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The UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system.

The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.

The UltraGuide USG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the ultrasound scan image of the internal organs, all displayed on the monitor of a personal computer.

The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device and the video of the US image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the UltraGuide USG 2000sa device:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document is a 510(k) summary for a medical device cleared in 2002. At that time, explicit quantifiable acceptance criteria (e.g., specific accuracy metrics, sensitivity, specificity) for device performance as we often see in modern submissions were not always explicitly stated or required in the same way for "substantial equivalence" claims. The focus here is on demonstrating equivalence to a legally marketed predicate device.

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

No specific test set or sample size for a clinical study is mentioned. The submission states, "Since this system uses the same technology as the predicate device, a clinical test is not necessary." This indicates that no new clinical data was generated for the USG 2000sa for its 510(k) clearance.

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

Not applicable, as no new clinical test set was used for the submission.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set was used.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "a clinical test is not necessary."

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

The device is described as enhancing the ultrasonic image and predicting the needle path for display on a computer monitor. This implies a human-in-the-loop interaction, where the user interprets the enhanced image. A standalone (algorithm-only) performance evaluation, separate from human interaction, is not indicated or discussed for this type of device. The clearance is based on the technology being equivalent to a predicate, not on a new standalone performance claim.

7. The Type of Ground Truth Used

No new ground truth from clinical data was established for the USG 2000sa's 510(k) clearance. The basis for safety and efficacy was the substantial equivalence to the predicate device, UltraGuide 1000. For the bench tests, the "ground truth" would have been established by engineering standards for electrical safety and electromagnetic compatibility rather than medical ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that typically requires a large training set in the modern sense. Its function relies on established physical principles of magnetic tracking and visual overlay, rather than learning from a large dataset.

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

Not applicable, as there is no mention or implication of a training set for an AI/ML model.

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The CTG 2000sa system is a stereotactic accessory for Computed Tomography (CT) systems. It displays the simulated image of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the CT image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.

The device is intended to be used in clinical applications and for anatomical structures where computed tomography is currently used for visualizing such procedures.

The CTG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the CT image of the internal organs, all displayed on the monitor of a personal computer.

The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device, and the video of the CT image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.

Here's an analysis of the provided 510(k) summary regarding the UltraGuide CTG 2000sa device:

Based on the provided text, the device does not have explicitly stated acceptance criteria or a detailed study proving its direct performance against such criteria. The submission relies heavily on substantial equivalence to a predicate device and a lack of necessity for a clinical test due to using the same technology.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. No dedicated "test set" for a clinical study is described. The "accuracy tests" were performed in phantoms, but no sample size for these phantom studies is mentioned.
• Data Provenance: Not applicable. No human data (retrospective or prospective) is mentioned in the context of device performance testing.

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

• Not applicable. No human test set or ground truth establishment by experts is described for this device's performance evaluation.

4. Adjudication Method for the Test Set

• Not applicable. No human test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: No. The document explicitly states: "Since this system uses the same technology as the predicate device, a clinical test is not necessary."
• Effect Size: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was it done?: Yes, to some extent, in the form of "Accuracy tests ... in phantoms." However, the details of these tests, including specific metrics, performance thresholds, and a statistical analysis, are not provided. The device's primary function is to provide visual enhancement and guidance for a human operator, so a purely standalone performance would be about the accuracy of its display.

7. Type of Ground Truth Used

• For "Accuracy tests in phantoms": The ground truth would likely be the known, precisely measured positions and paths within the phantoms.
• Overall: The submission relies on the established safety and efficacy of the predicate device, CT-Guide 1010 (K002258).

8. Sample Size for the Training Set

• Not applicable. This device is a visualization and guidance system based on physical tracking technology and computational overlay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

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

• Not applicable, as there is no mention of a training set for a machine learning model.

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The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems. The system is MRI-compatible. It displays the simulated image of a rigid insertion instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the MR image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.

The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance is currently used for visualizing such structures.

The MR-Guide 2000 provides visual guiding information of the interventional instrument by overlaying graphics depicting its relative position and its predicted future path on the MR image of the internal organs all displayed on the monitor of a personal computer.

This document describes the UltraGuide MR-Guide 2000, a guiding system for interventional instruments used with Magnetic Resonance (MR) imaging.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

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

The provided text does not explicitly state specific numerical acceptance criteria for performance (e.g., accuracy thresholds, precision values, sensitivity, specificity). Instead, it relies on a claim of "equivalence to predicate devices in safety and efficacy."

