(67 days)
The VUE 100 ultrasound system is used by or under the direction of a certified physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, and small organ applications. Small organs include Thyroid, Breast, and Testicles.
The VUE 100 is a portable ultrasound system. It is used to acquire and display real time 2D ultrasound images. Currently the system supports two mechanical sector probes, 4S2 (3MHz) and 6S4 (5MHz).
The provided text describes a 510(k) summary for the Mobilsonic VUE 100 Ultrasound Imaging System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria through a dedicated study.
Therefore, many of the requested details about acceptance criteria, study methods, and performance metrics are not available in this specific regulatory submission. The 510(k) process for ultrasound systems typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed predicate device.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
Acceptance Criteria and Device Performance
Since this is a 510(k) summary focused on substantial equivalence, there are no explicit "acceptance criteria" presented in terms of quantitative performance metrics for the device itself in comparison to a benchmark. Instead, the acceptance is based on demonstrating equivalence to the predicate device, the Pie Medical 50S Tringa (K020112).
| Criterion (Implicit based on 510(k) submission) | Reported Device Performance (Mobilsonic VUE 100) |
|---|---|
| Intended Use Equivalence | Fetal, Abdominal, Pediatric, Small Organ, Peripheral Vascular applications (same as predicate for these) |
| Transducer Type Equivalence | Mechanical Sector (same as predicate) |
| Imaging Modes | 2D (predicate had 2D/M-Mode, so the VUE 100 is "less capable" in this aspect, but still considered safe and effective for its stated modes) |
| 2D Frequency MHZ (Range) | 3.0/5.0 (Predicate had 3.5/5.0/7.5) |
| Biopsy Guidance | No (same as predicate) |
| Display Type | LCD (same as predicate) |
| Monitor Size (inches) | 5.6 (Predicate had 5.4) |
| Digital Archival Capabilities | Yes (same as predicate) |
| VCR | Yes (same as predicate) |
| M&A Capabilities (Measurement & Analysis) | Fetal & Abdominal (Predicate had Cardiac, Fetal & Abdominal) |
| Electrical Safety Standards Compliance | UL 2601 (Predicate had EN60601-1, but both are recognized safety standards) |
| Ultrasound Safety Standards Compliance | Track 1 (same as predicate) |
Note: The FDA's substantial equivalence determination implies that the differences in technical characteristics (e.g., frequency range, M-Mode capability, M&A capabilities, specific electrical safety standard) do not raise new questions of safety or effectiveness.
Study Details
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Sample size used for the test set and the data provenance:
- Not available. The document does not describe a clinical study or a test set with patient data for performance evaluation. The submission relies on technical comparison to a predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not available. No ground truth establishment experts are mentioned as part of a performance study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not available. No test set or adjudication process is described.
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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:
- No. This device is an ultrasound imaging system, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant to this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not available. This is an imaging device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not available. No performance study with ground truth data is described. The "ground truth" for this submission is the predicate device's established safety and effectiveness.
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The sample size for the training set:
- Not applicable/Not available. As an imaging device, there isn't a "training set" in the context of an AI/ML algorithm.
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How the ground truth for the training set was established:
- Not applicable/Not available. See point 7.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.