Search Results

The TSolution One® Total Knee Application is intended for use as a device that uses of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA).

The TSolution One® Total Knee Application is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made.

The TSolution One® Total Knee Application is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Total Knee Application facilitates accurate positioning of TKA implants, relative to these alignment axes.

The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:

Aesculap Columbus Knee System
Corin Unity Knee
DJO Surgical EMPOWR 3D Knee
DJO Surgical EMPOWR Knee System
Ortho Development Balanced Knee
Total Joint Orthopedics Klassic Knee System
United U2 Knee
Zimmer Biomet Persona

Device Description

Like its predicate, the TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planning workstation and implementation tool for treatment of patients who require total ioint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).

The TSolution One® Total Knee Application consists of TPLAN and TCAT. TPLAN is a three-dimensional (3D) preoperative planning workstation that aids a surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy. TCAT consists of an electromechanical arm, an arm base including control electronics and computer, a display monitor, operating software, pendant control, and tools and accessories, for the implementation of the preoperative plan. TCAT and TPLAN when used according to the instructions for use, make submillimeter precision bone preparation possible before and during TKA surgical procedures.

AI/ML Overview

The acceptance criteria and study proving the device meets them are described below:

Acceptance Criteria and Reported Device Performance

The document states that "Performance testing to verify the cutting accuracy of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device. This testing demonstrated that the TSolution One® Total Knee Application 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."

Therefore, the specific quantitative acceptance criteria are not explicitly detailed but are implied to be met based on the predicate device's standards.

Acceptance Criteria Category	Reported Device Performance
Cutting Accuracy	Passed
Cadaver Lab Validation	Passed
Software Testing	Passed

Study Details

Sample Size for the Test Set and Data Provenance:
- Cutting Accuracy Verification: Not specified.
- Cadaver Lab Validation Testing: Not specified, but involved "simulated surgical testing in a cadaver model". The provenance of the cadaver models (e.g., country of origin, retrospective or prospective) is not mentioned.
Number of Experts and Qualifications for Ground Truth: Not specified, as the testing focuses on device performance against established criteria rather than expert interpretation of outputs.
Adjudication Method: Not applicable/specified for this type of performance testing.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The document focuses on the device's technical performance and equivalence to a predicate device, not on comparing human reader performance with and without AI assistance.
Standalone (Algorithm Only) Performance: Yes, the testing described appears to be a standalone performance evaluation of the TSolution One® Total Knee Application, specifically its cutting accuracy and functionality in a cadaver model, without human-in-the-loop performance measurement.
Type of Ground Truth Used for Test Set:
- For "Cutting Accuracy Verification" and "Cadaver Lab Validation Testing," the ground truth would inherently be based on precise physical measurements of resections and implant positioning against the pre-surgical plan. While not explicitly stated, this implies highly accurate measurement tools and established anatomical references for assessment.
- For "Software Testing," the ground truth would be defined by the software's functional specifications and expected outputs.
Sample Size for the Training Set: Not specified. The document describes performance testing and validation for a device modification (adding more compatible implant systems), not the development or training of an AI algorithm from scratch.
How the Ground Truth for the Training Set Was Established: Not specified, as the document doesn't detail the development or training phase of the device's original algorithms.

Ask a Question

Ask a specific question about this device

K Number

K203040

Device Name

TSolution One Total Knee Application

Manufacturer

THINK Surgical, Inc.

Date Cleared

2020-11-13

(38 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K191369,K201255

Intended Use

The TSolution One® Total Knee Application is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The TSolution One® Total Knee Application is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be as safe and effective and where references to rigid anatomical structures may be made.

The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:

. Zimmer Persona™ Knee System
. Corin Unity Knee System
. Aesculap Columbus Knee System
. DJO Surgical® EMPOWR 3D Knee® System
. United U2 Knee System

Device Description

Like its predicate, the TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planning workstation and implementation tool for treatment of patients who require total joint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).

AI/ML Overview

The provided text describes the TSolution One® Total Knee Application, a robotic surgical tool for total knee arthroplasty (TKA). The document is a 510(k) summary demonstrating substantial equivalence to a predicate device (K201255).

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Cutting Accuracy Verification	Passed (Met test criteria and specifications of the predicate device)
Cadaver Lab Validation Testing	Passed (Met test criteria and specifications of the predicate device)
Software Testing	Passed (Met test criteria and specifications of the predicate device)
Electromagnetic Compatibility and Electrical Safety	Passed (Met the requirements of applicable IEC standards and met test criteria and specifications of the predicate device)
Biocompatibility Testing on Changed Materials	Passed (Performed according to ISO 10993-1:2009 standard for any new patient contacting materials, and met test criteria and specifications of the predicate device)

2. Sample Size for Test Set and Data Provenance:

The document mentions "simulated surgical testing in a cadaver model" for validation testing but does not specify the sample size for this test set (e.g., number of cadavers or knees).
Data provenance: The cadaver model suggests human anatomical data, likely from a biospecimen provider, but does not specify the country of origin. The study was prospective simulation.

