Resona 19/Resona 19 Exp/Resona I9T/Resona 19 Easi/Resona 19 Nasa/Resona IV/Imagyn 19/Imagyn 19/Imagyn 19S/ Imagyn 19 Easi/Nuewa 19/Nuewa 19T/Nuewa 19 Exp/Nuewa 19 Easi/Anesus 19/Anesus 19 Easi/Eagus 19 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, transvaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology and Thoracic/Pleural exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp. Nuewa I9 Easi. Anesus I9, Anesus I9 Easi. Eagus I9 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, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STO, Contrast imaging (Contrast agent for Liver).
The Resona I9, Resona I9 Exp. Resona I9S, Resona I9T, Resona I9 Easi, Resona 19 Nasa, Resona IV, Imagyn 19, Imagyn 19S, Imagyn 19 Easi, Nuewa 19, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
The provided text is a 510(k) summary for the Resona I9 series Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of features. It explicitly states that clinical studies were not required or performed for this submission.
Therefore, many of the requested elements regarding acceptance criteria and a study proving the device meets these criteria (especially those related to AI performance, human reader improvement, and ground truth establishment) cannot be found in this document. The device described is a general-purpose diagnostic ultrasound system, not an AI-powered diagnostic tool, which further explains the absence of such information.
However, I can extract the general acceptance criteria for this type of device based on the non-clinical tests performed to demonstrate safety and effectiveness.
Here's a breakdown of the information available and the parts that are explicitly stated as "Not Applicable" or absent:
Acceptance Criteria and Device Performance
Since this is a 510(k) for a diagnostic ultrasound system and not an AI-driven device with specific performance metrics like sensitivity/specificity, the acceptance criteria are related to safety, electrical performance, acoustic output, and compatibility. The "reported device performance" is the manufacturer's claim that the device passed these tests and conforms to the standards.
While there isn't a table of specific numerical performance criteria (e.g., minimum diagnostic accuracy), the general acceptance is based on conformity to recognized medical device standards and comparability to predicate devices.
| Acceptance Criterion (General) | Reported Device Performance (as stated in the document) |
|---|---|
| Acoustic Output Safety (below FDA limits) | "The acoustic power levels of Resona I9... are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)." |
| Biocompatibility (for patient contact materials) | "The patient contact materials of the transducers and needle-guided brackets... are the same to the predicate devices or tested under ISO 10993-1." |
| Cleaning and Disinfection Effectiveness | "Resona I9... has been evaluated for... cleaning and disinfection effectiveness." (Implied acceptance by passing evaluation) |
| Electrical Safety (conforms to standards) | "Resona I9... is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233)." |
| Thermal Safety | "Resona I9... has been evaluated for... thermal... safety." (Implied acceptance by passing evaluation) |
| Mechanical Safety | "Resona I9... has been evaluated for... mechanical safety." (Implied acceptance by passing evaluation) |
| Electromagnetic Compatibility (EMC) | Confirms compliance with IEC 60601-1-2 Edition 4.0 2014-02 for electromagnetic disturbances. |
| Usability (conforms to standards) | Confirms compliance with IEC 60601-1-6 Edition 3.1 2013-10 (usability) and IEC 62366-1 Edition 1.0 2015-02 (usability engineering). |
| Software Life Cycle Processes (conforms to standards) | Confirms compliance with IEC 62304 Edition 1.1 2015-06 for medical device software. |
| Risk Management (conforms to standards) | Confirms compliance with ISO 14971 Second edition 2007-03-01 for risk management. |
| Quality System Conformance | "The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems." |
Study Details (Based on the Provided Document)
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Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. The document states "Non-clinical Tests" were performed, but does not provide details on specific sample sizes for these tests (e.g., how many transducers were tested for acoustic output, or how many materials for biocompatibility). The document describes the system and its features, not a clinical trial or performance study based on patient data.
- Data Provenance: Not specified, as it's not a clinical data study. Non-clinical tests are typically performed in a lab setting by the manufacturer.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this is a 510(k) based on non-clinical testing and comparison to a predicate device, there is no mention of expert-established ground truth for a test set in the context of diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set with human assessment and adjudication is mentioned.
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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:
- No. The document explicitly states: "Clinical Studies: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically undergo MRMC studies for AI performance improvement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a diagnostic ultrasound imaging system, not a standalone AI algorithm. While it mentions "new software and hardware options" and features like "Smart Scene 3D" or "High frame rate STE," these are described as "improvements or enhancement based on the cleared functions to facilitate users," implying integrated features within the ultrasound system, not a separate AI algorithm requiring standalone performance validation against a ground truth. None of these features are presented as standalone diagnostic algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For the non-clinical tests, "ground truth" would be the established scientific/engineering standard for a given test (e.g., a calibrated device for acoustic output measurements, or a specified biochemical reaction for biocompatibility). There is no clinical ground truth (like pathology or outcomes data) mentioned, as no clinical studies were performed.
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The sample size for the training set:
- Not Applicable. The document does not discuss a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not Applicable. No training set is mentioned in the context of machine learning.
In summary, the provided 510(k) document is for a general diagnostic ultrasound system and asserts substantial equivalence via non-clinical testing and comparison to predicate devices, not through clinical performance studies involving a test set, expert readers, or AI algorithm validation against ground truth.
§ 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.