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The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Total Knee Arthroplasty (TKA).

The implant systems compatible with the system: Triathlon Total Knee System (CR/CS/PS/PSR cemented and cementless primary); Triathlon Total Knee System (TS inserts cemented primary).

The Mako System with the subject Mako Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a camera, a computer, dedicated instrumentation, an operating software, and tools and accessories. The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement, and interpretive/intraoperative navigation of the patient's anatomy.

Once configured for a specific application, the Mako robotic arm can serve as the surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

Based on the provided FDA 510(k) clearance letter for the Mako Total Knee Application (3.0), here's an analysis of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is an FDA 510(k) clearance letter, which determines substantial equivalence to a predicate device. It is not a detailed clinical study report. Therefore, specific numerical acceptance criteria and "performance against criteria" for detailed metrics (like sensitivity, specificity, AUC for AI models) common in AI/ML medical devices are not explicitly stated in this document. Instead, the focus is on whether the modifications to the Mako Total Knee Application (3.0) maintain the safety and effectiveness of the existing predicate device (K241011).

The "acceptance criteria" here are generally inferred from the types of non-clinical performance testing conducted to demonstrate that the modified device functions as intended and is as safe and effective as its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the document (510(k) summary), precise numerical acceptance criteria and corresponding reported performance values are not detailed. The performance data section broadly lists the types of tests conducted.

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

The document does not specify the sample sizes (e.g., number of cadavers for validation, number of units for software testing) or the data provenance (e.g., country of origin, retrospective/prospective). The testing listed is primarily non-clinical (lab-based, cadaveric, bench testing) to verify the device's functionality and safety modifications.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This document describes a stereotaxic instrument for orthopedic surgery, not an AI/ML diagnostic or predictive model that requires expert annotation for ground truth. Therefore, the concept of "experts establishing ground truth" in the context of radiological image interpretation, for example, is not applicable here. Ground truth in this context would refer to precisely known anatomical landmarks or simulated bone cuts, which are inherent to the engineering and design validation processes of a surgical robot.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in human-annotated datasets, particularly common in AI/ML diagnostic applications. Since this device is a surgical robotic system undergoing non-clinical technical validation, such adjudication methods are not relevant or mentioned. The validation would follow engineering testing protocols, where "ground truth" (e.g., accuracy of a cut relative to a plan) is measured by precise instruments or physical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention any MRMC study. This type of study is primarily relevant for diagnostic AI tools where human readers (e.g., radiologists) interpret images with and without AI assistance to assess the AI's impact on their performance. The Mako Total Knee Application is a surgical assist system, and its validation focuses on the precision and safety of its robotic assistance, not on diagnostic reading improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a "human-in-the-loop" system, assisting the surgeon. The "Bone Registration and Resection Accuracy" and "Software Performance Verification" tests can be considered evaluations of the system's (algorithm + hardware) performance in a controlled environment, which includes the interaction of the software with the physical components. The document doesn't explicitly separate "algorithm only" performance for a non-diagnostic device. The system's performance is inherently tied to its function as an assistive tool to the surgeon.

7. The Type of Ground Truth Used

For the performance testing mentioned (e.g., "Bone Registration and Resection Accuracy," "Cadaveric Design Validation"), the ground truth would be established through:

• Precision Metrology: Highly accurate measurement equipment to verify the robotic arm's movements, resections, and landmark registrations against a pre-defined geometric plan or a physical standard.
• CT-based models: The system relies on CT data, so the "ground truth" for anatomical structures would be derived from these high-resolution imaging scans, verified by anatomical experts or engineering specifications.
• Controlled experimental setups: In cadaveric studies, the "ground truth" for ideal surgical outcomes (e.g., correct implant placement, precise bone cuts) would be defined by surgical and engineering standards and then measured on the cadaveric specimens post-procedure.

8. The Sample Size for the Training Set

This document describes a modification to an existing stereotaxic instrument, not a de novo AI/ML model that is "trained" on a dataset in the conventional sense. The "software changes" involve an update to the programming language, UI, features, and an optional planning tool (page 5). These are software updates to an existing system, rather than training a deep learning model. Therefore, the concept of a "training set" for an AI/ML algorithm isn't directly applicable as described here. The system likely uses fixed algorithms based on physics and geometry, possibly with some learned parameters from system calibration and empirical testing, but not in the framework of a large-scale data training process.

