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CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.

These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA), and total hip atthroplasty (THA).

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.

CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:

• . Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
• Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.

Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

Here's a breakdown of the acceptance criteria and study information for the Real Intelligence Cori (Cori) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit numerical acceptance criteria for a new clinical study. The "acceptance criteria" are implied through various verification and validation activities.

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

The document does not explicitly mention a "test set" in the context of a clinical study with real patient data for the TENSIONER update. The testing described is primarily bench testing, software verification, and usability engineering validation.

• Bench Testing: No specific sample sizes for physical components are detailed, but "comprehensive performance testing" and "physical performance testing for all system components" are mentioned.
• Usability Engineering Validation: It involved "representative users" in a "simulated use environment." The exact number of users is not provided nor is the data provenance (e.g., country) specified. Given it's a simulated environment, it's not patient data.

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

This information is not provided in the document. The testing described does not seem to involve the establishment of "ground truth" by experts in the context of a diagnostic or predictive device study, but rather verification against design requirements and usability assessments.

4. Adjudication Method for the Test Set

This information is not provided as the document does not describe a study involving expert review for establishing ground truth in a clinical data set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The submission focuses on demonstrating substantial equivalence through non-clinical testing and usability, particularly regarding the addition of the TENSIONER accessory and associated software update. There is no information on how human readers (or surgeons, in this context) improve with or without AI assistance, as the device itself is a surgical navigation and robotic-assisted system, not an AI diagnostic tool that assists human readers in interpreting images.

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

This concept is not directly applicable in the terms of a diagnostic AI algorithm. The CORI system is a robotic-assisted surgical navigation and burring system. Its "performance" is inherently tied to its interaction with a human surgeon during a procedure (e.g., controlling bur engagement, providing navigation). The document describes rigorous software verification and validation, which would assess the algorithm's functionality in a standalone manner prior to human interaction, but not as an "algorithm only without human-in-the-loop performance" in the typical sense of a diagnostic AI system's clinical performance.

7. The Type of Ground Truth Used

For the software and system performance, the "ground truth" would be the design specifications and requirements that the device and its algorithms are designed to meet. For usability, the ground truth is the ability of users to safely and effectively operate the device as intended, which is assessed through usability engineering validation. There is no mention of pathology, outcomes data, or expert consensus on clinical cases.

8. The Sample Size for the Training Set

This submission is for an update to an existing system (CORI K220255) to integrate the TENSIONER accessory and software upgrade. The document does not describe the development or training of a new AI algorithm for which a "training set" would typically be referenced. Therefore, no sample size for a training set is provided. The "training" for this submission would involve the development of the software to manage the TENSIONER, which is verified against design requirements.

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

As no training set for a new AI algorithm is described, this information is not applicable/not provided. The software associated with the TENSIONER is verified against engineering and design specifications.

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CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include:

• · unicondylar knee replacement (UKR),
• · total knee arthroplasty (TKA),
• · revision knee arthroplasty, and
• · total hip arthroplasty (THA).

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.

CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:

• . Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
• . Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.

Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

This document describes the Real Intelligence CORI surgical navigation and burring system. The current submission (K220958) is an update to a previously cleared device (K220255), specifically updating the Indications for Use to include revision knee arthroplasty procedures.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for performance metrics like accuracy or precision. Instead, it relies on demonstrating that the device's performance is not negatively impacted by the expanded indications and is "as safe and effective" as the predicate device.

The reported device performance primarily focuses on the successful completion of a simulated revision knee arthroplasty procedure and confirmation that existing accuracy is maintained.

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

• Sample Size for Usability Testing: Not explicitly stated as a number. The document mentions "participating surgeons" and "representative users."
• Sample Size for Accuracy Analysis: Not explicitly stated. The analysis focused on confirming non-impact rather than new testing on a specific sample size.
• Data Provenance: The usability testing was performed in a "simulated use environment," implying a lab or controlled setting. The document does not specify a country of origin, but Blue Belt Technologies, Inc. is based in Plymouth, Minnesota, USA. The testing appears to be prospective as it was conducted for this submission.

