(30 days)
The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).
The ACUSON Freestyle™ Diagnostic Ultrasound System is a portable ultrasound imaging system where the system operates with linear and curvilinear array transducers. These transducers may be used in a wireless mode or using a probe adaptor cable and is capable of the following modes (these modes below can be operated in combination or individually):
- । B-Mode
- -Color Doppler Mode
- -Amplitude Doppler Mode
The ACUSON Freestyle™ Diagnostic Ultrasound System includes a main unit console with user interface controls, a 15-inch video display, and system electronics. The main unit weighs approximately 10.5 pounds and is 13.2 inches high, 14.7 inches wide, and 5 inches deep. The system may be mounted on a small roll stand, monitor arm, or tabletop. An optional external receiving antenna can be mounted to the unit console, this provides better line of sight to the wireless transducers. The system provides an intuitive and easy-to operate user interface. It has a compact and portable design and offers DICOM archival and networking capability.
The provided text describes the ACUSON Freestyle Diagnostic Ultrasound System (VA41A), a modification of a previously cleared device (ACUSON Freestyle 4.0, VA40A). The document focuses on demonstrating substantial equivalence to the predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with quantitative performance metrics.
However, based on the information provided, we can infer the acceptance criteria relate to maintaining equivalence with the predicate device and adhering to established medical device standards. The "study" proving acceptance criteria is a substantial equivalence determination based on comparison and non-clinical testing.
Here's an breakdown based on your request, as much as can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly stated as being substantially equivalent to the predicate device in terms of:
- Intended Use and Indications for Use
- Technological Characteristics
- Safety and Effectiveness
The document does not provide quantitative performance metrics against specific, pre-defined acceptance criteria (e.g., minimum sensitivity, specificity, or image resolution values). Instead, it asserts that the new device, VA41A, maintains the performance and safety profile of the predicate device, VA40A, which was already cleared.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Summary of Comparison) |
|---|---|
| Intended Use | Identical: The device maintains the same intended use: "diagnostic imaging or fluid flow analysis of the human body performed by an appropriately trained healthcare professional in a healthcare setting." |
| Indications for Use | Modified but Substantially Equivalent: Existing indications (Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal Conventional, Musculoskeletal Superficial) are identical. Some indications (Fetal, Cardiac, Neonatal Cephalic, Intraoperative Neurological) were deleted. The addition of the L17-5 transducer expands capabilities for existing indications but does not introduce new types of clinical applications. |
| Technological Characteristics | Largely Identical with Minor Modifications/Enhancements: |
- Imaging modes (B-Mode, Color Doppler, Amplitude Doppler, M-mode, PWD) are identical.
- Transducer frequencies are identical for existing transducers (L8-3, L13-5, C5-2).
- New Transducer: Introduction of L17-5 (5.0 - 17.0 MHz) with higher frequency for improved near-field resolution.
- Imaging functions (Multi-Hertz, Beam-free, Spatial Compounding, Speckle Filter, TGC, Auto Send, Auto Study Management, Needle V, Measurements, Trapezoidal Imaging, Cine Capture) are identical, with new Dual Mode and Split Mode.
- Wireless features, FCC compliance, battery operation, connectivity, monitoring, OS, output display, patient contact materials, and UL certification are identical. |
| Safety and Effectiveness | Confirmed by Compliance: Evaluated for acoustic output, cleaning, disinfection, thermal, electromagnetic, and mechanical safety. Found to conform to applicable medical device safety standards (AIUM/NEMA UD-2, UD-3, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, IEC 60601-1-6, IEC 62304, ISO 10993-1, ISO 14971). No new issues of safety or effectiveness are raised. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Since the ACUSON Freestyle Diagnostic Ultrasound System is a class II device and uses the same technology and operating principles as existing predicate device, ACUSON Freestyle Ultrasound System (K162417), therefore clinical studies were not required to support substantial equivalence."
This indicates that there was no dedicated clinical test set for evaluating the performance of the VA41A in human subjects. The assessment relies on a comparison to the predicate device and non-clinical engineering and safety testing. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not applicable here because such a study was not performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there was no clinical test set requiring ground truth establishment from human readings, this information is not applicable.
4. Adjudication Method for the Test Set
As there was no clinical test set requiring ground truth establishment from human readings, this information is not applicable.
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
The device described is a diagnostic ultrasound system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an AI algorithm's performance in isolation. As the device is an ultrasound system and not an AI algorithm for image interpretation, this is not applicable. The "device" itself is the imaging system, and its performance is evaluated through engineering and safety standards, and equivalence to a predicate, not as an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing and comparison to standards, the "ground truth" would be established by:
- Engineering specifications and measurements: For acoustic output, thermal properties, electromagnetic compatibility, and mechanical safety.
- Standard compliance: Adherence to recognized national and international standards (e.g., AIUM/NEMA, ANSI AAMI, IEC, ISO).
- Predicate device characteristics: The established performance and safety profile of the legally marketed predicate device (ACUSON Freestyle 4.0, VA40A).
8. The Sample Size for the Training Set
As this is not an AI/ML device, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set was Established
As this is not an AI/ML device, the concept of a "training set" and its ground truth establishment is 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.