Search Results

Diagnostic Ultrasound
Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (Testes, adult female breast, and thyroid), Cardiac, Peripheral Vascular.
Mode of Operation: A, B, M, PWD, Color Doppler, Amplitude Doppler, Combined (Single B mode or multi-B mode will operate in single combination with M-Mode, or PWD, or color Doppler, or amplitude Doppler), Other (Contrast Harmonics mode to optimize the image when using contrast media).

Model 1.0 Diagnostic Ultrasound System with Contrast Harmonic Imaging. Addition of Contrast Harmonics mode to optimize the image when using contrast media. Contrast Harmonic modes will utilize second harmonics.

This document is an FDA 510(k) clearance letter for a diagnostic ultrasound system. It primarily addresses the regulatory approval process rather than specific performance metrics or clinical study details. Therefore, direct answers to many of your questions, especially those regarding acceptance criteria and study results, are not present in the provided text.

However, based on the information provided, here's what can be inferred and what cannot:

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

This information is not provided in the document. The clearance letter confirms substantial equivalence but does not detail specific acceptance criteria for performance or the results against those criteria. The main "acceptance criteria" discussed are regulatory compliance and the condition of submitting a post-clearance special report on acoustic output measurements.

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

This information is not provided. The document does not describe any specific test set or data provenance for performance evaluation.

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)

This information is not provided. The document does not describe any test set for which ground truth was established by experts.

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

This information is not provided. No 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

This information is not provided. This document pertains to a diagnostic ultrasound system and its "Contrast Harmonic Imaging" mode, not an AI-assisted device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

This information is not applicable. The device is an ultrasound system, not an algorithm, so a standalone algorithm performance test is not relevant.

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

This information is not provided. No specific "ground truth" related to performance evaluation is mentioned. The clearance is based on substantial equivalence to predicate devices, which implies that the new device performs similarly and is safe and effective for its intended uses.

8. The sample size for the training set

This information is not provided. As this is a traditional diagnostic device, not an AI/ML device, a "training set" in the context of machine learning model development is not applicable.

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

This information is not applicable for the same reasons as point 8.

Summary of what is present:

• Device: Model 1.0 Diagnostic Ultrasound System with Contrast Harmonic Imaging and Transducer Model Number 214U.
• Clearance Type: 510(k) clearance, indicating substantial equivalence to legally marketed predicate devices.
• Intended Use: Diagnostic Ultrasound for various clinical applications (Fetal, Abdominal, Pediatric, Small Organ - Testes, adult female breast, thyroid, Cardiac, Peripheral Vascular) using various modes (B, M, PWD, Color Doppler, Amplitude Doppler, Combined).
• New Feature: Addition of Contrast Harmonics mode to optimize images when using contrast media, utilizing second harmonics.
• Post-Clearance Condition: The manufacturer must submit a post-clearance special report containing acoustic output measurements based on production line devices. This is a condition for the substantial equivalence determination to apply to production units.
• Predicate Devices: Model 1.0 was previously cleared under K963863, K952551, and K982498.

This document focuses on the regulatory process of clearance for a new feature (Contrast Harmonic mode) on an existing device, confirming its safety and effectiveness through substantial equivalence to previously cleared devices. It does not contain detailed performance study data, as might be found in a clinical trial report.

Ask a specific question about this device