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The iNSIGHT Color DopplerUltrasound System is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.

The iNSIGHT Color Doppler Ultrasound Systems are integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. Their basic function is to acquire ultrasound signal and display the images in the following imaging operations: B, M, PW, CW, CDI, PDI, DPDI, TDI, MC and THI imaging mode, Spatial Compounding Imaging, Panoramic B and Color mode, Freehand 3D, 4D Imaging, Strain imaging, ARFI Elasticity Imaging.

The provided text is a 510(k) summary for the iNSIGHT Color Doppler Ultrasound System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document primarily focuses on regulatory compliance, outlining the device's technical characteristics, regulatory classifications, and a comparison with previously cleared predicate devices (K090059 and K130881).

Here's a breakdown of what is and isn't present in the given text regarding your request:

What is (partially) present:

• Non-Clinical Test Conclusion: The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It also mentions "bench testing for the features providing strain and elasticity quantitative has been conducted to show that the accuracy of the strain and elasticity imaging of the proposed device; the result has been analyzed that they are accepted for clinical use."
• Type of Ground Truth (for non-clinical testing): For the "strain and elasticity quantitative measurements," the ground truth seems to be implicitly established through the "accuracy" of the measurements, likely against a known standard or phantom in a bench test setting, rather than expert consensus, pathology, or outcomes data from human subjects.

What is NOT present in the provided text:

1. A table of acceptance criteria and the reported device performance: The document lists several IEC and ISO standards that the device complies with (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, ISO 10993-5, ISO 10993-10). These are general safety and performance standards for medical electrical equipment and diagnostic ultrasound, not specific performance metrics or acceptance criteria for image quality or diagnostic accuracy. While compliance with these standards could be considered a form of acceptance criteria, the document does not report specific device performance against these. The only performance mention is for "strain and elasticity quantitative measurements" stating they were "accepted for clinical use," but without quantitative details.
2. Sample size used for the test set and the data provenance: No details are provided regarding sample sizes for any performance testing, nor the origin (country, retrospective/prospective) of any data.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there are no details of a test set requiring expert ground truth in the provided document beyond the general statement of "bench testing."
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was performed or reported.
6. Standalone (algorithm only without human-in-the-loop performance) study: While "bench testing" was mentioned for strain and elasticity, specific details of a standalone performance study in the context of diagnostic accuracy are not provided. The device is an ultrasound system, not an AI algorithm that would typically undergo standalone algorithm-only performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As noted, for the limited performance mention, it implies comparison to known values in a bench test, not clinical ground truth.
8. The sample size for the training set: Not applicable, as this is an ultrasound imaging system, not an AI/machine learning model where a training set of data would be typically discussed in this context.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) summary focuses on validating the substantial equivalence of the iNSIGHT Color Doppler Ultrasound System to existing predicate devices based on its intended use, technology characteristics, and adherence to established medical device safety and performance standards. It does not include a detailed study with specific acceptance criteria for diagnostic performance outcomes (like sensitivity, specificity, accuracy) or the data supporting such performance, nor does it describe any clinical studies. The mention of "bench testing" relates to the accuracy of "strain and elasticity quantitative measurements" but lacks specific details regarding the methodology or quantitative results in relation to defined acceptance criteria.

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