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AM is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic 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 procedures where ultrasound is currently used for visualizing such procedures.

AM is an accessory to ultrasound systems that provides guidance for the placement of needles or needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters). AIM consists of four (4) principal components: an electromagnetic position tracking system; tracking sensors and mounts for the ultrasound transducer and the needle; custom guidance software installed on a computer; and a stereoscopic monitor with passive glasses for viewing the monitor.

Here's a breakdown of the acceptance criteria and study details for the AIM device, based on the provided 510(k) Premarket Application:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of distinct attempts or phantom targets. However, the study involved "placement attempts in tumor mimics within agar phantom gels, both with and without AlM's guidance, at two different angles of approach - 0 degrees ("in plane"), and 90 degrees ("out of plane")." This implies multiple attempts were made.
• Data Provenance: The study used "agar phantom gels." This indicates a prospective study conducted in a controlled phantom environment. The country of origin for the data is not specified, but given the submission to the FDA, it's likely U.S.-based or conducted under relevant U.S. guidelines.

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

• The documentation does not explicitly state the use of "experts" to establish ground truth for the test set.
• The study involved a "novice user" performing placement attempts. The ground truth for success (i.e., accurate placement within the tumor mimic) would have been objectively determined based on the physical outcome of the needle placement within the phantom (e.g., visual confirmation of the needle tip within the target).

4. Adjudication Method for the Test Set

• No explicit adjudication method (like 2+1 or 3+1) is mentioned or appears applicable given the nature of the phantom study and objective success criteria.
• Success was likely determined objectively by direct observation or measurement of the needle's final position relative to the phantom's target.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted.
• The study involved a single "novice user" comparing their own performance with and without AIM's guidance. This is a within-subject comparison for a single user, not an MRMC study.
• Effect Size (if interpreting the novice user's improvement): The improvement with AIM was substantial: 92% success rate with AIM vs. 8% without. This represents an 84 percentage point increase in success for the novice user.

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

• No, a standalone (algorithm only) performance study was not done.
• The device (AIM) is an accessory for guidance with a human user in the loop, specifically guiding needle placement. The study evaluates the human user's performance with the assistance of the AIM device.

7. The Type of Ground Truth Used

• The ground truth used was objective physical placement within "tumor mimics within agar phantom gels." Success was defined by the needle being accurately placed within these targets. This is a form of experimental ground truth derived from a controlled physical setup.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a training set sample size. The AIM device is described as
  an accessory that provides real-time guidance based on electromagnetic tracking and an overlay, implying it's not a machine learning model that requires a distinct "training set" in the conventional sense for its core functionality. Its "training" might relate more to calibration procedures.

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

• As no training set is mentioned in the context of machine learning, there is no information on how ground truth for a training set was established.

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The InVision System is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic 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 procedures where ultrasound is currently used for visualizing such procedures.

The InVision System is an accessory to ultrasound systems that provides guidance for the placement of needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters).

The InVision System consists of four (4) principal components:

• a passive infrared position tracking system; (1)
• (2) tracking mounts for the ultrasound transducer and the needle;
• custom guidance software installed on a computer; and (3)
• (4) a stereoscopic monitor with passive glasses for viewing the monitor.

Acceptance Criteria and Study for the InVision System

Based on the provided K083728 510(k) Premarket Application for the InVision System, the following information can be extracted regarding its acceptance criteria and the study conducted to demonstrate compliance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes bench tests that were conducted. However, it does not explicitly state specific quantifiable acceptance criteria with corresponding reported performance metrics. Instead, it offers a general statement about the study's outcome.

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

The document states that "Bench tests were conducted." This implies an artificial or controlled environment rather than a clinical trial with human subjects.

• Sample Size: The specific sample size for the "bench tests" is not provided.
• Data Provenance: The data provenance is laboratory/bench testing, not human subjects. Therefore, there is no country of origin or retrospective/prospective designation in the traditional clinical sense.

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

Given that the testing involved "bench tests" and not clinical data requiring expert interpretation, there is no mention of experts used to establish ground truth for a test set in the traditional sense linked to medical imaging diagnosis or intervention. The ground truth for bench tests would typically be established through precise measurements and known physical parameters.

4. Adjudication Method for the Test Set

As the testing was "bench tests" and did not involve human expert interpretation of medical images for ground truth, an adjudication method (like 2+1, 3+1) is not applicable and not mentioned.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted according to the provided text. The study focused on bench testing and comparison to a predicate device's effectiveness, not on the improvement of human readers with AI assistance.

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

The document refers to "bench tests" to evaluate the "performance characteristics of the InVision System." Since the InVision System is an accessory that enhances the ultrasonic image and predicts the needle path for physician guidance, the "standalone" performance in this context would likely refer to the accuracy of its tracking system, prediction algorithms, and display overlay in a controlled environment. The results of these bench tests are the closest indication of standalone performance, demonstrating its capability of "safely and accurately performing the stated intended use."

7. Type of Ground Truth Used

The "bench tests" would likely use known physical parameters and precise measurements as the ground truth. For instance, the ground truth for needle position and predicted path would be established by physical measurements in a phantom or controlled setup, and the system's output would be compared against these known values. No mention of expert consensus, pathology, or outcomes data as ground truth is made, which aligns with bench testing rather than clinical study.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This suggests that either:

• The system was not developed using machine learning that requires a distinct training set in the modern sense.
• The details of any internal development/training data were not deemed necessary to include in the 510(k) summary for this type of device and submission.

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

Since no training set information is provided (as per point 8), there is no information on how ground truth for a training set was established.

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