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The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning and is intended to assist the physician in positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking.

The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of instruments during Computed Tomography (CT) quided percutaneous procedures. The system is used for trajectory planning based on CT images and is intended to assist the physician in positioning of an instrument, such as a needle, and reviewing instrument position during advancement to the target. The system guides (i.e., positions and steers) the instrument according to a predefined trajectory. The physician controls advancement of the instrument along the trajectory using a foot pedal or a pushbutton on the control room console. The system also allows for monitoring of motion associated with respiration during the procedure.

The XACT ACE Robotic System comprises the following main components:

• . XACT ACE Robot which is placed on the patient and includes the robot positioning unit & the insertion module assembly
• . XACT ACE Console which includes a Control Unit, central computer (in the Control Unit) and monitor workstation for user trajectory planning, user interface and review of instrument position

Below is the information extracted from the provided text regarding the acceptance criteria and the study proving the device meets them. It's important to note that the provided text primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly detailing specific acceptance criteria for a novel device. The performance data section describes tests conducted, and the clinical data section reports outcomes, which implicitly relate to the device's acceptable performance.

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

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

• Abdominal Study:

  • Sample Size: 60 completers (33 men, 27 women)
  • Provenance: Prospective clinical trial (NCT03008603) conducted at 2 centers. Country of origin not specified, but the submitter is from Israel.

• Lung Study:

  • Sample Size: 20 patients (10 men, 10 women)
  • Provenance: Prospective clinical trial (NCT04651517) conducted at 2 clinics in the US.

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)

The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the clinical study "test sets." Clinical studies for robotic systems typically involve physicians (e.g., interventional radiologists) performing the procedures, and their assessment of successful targeting and outcomes implicitly serves as the ground truth.

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

The document does not specify any adjudication method (like 2+1 or 3+1) used for the clinical study outcomes or ground truth determination.

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

A multi-reader multi-case (MRMC) comparative effectiveness study with human readers (or expert operators) with and without AI assistance was not reported or implied in the provided text. The XACT ACE Robotic System is itself a robotic assistance system, and the studies evaluated its performance as a whole, rather than comparing human interpretation/performance with and without it.

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

The XACT ACE Robotic System is described as a "user-controlled positioning system intended to assist in the planning and advancement of an instrument." This inherently implies a human-in-the-loop system. Therefore, a standalone (algorithm only) performance evaluation was not done as it would not represent the intended use of the device. The "Steering Accuracy test" was evaluated in a "simulated clinical setup," which would likely involve the robotic system performing an action (steering) but still within the context of a controlled, human-planned trajectory.

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

For the clinical studies (abdominal and lung), the ground truth appears to be based on clinical outcomes data and physician assessment of the procedure's success.

• "All procedures completed with the ACE system reached the target in one needle insertion." (Abdominal study)
• "Clinical data in lung procedures confirm the performance and safety of the device, supporting the same performance profile..." (Lung study)
• "minimal adverse events."

This implies that successful targeting (reaching the intended lesion/target) and safety (absence of significant adverse events) were the primary measures of ground truth, assessed by the clinicians performing or overseeing the procedures. Pathology confirmation of biopsy results would also be an implicit ground truth where applicable, but not explicitly stated as the primary ground truth for system accuracy.

8. The sample size for the training set

The document does not provide information regarding a separate "training set" or its sample size. This type of information is typically relevant for AI/machine learning models where a distinct training phase is required. The XACT ACE Robotic System is described as a robotic positioning system with software updates, but not explicitly as a machine learning system that would require a distinct "training set" in the conventional sense for its core functionality. The performance data refers to validation and verification tests, and clinical trials for effectiveness and safety.

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

Since no "training set" is mentioned or implied for a machine learning context, the document does not describe how ground truth for a training set was established.

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The XACT Robotic System, ACE Model is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning and is intended to assist the physician in positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking.

The XACT Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of instruments during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning based on CT images and is intended to assist the physician in positioning of an instrument, such as a needle, and reviewing instrument position during advancement to the target. The system guides (i.e., positions and steers) the instrument according to a predefined trajectory. The physician controls advancement of the instrument along the trajectory using a foot pedal. The system also allows for monitoring of motion associated with respiration during the procedure.

The XACT Robotic System, ACE Model comprises the following main components:

• . XACT Robot which is placed on the patient and includes the robot positioning unit & the insertion module assembly
• . XACT Console which includes a Control Unit, central computer (in the Control Unit) and monitor workstation for user trajectory planning, user interface and review of instrument position

I am sorry, but the provided text does not contain the detailed information necessary to answer your request fully. The document is an FDA 510(k) clearance letter and a summary of the device's characteristics and performance tests.

Here's what I can provide based on the given text, and what is missing:

Information available from the text:

• Device Name: XACT Robotic System, ACE Model
• Predicate Device: XACT Robotic System (K191332)
• Performance Tests Conducted: Mechanical Accuracy, Registration Precision, CT Phantom Accuracy, Robot Rigidity, Axes Mapping, Complete SW STD, Electrical safety (IEC 60601-1), Electromagnetic compatibility (IEC 60601-1-2).

