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The Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), 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 Robotic Arm Interactive Orthopedic System (RIO), 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 .
• Restoris Porous Partial Knee System ●

Partial Knee Application is an upgrade to RIO-PKA (K112507). The features of this application are to improve overall performance of the system in supporting partial knee arthroplasty. Partial Knee Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.

The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, cutting system, and a robotic arm. The system's architecture is designed to support partial knee procedures. With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.

RIO's 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 document describes the MAKO Surgical Corporation's Partial Knee Application (PKA) device, which received 510(k) clearance from the FDA. The document summarizes various performance tests conducted to demonstrate the device's substantial equivalence to predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table summarizing the validation and verification methods, their acceptance criteria, and the results, as shown below:

2. Sample Sizes Used for the Test Set and Data Provenance:

The document provides a list of tests and states "Pass" for each, but it does not specify the sample sizes used for any of the individual tests comprising the test set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of data). The studies are described as "nonclinical performance testing" and "simulated-use environment," indicating they were likely conducted in a lab or pre-clinical setting rather than with human patients.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The validation tests, particularly the "Full System Run-through test" and the "PKA System Validation," mention assessing "adequate functionality" and satisfying "customer requirements," which would implicitly involve expert assessment, but details are not given.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the tests (functional and system accuracy), it's more likely that predefined technical specifications were used as criteria rather than a consensus among multiple human adjudicators for subjective assessments.

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

The document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The studies described are focused on the device's functional performance and accuracy, not on comparing the performance of human readers with and without AI assistance.

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

The "Partial Knee Application (PKA)" is described as being "intended to assist the surgeon" and "provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation." The "RIO's robotic arm... can serve as surgeon's 'intelligent' tool holder or tool guide." This clearly indicates a design for "human-in-the-loop" operation. Therefore, a standalone (algorithm-only) performance study is not explicitly described or implied as being relevant given the device's assistive nature. However, certain functional tests (e.g., System Accuracy Test, PKA Application Performance Test) would evaluate the algorithm's performance independent of surgical action, but within the context of ultimately assisting a surgeon.

7. The Type of Ground Truth Used:

The ground truth for most of these tests appears to be based on engineering specifications and predefined performance metrics. For example, the "System Accuracy Test" aims to determine "overall system accuracy as a result of bone registration and bone resection accuracy." This implies a comparison against a known, accurate standard or measurement. For the "Full System Run-through test" and "PKA System Validation," the ground truth would be the successful completion of the PKA procedure according to established clinical protocols and "customer requirements" (likely derived from surgical best practices and outcomes) in a simulated environment. There is no mention of pathology or long-term outcomes data used as ground truth in these nonclinical tests.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. As this device seems to be a complex robotic surgical assistance system, there would undoubtedly be internal development and training data used for its algorithms and software. However, such details are not disclosed in this 510(k) summary.

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

Similar to question 8, the document does not provide information on how the ground truth for any potential training set was established.

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The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:

· Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.

· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.

· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

The RESTORIS ® Porous Femoral Component and PST® Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.

The RESTORIS® Porous Partial Knee System is a knee joint femorotibial (unicompartmental) prosthesis. The RESTORIS® Porous Partial Knee System consists of femoral components and tibial baseplate components that are compatible with and intended for use with MAKO's predicate RESTORIS MCK Tibial Onlay Insert Components (K090763 or K133039).

The RESTORIS® Porous Femoral Component and PST® Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.

The Porous Femur components: sizes 1 through 8, CoCr with a CoCr porous coating for cementless fixation, asymmetric design (meaning that left medial implants can be used on the right lateral compartment and right medial implants can be used on the left lateral compartment; abbreviated hereafter as LM/RL and RM/LL)

PST® Tibial Baseplate components: sizes 1 through 8. Ti6Al4V allov with MAKO's predicate porous surface (porous structured technology, referred to as "PST®"), asymmetric (LM/RL-RM/LL).

The provided document is a 510(k) premarket notification for a medical device, the RESTORIS® Porous Partial Knee System. It focuses on demonstrating substantial equivalence to a predicate device based on manufacturing materials, design, technological characteristics, and performance data.

However, this document does not contain the information requested regarding acceptance criteria and the study proving a device meets them in the context of AI/ML performance. The device described is a physical knee implant, not an AI-powered diagnostic or therapeutic tool.

Therefore, I cannot extract the following information from this document:

1. A table of acceptance criteria and the reported device performance: This document reports on non-clinical performance testing for a physical implant (e.g., snaplock strength, micromotion, wear), not AI model metrics like sensitivity, specificity, or AUC.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical implant, not an AI-assisted diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to physical implant performance testing in this context.
8. The sample size for the training set: Not applicable (no AI model).
9. How the ground truth for the training set was established: Not applicable (no AI model).

