The Resona 7/Resona 7CV/Resona 7S/Resona 7S/Resona 7OB 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), adult cephalic, trans-vaginal,musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, TDI mode, 3D/4D mode, Color M-mode, iScape mode, Elastography, LVQ, Ultrasound Fusion Imaging, V Flow or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 13.5MHz.
This represents an FDA 510(k) clearance letter for an ultrasound system, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI algorithm.
Therefore, many of the requested details about acceptance criteria, study sample sizes, expert involvement, and ground truth for an AI device are explicitly stated as "Not Applicable" or cannot be extracted from this document, as this is for a general diagnostic ultrasound system and not specifically an AI-powered diagnostic algorithm.
Here's the information that can be extracted and a clear indication where the requested information is not available in this document:
1. A table of acceptance criteria and the reported device performance
This document does not provide specific performance acceptance criteria with numerical targets (e.g., sensitivity, specificity, or image quality metrics) or reported device performance for an AI algorithm. The device, a Diagnostic Ultrasound System, is cleared based on substantial equivalence to predicate devices and compliance with safety and performance standards. The "performance" described is largely about its functional capabilities and safety.
| Feature | Acceptance Criteria (Explicitly Stated as Conformance) | Reported Device Performance (Implicitly by Conformance) |
|---|---|---|
| Intended Use | Substantially equivalent to predicate device DC-8 (K150080) | The subject device has the same intended uses as the predicate device. |
| Patient Contact Materials | Compliance with ISO 10993-1 | Tested and conforms to ISO 10993-1. |
| Acoustic Power Levels | Below FDA limits and same as predicate device DC-8 (K150080) | Acoustic power levels are below FDA limits and are the same as the predicate device. |
| Electrical and Physical Safety | Compliance with FDA recognized electrical and physical safety standards, same as predicate device DC-8 (K150080) | Designed in compliance with specified standards and found to conform. |
| Imaging Modes | Same as predicate devices | Has the same imaging modes as the predicate devices. |
| Functions | Same as predicate devices | All functions are the same as the predicate devices. |
| Transducers | Similar to predicate devices | Has similar transducers with the predicate devices. |
| Quality System | Conforms to 21 CFR 820, ISO 9001 and ISO 13485 quality systems | The design, development and quality process confirms with these standards. |
| Acoustic Output (Measurements & Display) | Compliance with UD 2 (Revision 3) and UD 3 | Non-clinical tests relied on compliance with these standards. |
| Medical Device Software | Compliance with IEC 62304 | Non-clinical tests relied on compliance with this standard. |
| Risk Management | Compliance with ISO14971 | Non-clinical tests relied on compliance with this standard. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document states "Non-clinical Tests:" and lists compliance with standards, but no details on specific test sets for performance evaluation (especially for an AI component) are given. Clinical tests are explicitly stated as "Not Applicable."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. No clinical test data or expert-adjudicated ground truth is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as no specific test set requiring adjudication is described.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned in this document. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool needing such a study for this clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided and is not applicable to this type of device clearance. The device described is a diagnostic ultrasound system that produces images for human interpretation, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. Clinical tests are explicitly stated as "Not Applicable."
8. The sample size for the training set
This information is not provided in the document. No AI algorithm development with a training set is discussed.
9. How the ground truth for the training set was established
This information is not provided in the document. No AI algorithm development with a training set and corresponding ground truth establishment is discussed.
§ 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.