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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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