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The LOGIQ Vita / S20 Series are intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo- skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

The LOGIQ Vita / S20 Series are intended to be used in a hospital or medical clinic.

The LOGIQ Vita / S20 Series are full featured, Track 3, general purpose diagnostic ultrasound systems which consists of a mobile console approximately 530 mm wide (Caster), 835 mm deep (front and back handle) and 1314 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 14-inch high-resolution color touch screen and 23.8-inch Wide screen High-Resolution HDU monitor and 23.8-inch Wide screen High-Resolution LCD monitor.

The provided FDA 510(k) clearance letter and summary do not contain detailed information about specific acceptance criteria, reported device performance metrics, or a study specifically designed to prove that the device meets those criteria.

The submission is for a new diagnostic ultrasound system (LOGIQ Vita / S20 Series) that leverages the design and clinical data of a predicate device (LOGIQ Fortis K253366). The core argument for substantial equivalence is that the new device has "no changes to the features, accessories, or components that require new clinical studies to support substantial equivalence."

This means that the provided document does not describe a new study that proves the device meets acceptance criteria in the way you've requested. Instead, it asserts that because the new device is substantially equivalent to a previously cleared device, the existing evidence for the predicate device's safety and effectiveness applies.

However, based on the information provided, we can infer some details:

1. Table of acceptance criteria and reported device performance:

The document explicitly states: "The subject of this premarket submission, the LOGIQ Vita / S20 Series, leverages the same clinical data as the predicate and no changes to the features, accessories, or components that require new clinical studies to support substantial equivalence."

This implies that the acceptance criteria and reported device performance are identical to those established for the predicate device, LOGIQ Fortis (K253366). Since the details of that predicate device's performance study are not included in this document, we cannot populate this table with specific quantitative metrics.

Regarding the study proving the device meets acceptance criteria:

The document explicitly states: "The subject of this premarket submission, the LOGIQ Vita / S20 Series, leverages the same clinical data as the predicate and no changes to the features, accessories, or components that require new clinical studies to support substantial equivalence."

This means there was no new, independent clinical study conducted for the LOGIQ Vita / S20 Series to demonstrate it meets acceptance criteria beyond what was established for the predicate device (LOGIQ Fortis K253366). The substantial equivalence argument relies on the fact that the changes are minor and do not impact the core safety and effectiveness established by the predicate.

Given this, the subsequent questions, which would typically describe such a study, cannot be answered directly from the provided text for the LOGIQ Vita / S20 Series. If such information exists, it would be found in the 510(k) submission for the LOGIQ Fortis (K253366) predicate device.

Based on the provided document, here's what we can state:

• 2. Sample size used for the test set and the data provenance: Not applicable for a new study. The device "leverages the same clinical data as the predicate," meaning no new test set was used for this 510(k).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a new study.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a new study.
• 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 mentions "AI algorithms" in the context of UGAP/UGFF features being identical to the predicate, but it does not describe an MRMC comparative effectiveness study to measure human reader improvement.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document states that the liver assessment features (UGAP/UGFF) utilize AI algorithms, and these are identical to the predicate device. However, it does not describe a standalone performance study specifically for the AI components in this submission. The assertion is that these features have not changed since the predicate.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new study.
• 8. The sample size for the training set: Not applicable for a new study.
• 9. How the ground truth for the training set was established: Not applicable for a new study.

In conclusion, the clearance for the LOGIQ Vita / S20 Series is based on its substantial equivalence to the predicate LOGIQ Fortis (K253366), rather than a new, dedicated study demonstrating its performance against new acceptance criteria. The performance and safety data are derived from the predicate device.

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The Sonosite iLOOK Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

• Pediatric
• Peripheral vessel
• Needle Guidance

Modes of operation include: B Mode (B), Color Power Doppler, Color Velocity Doppler, Multi-beam imaging, and combined modes, including duplex imaging: B+C.

This device is indicated for Prescription Use Only.

The Sonosite iLOOK system is intended to be used in medical practices, clinical environments, including healthcare facilities, hospitals, clinics, and clinical point-of-care for diagnosis of patients. The system includes a transducer and a display connected together wirelessly. The transducer is powered by battery, while the display is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.

The Sonosite iLOOK Ultrasound System is a fully featured, general-purpose, software-controlled diagnostic ultrasound system utilizing an all-digital architecture. The system is a portable ultrasound device consisting of a display, adjustment handle, wireless L15-5 linear ultrasound transducer, and a transducer holder with a built-in wireless charger.

The system is designed to acquire and display high-resolution, real-time ultrasound data in 2D, Color Power Doppler (CPD), Color Velocity Doppler (CVD), or a combination of these modes. It provides measurement capabilities for anatomical structures and pediatric biometry, offering information for clinical diagnostic purposes.

The system includes a variety of accessories, including an optional stand. Additionally, it features Digital Imaging and Communications in Medicine (DICOM) capabilities, along with general computer communication functionalities, including wireless networking. These capabilities enable the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops.

The system features a single USB port, allowing the use of compatible storage devices, such as memory sticks and hard drives. An AC adapter is included in the stand module, enabling manual connection to AC power.

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