3. Number of Experts and Qualifications for Ground Truth:

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not explicitly mentioned or described in the provided text. The document focuses on the device's technical performance and substantial equivalence to a predicate, rather than human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

The testing described appears to be for the standalone device, as it focuses on verifying cutting accuracy, software performance, and other technical aspects of the TSolution One® Total Knee Application. While it operates "under the direction of the surgeon," the described performance tests (cutting accuracy, software, EMC) are inherently standalone assessments of the system's capabilities. There is no explicit mention of human-in-the-loop performance measurement in the reported tests.

7. Type of Ground Truth Used:

For cutting accuracy and cadaver lab validation, the ground truth would likely be based on direct measurements of the resected bone surfaces against the pre-surgical plan, using high-precision metrology tools. This is implied by the nature of "cutting accuracy verification" and "cadaver model validation."

8. Sample Size for Training Set:

The document does not provide any information about the sample size used for the training set. It describes the device's technological characteristics and performance testing but not its development or training data.

9. How Ground Truth for Training Set Was Established:

The document does not provide any information on how the ground truth for the training set was established.

Ask a Question

Ask a specific question about this device

K Number

K193135

Device Name

TSolution One Total Knee Application

Manufacturer

Think Surgical, Inc.

Date Cleared

2019-12-11

(29 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K191369

Intended Use

The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:

· Zimmer Persona™ Knee System
· Corin Unity Knee System
Aesculap Columbus Knee System
· DJO Surgical® EMPOWR 3D Knee® System

Device Description

The TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planning workstation and implementation tool for treatment of patients who require total joint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).

AI/ML Overview

This document describes a 510(k) premarket notification for the TSolution One® Total Knee Application by Think Surgical, Inc. The submission is a "Special 510(k)" because it concerns modifications to a previously cleared device (K191369). The primary modifications are the addition of compatibility with three new knee implant systems (Corin Unity Knee System, Aesculap Columbus Knee System, and DJO Surgical® EMPOWR 3D Knee® System) and corresponding labeling changes.

Here's an analysis of the provided information concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria. Instead, it refers to prior testing and states that the current device met all test criteria and specifications and passed various tests. The claim of equivalence is based on the new device performing similarly to the predicate device, which had already met specified criteria.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Cutting Accuracy Verification	"similar test methods and acceptance criteria to those used for the predicate device"	"Passed"
Cadaver Lab Validation Testing	"methods and acceptance criteria similar to that used for the predicate device"	"Passed"
Software Testing	(Implied to be sufficient for proper function)	"Passed"

2. Sample Size Used for the Test Set and Data Provenance

The document states:

Cutting Accuracy Verification: "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." No specific sample size (e.g., number of tests, number of bone samples) is provided for this testing.
Cadaver Lab Validation Testing: "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." No specific sample size (e.g., number of cadavers, number of procedures) is provided.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective in nature, as new testing was conducted specifically for this submission to verify the modifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document mentions "simulated surgical testing in a cadaver model" and that the robotic surgical tool operates "under the direction of the surgeon." While this implies clinical involvement, it does not specify the number of experts, their qualifications, or their role in establishing ground truth for the test set used for regulatory submission. The focus is on the device's ability to precisely implement a presurgical plan, rather than on expert interpretation of outcomes for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The testing described (cutting accuracy, cadaver lab validation, software testing) suggests objective, quantifiable measurements against engineering specifications or predetermined surgical plans, rather than a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned in this document. The submission is a Special 510(k) for modifications to an existing device, focusing on demonstrating that the changes do not negatively impact safety or effectiveness. There's no comparative study presented on human reader performance with or without AI assistance. The device is an AI/robotic system assisting surgeons, but its comparative effectiveness against unaided human surgeons is not described here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes the TSolution One® Total Knee Application as consisting of:

TPLAN: "a three-dimensional (3D) preoperative planning workstation that aids a surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy."
TCAT: "an electromechanical arm... for the implementation of the preoperative plan."
The core function is a "robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan." This clearly indicates a "human-in-the-loop" system.

However, the "Cutting Accuracy Verification" and "Software Testing" could be considered "standalone" tests of the algorithm's and robotic arm's mechanical precision and software functionality in a controlled environment, even if the overall system is always used with a surgeon. The cadaver lab testing also evaluates the system's performance, but still within the context of a simulated surgical procedure involving a human operator.

