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The Diagnostic Ultrasound System Aplio flex Model CUS-AFL00 and Aplio go Model CUS-AGG00 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organ (thyroid, breast and testicle), neonatal cephalic, trans-rectal, transvaginal, musculoskeletal (both conventional and superficial), cardiac, peripheral vascular, and thoracic/pleural.

This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler , Power Doppler as well as Tissue Harmonic Imaging, Combined Modes and Acoustic attenuation mapping.

This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

The Aplio flex, Model CUS-AFL00 and Aplio go, Model CUS-AGG00, V2.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ an array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2.5MHz to 12MHz.

The provided text is a 510(k) summary for the Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with explicit acceptance criteria and corresponding results for specific device performance metrics.

Therefore, the document does not contain the detailed information required to fully answer your request, especially regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• MRMC comparative effectiveness study results (effect size).
• Details on standalone performance.
• Training set details and ground truth establishment for the training set.

The document states generally that "Risk Analysis and verification and validation activities demonstrate that the established specifications for these devices have been met" and "Additional performance testing included in the submission was conducted in order to demonstrate that the requirements for the new features were met." However, it does not elaborate on what those specific specifications or requirements were, nor does it quantify the performance against them.

The information that can be extracted or inferred is as follows:

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

The document does not provide a table with specific, quantifiable acceptance criteria and corresponding performance metrics for the Aplio flex and Aplio go Software V2.0. The overall "acceptance criterion" implied throughout the document is demonstrating substantial equivalence to the predicate device (Xario 200G/100G Diagnostic Ultrasound System, Software Version 1.1, K182596) in terms of safety and effectiveness, and meeting established specifications in verification and validation activities.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical performance evaluation (e.g., patient cases, images). The testing mentioned is broadly "Risk Analysis and verification and validation activities" and "Additional performance testing for new features." This suggests engineering and system-level testing rather than a clinical performance study with a distinct test set. Therefore, sample size and data provenance are not reported.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided, as the document does not describe a clinical study with a ground truth established by experts.

4. Adjudication method for the test set

This information is 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 does not mention an MRMC comparative effectiveness study or any AI components that would assist human readers in a way that would require an "AI vs without AI assistance" comparison. The device is a diagnostic ultrasound system, not an AI-powered diagnostic aide in the sense of an algorithm interpreting images for a human.

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

This information is not provided, and based on the device description as a diagnostic ultrasound system, a standalone "algorithm only" performance would not be the primary focus for its type of application.

7. The type of ground truth used

This is not explicitly stated in relation to a clinical performance study. For the verification and validation, the "ground truth" would generally be established by engineering specifications, validated test methods, and potentially physical phantoms or established reference measurements for image quality, functional performance, and safety parameters.

8. The sample size for the training set

The document does not mention a "training set," which would typically be relevant for machine learning or AI-driven devices. This device is presented as an ultrasound system, not an AI model that requires a training set in the typical sense.

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

As no training set is mentioned, information on how its ground truth was established is not provided.

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