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The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The WS80A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The WS80A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The WS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided document is a 510(k) Premarket Notification for the SAMSUNG MEDISON WS80A Diagnostic Ultrasound System. It details an ultrasound system and its transducers, along with several software features.

Here's an analysis based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format (e.g., "accuracy must be > 90%"). Instead, it states that "Results of all conducted testing and assessments were found acceptable and did not raise any new issues of safety or effective." This implies the acceptance criteria were met by demonstrating functionality and safety equivalent to predicate devices.

The reported device performance is described qualitatively as "found acceptable" for the functionalities listed.

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

The document does not explicitly state the sample size used for the test set for the software features (IOTA-ADNEX, BiometryAssist, CrystalVue Flow, Needle Mate).

The data provenance is not explicitly mentioned as country of origin nor as retrospective or prospective data. The nature of the tests (bench and non-clinical) suggests controlled testing environment rather than clinical patient data for performance evaluation of new features in this submission.

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

The document does not provide information on the number of experts used to establish ground truth for the test set, nor their specific qualifications. For features like IOTA-ADNEX and BiometryAssist, which provide statistical information or aid in measurements, the "ground truth" would likely be established through comparison with established clinical methods or manual expert measurements. However, these details are not present.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The nature of "performance tests" and "image performance assessments" indicates an internal validation process, but details on how discrepancies or uncertainties were resolved are not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document states: "Not applicable. The subject of this submission, WS80A, did not require clinical studies to support substantial equivalence." This indicates that no MRMC comparative effectiveness study was done as part of this 510(k) submission. The evaluation focused on equivalence to predicate devices and adherence to safety standards.

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

The document describes "performance tests" for the functionality of "IOTA-ADNEX" and "BiometryAssist" and "image performance assessments" for "CrystalVue Flow" and "Needle Mate". While these tests evaluate the software features themselves, the document does not explicitly describe them as standalone algorithm-only performance studies independent of human interaction or interpretation steps. The phrasing "helps the user measure fetal growth indices" for BiometryAssist suggests a human-in-the-loop function. Given the lack of clinical study described, these were likely technical validations rather than full standalone clinical performance evaluations.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used for the performance evaluation of the software features. For "IOTA-ADNEX" and "BiometryAssist," ground truth would typically refer to validated clinical diagnoses, pathological findings, or precise manual measurements, but these details are not provided. For "CrystalVue Flow" and "Needle Mate," ground truth would relate to objective image quality metrics or expert assessment of image features, also not detailed.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. This is expected, as the document describes a 510(k) submission for an ultrasound system and its features, not a particular AI model that would typically have a distinct training set. The features listed (IOTA-ADNEX, BiometryAssist, CrystalVue Flow, Needle Mate) are likely algorithms or advanced processing techniques, but details about their development (e.g., training data) are not included in this regulatory document.

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

As no information is provided regarding a training set, the document does not describe how ground truth for a training set was established.

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