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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 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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