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The Sofia™ (ATUS) device is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.

The Sofia™ (ATUS) device consists of three (3) major components 1) an exam table which houses the examination pyramid, motor drive assembly, fluidics evacuation and storage system, and the power supply assembly 2) an ultrasound probe which is embedded into the exam pyramid on one end and connected to the ultrasound system on the other end, 3) an ultrasound system that acquires and stores the ultrasound data from the patient's breast exam.

The provided text describes the 510(k) summary for the Sofia™ (ATUS) Imaging Device (K080555). However, it does not contain information about specific acceptance criteria or a study proving the device meets them, in the context of device performance metrics like sensitivity, specificity, or accuracy.

The document focuses on demonstrating substantial equivalence to predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to legally marketed devices.

Here's a breakdown of what is available in the document related to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) are mentioned for the Sofia™ (ATUS) device itself.
• The document primarily states that the device is substantially equivalent to predicate devices.
• The "Summary of Studies" section refers to non-clinical design verification and validation tests, including mechanical performance and simulated use tests.
• Performance information: "The results of the Sofia™ (ATUS) systems performance evaluations demonstrate that the Sofia™ (ATUS) device design is well suited for its intended use." This is a general statement, not a quantified performance metric.
• Electrical Safety Testing: The document lists several IEC, UL, and CAN/CSA standards that the device will be tested against by an independent laboratory prior to commercial distribution. These are safety and electromagnetic compatibility standards, not clinical performance metrics. The specific results of these tests are not reported in this 510(k) summary, only the commitment to perform them.

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

• No information is provided regarding a clinical test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are non-clinical (mechanical, simulated use, electrical safety).

3. Number of Experts and Qualifications for Ground Truth:

• No information is provided about experts used to establish ground truth for a test set. The clinical claim is based on substantial equivalence to predicate devices, not de novo clinical performance validation against a ground truth.
• An "expert in the field of acoustic sonography" provided an opinion and performed acoustic output testing, which relates to safety and operational characteristics, not clinical diagnostic accuracy.

4. Adjudication Method:

• No adjudication method is mentioned as there is no described clinical test set or ground truth establishment process in the context of diagnostic performance.

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

• No MRMC comparative effectiveness study is mentioned. The submission does not describe any human reader studies, with or without AI assistance. The device itself is an imaging system, and at the time of this filing (2008), the term "AI" as applied to medical device assistance was not prevalent in such summaries.

6. Standalone (Algorithm Only) Performance:

• No standalone (algorithm only) performance is described. The device is an ultrasound imaging system; its output is images for interpretation by a human radiologist. There's no indication of an embedded algorithm for automated diagnostic interpretation independent of a human.

7. Type of Ground Truth Used:

• No specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned because no clinical performance study against a ground truth is described in this 510(k) summary. The "ground truth" for this 510(k) is primarily the established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set:

• No information about a training set sample size is provided. This device is an imaging system, not a machine learning algorithm that requires a training set in the typical sense for diagnostic output.

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

• Not applicable, as no training set for a diagnostic algorithm is described.

In summary, the K080555 document for the Sofia™ (ATUS) Imaging Device is a 510(k) submission primarily establishing substantial equivalence to existing ultrasound systems. It focuses on the device's design, intended use, and non-clinical safety/performance validations, rather than detailing a clinical study with specific acceptance criteria, ground truth, or statistical performance metrics.

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