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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 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 surgical shoulder 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 patient imaging databased model of the anatomy. These procedures include:

• · Reverse Shoulder Arthroplasty (primary joint replacement)
  The implants compatible with the system are:

• · Aequalis PerFORM Reversed Glenoid (cementless)

• · Aequalis PerFORM + Reversed Glenoid (cementless)

The Mako System with the subject Mako Shoulder 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 application, and tools and accessories. The Mako System uses patient CT data to assist the physician with presurgical implant placement planning and intraoperative tracking of the patient's scapula.

The system's architecture is designed to support reverse shoulder 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 presurgical 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.

Here's a breakdown of the acceptance criteria and study information for the Mako Shoulder Application (1.0), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance tests but does not explicitly state numerical acceptance criteria or quantifiable performance metrics for these tests. The conclusions broadly state that performance testing demonstrates equivalence and that the device is safe and effective.

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

The document does not specify the sample sizes (e.g., number of cases, number of cadavers) used for the software functional testing, cutting system accuracy, reliability, software performance verification, system testing, cadaveric design validation, or summative evaluation.

The data provenance is from non-clinical performance testing, primarily involving software and hardware evaluations, and cadaveric design validation. There is no mention of human clinical data or its provenance (e.g., country of origin, retrospective/prospective).

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

The document does not specify the number of experts or their qualifications for establishing ground truth for any of the performance tests. The testing appears to be primarily engineering and design validation based, rather than clinical ground truth establishment. For the cadaveric design validation, it's plausible that surgeons or surgical experts were involved, but this isn't explicitly stated, nor are their qualifications.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1, none). This type of adjudication is typically used in studies involving human interpretation or subjective assessments, which are not detailed in this section of the submission. The performance testing described suggests objective measurements and validations against predefined specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described. Such studies are typically conducted to evaluate the impact of AI or assisted devices on human reader performance in areas like diagnostic imaging. This submission focuses on the safety and effectiveness of a surgical guidance system through engineering and cadaveric validation.

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

The performance testing described (Software Functional Testing, Cutting System Accuracy, Reliability, Software Performance Verification, System Testing) constitutes standalone testing of the algorithm and hardware components. The "Cadaveric Design Validation" also tests the system's performance, albeit in a simulated surgical environment where a "human-in-the-loop" (the surgeon operating the system) is inherent to its use. However, the initial listed tests would primarily assess the underlying algorithmic and mechanical performance without necessarily measuring full human interaction.

7. The Type of Ground Truth Used

The ground truth for the various tests would be based on:

• Design Specifications/Requirements: For software functional testing, reliability, and software performance verification, the ground truth is adherence to predefined engineering and functional specifications.
• Physical Measurements/Engineering Standards: For cutting system accuracy, ground truth would be precise measurements against known physical standards or benchmarks.
• Anatomical Accuracy/Surgical Goals: For cadaveric design validation, the ground truth would relate to the accurate execution of the pre-planned surgical procedure on the cadaveric specimen, evaluated against anatomical landmarks and surgical objectives.

There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth in this document.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. The Mako Shoulder Application uses patient CT data for pre-operative planning and intraoperative guidance, but the document does not discuss how the underlying algorithms were "trained" using specific datasets, nor the size of any such training data. The mention of BLUEPRINT (K232265) for the preoperative workflow implies use of an established planning software, but details about its training data are not provided in this 510(k) summary.

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

As no training set is discussed or specified in this document, there is no information on how its ground truth was established.

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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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RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

• · Medial unicondylar
• · Lateral unicondylar
• · Patellofemoral
• · Medial bi-compartmental (medial unicondylar and patellofemoral)

RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

The purpose of this Changes Being Effected premarket notification is to add a contraindication for the Restoris Multicompartmental Knee (MCK) System. Additionally, minor modifications are being made to the contraindications for clarity. There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices. The subject implant components are identical to the predicate components. The Restoris MCK system was most recently cleared in K180612, and has also been cleared previously in K172326, K150307, K090763, K082172, K082088, K082081, and K080368.

This FDA 510(k) submission [K220930] for the Restoris Multi-Compartmental Knee System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document explicitly states:

• "The purpose of this Changes Being Effected premarket notification is to add a contraindication for the Restoris Multicompartmental Knee (MCK) System. Additionally, minor modifications are being made to the contraindications for clarity." (Page 4)
• "There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices." (Page 4)
• "No additional testing was performed as part of this submission, as the only changes being made are to the labeling for the devices. There is no impact to the device design or the physical characteristics of the devices. Testing submitted as part of previously cleared premarket notifications is applicable to this submission." (Page 5)

Therefore, based on the provided text, I cannot fill in the requested information about acceptance criteria and study results because this particular 510(k) submission is for a labeling change and explicitly states that no new testing was performed. The performance data and acceptance criteria would have been part of previous 510(k) submissions (e.g., K180612, K172326, etc.) referenced in this document.

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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)

• · 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 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 Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with 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 unicondylar knee replacement and/or patellofemoral knee replacement.

The Implant systems with which the system is compatible:

• Restoris Multicompartmental Knee System

The MAKO System with the Partial 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 svstem 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 is a 510(k) summary for the MAKO Partial Knee Application. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the acceptance criteria and detailed study information requested in your prompt (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, or details about standalone or MRMC studies).

The "Performance Data" section briefly lists three types of non-clinical performance testing:

1. Cutting Accuracy Verification
2. Cadaver Validation of Mako System with New Burr
3. Biocompatibility Evaluation

It concludes that these tests "demonstrate that the characteristics of the MAKO Partial Knee Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate and does not raise new questions of safety and effectiveness, and therefore supports a determination of Substantial Equivalence."

Therefore, based only on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, or expert involvement. The document focuses on regulatory equivalence rather than a detailed breakdown of performance study results.

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