Search Results

The Vave Personal Ultrasound is intended for diagnostic ultrasound imaging in B-Mode.

It is indicated for diagnostic ultrasound imaging in the following applications: Fetal/Obstetric, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Thoracic/Pleural, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body.

The Vave Personal Ultrasound is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

The Vave Personal Ultrasound is a handheld ultrasound imaging system consisting of the following components: Ultrasound Probe, Display Application, Battery Charger.

The ultrasound probe, including its embedded software, is designed to acquire ultrasound image data and to wirelessly transmit the data to the display application software. The display application software runs on a commercial off-the-shelf mobile device. The operating system of the mobile device can be either iOS or Android. The ultrasound probe is completely wireless and is powered by a removable Li-ion battery is charged with a proprietary charging system.

The Vave Personal Ultrasound is intended for use in environments where healthcare is provided by healthcare professionals, including home healthcare environments and emergency medical services, ambulance, or aircraft environments.

Based on the provided document, here's an analysis of the acceptance criteria and the study conducted for the Vave Personal Ultrasound:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum sensitivity/specificity, image quality metrics) or report the device's performance against such metrics. Instead, the justification for substantial equivalence is based on the device having the "same intended use and fundamental technological characteristics as the identified predicate devices" and that it "introduces no new indications for use, modes, features, or technologies relative to the predicate devices."

The non-clinical testing performed focuses on safety and electrical performance standards, rather than diagnostic performance metrics.

Table of Acceptance Criteria and Reported Device Performance:

• Same intended use as predicate device.
• Same fundamental technological characteristics as predicate device.
• No new indications for use, modes, features, or technologies requiring new clinical validation. |
  | Safety & Electrical Performance | Compliance with specific IEC/ANSI/ISO standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, etc.) | "The collective results of the non-clinical testing demonstrate that the Vave Personal Ultrasound meets the established specifications necessary for consistent performance for its intended use." (Specific quantitative results of these tests are not provided in this summary, but the claim is compliance.) |
  | Software Life Cycle | Compliance with IEC 62304 | Included in the list of conducted non-clinical tests, implying compliance. |
  | Usability | Compliance with IEC 62366-1 | Included in the list of conducted non-clinical tests, implying compliance. |
  | Biocompatibility | Compliance with ISO 10993-1 | Included in the list of conducted non-clinical tests, implying compliance. Also stated "All materials with patient contact are biocompatible and can be disinfected." |

2. Sample Size and Data Provenance for Test Set

The document explicitly states: "The Vave Personal Ultrasound introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing."

Therefore, no separate clinical test set of patient data was used to demonstrate diagnostic performance. The justification relies on the established safety and effectiveness of the predicate devices.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Since no clinical test set was used to assess diagnostic performance of the Vave Personal Ultrasound, there were no experts establishing ground truth for such a set.

4. Adjudication Method (Test Set)

Not applicable, as no clinical test set for diagnostic performance was used.

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

No MRMC study was performed or cited for the Vave Personal Ultrasound. The submission is based on substantial equivalence to existing cleared devices, not on demonstrating improved human reader performance with AI assistance. The device itself is an ultrasound imaging system, not an AI-powered diagnostic assist tool in the context of this document.

6. Standalone (Algorithm Only) Performance

Not applicable, as the device is an ultrasound imaging system, not an algorithm, and its performance justification is based on equivalence to predicate devices, not on a standalone algorithm's diagnostic accuracy.

7. Type of Ground Truth Used (Test Set)

No ground truth from patient data (e.g., pathology, outcomes data, expert consensus) was used to assess the diagnostic performance of the Vave Personal Ultrasound directly in this submission. The "ground truth" for the device's acceptability relies on its engineering performance meeting established standards and its functional equivalence to predicate devices.

8. Sample Size for the Training Set

Not applicable. The Vave Personal Ultrasound is a hardware ultrasound imaging system. It does not appear to involve machine learning models that would require a "training set" of images in the typical AI/ML sense. Its "training" would refer to its design and manufacturing processes meeting established engineering and quality standards.

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

Not applicable, as there is no mention of a machine learning training set. The "ground truth" for the device's design and manufacturing is established through adherence to recognized performance, safety, and quality standards (e.g., IEC 60601 series, ISO 10993, IEC 62304), and verification/validation processes as summarized in the "Quality Assurance Measures" section.

Ask a specific question about this device