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

As noted above, a "training set" in the context of AI/ML model development is not indicated for this device based on the document. The system's "ground truth" for its core functions (registration, resection guidance) would be established by fundamental engineering principles, anatomical studies, and precise metrology during its initial development and subsequent validation.

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The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:

· Total Knee Arthroplasty (TKA)

The implant systems compatible with the system:

• · Triathlon Total Knee System (CR/CS/PS/PSR cemented and cementless primary)
• · Triathlon Total Knee System (TS inserts cemented primary)

The Mako System with the subject Mako Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, camera, a computer, dedicated instrumentation, operating software, and tools and accessories. The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.

Once configured for a specific application, the Mako robotic-arm can serve as the surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

The provided text is a 510(k) Summary for the Mako Total Knee Application, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, and comparative technological characteristics. However, it does not contain the specific details required to answer your questions regarding acceptance criteria, study methodologies (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance), or ground truth establishment.

The document states: "Performance Data - The modified Mako System with the subject Mako Total Knee Application has been evaluated through the following non-clinical performance testing: Software Functional Testing, Cutting System Accuracy, Cable Reliability, Software Performance Verification, System Testing, Cadaveric Design Validation, Summative Evaluation."

While it lists categories of testing, it does not provide the acceptance criteria for these tests, nor does it detail the specific results, sample sizes, number or qualifications of experts, or ground truth methods used in any of these evaluations. It only concludes that "performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device."

Therefore, I cannot provide the requested information based on the text provided. The document focuses on regulatory justification for substantial equivalence rather than a detailed technical report of the validation studies conducted to prove performance against specific acceptance criteria.

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Ask a specific question about this device

The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:

• · Total Knee Arthroplasty (TKA)
  The implant systems compatible with the system:

• · Triathlon Total Knee System (CR/CS/PS/PSR cemented and cementless primary)

• · Triathlon Total Knee System (TS inserts cemented primary)

• · Kinetis Total Knee System (CR/UC)

The Mako System with the subject Mako Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.

Once configured for a specific application, the Mako robotic-arm can serve as the surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

The provided document is a 510(k) summary for the Mako Total Knee Application, which describes modifications to an existing device. It discusses the device's intended use and technical characteristics compared to a predicate device, as well as performance testing conducted. However, it does not contain specific acceptance criteria, detailed study results, or the other specific information requested in your prompt regarding dataset details, expert qualifications, and comparison to human performance with AI assistance.

Therefore, I cannot populate the requested table and answer many of your specific questions based solely on the provided text. The document states that "performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device," but it does not provide the specific metrics or acceptance criteria used to make this determination, nor does it present the detailed results from the "Simulated-use cadaveric surgeon validation" or "Knee alignment clinical outcomes data review."

Below is a table where I have filled in what little information is directly available and indicated where requested information is not present in the provided text.

Acceptance Criteria and Device Performance Study Details for Mako Total Knee Application (K193515)

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The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:

• · Total Knee Arthroplasty (TKA)
  The implant systems compatible with the system:

• · Triathlon Total Knee System (CR/CS/PS cemented and cementless primary)

• · Triathlon Total Knee System (TS inserts cemented primary)

• · Kinetis Total Knee System (CR/UC)

The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Make System is indicated for use in surgical knee and hip procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:

• · Unicondylar knee replacement and/or patellofemoral knee replacement
• · Total Hip Arthroplasty (THA)

The Mako System with the subject Total Hip Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic/haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.

Once configured for a specific application, the Mako robotic-arm can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

The Mako System with the subject Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic/haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.

Once configured for a specific application, the Mako robotic-arm can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

The provided text describes the regulatory clearance for the Mako Total Hip Application and Mako Total Knee Application, but it does not contain information about acceptance criteria or specific study details proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results with acceptance criteria.

Specifically, it mentions:

• Non-clinical performance testing: "Software testing", "Treatment Design Application Full Software Run Through", "Bone Registration Accuracy Verification", and "Mako Total Hip/Knee Application Full System Run Through".
• Conclusion: "Performance testing has demonstrated that the characteristics of the subject Mako Total Hip/Knee Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness."

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts, their qualifications, or ground truth establishment details for the test set.
4. Adjudication methods.
5. MRMC study information.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the level of detail requested as this information is not present in the document. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than detailing the full performance study methodology and results.

