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The Acessa Guidance System is indicated for enhancing the ultrasonic image of the Acessa Handpiece and for predicting its future path 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 as an optional accessory for use during the Acessa System procedure.

The Acessa Guidance System consists of the following components: Guidance Controller (Model Number 5100), Guidance Ultrasound Transducer Sleeve (Model Number 5500), Guidance Field Generator (Model Number 5200), Guidance Handpiece Cable (Model Number 5400), and Power Cord (Model Number 4110). The Acessa Guidance System uses electromagnetic tracking technology to track the positions of the Guidance Ultrasound Transducer Sleeve and the Guidance Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Guidance Handpiece shaft's future path in relation to the features in the ultrasound slice. The Acessa Guidance System is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

The Acessa Guidance System includes the following performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify sample sizes for any of the listed performance tests.
• The provenance of the data (e.g., country of origin, retrospective or prospective) is not provided for any of the tests.

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

• This information is not provided in the document. The tests described are primarily engineering, biocompatibility, and simulated environment tests, rather than clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set:

• This information is not applicable as the provided testing is not a clinical study involving human reader interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not conducted or described in this document. The device is a guidance system, and the testing focuses on its engineering and functional performance rather than its impact on human reader performance in a diagnostic context.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• The document describes performance testing that largely functions as "standalone" performance for the device's components (electrical, safety, biocompatibility, mechanical). The "system worse-case accuracy comparison testing in a simulated clinical environment" evaluates the algorithm's accuracy in a controlled setting without explicit mention of human-in-the-loop performance influencing the measurement. However, the device is an "optional accessory" for use during a procedure and is meant to enhance ultrasonic images and predict tool paths, implying human interaction during its intended use. Therefore, while some tests are algorithmic/system performance, it's not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used:

• Electrical and Safety Testing: Ground truth is established by the specified international standards (e.g., ANSI/AAMI ES 60601-1).
• Biocompatibility Testing: Ground truth is established by the specified international standards (e.g., ISO 10993 series).
• Mechanical (Guidance Sleeve end cap tensile testing): Ground truth would be engineered specifications or established industry standards for material strength.
• Accuracy (System worse-case accuracy comparison): Ground truth would be defined reference points or known positional values within the simulated clinical environment.
• Software Validation: Ground truth would be the software requirements specifications and expected functional behavior.

8. The Sample Size for the Training Set:

• The document does not mention a "training set" in the context of machine learning or AI models. The software is noted to be from the manufacturer of the predicate device and based on their cleared device, implying reuse or adaptation of existing software rather than a de novo development requiring a distinct training phase.

9. How the Ground Truth for the Training Set was Established:

• This information is not applicable as no training set for an AI model is described.

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