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The SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

The SonoSite SII Ultrasound System is a general purpose ultrasound system 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: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel

SONOSITE EDGE II ULTRASOUND SYSTEM: The SonoSite Edge II Ultrasound System is a portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge II is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge II can operate on either battery or AC power.

SONOSITE SII ULTRASOUND SYSTEM The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.

The provided text is a 510(k) Premarket Notification summary for the FUJIFILM SonoSite Edge II and SonoSite SII Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a novel AI/ML algorithm.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML algorithm. The document discusses:

• Indications for Use: The clinical applications for which the ultrasound systems are intended.
• Technological Characteristics: A comparison of the subject devices (SonoSite Edge II and SII) with their predicate devices (various SonoSite Edge and FC1 models), highlighting similarities in intended use, transducer types, frequency ranges, maximum acoustic outputs, modes of operation (e.g., B-mode, M-mode, Color Doppler), ECG features, DICOM compatibility, and various safety and electromagnetic compatibility standards.
• Non-Clinical Tests Summary: Mention of electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output evaluations, and conformity to applicable mandatory medical device safety standards.
• Clinical Tests Summary: Explicitly states that clinical studies were not required to support the determination of substantial equivalence.

Since this document describes an ultrasound system (a hardware device) and its transducers, and not an AI/ML algorithm, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sensitivity, specificity, AUC) are not addressed. The "acceptance criteria" here are implicitly about demonstrating equivalence to existing, cleared ultrasound systems based on technological characteristics and non-clinical safety/performance data.

Specifically, the requested information cannot be extracted from the provided text because:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of AI/ML performance. The tables list device features and intended uses, comparing them to predicates.
2. Sample size used for the test set and the data provenance: No test set or data provenance for AI/ML performance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no AI/ML performance ground truth is established.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or mentioned for AI/ML assistance.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a hardware ultrasound system.
7. The type of ground truth used: Not applicable for AI/ML. The provided information relates to the regulatory approval of a medical device (ultrasound system) based on substantial equivalence to predicates.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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