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

• Usability Testing: The document mentions "participating surgeons" and "representative users." The specific number is not provided, nor are their detailed qualifications (e.g., years of experience, specific orthopedic specialties). However, it implies they were qualified surgeons capable of performing revision knee arthroplasty procedures.
• Accuracy Analysis: For the accuracy analysis, no experts are explicitly mentioned as establishing ground truth in the context of a test set, as the analysis primarily confirmed that no changes were made that would impact the existing accuracy parameters, which would have been established during the predicate device's clearance.

4. Adjudication Method for the Test Set

Not applicable/not specified. The studies described are usability testing and an analysis of impact on accuracy. There is no mention of an adjudication process typically associated with diagnostic performance studies involving multiple readers.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical navigation and burring system, not an AI-assisted diagnostic imaging device for "human readers." The evaluation focused on usability and maintenance of surgical accuracy.

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

The device itself is inherently "human-in-the-loop" as it assists a surgeon. The system controls bur engagement based on proximity to a planned target surface, but the surgeon operates the bur and plans the surgical implant location. No "standalone" algorithm-only performance is described, as it's an intraoperative assistance system.

7. The Type of Ground Truth Used

• Usability Testing: The "ground truth" for usability was the ability of surgeons to "safely and effectively" complete a revision knee arthroplasty procedure in the simulated environment, and validation of the instructions for use. This can be considered a form of expert observation and task completion verification against defined procedural steps and safety metrics.
• Accuracy Analysis: For accuracy, the ground truth would be the established accuracy parameters of the predicate device. The analysis confirmed that the updated indications did not alter the physical system or software in a way that would modify these established accuracy limits.

8. The Sample Size for the Training Set

Not applicable. This document describes a surgical navigation system, not a machine learning model that requires a training set in the conventional sense. The "training" of the system would imply its design, development, and validation based on engineering principles and previous surgical data, but not a distinct "training set" of patient data for an AI algorithm. The device uses "intraoperatively-defined bone landmarks and known geometry of the surgical implant" but this is real-time operation, not a pre-trained model on a dataset.

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

Not applicable, as there is no traditional "training set" for a machine learning algorithm described in this submission. The system's functionality is based on established engineering principles, navigation technologies, and predefined anatomical and implant geometries.

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CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA), and total hip arthroplasty (THA).

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.

CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:

• Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
• Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.

Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

I am sorry, but the provided text does not contain the specific information required to answer your request.

Here's why:

• Acceptance Criteria and Reported Device Performance: The document states that "Verification and validation testing demonstrated the safety and efficacy of CORI when the system is used to place porous total knee implants intended for use without bone cement." and "Comprehensive verification testing demonstrated that the system meets required design inputs." However, it does not list the specific acceptance criteria (e.g., target accuracy, precision thresholds) or report the numerical performance results against these criteria.
• Sample Size and Data Provenance for Test Set: The document mentions "Verification and validation testing" and "Summative usability testing" but does not provide details on the sample size used for these tests (e.g., number of procedures, number of patients, number of simulated cases) or the provenance of the data (e.g., country of origin, retrospective/prospective).
• Experts for Ground Truth: There is no mention of experts used to establish a ground truth for a test set, nor their qualifications or number.
• Adjudication Method: No information regarding an adjudication method is provided.
• MRMC Comparative Effectiveness Study: The document does not describe any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention any effect size for human reader improvement with AI assistance.
• Standalone Performance: While the document describes the device's functionality, it does not explicitly state or provide data for a standalone (algorithm only without human-in-the-loop) performance evaluation. The description focuses on its function as an assistant to the surgeon.
• Type of Ground Truth: The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for any of its testing.
• Sample Size for Training Set & Ground Truth for Training Set: The document is a 510(k) summary for a premarket notification, which focuses on device modifications and substantial equivalence. It does not provide details about the training set used for the underlying AI/software components, including its size or how its ground truth was established.

The document primarily focuses on establishing substantial equivalence to a predicate device (K212537) by highlighting that the subject device (CORI) has the same intended use and technological characteristics, with the main difference being an updated indication for use to support porous total knee implants. It confirms that non-clinical testing and usability testing were performed but does not delve into the detailed results or methodologies that would be needed to answer your specific questions about acceptance criteria and study particulars.

