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The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).

The CT-Guide is intended to be used in clinical interventions in the lung and liver, where CT is currently used for visualizing such procedures.

The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle; (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.

Here's an analysis of the provided text regarding the CT-Guide Needle Guidance System's acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the device's performance (e.g., target accuracy in millimeters, success rate percentage). Instead, it uses qualitative statements about the studies' outcomes.

Since specific acceptance criteria are not provided, the table below will reflect the general statements made in the document about performance.

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

• Sample Size for Test Set: Not specified. The document only states "a prospective, multi-center clinical study was conducted."
• Data Provenance: Prospective, multi-center clinical study. The country of origin is not explicitly stated for the clinical study data itself, although the submitter is based in Israel and the FDA clearance is for the US market. The bench tests were done on a "custom phantom setup," implying laboratory testing.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document only mentions a "prospective, multi-center clinical study" but does not detail how outcomes were assessed or adjudicated.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The study described is an evaluation of the device's performance in clinical use, not a comparison of human readers with and without AI assistance.
• Effect Size: Not applicable, as an MRMC study was not described.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: The core function of the CT-Guide is a guidance system that displays instruments on a CT-based model for a human operator. The "Performance Data" section discusses "bench tests conducted on a custom phantom setup" and "The CT-Guide software was validated and tested." These could be interpreted as standalone tests of the system's accuracy and software functionality prior to human interaction within the clinical study. However, the document doesn't explicitly separate "algorithm only" performance from the overall system's performance, as the system's purpose is to guide human intervention. The clinical study implicitly includes human interaction.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the clinical study, the ground truth or outcome measure is implied to be related to the successful and safe conduct of "clinical interventions in the lung and liver." The document states, "The results demonstrate that the system is safe and effective for its intended use." This suggests clinical outcomes and safety profiles served as the ground truth. For the bench tests, the ground truth would have been derived from the "custom phantom setup" with known geometrical properties or reference points.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The document describes a medical device (hardware and software) that assists in procedures, not a machine learning or AI model that requires a "training set" in the conventional sense. The "CT-Guide software was validated and tested," which likely refers to traditional software verification and validation, not machine learning model training.

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

• Ground Truth for Training Set: Not applicable, as no machine learning training set is described.

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The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).

The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.

The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle: (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.

The CT-Guide Needle Guidance System underwent performance and accuracy testing through several bench tests conducted on a custom phantom setup. All results were reported as satisfactory and met predefined specifications. The CT-Guide modified software was validated and tested. Additionally, the system was retested for electromagnetic compatibility and electrical safety per IEC 60601-1 and IEC 60601-1-2. In all instances, the CT-Guide functioned as intended, and testing results were as expected. This submission is a Special 510(k) for modifications to a previously cleared device (K110812), and thus primarily relies on showing that the modified device remains as safe and effective as the predicate.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The study was conducted using "several bench tests conducted on a custom phantom setup."

• Sample Size: Not explicitly stated as a numerical sample size of cases or images, but rather described as "several bench tests." The phantom setup implies a controlled, non-human testing environment.
• Data Provenance: The data is from bench tests using a custom phantom, not from human subjects or clinical data (retrospective or prospective). Country of origin is not specified for the phantom tests, but the device manufacturer is based in Israel.

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

Not applicable. The ground truth for bench tests on a phantom is typically based on the known physical properties and measurements of the phantom itself, not on expert clinical judgment.

4. Adjudication Method for the Test Set

Not applicable, as ground truth was established through physical measurements on a phantom, not expert review requiring adjudication.

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 mentioned. The study described focuses on technical performance of the device itself rather than human reader improvement with AI assistance. This device is a "Needle Guidance System," implying a tool that assists during interventions rather than an AI for diagnostic image interpretation.

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

The performance testing described ("bench tests conducted on a custom phantom setup") would generally be considered a form of standalone performance assessment for the device's accuracy and functionality in a controlled environment, separate from human-in-the-loop clinical use.

7. The Type of Ground Truth Used

The ground truth was established using a "custom phantom setup," implying objective physical measurements and known properties of the phantom.

8. The Sample Size for the Training Set

Not applicable. The description provided is for performance testing of a device's modifications, not for the training of an AI algorithm from a dataset.

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

Not applicable, as there is no mention of an AI training set in the document.

Ask a specific question about this device

The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).

The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.

The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle; (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.

The provided text describes the ActiViews Ltd.'s CT-Guide Needle Guidance System (K110812). Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:
   The document states a "prospective, multi-center clinical study was conducted," but it does not specify the sample size for the test set (number of patients or procedures). The data provenance is prospective and multi-center, but the specific countries of origin are not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the given text.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not provided in the given text.

4. 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:
   An MRMC comparative effectiveness study is not explicitly mentioned. The clinical study aimed to establish safety and effectiveness of the system rather than compare human readers with and without AI assistance. Therefore, no effect size for human reader improvement with AI assistance is provided.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The device is described as a "Needle Guidance System" and an "accessory for Computed Tomography ("CT") systems" that "displays an interventional instrument on a computer monitor." This implies a human-in-the-loop system, as the human operator (clinician) uses the guidance for the interventional procedure. Therefore, a standalone (algorithm-only) performance study would not be applicable or described for this type of device, and is not mentioned.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the clinical study, the text states, "The results established that the system is safe and effective for its intended use." While "safety and effectiveness" are outcomes, the specific type of ground truth used to measure these outcomes (e.g., successful lesion targeting confirmed by follow-up imaging, biopsy results, lack of complications) is not detailed. For the bench tests, predefined specifications were met, implying a ground truth based on engineering or performance metrics.

7. The sample size for the training set:
   The document does not specify a training set sample size. It mentions "software was validated and tested," but no details on training data.

8. How the ground truth for the training set was established:
   This information is not provided in the given text.

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