Search Results

The Diagnostic Ultrasound Systems Aplio a550 Model CUS-AA550 and Aplio a450 Model CUS-AA450 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

The Aplio a550 Model CUS-AA550 and Aplio a450 Model CUS-AA450 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 20 MHz.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Aplio a550 and a450 Diagnostic Ultrasound Systems:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provided does not contain a specific table outlining acceptance criteria and reported device performance metrics in the format typically associated with diagnostic performance studies (e.g., sensitivity, specificity, AUC). Instead, the document focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and functionalities.

The acceptance criteria are implicitly met by the device's adherence to relevant international and national standards for medical devices and its functional equivalence to the cleared predicate device. The "reported device performance" in this context refers to the device's ability to perform its intended diagnostic ultrasound imaging functions, which is asserted through compliance with these standards and comparison to a predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical studies were required to demonstrate safety and efficacy of the Aplio a550/a450 systems."

Therefore, there is:

• No specific sample size for a test set related to diagnostic performance.
• No data provenance (country of origin, retrospective/prospective) for a clinical test set because no clinical studies were performed for the 510(k) clearance of this specific device. The clearance relies on substantial equivalence to a previously cleared predicate device and engineering testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical studies were conducted for this 510(k) clearance, no experts were used to establish ground truth for a clinical test set for this specific submission.

4. Adjudication Method for the Test Set

As no clinical studies were conducted for this submission, no adjudication method was applied for a clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done for this 510(k) submission. The clearance is based on substantial equivalence to the predicate device, not on demonstrating improved human reader performance with AI assistance.

6. Standalone Performance Study (Algorithm Only)

The document primarily describes a diagnostic ultrasound system, not an AI algorithm as a standalone device. The functionalities mentioned (e.g., Shear Wave Elastography, SMI, Smart Fusion, Smart Navigation, Auto-NT, 2D Wall Motion Tracking, Auto EF Measurement, CHI, CHI-Q, Shadow Glass) are features of the ultrasound system itself. While some of these might involve advanced image processing or "smart" features that could be considered algorithmic, the submission does not present them as standalone AI algorithms with separate performance studies. The overall device's performance is demonstrated through compliance with standards and equivalence to its predicate.

Therefore, no standalone (algorithm only) performance study was reported in this 510(k) summary in the context of an AI algorithm.

7. Type of Ground Truth Used

Given that no clinical studies were required for this submission, no clinical ground truth data (like expert consensus, pathology, or outcomes data) was used to demonstrate the safety and efficacy of this specific device in this 510(k) submission. The regulatory pathway relied on non-clinical testing and comparison to a predicate device.

8. Sample Size for the Training Set

Since no clinical studies were required and the clearance is based on substantial equivalence and engineering testing, no training set for an AI model or similar clinical data set is described in this document. The "training" would implicitly refer to the development and internal validation processes of the system's software and hardware, which are part of the manufacturer's quality system.

9. How the Ground Truth for the Training Set Was Established

As no specific training set for an AI model or clinical data set is detailed, this information is not applicable and not provided in the document. The general "ground truth" for the device's functionality would stem from engineering specifications, phantom testing, and comparisons to established performance benchmarks of the predicate device, all verified through internal testing and adherence to stated standards.

Ask a specific question about this device