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The AcuSee AS-P1000 system is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle and for predicting its future path on a display, 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 procedures where ultrasound is currently used for visualization.

The AcuSee AS-P1000 system is intended to be used in a clinical setting.

The AcuSee AS-P1000 system is a medical device that tracks instrument positioning during ultrasoundguided procedures to provide instrument guidance to the end user. With accessories attached to the transducer probe and needle or needle-like rigid device, the AcuSee AS-P1000 system identifies and tracks the probe and the device within the field of view through optical detection technology. By coupling positioning information with the ultrasound image, the projected instrument pathway is displayed to the user for guiding instrumentation. The AcuSee AS-P1000 system is an accessory to any compatible ultrasound machine and transducer probe.

The provided text is an FDA 510(k) summary for the AcuSee AS-P1000 System. It describes the device, its intended use, and a comparison to a predicate device (Clear Guide ONE). However, it does not contain the detailed performance testing results required to fill out a table of acceptance criteria and reported device performance, nor does it provide information on sample sizes, ground truth establishment methods (especially for a test set), number of experts, adjudication methods, MRMC studies, or standalone performance.

The document mainly focuses on demonstrating substantial equivalence based on technological characteristics and adherence to safety standards, rather than providing specific quantitative performance metrics of the device's accuracy in tracking and predicting needle paths.

Therefore, I cannot fulfill all parts of your request. I will indicate where information is missing.

Here's a breakdown of what can and cannot be extracted from the provided text:

Device: AcuSee AS-P1000 System
Intended Use: Augmenting the ultrasonic image of an interventional needle or needle-like rigid device and predicting its future path on a display.

1. Table of Acceptance Criteria and Reported Device Performance

This information is largely missing from the provided document. The document states that "Performance data was collected to demonstrate that the AcuSee AS-P1000 system achieves its intended function in a manner that is as effective as the predicate device" and that "The results of performance testing show that the AcuSee AS-P1000 system is as safe and as effective as the predicate device." However, no specific quantitative acceptance criteria or reported performance metrics (e.g., accuracy of needle tip prediction, tracking precision, latency) are provided.

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

• Sample Size for Test Set: Not specified. The document mentions "Performance Testing" and "Bench testing" but does not detail the datasets or sample sizes used for these tests.
• Data Provenance: The document generally refers to "Performance data" and "Bench testing." No information is provided regarding the country of origin of data or whether it was retrospective or prospective.

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

Not applicable/Not specified. The device tracks physical objects (needles) and their projected paths. "Ground truth" in this context would likely refer to highly precise physical measurements rather than expert consensus on imaging interpretation. The document does not mention the use of experts for establishing ground truth for the performance tests.

4. Adjudication method for the test set

Not applicable/Not specified. As the ground truth would likely be established by physical measurement systems, an adjudication method in the context of human expert review is not relevant here, and none is mentioned.

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. The document explicitly states "Clinical Testing: None." This device is a real-time intra-procedural guidance system, not an AI for image interpretation or diagnosis. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant and was not conducted.

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

Yes, implicitly. The "Performance Testing" and "Bench testing" described would be a standalone evaluation of the algorithm's tracking and prediction capabilities against a known physical ground truth, without a human operator's influence on the measured performance of the tracking. However, no specific metrics from these tests are provided.

7. The type of ground truth used

Inferred: Likely physical measurements/engineering ground truth established through precise measurement systems during "Bench testing." The device tracks physical objects (needles and probes) and overlays their perceived position and predicted path onto an ultrasound image. The ground truth for such a system would typically involve highly accurate optical or mechanical tracking references.

8. The sample size for the training set

Not specified. The document does not mention any training data or training sets, as it describes an optical tracking system, not a machine learning model that typically requires a distinct training phase with labeled data. If there are internal models or calibrations, the data used for those is not disclosed.

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

Not applicable/Not specified. As no training set is mentioned in the context of typical machine learning, this information is not provided.

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