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CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.

These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA) and total hip arthroplasty (THA).

For Knee applications, CORI is indicated for use with cemented implants only.

CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI uses established technologies of navigation, via a passive infrared tracking camera.

For robotic knee applications, CORI software can control the cutting engagement of the surgical bur based on its proximity to the planned target surface. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

For the hip navigation application, CORI incorporates the Brainlab HIP7 software (K193307) which will be market by Smith & Nephew as RI.HIP NAVIGATION. It uses instruments and reference arrays, which are tracked by the IR camera, to determine pelvis and femur anatomical landmarks as well as implant orientation. RI.HIP NAVIGATION assists the orientation of prosthetic hip implants and enables measurement of leg length and offset when used intraoperatively in combination with CORI.

This document does not contain the requested information about acceptance criteria and a study proving device performance as it is a 510(k) summary for a medical device (REAL INTELLIGENCE CORI) seeking clearance for a new indication (Total Hip Arthroplasty - THA).

Here's why the requested information is not present in this document:

• 510(k) Summaries Focus on Substantial Equivalence: A 510(k) summary aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or different characteristics that do not raise new questions of safety or effectiveness.
• Performance Data is Summarized, Not Detailed: While the document mentions "Design verification and validation tests were performed on CORI to demonstrate that the changes presented in this submission meet all design input requirements and that CORI is as safe and effective as its predicate device," it does not provide the detailed acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth methodologies that you've asked for. These details would typically be found in the full 510(k) submission, not in the publicly available summary.
• "No human clinical testing was required": The document explicitly states this, which means there wouldn't be studies involving human readers, comparative effectiveness, or certain types of ground truth (like pathology from live patients) that might be expected from a device requiring clinical trials. The focus here is on bench testing and software validation.
• Focus on Bench Testing and Software Validation: The section on "Non-Clinical Testing (Bench)" mentions software integration testing (adhering to IEC 62304 and FDA guidance) and usability engineering validation testing (for safe and effective use in a simulated environment). This indicates the type of testing performed, but not the specific quantitative performance metrics you've requested.

Therefore, I cannot extract the table of acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, type of ground truth, or training set information from the provided text. This document is a high-level summary for regulatory clearance, not a detailed technical report of performance studies.

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CORI 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 determined. These procedures include unicondylar knee replacement (UKR) and total knee arthroplasty (TKA).

CORI is indicated for use with cemented implants only.

CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI uses established technologies of navigation, via a passive infrared tracking camera, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, CORI aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location.

CORI software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:

• Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
• . Speed control regulates the signal going to the drill motor controller itself and limits the speed of the drill if the target surface is approached.

Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

The acceptance criteria and study proving device performance are described below, based on the provided text for the Real Intelligence Cori (CORI) device.

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

The document mentions "Comprehensive performance testing demonstrated that the system meets required design inputs" and "The comparative results of the cut-to-plan accuracy data is acceptable and equivalent to the predicate devices." However, specific quantitative acceptance criteria and detailed reported performance metrics are not explicitly stated in the provided text. The submission focuses on substantial equivalence to predicate devices (K193120 and K191223) rather than presenting new, specific acceptance criteria with distinct performance numbers for this iteration of CORI.

It can be inferred that the acceptance criteria for accuracy are implicitly tied to demonstrating equivalence to the predicate devices, which are also navigational systems for orthopedic surgery.

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 primarily describes bench testing and states, "No human clinical testing was required to determine the safety and effectiveness of CORI." Therefore, the concept of a "test set" in the context of clinical data provenance (country, retrospective/prospective) does not directly apply here.

The performance data consisted of "physical performance test for all system components and system accuracy testing." The sample size for these non-clinical tests is not specified.

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)

Since "No human clinical testing was required" and the testing primarily involved "physical performance test for all system components and system accuracy testing," the concept of "experts" establishing ground truth for a clinical test set is not applicable in the traditional sense. The "ground truth" for accuracy testing would have been established through validated measurement techniques (e.g., precise optical metrology, CMM measurements) under controlled laboratory conditions, not by human expert assessment of medical images or outcomes.