However, it does mention "Accuracy tests were done in phantoms." While no specific accuracy values are reported in this summary, the success of the 510(k) suggests that the accuracy achieved in phantom testing was deemed acceptable by the FDA for demonstrating substantial equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "Accuracy tests were done in phantoms." It does not specify the number of phantoms or the number of measurements taken within those tests.
• Data Provenance: The "Accuracy tests were done in phantoms" implies a synthetic/benchtop, experimental setting. The country of origin of this data is not specified, but the applicant is UltraGuide Ltd. located in Israel. The nature of the test is non-clinical/bench testing.

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

Not applicable. For phantom accuracy tests, the "ground truth" is typically established by the known physical properties and measurements of the phantom itself, often using highly precise measurement tools, not human experts.

4. Adjudication method for the test set

Not applicable. As noted above, the ground truth for phantom tests is not typically established by human experts 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 performed or reported. The device is a guiding system, not an AI-assisted diagnostic tool that would typically involve human reader studies.

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

Yes, a form of standalone performance evaluation was done through the "Accuracy tests done in phantoms." This type of testing evaluates the device's inherent capability to track and display information accurately without direct human interaction influencing the measurement itself (though human operators would set up and execute the tests).

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

For the accuracy tests mentioned, the ground truth would be the known physical dimensions and positions within the phantoms, established through precise measurements independent of the device being tested.

8. The sample size for the training set

Not applicable. This device is a "frameless stereotactic guiding accessory" that uses a magnetic tracking system for real-time guidance. It is not an AI/machine learning algorithm that typically undergoes distinct "training" with a dataset in the way a diagnostic image analysis algorithm would. Its function is based on physical principles of magnetic tracking and geometric calculations, not learned patterns from a training dataset.

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

Not applicable, as there is no mention of a training set or AI/machine learning model in the traditional sense outlined in the filing.

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The UltraGuide 1000 system is indicated for enhancing the ultrasonic image of an interventional needle or needlelike rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.

The UltraGuide 1000 provides visual enhancement of the interventional needle by overlaying the image of insertion device and its predicted future path on the insertion action and of the internal organs, all displayed on the monitor of a personal computer. The device uses magnetic transmitters and receivers, sold under the trade name "MiniBirds," to determine the location and orientation of the ultrasound scan head and the interventional needle. The positions and orientations of the interventional device, and the video of the ultrasound image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.

The provided text offers limited information regarding specific, quantifiable acceptance criteria and detailed study results that explicitly "prove" the device meets such criteria. However, I can extract and infer some information based on the content provided.

Here's an attempt to structure the answer based on the given information:

Acceptance Criteria and Device Performance

The submission focuses on establishing substantial equivalence to predicate devices in terms of safety and efficacy, rather than meeting specific quantifiable performance metrics. The implicit acceptance criterion is that the UltraGuide 1000 performs at least as well as or better than the predicate devices without introducing new safety concerns.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: "over 50 patients"
   • Data Provenance: Not explicitly stated, but the context of a clinical test implies prospective data collection for the specific study. No country of origin is specified for the patient data itself.

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 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:

   • A formal MRMC study as it's typically understood for AI evaluation (with multiple human readers evaluating cases with and without AI assistance to measure improvement) is not described.
   • The clinical test involved a comparison between UltraGuide 1000 and EchoTip needles in amniocentesis. While it's a comparative effectiveness study, it's not structured as an MRMC study with explicit "human readers with/without AI assistance" effect size reporting. The reported effect is "more rapid and safer placement of the needles and a more rapid procedure" when using the UltraGuide 1000, implicitly indicating improvement over the predicate.

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

   • No, a standalone algorithm-only performance study is not described. The device is described as a "Visualization Enhancement System" and is used "by overlaying the image of insertion device and its predicted future path" to assist a human operator. Its performance is implicitly tied to human interaction.

6. The type of ground truth used:

   • For the clinical test, the "ground truth" seems to be based on observed clinical outcomes and performance metrics during the amniocentesis procedure (e.g., speed of placement, safety, occurrence of adverse events). It does not appear to rely on an external "ground truth" like pathology for diagnostic accuracy.

7. The sample size for the training set:

   • This information is not provided. The "UltraGuide 1000" is described as a "Visualization Enhancement System" that uses magnetic tracking and calculations. There is no mention of a machine learning or AI component requiring a "training set" in the traditional sense, although it would have undergone internal engineering and calibration.

8. How the ground truth for the training set was established:

   • As there is no explicit mention of a machine learning or AI "training set," this information is not applicable/provided.

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