The document only states that "Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application/Mako Total Knee Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness." It mentions non-clinical performance testing including:

• Treatment Design Application Full Software Run Through
• Bone Registration Accuracy Verification
• Mako Total Hip/Knee Application Full System Run Through

However, it does not provide any specific quantitative acceptance criteria, the results against these criteria, or the detailed methodologies (like sample size, type of ground truth, expert qualifications, etc.) of these performance tests.

To answer your request, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states performance testing was done and concluded equivalence and safety/effectiveness, but no specific metrics or targets are given.
2. Sample sizes used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable for this type of device, which is a surgical robotic system for guidance, not an AI-assisted diagnostic tool for human readers. No MRMC study details are provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document refers to "non-clinical performance testing" including software run-throughs and accuracy verification, which might be considered standalone testing of system components, but it doesn't provide details on what constitutes "standalone performance" in this context or its results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. The testing relates to "Bone Registration Accuracy Verification," implying an objective measurement against a known standard, but the specific ground truth methodology is not detailed.
8. The sample size for the training set: Not applicable based on the nature of the device (surgical guidance system, not a machine learning model requiring a separate training set for algorithm development described here). If it were a machine learning algorithm, this would be highly relevant, but the description points to verifying the performance of a software tool that processes CT data for surgical planning and guidance.
9. How the ground truth for the training set was established: Not applicable for the same reason as point 8.

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The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:

• Total Knee Arthroplasty (TKA)

The implant systems compatible with the system:

• · Triathlon Total Knee System (CR/CS/PS cemented and cementless primary)
• · Triathlon Total Knee System (TS inserts cemented primary)
• · Kinetis Total Knee System (CR/UC)

The Mako System with the Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic/haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.

The Mako robotic arm, once configured for a specific application, can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

The provided text focuses on the FDA's 510(k) clearance for the Mako Total Knee Application (K172219), stating its substantial equivalence to a predicate device (K170581). This document does not contain the detailed acceptance criteria or the specific results of a study that proves the device meets those criteria in the format typically used for AI/ML device performance evaluation (e.g., sensitivity, specificity, or clinical outcome measures, MRMC studies, etc.). Instead, it describes performance testing in the context of a robotics-assisted surgical system.

However, based on the information provided, we can infer some aspects and construct a response within the given limitations.

Here's an attempt to answer your questions based only on the provided text, highlighting what information is not available:

Acceptance Criteria and Device Performance for MAKO Total Knee Application (K172219)

The provided document describes a 510(k) submission for the MAKO Total Knee Application. Unlike AI/ML medical devices that often have specific performance metrics like sensitivity and specificity measured against a ground truth, this device is a surgical assistance system (stereotaxic instrument). Its "performance" revolves around its ability to provide accurate spatial guidance and integrate with specific implants, demonstrating substantial equivalence to a previously cleared device.

Since the document is a 510(k) clearance letter and summary, it primarily focuses on establishing "substantial equivalence" to a predicate device, rather than detailing a study with explicit quantitative acceptance criteria for each specific metric typically seen in AI/ML validation.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a table with explicit numerical acceptance criteria for statistical metrics (like sensitivity/specificity for diagnostic AI) or detailed performance results in that format. Instead, the performance evaluations mentioned are designed to demonstrate the system's accuracy and functionality for its intended surgical guidance purpose. The "acceptance" is implicitly tied to demonstrating functionality and accuracy comparable to the predicate device.

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

• Sample Size: The document mentions "Cutting Accuracy Verification" and "Full system Cadaver Validation." The specific number of cases or cadavers used for these tests is NOT provided.
• Data Provenance: The document does not specify the country of origin. The validation involved "Cadaver Validation," implying a laboratory or simulated surgical environment. The studies are non-clinical performance testing. It does not state whether it was retrospective or prospective in a clinical setting, as it's a non-clinical, pre-market submission.