The "Performance Data" section lists non-clinical performance testing related to the physical characteristics and function of the knee implant, such as:

• Insert Snaplock Strength
• Tibial Insert / Baseplate Micromotion
• Tibio-Femoral Range of Motion
• Tibio-Femoral Instability
• Tibio-Femoral Contact Area and Stress
• Tibial Insert Fatigue
• Tibial Insert Wear

The conclusion states that "The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices." This is the general "acceptance" for a 510(k) submission for this type of device, demonstrating it functions as intended and is as safe and effective as a legally marketed predicate. However, detailed, quantitative acceptance criteria for each test (e.g., "snaplock strength > X N") are not provided in this summary, nor are the specific results for each test.

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The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The RIO 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)

MAKOplasty Total Hip Application is an upgrade to RIO-THA (K121064). The features of this application are to improve overall performance of the system in supporting total hip arthroplasty. MAKOplasty Total Hip Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.

The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, cutting system, and a robotic arm. The system's architecture is designed to support two main surgical applications: total hip procedures and partial knee procedures. With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.

RIO's 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 an analysis of the provided text regarding the acceptance criteria and study information for the MAKOplasty Total Hip Application, based on the requested format.

It's important to note that the provided document is an FDA 510(k) K141989 summary which often has specific limitations in detailing study methodology, especially for performance data. Much of the requested information (e.g., specific sample sizes for test/training, number and qualifications of experts, adjudication methods, MRMC studies, specific ground truth types with details) is not explicitly stated in this type of document. The summary focuses on demonstrating substantial equivalence through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria alongside corresponding reported device performance values in the way one might expect from a detailed study report. Instead, it lists "Non-clinical Performance Testing" and states a general conclusion.

Explanation: The document lists several "non-clinical performance tests" and concludes that "The results of testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues." This implies that the acceptance criteria for each of these tests were met, demonstrating the device's functionality and safety. However, the specific quantitative pass/fail criteria for each test (e.g., what constitutes "working as intended" for a communication test, or a specific tolerance for a functional test) are not detailed.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "non-clinical performance testing" which typically involves bench testing, simulated use, and potentially cadaveric studies, rather than a "test set" in the context of clinical data.
• Data Provenance: Not applicable in the context of clinical data. The tests described are non-clinical, likely conducted in a lab or simulated environment.

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

• Number of Experts: Not applicable/not stated. For non-clinical functional and performance tests, "ground truth" is typically established by engineering specifications, calibration standards, or simulated outcomes, rather than expert consensus on patient data.
• Qualifications of Experts: Not applicable/not stated.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Given the non-clinical nature of the tests, an adjudication method for conflicting expert opinions on a data set is not relevant. Performance is measured against predetermined engineering or functional specifications.

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

• MRMC Study: No. The document does not mention an MRMC comparative effectiveness study, nor does it discuss human reader performance with or without AI assistance. The MAKOplasty Total Hip Application is a robotic surgical assistance system, not an AI diagnostic tool that human readers would interpret.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no such study is described.

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

• Standalone Study: Yes, in the sense of the defined "non-clinical performance testing." The tests listed (e.g., RIO Arm and MICS communication, functional tests) evaluate the device's components and system functionality in a controlled, non-human-in-the-loop environment. The device assists a surgeon; these tests determine if the assistance system itself works as intended algorithmically and mechanically.

7. The Type of Ground Truth Used

• Ground Truth Type: For the non-clinical performance tests, the "ground truth" is likely based on:
  • Engineering Specifications: Whether components communicate correctly, threads connect properly, and mechanical parts function within defined tolerances.
  • Simulated Outcomes: Verification that the system performs its intended function (e.g., provides correct spatial boundaries, achieves desired reaming accuracy in a simulated environment) as per design goals.
  • Design Requirements: Conformance of the system's output to its specified design requirements.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not stated. The document describes a robotic surgical assistance system. While such systems involve complex algorithms, the development process (including feature training or calibration) would be part of the overall design and verification/validation, but a specific "training set" in the context of a machine learning-based diagnostic algorithm on a dataset is not described or implied for this device's 510(k) submission. Pre-operative planning uses patient CT data, but that's for individual patient planning, not for training a general algorithm.

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

• Ground Truth for Training Set: Not applicable/not stated, for the reasons outlined in point 8.

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RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multicompartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic 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.

RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (RESTORIS™ MCK Uni) and a patellofemoral implant system (RESTORISTM MCK PF).

• RESTORIS™ MCK Uni: .
  • Unicompartmental femoral condyle components o
  • Unicompartmental tibial onlay components (tibial baseplate and tibial onlay o insert)
  • Unicompartmental tibial inlay components 0
• RESTORIS™ MCK PF: .
  • Patellofemoral trochlear components o
  • Patella components o

The RESTORIS™ MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In RESTORIS™ MCK combinations where multi-compartmental areas are being treated, the RESTORIS™ MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.

