(29 days)
The FUJIFILM FC1Ultrasound 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:
Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Peripheral Vessel
The FC1 Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes.
The provided text is a 510(k) Summary for the FUJIFILM FC1 Ultrasound System. It details the device's characteristics and its equivalence to legally marketed predicate devices, but it does not contain information about specific acceptance criteria, a study proving performance against those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies. The document states that clinical studies were not required.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria or report specific performance metrics (e.g., sensitivity, specificity, accuracy) for the device. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, safety standards compliance, and intended use.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document states:
"The FC1 Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical studies requiring ground truth establishment were conducted.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies requiring adjudication were conducted.
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. The document describes an ultrasound system, not an AI or CAD system designed to assist human readers. Moreover, no clinical studies were performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not an algorithm being evaluated for standalone performance. No clinical studies were performed.
7. The Type of Ground Truth Used
Not applicable, as no clinical studies requiring ground truth were conducted.
8. The Sample Size for the Training Set
Not applicable, as the device is not an AI/ML algorithm that requires a training set in the conventional sense. The "study" mentioned in the request refers to the overall evaluation for 510(k) clearance, which did not involve clinical performance data or training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as the device is not an AI/ML algorithm, and no training set with established ground truth was used.
Summary of what the document does provide regarding "studies" and performance:
The document primarily details the non-clinical tests conducted to ensure safety and effectiveness and establish substantial equivalence to predicate devices. These include:
- Electrical, thermal, mechanical, and EMC safety evaluations: The device was found to conform to applicable mandatory medical device safety standards.
- Cleaning/disinfection evaluation.
- Biocompatibility evaluation.
- Acoustic output evaluation.
- Quality assurance processes: Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation were employed.
- Compliance with FDA recognized standards: A list of ISO and IEC standards is provided (e.g., ISO 10993-1, IEC 60601-1, IEC 62304, IEC 62359, ISO 14971, NEMA UD 2-2004).
The "study that proves the device meets the acceptance criteria" in this context is the collection of these non-clinical evaluations and the demonstration that the device's technological characteristics, intended use, and safety profiles are substantially equivalent to existing predicate devices (SonoSite Edge K133454 and SonoSite X-Porte K152209), which themselves have established safety and effectiveness.
The document concludes that "The FC1 system and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electro-medical device safety standards." This is the primary "proof" for its acceptance.
§ 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.