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

• Not Applicable / Not Provided. For a surgical robotic system's "accuracy" and "functional performance," the ground truth is often established by engineering specifications, physical measurements, and comparison against established surgical methodologies or predicate device performance, rather than expert human interpretation of images like in diagnostic AI. The document does not refer to "experts" establishing a ground truth in the context of image labeling or diagnosis.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are interpreting data (like medical images) and their interpretations need to be reconciled to form a ground truth. This type of method is not mentioned for the non-clinical performance testing of a surgical robot.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is relevant for diagnostic or AI-assisted diagnostic devices where the performance of human readers (with and without AI assistance) is compared. This document describes a surgical robotic system for guiding procedures. The type of testing performed (Cutting Accuracy, Cadaver Validation) is not an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Partially Applicable, but not in the typical AI sense. The system works as a "surgeon's intelligent tool holder or tool guide." The "Cutting Accuracy Verification" would be a standalone test of the system's precision based on its programming and mechanics. However, its ultimate function is always "human-in-the-loop" as it assists a surgeon. The term "algorithm only" is less fitting for a hardware-software integrated robotic system where the algorithm drives the physical guidance. The non-clinical tests would evaluate the system's mechanical and computational accuracy.

7. The Type of Ground Truth Used

• Engineering Specifications / Physical Measurement / Pre-defined Anatomical Models. For "Cutting Accuracy Verification," the ground truth would be based on precise measurement of cuts against intended/programmed cuts or anatomical landmarks. For "Cadaver Validation," the ground truth would relate to the successful and accurate completion of surgical steps (e.g., implant alignment, bone preparation) as determined by established surgical principles and post-procedure measurements on the cadaver. It is based on CT-based models of anatomy which the system uses for reference.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. This device is a stereotaxic instrument that uses pre-operative CT data for planning and intraoperative guidance, not a machine learning algorithm that is "trained" on a large dataset of patient images in the way many AI/ML diagnostic tools are. Its "training" is in its engineering design and calibration.

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

• Not Applicable. As noted above, this device does not have a "training set" in the common machine learning sense. Its "knowledge" is embedded in its design, calibration, and the anatomical information derived from patient-specific CT scans.

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The Mako System is intended to assist the surgeon in providing software spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy.

These procedures include:

• · Total Knee Arthroplasty (TKA)
  The implants systems compatible with this system:
• · Triathlon Total Knee System (CR/CS/PS cemented Primary)
• · Kinetis Total Knee System (CR/UC)

The Mako System with the Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.

The Mako robotic arm, once configured for a specific application, can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

Here's a breakdown of the acceptance criteria and study information for the Mako Total Knee Application, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses primarily on verifying the integration of a new online portal (eRequest LifeCycle) into an existing device (Mako Total Knee Application, cleared via K143752). Therefore, the acceptance criteria are related to the successful functionality and integration of this change, rather than new performance criteria for the core surgical application itself.

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

The document does not explicitly state a specific numerical "sample size" in terms of cases or patients for the test set. The validation appears to be functional and simulated-use testing.

• Test Set Sample Size: Not explicitly stated as a number of cases/patients. The testing involved verifying product specifications and running through the eRequest system in a "simulated-use environment" with an "appropriate user."
• Data Provenance: Not applicable in the context of clinical data for this type of submission. The testing is for the integration and functionality of a software component (eRequest Lifecycle) within an existing device, not for clinical performance on patient data.

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

This information is not provided in the document. The "ground truth" for these tests relates to the proper functioning of the software and its adherence to product specifications and user requirements, not clinical diagnoses or outcomes adjudicated by medical experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the testing (product specification verification and functional run-throughs), a formal adjudication method by multiple experts is unlikely to have been employed.

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on a modification (integration of eRequest LifeCycle) to an existing cleared device (Mako Total Knee Application K143752). The studies are functional and simulated-use tests for this integration, not clinical comparative effectiveness studies showing human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone performance study was not done. The Mako System, by definition, is designed to "assist the surgeon" and serves as a "surgeon's 'intelligent' tool holder or tool guide." Its primary function involves human interaction for pre-surgical planning, implant placement, and intraoperative navigation. The software (eRequest LifeCycle) is part of the pre-operative planning workflow that supports the human surgeon.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the verification and validation tests in this submission appears to be:

• Product Specifications: For the "Product Specification Verification" test.
• Intended Functionality/Workflow Success: For the "eRequest – Full System Run Through" and "Planning Workflow - TKA Validation" tests, ensuring the system performs as designed and meets user/customer requirements in a simulated environment.

8. Sample Size for the Training Set

This information is not applicable and not provided. The submission is for a modification to an existing device, involving the integration of a new online portal (eRequest LifeCycle) for case management and file transfer. This is not an artificial intelligence/machine learning model where a "training set" of data would be used to develop an algorithm.

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

This information is not applicable and not provided, as there is no mention of a training set for an AI/ML algorithm in this submission.

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