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510(k) Data Aggregation
(198 days)
Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. If is intended for use in fetal, abdominal. Intraoperative, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, musculoskeletal(conventional, superficial), adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams.
This device is a general purpose diamostic 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.
Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, 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), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system.
This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.
The provided document is a 510(k) Summary for a Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and performance data for a new AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (especially for AI/CADe tools) is not present in this document.
However, I can extract information related to the device's broader regulatory and non-clinical testing.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the document as a set of quantified acceptance criteria and corresponding performance metrics for a specific function or feature. The document extensively compares the device to predicate devices and lists various non-clinical tests performed, implying that meeting standards is the "acceptance criteria."
However, I can infer the "acceptance criteria" based on the listed non-clinical tests and the "performance" as compliance with these standards and equivalence to predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Acoustic Output: Below FDA limits (NEMA UD 2-2004 (R2009)) | "The acoustic power levels of [Device Names] are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)." (Page 9) |
| Electrical and Physical Safety: Compliance with AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2 Ed. 4.0, IEC 60601-1-6 Ed. 3.1, IEC 60601-2-37 Ed. 2.1 | "Resona R9...is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233)." (Page 9) |
| Biocompatibility: Transducer materials tested under ISO 10993-1. Specific testing for ELC13-4U transducer. | "The patient contact materials of the transducers are tested under ISO 10993-1." (Page 9) "The materials used in the new transducers (except for ELC13-4U) and needle-guided brackets were the same as in the predicate device. And the ELC13-4U transducer was testing for biocompatibility." (Page 5) |
| Cleaning and Disinfection Effectiveness: Provided instructions for end-user. | "All the transducers and needle-guided brackets were provided non-sterile to the end user. And all the disinfection/sterilization methods for the new transducers and needle guide brackets were provided to the end user and the users are notified that disinfection /sterilizaiton are necessary in the Operation Manual." (Page 5) |
| Risk Management: Compliance with ISO 14971 | "This device has been tested and evaluated under the following standards: ...ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices." (Page 11) |
| Software Life Cycle Processes: Compliance with AAMI / ANSI / IEC 62304:2015 | "This device has been tested and evaluated under the following standards: ...AAMI / ANSI / IEC 62304:2015, medical device software - software life cycle processes." (Page 11) |
| Usability Engineering: Compliance with IEC 62366-1 Edition 1.0 2015-02 | "This device has been tested and evaluated under the following standards: ...IEC 62366-1 Edition 1.0 2015-02 medical devices - application of usability engineering to medical devices." (Page 11) |
| Overall Safety and Effectiveness Profile: Similar to predicate device. | "Based on the performance data as documented in the study, the Resona R9 series Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device." (Page 12) "The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems." (Page 12) |
| Functional Equivalence: Same intended uses, basic operating modes, technological characteristics, imaging modes, and comparable key safety and effectiveness features as predicate devices (e.g., Resona 7 (K171233), DC-80 (K192152), RS85 (K192903), etc., for specific features like AutoEF, Ultra-Micro Angiography, Smart Fetal HR). Transducers are similar or cleared. New features are comparable to features in other cleared predicate/reference devices. | "Resona R9...has the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes." (Page 8) "The subject device also has the same intended uses and basic operating modes as the predicate devices." (Page 8) "The Resona R9...has the same imaging modes as the predicated devices." (Page 10) "The Resona R9...has the same functions as the predicated devices." (Page 10) "The Resona R9...has similar tranducers with the predicated devices." (Page 10) |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a clinical study with a test set of patient data. The evaluation is based on non-clinical engineering and performance testing against recognized standards and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No human expert ground truth was established for a test set, as no clinical study is presented.
4. Adjudication method for the test set
Not applicable/Not provided. No test set or ground truth was established that would require adjudication.
5. 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
Not applicable/Not provided. This document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." (Page 11). Therefore, no MRMC study was conducted or reported. The device is a diagnostic ultrasound system, not specifically an AI/CADe tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. The document does not describe a standalone algorithm performance evaluation. Some features listed (e.g., Smart V Trace, Smart ICV, AutoEF, Smart Fetal HR, Smart Caliper, Smart Trace) imply quantitative analysis capabilities, but no performance metrics for these "smart" features are provided in a standalone context. These are likely integrated functions within the ultrasound system, not standalone AI algorithms intended for independent evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the referenced standards (e.g., NEMA UD 2, IEC 60601 series, ISO 10993-1).
8. The sample size for the training set
Not applicable/Not provided. This document describes a traditional medical device (ultrasound system) and its non-clinical testing for substantial equivalence, not the development or training of an AI/ML algorithm. Therefore, no training set information is provided.
9. How the ground truth for the training set was established
Not applicable/Not provided. As no training set is discussed, there's no information on how its ground truth might have been established.
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