(24 days)
The SpeqRT 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 Ltd SignosRT is a hand-held, diagnostic ultrasound system with an onscreen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, M-Mode, or Spectral Doppler (PW Doppler) on an LCD display.
The provided text describes the regulatory clearance of the SpeqRT ultrasound system, specifically for an update that includes a new L10 transducer. However, the document does not contain a study that quantitatively proves the device meets specific acceptance criteria in terms of clinical performance or accuracy thresholds.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices and adherence to safety and performance standards through non-clinical testing. It highlights the addition of a new transducer (L10) and associated software/materials updates.
Here's the information that can be extracted from the provided text, and where missing information is noted:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the form of quantitative performance thresholds for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating comparable or improved resolution to predicate devices through bench testing and compliance with various safety and performance standards.
| Acceptance Criteria (Implied from substantial equivalence) | Reported Device Performance |
|---|---|
| Imaging Performance | SpeqRT L10 imaging performance and measurement accuracy is described as "substantially equivalent" to S3-5 transducer predicate devices. The measured lateral and axial resolution for the SpeqRT L10 is explicitly stated as "less than the S3-5 transducer and predicates 7.5MHz transducer (K090505)", indicating better image resolution. |
| Measurement Accuracy | SpeqRT L10 measurement accuracy is described as "substantially equivalent" to S3-5 transducer predicate devices. |
| Biocompatibility | New materials for the S3, S3-5, and L10 transducers meet ISO-10993 standards (specifically ISO 10993-5:2009, ISO 10993-10:2002, ISO 10993-10:2010, ISO 10993-12:2007). |
| Electrical Safety | Complies with IEC 60601-1:2005, ES60601-1:2005, IEC 60601-2-37:2007, IEC 60601-1-2:2007. |
| Software Development & Verification | Developed and verified according to IEC 62304:2006. Verification reports, traceability, and risk analysis demonstrate the device operates as intended and risks are mitigated. |
| Mechanical Stress | Drop and push testing per ES60601-1; Mechanical Vibration per JIS Z 0232:2004; Drop Test (to concrete): 1 meter. |
| Environmental | Operating Temperature: 0 to 40°C; Humidity: 20% to 80% RH; Water Resistance: Transducer IPX7 lens, IPX1 probe. |
| Acoustic Output | Both S3-5 and L10 transducers maintain MI and TI to be |
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.