Missing Information:

The text does not provide the following crucial details needed for your request:

• A table of acceptance criteria and reported device performance: While performance tests are listed, the specific acceptance criteria for each test and the quantitative results showing the device met those criteria are not provided.
• Sample sizes used for the test set and data provenance: The document mentions tests but not the number of cases or samples used, nor the origin (country, retrospective/prospective) of any data if clinical studies were performed.
• Number of experts and their qualifications for establishing ground truth: This information is not present.
• Adjudication method for the test set: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: The text indicates performance and safety tests, but not comparative effectiveness studies with human readers.
• If a standalone study (algorithm only) was done: The device is a "user-controlled positioning system intended to assist in the planning and advancement of an instrument." This suggests it's a human-in-the-loop system, and a standalone algorithm performance without human interaction isn't directly relevant or discussed.
• The type of ground truth used: Not specified.
• Sample size for the training set: The document describes performance tests and comparisons to a predicate device, but not a "training set" in the context of an algorithm's development. This device is a robotic system, not an AI diagnostic algorithm in the typical sense that would have a training set of data.
• How the ground truth for the training set was established: Not applicable, as no training set for an algorithm is mentioned.

Conclusion based on the provided text:

The document describes a robotic system that assists in CT-guided procedures. It outlines several engineering and safety performance tests that were conducted to demonstrate substantial equivalence to a predicate device. However, it does not provide the specific quantitative acceptance criteria or results from these tests, nor does it delve into the details of clinical study design that would involve ground truth establishment, expert adjudication, or reader studies. It primarily focuses on the device's technological characteristics and safety and effectiveness from an engineering standpoint, rather than a diagnostic algorithm's performance.

Ask a specific question about this device

The XACT Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning and is intended to assist the physician in positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking.

The XACT Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of instruments during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning based on CT images and is intended to assist the physician in positioning of an instrument, such as a needle, and reviewing instrument position during advancement to the target. The system quides (i.e., positions and steers) the instrument according to a predefined trajectory. The physician controls advancement of the instrument along the trajectory using a foot pedal. The system also allows for monitoring of motion associated with respiration during the procedure.

The XACT Robotic System comprises the following main components:

• . XACT Robot Positioning Unit & Insertion Module Assembly which is placed on the patient
• XACT Control Unit (Central Computer) .
• . XACT Computer Work Station which includes the user interface for trajectory planning and review of instrument position
• XACT System Cart ●

The provided text describes the XACT Robotic System, a user-controlled positioning system intended to assist in CT-guided percutaneous procedures. While the document outlines several performance tests and mentions preliminary clinical data, it does not explicitly define acceptance criteria as a table with numerical targets, nor does it detail a comparative effectiveness study (MRMC) or a standalone AI algorithm. It provides some performance figures from pre-clinical and preliminary clinical studies.

Here's an attempt to extract the information based on the provided text, acknowledging the limitations regarding the completeness of "acceptance criteria" as you might expect in a formal table with specific thresholds:

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

The document doesn't present "acceptance criteria" in a formal table with specific numerical thresholds for each test. Instead, it describes performance tests and their outcomes.

2. Sample size used for the test set and the data provenance

• Test Set (Pre-clinical animal study):
  • Sample Size: 40 interventional procedures.
  • Data Provenance: Porcine model (animal study). Specific country of origin is not mentioned, but it's a pre-clinical study.
• Test Set (Preliminary clinical data):
  • Sample Size: 31 cases (interim set of subjects).
  • Data Provenance: Clinical data gathered in 2 clinical centers. Specific country of origin is not mentioned. It is prospective data collection since it's described as "preliminary clinical data, to supplement the bench and preclinical animal testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts for "ground truth" establishment in the context of the animal or clinical studies. The results from the animal study (target reach, accuracy) and clinical study (successful target reach, adverse events) are presented as direct measurements. For the clinical data, the procedures were performed by physicians, as indicated by "physician defined trajectory path" and "manual insertion according to routine clinical procedure," implying the usual clinical practice standards would serve as the "truth" for procedure success and safety. However, the exact process of establishing ground truth by a panel of experts is not described.

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

The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating outcomes in either the pre-clinical or preliminary clinical studies. Outcomes appear to be directly measured (e.g., distance from target, successful reach, reported adverse events).

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 is mentioned. The study focuses on the device's ability to assist in procedures, not on evaluating human reader performance with or without AI assistance, as the system is a robotic positioning system, not an AI-based diagnostic tool for image interpretation.

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

The device is a "user-controlled positioning system" and "intended to assist in the planning and advancement of an instrument." It is designed for human-in-the-loop operation, where the physician controls advancement and defines the trajectory. Therefore, a standalone (algorithm only) performance evaluation without human interaction would not be applicable or described for this type of device. The accuracy results (1.41mm ± 0.94mm) from the animal study could be considered a measure of the system's standalone (robotic execution) accuracy once a trajectory is defined.

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

• Pre-clinical Animal Study: The ground truth for accuracy was based on direct measurement of the "distance from the target" following robotic insertion in animal models. Successful target reach was also a direct outcome. Safety was assessed through reporting of adverse events.
• Preliminary Clinical Data: The ground truth for success appears to be whether the device "successfully reached the target" and whether the "procedure was completed successfully" (even if later by manual intervention). Safety was assessed by "no serious adverse events reported." These are outcomes-based or procedural success-based ground truths, likely determined by the operating physician and recorded.

8. The sample size for the training set

The document does not provide information about a "training set" for an AI algorithm because the XACT Robotic System is described as a "user-controlled positioning system," not explicitly an AI-driven image analysis or diagnostic tool that would typically undergo a separate training phase with a large dataset. While it has software for planning, the core function described is mechanical assistance and guidance.

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

As no training set for an AI algorithm is mentioned, the method for establishing its ground truth is also not applicable or described in the provided text.

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