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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 total hip arthroplasty 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;

including revision total hip arthroplasty procedures where:

• the primary acetabular component is well-fixed to the pelvic anatomy, and
• the acetabular component can be revised with either a cup or cup and wedge augment construct.

These procedures include: Total Hip Arthroplasty (THA)

The Mako System with the subject Mako Total Hip Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, camera, 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 FDA 510(k) summary document for the Mako Total Hip Application 5.0 indicates that no clinical studies were performed. Instead, the device was evaluated through non-clinical performance testing. The document focuses on demonstrating substantial equivalence to a predicate device (Mako Total Hip Application, cleared via K193128) based on these non-clinical tests.

Therefore, the following information, which typically relates to clinical studies and the use of expert adjudicated ground truth, is not available within this document:

• Acceptance Criteria and Reported Device Performance (Table): While performance testing was done, specific numerical acceptance criteria and reported device performance (e.g., accuracy metrics with thresholds) are not detailed in this summary. The summary states "performance testing demonstrates that the characteristics of the subject Mako Total Hip Application are equivalent to the characteristics of the predicate device," but does not provide quantitative results for these tests.
• Sample size for the test set and data provenance: No clinical test set.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no external expert ground truth was established for a clinical test set.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as no human reader studies were conducted.
• Standalone (algorithm only without human-in-the-loop performance) study: The device is a system with human-in-the-loop (surgeon assistance). While non-clinical accuracy tests were performed, these are not presented as "standalone algorithm performance" in the context of typical AI medical device evaluation.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical test set. For the non-clinical tests, physical measurements and system specifications would serve as the "ground truth."
• Sample size for the training set: Not applicable, as this is not a traditional AI/ML device relying on a large training data set in the sense of image recognition or predictive analytics. The software itself is developed and tested, but a "training set" as commonly understood in AI is not mentioned.
• How the ground truth for the training set was established: Not applicable.

However, the document does list the types of non-clinical performance testing performed:

• Software testing
• Bone registration accuracy verification
• Bone resection accuracy verification
• System verification
• Simulated-Use Cadaveric Surgeon Validation

The document concludes that "performance testing demonstrates that the characteristics of the subject Mako Total Hip Application are equivalent to the characteristics of the predicate device," and that "The subject device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness."

Therefore, based on the provided text, while non-clinical performance tests were conducted to demonstrate substantial equivalence, the specific quantitative acceptance criteria and detailed performance metrics that would typically comprise the requested table and clinical study details are not explicitly stated in this 510(k) summary.

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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 a surgical hip procedure 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 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 provided text is a 510(k) Pre-Market Notification from the FDA regarding the Mako Total Hip Application. It is a clearance document for a medical device that assists surgeons during Total Hip Arthroplasty (THA) procedures through stereotactic/haptic guidance.

However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

Specifically, the document states:

• "Performance Data - The Mako System has been evaluated through the following non-clinical performance testing: Software testing, Instrument performance testing, Mako Total Hip Application full system run through, Bone registration accuracy verification, Implant models and visuals verification, Full system cadaver validation, Biocompatibility verification."
• "Conclusions of Performance Testing: Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application are 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. Therefore, the performance testing supports a determination of Substantial Equivalence."

This outlines the types of tests performed and the conclusion of substantial equivalence, but it does not provide the specific numerical acceptance criteria, the reported performance metrics, sample sizes, data provenance, expert qualifications for ground truth, adjudication methods, or details about training sets.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

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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 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 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 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 Mako 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 device is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures, specifically Total Hip Arthroplasty (THA).

The device in question is a modification of a previously cleared device (K141989), with the modification being "An alternate online portal for case management and file transfer known as eRequest LifeCycle is being implemented for use during the preoperative planning phase of the Mako Total Hip Application." Therefore, the validation and verification focused on ensuring that this new portal and its integration did not negatively impact the existing functionalities or introduce new risks.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The tests described are functional verification and validation steps for software integration rather than clinical performance studies involving patient data.

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

The document does not specify the number or qualifications of experts used to establish a "ground truth" for the test set. The validation appears to be based on product specifications and user requirements, likely assessed by internal development and quality assurance teams, potentially with input from clinical users or subject matter experts in surgical workflows, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (such as 2+1 or 3+1). The tests are described as "Pass/Fail" based on whether the acceptance criteria were met.

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

An MRMC comparative effectiveness study was not done. The device is a surgical planning and guidance system for Total Hip Arthroplasty (THA), and the specific tests mentioned focus on the software integration of a new case management portal. There is no information provided regarding studies on human reader performance with or without AI assistance for this device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone algorithm-only performance study was not explicitly done or detailed in the provided text. The device is inherently a "human-in-the-loop" system, assisting surgeons. The testing focused on the functionality of the new eRequest LifeCycle within the overall Mako System, which is for pre-operative planning.

7. Type of Ground Truth Used

The "ground truth" for these tests appears to be product specifications, documented pre-operative planning workflows, and customer requirements. These are largely functional and performance specifications for the software system and its integration, rather than clinical ground truth like pathology, expert consensus on imaging, or outcomes data.

8. Sample Size for the Training Set

The document does not specify any sample size for a training set. Given the nature of the modification (a new online portal for case management), this is unlikely to involve a machine learning model that requires a training set in the conventional sense. The "training" here would refer to software development and testing cycles rather than data-driven model training.

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

As no training set is mentioned in the context of the device's modification, the document does not describe how ground truth for a training set was established.

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