray letters.

System (Additional Knee System) 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:

Table-2: Substantial Equivalence

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Image /page/8/Picture/0 description: The image is a logo for Think Surgical. The logo features a blue sphere with a white reflection at the top, resembling a stylized "T". Below the sphere is the word "THINK" in a bold, sans-serif font, with the "I" represented by a thin, vertical line extending from the sphere above. Underneath "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 features a stylized letter "T" in blue, with a needle-like shape extending downwards from the center of the "T". Below the "T" is the word "THINK" in a sans-serif font, and below that is the word "SURGICAL" in a smaller font.

There are no material changes to any of the direct patient contact components of the TMIN® Miniature Robotic System (Additional Knee System) as a result of Additional Knee System 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. 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 System) is substantially equivalent to the predicate. TMINI™ Miniature Robotic System cleared in K241031, 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 TMIN® Miniature Robotic System (Additional Knee System) 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 (Additional Knee System) to the legally marketed TMINI™ Miniature Robotic System cleared via K241031.

Regulation Number and Section

§ 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).