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The Speq ultrasound system is for non-invasive imaging of the human body and is intended for the following applications: Fetal, Abdominal, Pediatric, Musculo-skeletal, Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications.

The Signostics Pty Ltd Speq ultrasound system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode or M-Mode on an LCD display.

The provided text is a 510(k) Summary for the Signostics Pty Ltd Speq Ultrasound System. It describes the device, its classification, and comparison to predicate devices, along with its indications for use. However, it does not contain any information regarding acceptance criteria, studies proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or comparative effectiveness studies.

The document states that the Speq ultrasound system is "substantially equivalent to the predicate devices listed above. All systems transmit ultrasonic energy into patients, then process received echoes to produce on-screen images of anatomic structures within the body. All systems allow for measurements of structures to aid in diagnosis." This statement of substantial equivalence is the basis for regulatory clearance, rather than a detailed performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance studies based on the provided text. The document focuses on regulatory clearance through substantial equivalence, not detailed efficacy or performance studies with specific metrics.

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Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Multi View (MView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer.

The provided document is a 510(k) summary for the Esaote 7340 Ultrasound System, submitted to the FDA in 2008. It primarily details the device's intended use and compares its technological characteristics to predicate devices for demonstrating substantial equivalence.

Crucially, this document does NOT contain information about specific acceptance criteria, studies proving device performance against those criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or the type of ground truth used.

The tables within the document (pages 8-10, 15-16) list the clinical applications and modes of operation available on the 7340 system and its predicate devices, as well as for various transducers. The 'N' and 'P' in these tables indicate whether a particular clinical application and mode is 'New' (first introduced with this device for that application) or 'Previously cleared' (using transducers approved in prior submissions) for the specific transducer being discussed. This is a comparison for substantial equivalence, not a performance study against acceptance criteria.

Therefore, I cannot provide the requested information from this document. The sections you asked for are typically found in detailed performance studies, clinical trials, or validation reports, which are not included in this 510(k) summary.

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