7. The Type of Ground Truth Used

Based on the description of performance testing:

Cutting Accuracy Verification: The ground truth would likely be engineering specifications or predefined geometric targets. The robotic arm's actual cut surfaces or trajectory would be compared against these targets.
Cadaver Lab Validation Testing: The ground truth for this would likely be the preoperative plan generated by TPLAN. The actual resections performed by the TCAT robotic arm on cadaver bone would be measured and compared against the planned resections (e.g., bone resection depth, angle, implant position). This would be an objective, quantifiable ground truth based on the software's plan.
Software Testing: Ground truth for software testing generally involves verifying that the software functions according to its design specifications and requirements, producing expected outputs for given inputs.

8. The Sample Size for the Training Set

This document describes a device modification and substantial equivalence comparison, not the development of a novel machine learning algorithm from scratch. Therefore, information about a "training set" for an AI model is not provided. The TSolution One system uses CT images to create 3D models and a "library of FDA cleared components" for planning, but this is not described as a traditional machine learning training set.

9. How the Ground Truth for the Training Set Was Established

As no "training set" is mentioned or implied for a machine learning model, information on how its ground truth was established is not applicable to this document. The system's functionality relies on engineering principles, image processing, and pre-defined surgical planning rules.

Ask a Question

Ask a specific question about this device

K Number

K191369

Device Name

TSolution One Total Knee Application

Manufacturer

THINK Surgical, Inc.

Date Cleared

2019-10-08

(139 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K143752,K170430

Intended Use

The TSolution One Total Knee Application is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and where references to rigid anatomical structures may be made.

The TSolution One® Total Knee Application is compatible with the Zimmer Persona™ Knee System.

Device Description

The TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require total joint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: TSolution One® Total Knee Application

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Primary Safety Endpoint	Composite safety endpoint (7 relevant adverse events as defined by the Knee Society, each with expected incidence ≤2.7%, sum = 7.6%)	None of the seven adverse events identified were observed. 100% (115/115) of patients successfully completed the primary safety endpoint.
Primary Effectiveness Endpoint	Demonstrate a reduction in malalignment rate (coronal mechanical axis > ±3° from preoperative plan) by 50% compared to a historical 32% malalignment rate (i.e., achieve ≤ 16% malalignment).	ITT: 13.0% malalignment rate, a 59.2% reduction.
PP: 11.2% malalignment rate, a 65.0% reduction.

2. Sample Sizes and Data Provenance

Test Set (Clinical Trial): 115 patients were enrolled in the study (Intent-to-Treat group). 107 patients were in the Per-Protocol group for the effectiveness endpoint.
Data Provenance: Multi-center, prospective, non-randomized clinical trial carried out at six investigational sites in the US.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish ground truth for the test set beyond the involvement of "eight clinical investigators" in the study. Their specific qualifications (e.g., years of experience) are not detailed, but their role as clinical investigators implies medical expertise.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like "2+1" or "3+1" for assessing the primary endpoints. The outcomes (adverse events, malalignment rates) appear to be directly measured based on predefined criteria, rather than requiring expert consensus or adjudication of individual cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted to evaluate how human readers improve with AI vs. without AI assistance. This device is a robotic surgical tool, not an AI-assisted diagnostic imaging tool that human readers would interpret. The comparative effectiveness was against historical conventional manual TKA.

6. Standalone (Algorithm Only) Performance

The device is a robotic surgical tool that assists the surgeon, not a standalone algorithm for diagnosis or treatment decision-making without human intervention. Its performance is evaluated in the context of its use by a surgeon. The "cutting accuracy" and "software testing" results (table on page 6) refer to technical performance aspects of the system itself, which are a form of standalone testing for the specific functions of the device (e.g., how accurate are the cuts, does the software function as intended).

7. Type of Ground Truth Used

For Safety: Clinical observation and reporting of predefined adverse events (composite safety endpoint).
For Effectiveness: Direct measurement of coronal mechanical axis alignment from postoperative imaging at 3 months, compared to the preoperative plan and historical malalignment rates.

8. Sample Size for the Training Set

The document does not provide details on the sample size of any specific "training set" for the device's development or internal validation. It mentions the "library of FDA cleared components used to develop optimal implant size and location" for planning but doesn't quantify data used for algorithm training.

9. How Ground Truth for the Training Set Was Established

The document does not specify how ground truth for any potential training set was established. Given the nature of a surgical robotic system, its "training" might involve rigorous engineering validation, testing against known physical standards, and simulated surgical scenarios, rather than a traditional medical image dataset with expert-labeled ground truth like an AI diagnostic algorithm. The text focuses on the device's functionality rather than a machine learning model's training data.

Ask a Question

Ask a specific question about this device

Page 1 of 1