The provided document, a 510(k) summary for the RESTORIS™ Multicompartmental Knee (MCK) System, describes the device and its intended use, but it does not contain information related to acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document states that the device has been evaluated through "non-clinical performance testing" for various aspects, and concludes that "The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices." However, it does not specify what these performance criteria were, what the acceptance thresholds for these criteria were, or the detailed results demonstrating that these criteria were met.

Therefore, I cannot populate the table or answer the specific questions posed, as the information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices rather than presenting detailed clinical or performance study results against predefined acceptance criteria.

Key takeaway: This document does not pertain to an AI/ML powered device, so acceptance criteria and study design as outlined in the prompt are not applicable to the information provided.

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The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The RIO 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)

MAKOplasty Total Hip Application is an upgrade to RIO-THA (K093425). The features of this application are to improve overall performance of the system in supporting total hip arthroplasty. MAKOplasty Total Hip Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.

The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, drill system, and a robotic arm. The system's architecture is designed to support two main surgical applications: hip procedures and knee procedures (per K112507). With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.

RIO's 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.

This document describes the MAKOplasty Total Hip Application, an upgrade to the RIO-THA (Total Hip Arthroplasty) system. This device is intended to assist surgeons by providing software-defined spatial boundaries and real-time guidance during orthopedic procedures, specifically total hip arthroplasty, unicondylar knee replacement, and patellofemoral knee replacement. It uses patient CT data for pre-surgical planning and intraoperative navigation.

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "All testing Passed" for the verification activities and "Passed" for validation testing. The main performance characteristic is the device's ability to "support total hip arthroplasty procedures, and unicondylar and/or patellofemoral knee replacement" and a "System Accuracy" test. No specific quantitative metrics for accuracy (e.g., target deviation in mm) or other performance parameters are provided in the excerpt.

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

The document mentions "Total Hip Application Full Cadaver Validation Lab" for validation testing. However, it does not specify the sample size (number of cadavers or cases) used for this test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective). Cadaver labs are typically prospective and aim to simulate real-world surgical conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The nature of the "Full Cadaver Validation Lab" suggests surgical experts would be involved in assessing the outcomes, but their number and qualifications are not detailed.

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

The document does not describe any specific adjudication method for the test set in the validation lab.

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

The document does not mention an MRMC comparative effectiveness study involving human readers or an AI assistance component. The device itself is an assistive robotic system for surgical procedures, not an AI diagnostic tool primarily for human reader interpretation. No effect size for human reader improvement is provided.

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

The document describes the device as a "Robotic Arm Interactive Orthopedic System (RIO)" intended to "assist the surgeon" and serve as a "surgeon's 'intelligent' tool holder or tool guide." This indicates a human-in-the-loop system, not a standalone algorithm without human involvement. Therefore, a standalone performance study as typically understood for diagnostic AI was likely not performed or relevant in this context.

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

For the "Total Hip Application Full Cadaver Validation Lab," the ground truth would likely be based on objective measurements of implant placement, alignment, and other surgical parameters post-procedure, measured against pre-operative plans. This would involve expert assessment and direct measurement within the cadaveric setting, rather than pathology or long-term outcomes data. The document does not explicitly state the specific methods used to establish this ground truth.

8. The sample size for the training set

The document does not provide information about a "training set" or its sample size. This device is an upgrade to an existing robotic surgical system, and the information presented focuses on the verification and validation of the application itself, not on the training of an AI model in the conventional sense.

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

As no training set is mentioned for an AI model, this information is not applicable. The device's functionality is based on pre-programmed designs and real-time navigation guided by CT data, rather than machine learning trained on large datasets.

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The Restoris Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Restoris Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), 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.

Restoris PKA is an upgrade to the Tactile Guidance System v2.0, a.k.a RIO, which was cleared via K081867. The features of this application are to improve overall performance of the system in supporting unicondylar and/or patellofemoral knee replacement. Restoris PKA is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.

Restoris PKA provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation. RIO's robotic arm, once configured for use with Restoris PKA, can serve as a surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with softwaredefined spatial boundaries.

Here's a breakdown of the acceptance criteria and study information for the Restoris Partial Knee Application (PKA) as described in the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document summarizes the testing and indicates that "All acceptance criteria were satisfied" or "The testing successfully met the acceptance criteria specified in the validation protocol." However, the specific quantitative acceptance criteria themselves are not explicitly listed in this summary document. The document focuses on the conclusion that the criteria were met.

