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ARIETTA Prologue is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of following clinical applications: FETAL; ABDOMINAL - (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis)); INTRA-OPERATIVE (SPEC.)-(Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)); INTRA-OPERATIVE (NEURO); LAPAROSCOPIC; PEDIATRIC; SMALL ORGAN (SPEC.)-(Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy): NEONATAL CEPHALIC: ADULT CEPHALIC; TRANS-RECTAL - (Includes imaging for guidance of trans-rectal biopsy); TRANS-VAGIAL -(Includes imaging for guidance of trans-vaginal biopsy); TRANS-ESOPHAGEAL (NON-CARDIAC & CARDIAC) -ADULT/PEDIATRIC; MUSCULOSKELETAL (CONVENT./SUPERFIC.); Other (spec.) -WOUND (Includes imaging for Cavernous/Non-Cavernous wounds); Other (spec) - GYNECOLOGICAL; CARDIAC: ADULT/ PEDIATRIC and PERIPHERAL VESSEL.

An ultrasound diagnostic system with the following features:

• Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
• Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
• A computer system to control the transducer and analyze the signals resulting from the reflected echoes
• A video monitor with optional image recorder to display the computed image or derived Doppler data

The provided text is a 510(k) Premarket Notification for the ARIETTA Prologue Diagnostic Ultrasound System and Transducers. It focuses on demonstrating substantial equivalence to a predicate device (Noblus K142368, and K134016 for some indications) and does not contain detailed information about specific performance acceptance criteria or a dedicated study proving performance against such criteria in the way a clinical trial for an AI/CADe device would.

Instead, the document asserts substantial equivalence based on similarities in intended use, clinical applications, modes of operation, technology, and adherence to safety standards. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing performed to ensure the device is safe and effective as per FDA regulations for ultrasound devices, rather than a clinical performance study with specific quantifiable metrics.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for an AI/CADe component, as it is a diagnostic ultrasound system, not an AI/CADe device with specific diagnostic algorithms being validated. The acceptance criteria described are broadly related to safety and effectiveness compared to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a test set or data provenance in the context of a performance study for an AI/CADe device. The evaluations conducted were non-clinical tests (acoustic output, biocompatibility, EMC, electrical/mechanical safety) which typically involve testing the physical device and its components according to engineering standards, rather than analyzing clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is not a study for an AI/CADe device requiring expert-established ground truth from clinical data. The "ground truth" for the non-clinical tests would be the established engineering standards and specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical data test set or adjudication method is mentioned.

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

Not applicable. The document describes a diagnostic ultrasound system, not an AI-assisted diagnostic tool subject to MRMC studies comparing human readers with and without AI assistance.

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

Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" would be engineering specifications, applicable safety standards (e.g., IEC 60601-1, IEC 62304, ISO 10993-1), and FDA guidance documents. There is no mention of clinical ground truth (like pathology or outcomes data) being used for performance evaluation in this 510(k) submission.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device, and no training set for an algorithm is mentioned.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned for an AI/CADe algorithm.

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