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

Given that clinical data from human subjects was not used for this submission, an adjudication method for a clinical test set is not applicable.

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

No MRMC comparative effectiveness study was conducted, as stated: "No human clinical testing was required." The CORI system is an orthopedic stereotaxic instrument for surgical guidance, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

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

The document describes the CORI device as a "computer-assisted orthopedic surgical navigation and surgical burring system" that "assists the surgeon" and provides "software-defined spatial boundaries." It also states, "Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill." This indicates that the device is designed to be human-in-the-loop, providing assistance to a surgeon.

However, "Performance data consisted of physical performance test for all system components and system accuracy testing," which implies that the accuracy of the algorithm's guidance and burring control was tested in a standalone, bench setting, separate from a surgeon's subjective usage. The "cut-to-plan accuracy data" would represent the standalone performance of the algorithm and hardware.

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

For the non-clinical "system accuracy testing" and "cut-to-plan accuracy data," the ground truth would have been established through precise, objective physical measurements (e.g., using metrology equipment) of the planned bone resection versus the actual bone resection created by the device on a test medium. This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The document refers to the device as a "computer-assisted orthopedic surgical navigation and surgical burring system" that uses "established technologies." While it mentions "software verification testing" and development in accordance with IEC 62304, there is no specific mention of a "training set" in the context of machine learning. If machine learning models were used, details about their training setup are not provided in this regulatory submission summary. The equivalence is primarily based on the functional and technological similarities to predicate devices and performance in physical accuracy tests.

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

As no "training set" in the context of machine learning is explicitly mentioned, how its ground truth was established is not provided. If the system is primarily rule-based or model-based on known geometry and intraoperative data rather than a data-driven machine learning model, then a traditional "training set" with established ground truth would not be applicable. The "ground truth" for the system's underlying models would be based on engineering specifications and anatomical models.

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Indications for use:

CORI is indicated for use in unicondylar knee replacement (UKR) surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.

CORI is indicated for use with cemented implants only.

CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI uses established technologies of navigation, via a passive infrared tracking camera, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, CORI aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location.

CORI software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:

• . Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
• . Speed control regulates the signal going to the drill motor controller itself and limits the speed of the drill if the target surface is approached.

Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

The provided text is a 510(k) Summary for the "REAL INTELLIGENCE CORI (CORI)" device. It details the device's intended use, indications for use, technological characteristics, and comparison to a predicate device (NAVIO Surgical System).

However, the document does not contain the specific information required to answer the prompt regarding acceptance criteria and the study proving the device meets these criteria. The text mentions "Design verification and validation testing was performed to demonstrate that CORI meets all design requirements" and "Comprehensive performance testing demonstrated that the system meets required design inputs," but it does not provide details of:

• A table of specific acceptance criteria values (e.g., accuracy thresholds, precision targets).
• Reported device performance values for these criteria.
• Sample sizes used for the test set.
• Data provenance (country, retrospective/prospective).
• Number/qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details (effect size, human improvement).
• Standalone performance details.
• Type of ground truth used (expert consensus, pathology, outcomes).
• Training set sample size and ground truth establishment for training set.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through shared intended use, indications, and technological characteristics, along with various general performance tests (biocompatibility, EMC, software verification, usability). It states, "No human clinical testing was required to determine the safety and effectiveness of CORI."

The closest the document comes to specific performance data is: "The comparative results of the cut-to-plan accuracy indicate that CORI implant placement accuracy data is acceptable and equivalent to the UKR implant placement accuracy data for the NAVIO system." However, it does not provide the numerical accuracy data itself or the acceptance criteria for "acceptable."

Therefore, based solely on the provided text, I cannot fulfill the request for detailed information about acceptance criteria and the study proving the device meets them. The document indicates that such testing was done ("Design verification and validation testing was performed to demonstrate that CORI meets all design requirements"), but it does not disclose the specific criteria or the quantitative results.

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