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

• Verification Testing (Integration & Registration):

  • Sample Size: Sawbone models were used for both the integration and registration verification tests. The exact number of sawbone models is not specified.
  • Data Provenance: Retrospective (synthetic models).

• Validation Testing (Usability):

  • Sample Size: Two (2) cadaveric specimens were used.
  • Data Provenance: Prospective (cadaveric specimens).

• Validation Testing (Overall System Performance):

  • Sample Size: Three (3) cadaveric specimens were used.
  • Data Provenance: Prospective (cadaveric specimens).

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

• Verification Testing: Not applicable, as testing was against predefined system specifications or expected outcomes.
• Validation Testing (Usability): Three (3) users participated in completing the procedure. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated. They are generally referred to as "users," implying they are likely surgeons or trained medical professionals using the device in a simulated environment.
• Validation Testing (Overall System Performance): One surgeon performed the procedure, and four (4) independent reviewers assessed the outcome. The specific qualifications of these surgeons/reviewers are not explicitly stated.

4. Adjudication Method for the Test Set

• Verification Testing: Not applicable, as outcomes were likely assessed against objective technical specifications.
• Validation Testing (Usability): The method of adjudication for the "acceptance criteria" being met is not detailed beyond the conclusion that they were met. It's implied to be based on the experience of the 3 users.
• Validation Testing (Overall System Performance): One surgeon performed the procedure, and four (4) independent reviewers assessed it. The specific adjudication method among the four reviewers (e.g., 2+1, 3+1, simple majority) is not specified. It just states they independently reviewed the procedure.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• A MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was not explicitly described in this 510(k) summary. The studies described focus on the device's performance in guiding a surgeon directly during a procedure, not on a diagnostic reading task. The device assists the surgeon rather than providing interpretations for readers.

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

• Yes, in part. The Verification Testing for "registration with the Restoris PKA satisfies the specified accuracy requirements" using "the software's improved bone model imaging algorithm" can be considered a form of standalone testing for a specific algorithmic component (registration accuracy). However, the overall device (Restoris PKA) is intended for human-in-the-loop surgical assistance, so the primary validation is in that context.

7. The Type of Ground Truth Used

• Verification Testing (Integration & Registration): The ground truth was likely based on pre-defined engineering or system specifications and benchmarks for integration functionality and accuracy of registration.
• Validation Testing (Usability & Overall System Performance): The ground truth for these cadaveric studies would be the successful and accurate completion of the simulated surgical procedure as assessed by the participating surgeons/reviewers against clinical standards and the stated "needs of the user" for unicondylar and/or patellofemoral knee replacement. This is a form of expert assessment of procedural correctness and outcome.

8. The Sample Size for the Training Set

• The 510(k) summary does not provide any information regarding a specific training set or its sample size for the Restoris PKA. This document describes verification and validation testing, not the development or training of an AI model in the conventional sense. The device "assists a surgeon with presurgical planning and interpretive/intraoperative navigation" using "patient CT data," implying it's a guidance system built upon established biomechanical models and image processing, rather than a deep learning model requiring a distinct training dataset for its core function.

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

• As no training set is described, there's no information on how its ground truth might have been established.

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RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, 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 MCK is for single use only and is intended for implantation with bone cement.

The Restoris MCK is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). Restoris MCK Uni and Restoris MCK PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial or lateral side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The provided document is a 510(k) summary for the MAKO Surgical Corp. Restoris MultiCompartmental Knee System (Restoris MCK). This document describes the device, its components, materials, and intended use, and states its substantial equivalence to a predicate device.

However, it does not contain any information regarding specific acceptance criteria, performance data, or detailed study methodology (like sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, or MRMC studies) related to the device's clinical or algorithmic performance.

The document is a regulatory submission demonstrating substantial equivalence to a previously cleared device, not a report of performance testing against predefined acceptance criteria from a study.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on the text provided. The 510(k) summary focuses on the device description and its substantial equivalence to a predicate device, as opposed to a detailed performance study with specific metrics and acceptance criteria.

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The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee replacement used in conjunction with the MAKO Tactile Guidance System in individuals with osteoarthritis or post traumatic arthritis of the medial tibiofemoral and/or patellofemoral articular surfaces.

The MAKO Modular Knee Compartmental Implant System is for single use only and is intended for implantation with bone cement.

The MMKC is composed of a unicompartmental implant system (MMKC-Uni) and a PF implant system (MMKC-PF). MMKC-Uni and MMKC-PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. MMKC-UNI is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

This document is a 510(k) summary for the MAKO Surgical Corp. Compartmental Knee Implant System (MMKC). It describes the device, its components, materials, sterilization, and indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot provide the requested table and study details based on the provided text. The document focuses solely on the regulatory submission and declaration of substantial equivalence to predicate devices, without presenting performance data.

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