(129 days)
Consona N6, Consona N6 Pro, Consona N6 Super, Consona N6S, Consona AE, Consona AT, Consona N6 Exp, Consona No Elite, Consona N6T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.
It is intended for use in fetal, abdominal, Intra-operative, small organ(breast, thyroid, testes), neonatal cephalic,adult cephalic,trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), Thoracic/Pleural, cardiac adult, cardiac pediatric, Trans-esoph., peripheral vessel and urology exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, PW+Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast imaging (Contrast imaging (Contrast agent for Liver).
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include : B. M. PWD. CWD. Color Doppler. Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, Amplitude PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
Subject device can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
This document is a 510(k) summary for a diagnostic ultrasound system (Consona N6 series). It appears the device does not rely on AI features requiring specific performance metrics or a human-in-the-loop study for its predicate equivalence. The summary explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
Therefore, the requested information about acceptance criteria, specific study designs (MRMC, standalone), ground truth establishment for a test set and training set, and expert qualifications for AI/ML performance evaluation cannot be extracted from this document because such studies were not deemed necessary for this device's regulatory review.
The document describes a general diagnostic ultrasound system and focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: Similar applications (fetal, abdominal, cardiac, etc.)
- Technological Characteristics: Similar imaging modes (B, M, Doppler), transducers, and features.
- Non-clinical Tests: Compliance with acoustic output, biocompatibility, electrical safety, and software standards.
The only "new option" mentioned that might be interpreted as having an "intelligent" component is "Smart Calc," described as: "Semi-automatically recognizes the contour of the target area and measures the diameter, area and circumference of the target area. The user needs to identify the target area first. When the measures results are not satisfactory, the user can use the trackball to manually edit the contour." However, this is presented as an enhancement based on cleared functions, not a new intended use or a feature requiring a specific AI/ML performance study as typically understood in the context of FDA submissions for AI-enabled devices.
Summary of what cannot be provided given the document:
- Table of acceptance criteria and reported device performance for AI features: Not provided as specific AI performance studies were not cited.
- Sample size and data provenance for a test set: Not applicable; no such test set was described for AI performance.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study, effect size: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable for AI performance studies.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
Information that can be extracted related to the device as a whole (not AI-specific):
- Non-clinical Tests: The device underwent testing for acoustic output (NEMA UD 2-2004), electrical safety (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37), usability (IEC 60601-1-6, IEC 62366-1), risk management (ISO 14971), biocompatibility (ISO 10993-1), and software lifecycle processes (IEC 62304). This demonstrates the device meets general safety and performance criteria through adherence to recognized standards.
- Clinical Studies: Explicitly stated as "Not applicable."
- Device Performance: The conclusion states that the device "was found to have a safety and effectiveness profile that is similar to the predicate device" based on "performance data as documented in the study" (referring to the non-clinical tests described).
In conclusion, this document does not contain the information requested about AI acceptance criteria and study designs because the device, as described for this 510(k) submission, does not appear to be an AI-enabled device requiring such specific performance evaluations for its regulatory clearance, or at least, those details are not provided in this public summary.
§ 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.