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The IGAR System is intended to acquire magnetic resonance (MR) images of the breast anatomy and permits access to the breast for biopsy and localization procedures. A front breast restraint immobilizes the patient's breast to permit three-dimensional MR imaging to identify the location of the breast lesion(s) for the purposes of selecting a target for biopsy. The IGAR System guides a breast biopsy tool to the target location of the breast from which a biopsy can be obtained. The IGAR System is intended to be used by qualified professionals.

The IGAR System is a tool-positioning system for enabling accurate MR-quided breast biopsies. The IGAR System is designed to provide biopsy tool guidance and accurate targeting of lesions in the breast while the patient is in the MRI room– this creates the ability to "see and evaluate" within a single session. The system consists of the following components: Workstation, Patient Support, Manipulator, Pendant, Control Cart. The IGAR System integrates with an FDA-cleared MRI system from GE, 3 Tesla (3T) GE Discovery™ MR750 - 60cm (Bore size).

The IGAR System is intended to acquire magnetic resonance (MR) images of the breast anatomy and permits access to the breast for biopsy and localization procedures.

Here's an analysis of its acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text mentions "Predefined acceptance criteria for targeting accuracy were met" and "Verification test results demonstrate acceptance criteria were met, and design outputs met the design input requirements." However, it does not explicitly list the quantitative acceptance criteria for targeting accuracy or other functional aspects.

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

The primary study mentioned for performance evaluation is phantom accuracy testing.

• Sample Size: Not explicitly stated. The text only mentions "a representative clinical setting using a simulated tissue phantom." This suggests a single or limited number of phantoms rather than a large test set of patients.
• Data Provenance: The data is from non-clinical bench testing ("simulated tissue phantom"). No information on country of origin for this specific test, as it's a lab-based test. It is not prospective or retrospective patient data.

No information is provided for the test sets of other non-clinical tests (software, functional bench testing, biocompatibility, usability, reprocessing).

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

For the phantom accuracy testing, the "ground truth" would be the known, pre-defined target location within the phantom. This ground truth is inherent to the experimental setup rather than established by experts.

For usability/human factors evaluation, the evaluation would typically involve user testing, but the number and qualifications of "experts" (users or evaluators) are not specified.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1 consensus) is not applicable to the non-clinical phantom accuracy testing. The ground truth is objectively defined by the phantom's design and measurement setup. For usability, a formal adjudication method for "use errors" or "problems" is not described, but typically involves observation and expert review.

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

No, an MRMC comparative effectiveness study was not conducted according to the provided text. The document explicitly states: "Clinical Data was not required for this submission." The studies described are non-clinical, primarily bench and phantom testing.

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

The IGAR System is described as a "tool-positioning system" that guides a biopsy tool. Its components include a "Workstation" where a clinician selects a biopsy target and plans the needle path, and a "Manipulator" that positions tools. This strongly implies a human-in-the-loop system. The phantom accuracy testing evaluates the system's ability to guide the tool to the target, which is an assessment of the algorithm's performance within the human-operated workflow, but not in a fully standalone diagnostic capacity. The text does not describe any standalone algorithm performance studies for diagnosis or interpretation without human interaction.

7. The Type of Ground Truth Used

For the primary performance study mentioned (phantom accuracy testing), the ground truth used was predefined target locations within a simulated tissue phantom. This is an objective, known ground truth derived from the experimental setup.

8. The Sample Size for the Training Set

The document does not mention any "training set" or "training data." The device is verified through non-clinical testing against design inputs and acceptance criteria. As there are no AI algorithms described that learn from data, the concept of a training set is not applicable in the provided description. The software verification and validation is focused on design output meeting requirements, not on a learning algorithm's performance on a training dataset.

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

As no training set is mentioned or implied for an AI algorithm, no ground truth establishment method for a training set is applicable or described.

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