(33 days)
The FUJIFILM SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic
Fetal - OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid, testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac)
Peripheral Vessel
The SonoSite Edge II Ultrasound System is a portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge II is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge II can operate on either battery or AC power.
This document is a 510(k) premarket notification for the FUJIFILM SonoSite Edge II Ultrasound System. It is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission is not a clinical study designed to test acceptance criteria for an AI/ML device in the way you've outlined.
Therefore, many of the specific questions about acceptance criteria for AI/ML performance, sample size for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to this document. This document focuses on demonstrating physical, technological, and intended use equivalence to existing ultrasound systems.
However, I can extract information relevant to similar underlying principles where applicable:
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, AUC) that one would typically see for an AI/ML device's diagnostic performance. Instead, the acceptance criteria are based on substantial equivalence to predicate devices in terms of:
- Intended Use: The device performs diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications.
- Technological Characteristics: The device utilizes similar transducer types, frequency ranges, modes of operation (B-mode, M-mode, Doppler, etc.), and patient contact materials as the predicate devices.
- Safety and Effectiveness: Demonstrated by compliance with recognized FDA standards for electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output. This is a qualitative acceptance criterion based on meeting established regulatory standards, not a quantitative performance metric.
| Acceptance Criterion Type | Description from Document | Reported Device Performance (as stated or implied) |
|---|---|---|
| Intended Use Equivalence | The FUJIFILM SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal - OB/GYN, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel. | The device's "Indications for Use" (Pages 3-15) show a comprehensive list of clinical applications and modes of operation that are either "new indications" (N) or "previously cleared by FDA" (P) for specific transducers, demonstrating that it covers a range of uses comparable to or expanding upon the predicate devices. The listed indications for use are directly provided as the device's intended performance. |
| Technological Equivalence | The device should share fundamental scientific technology, transducer types, frequency, modes of operation, and patient contact materials with its predicates. | A detailed comparison table (Pages 17-18) explicitly states that the SonoSite Edge II uses the same fundamental scientific technology, transducer types (Linear, Curved, Intracavitary, Phased Array, Trans-esophageal), frequency range (1.0-15.0 MHz), and modes of operation (B-mode, M-mode, Color Doppler, Pulsed Wave Doppler, Continuous Wave Doppler, etc.) as the predicate devices (SonoSite Edge K133454 and SonoSite X-Porte K152209). Patient contact materials are also listed as equivalent. |
| Safety and Effectiveness | The device must conform to applicable mandatory medical device safety standards for electrical, thermal, mechanical, and EMC safety, as well as cleaning/disinfection, biocompatibility, and acoustic output. | The device has been "evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to applicable mandatory medical device safety standards." (Page 21) A list of specific FDA-recognized standards (ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, IEC 62359, ISO 14971, NEMA UD 2-2004) is provided, indicating adherence to regulatory requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
This document is for a traditional diagnostic ultrasound system, not an AI/ML device. Therefore, there is no "test set" of patient data in the sense of an AI/ML algorithm's performance evaluation. The "testing" referred to is against engineering and safety standards.
The document explicitly states under "Summary of Clinical Tests": "The SonoSite Edge II Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." (Page 21). This means no patient data was used for a clinical performance evaluation in the context of this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. As no clinical studies were required, there was no ground truth for a test set to be established by experts.
4. Adjudication Method for the Test Set:
Not applicable, as no test set of clinical images requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. The document states that clinical studies were not required. The comparison is between the technological characteristics and indications for use of the new device and its predicates, not an improvement in human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware and software system for diagnostic imaging, not an AI/ML algorithm that operates independently.
7. The Type of Ground Truth Used:
Not applicable in the context of diagnostic accuracy. The "ground truth" for this submission revolves around:
- Confirmation that the device functions as designed and meets technical specifications.
- Compliance with recognized industry and regulatory safety standards.
- Verification that the device's capabilities align with its stated intended uses and are substantially equivalent to its predicates.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML product developed with training data.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
§ 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.