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Delta 32 and Delta 32 TACT® are intended to be used for diagnostic digital spot and 3D imaging, and optionally for digital stereotactic breast biopsy. Delta 32 and Delta 32 TACT® are intended to be used with the base mammographic system Diamond. However, a PC workstation of Delta 32 and Delta 32 TACT® can also be used as stand-alone for viewing images taken by Delta 32 and Delta 32 TACT®. The TACT® add-on provides means for digital 3D spot imaging using 2D projection images acquired with the system.

Delta 32 and Delta 32 TACT® is a mammographic diagnostic digital mammography spot and 3D imaging system, which can also be used for digital stereotactic breast biopsy. The base system is the Diamond mammographic system (#K955411), on which the Delta 32 and Delta 32 TACT® is installed. The images are acquired by a CCD camera identical to our Delta 32 (#K002472). The needle guiding system is the same than previously, Cytoguide biopsy unit (#K885020). A PC workstation receives images and computes the necessary needle coordinates for Cytoguide unit. The PC also performs the optional TACT® 3D reconstruction identically to the Delta 32 TACT® system described in (#K002472). The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Delta 32 with optional add-on TACT® device:

Acceptance Criteria and Device Performance Study for Delta 32 with optional add-on TACT®

The evaluation for the diagnostic use of the Delta 32 and Delta 32 TACT® was based on a clinical study comparing the subjective image quality of the digital system to screen and diagnostic film systems. The study used a Likert scale from +4 (digital image absolute better) to -4 (film image absolute better).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The average Likert score must be greater than X"). However, the performance indicated by the statistical significance (p < 0.0001) suggests that the digital system was deemed statistically significantly better than film. This statistical significance likely serves as the implicit acceptance criterion.

2. Sample Size and Data Provenance

• Test Set Sample Size: 60 symptomatic cases.
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be retrospective based on the description of performing exams on "symptomatic cases." The filing company is from Finland, so it is plausible the data came from Finland.

3. Number of Experts and their Qualifications for Ground Truth

The document does not specify the number of experts used to establish the ground truth or their qualifications. The study focused on subjective image quality, which implies expert assessment, but details on these experts are missing.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the "subjective image quality" assessment, it is possible that individual expert opinions were averaged or a consensus was reached, but this is not detailed.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is described where human readers improve with AI vs without AI assistance. The study described compares the image quality of different modalities, not human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The document states: "The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®." This implies the system's ability to display images independently, but it does not describe a standalone performance study of an algorithm without human-in-the-loop performance in terms of diagnostic accuracy or equivalent metrics. The study focuses on subjective image quality compared to film.

7. Type of Ground Truth Used

The ground truth used was subjective image quality assessed by comparing digital images (TACT® 3D slices and DSM) against diagnostic film images (DFM). This is an expert-based subjective assessment. It is not pathology, outcomes data, or an explicit expert consensus on a diagnosis.

8. Sample Size for the Training Set

The document does not provide information about a training set size. This study appears to be a clinical validation of the device's image quality rather than an evaluation of an AI/machine learning algorithm that would typically involve a separate training set. The device itself is a digital imaging system with an optional 3D reconstruction feature (TACT®).

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for an AI/machine learning model, the document does not describe how ground truth for a training set was established.

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