(30 days)
The 500P Transcranial and Vascular Doppler is to be used for the assessment of circulation in the adult cephalic, (intracranial and extracranial) and peripheral vascular vessels. It is to be used in hospitals, clinics and physicians offices by trained medical personnel by prescriptions or doctors orders. It is not to be used for Obstetrics.
The 500P device consists of a battery operated (also can be used with a medical grade AC adapter) Doppler and display unit with a choice of 2 mHz, 4 mHz, 5 mHz or 8 mHz transducers. The 2 mHz probe is a pulsed Doppler, used for insonating the adult intracranial arteries. The 4mHz, 5 mHz or 8 mHz CW probes are used for insonating the peripheral arteries. The system consists of the transducers, system electronics, a memory and a USB interface for an external computer. All of the transducers are connected to the system using quick disconnect connectors. The 500P Transcranial and Vascular Doppler provides the healthcare professional with the state of blood flow in the intracranial and extracranial vascular arteries.
The provided 510(k) submission for the Multigon Model 500P Pocket Transcranial and Vascular Doppler Spectrum Analyzer is primarily a comparative submission seeking substantial equivalence to predicate devices, rather than a submission detailing original clinical or analytical validation studies against pre-defined acceptance criteria.
The submission does not contain specific acceptance criteria or a study designed to prove the device meets these criteria in the traditional sense of a clinical trial or performance study with quantitative results against specified metrics. Instead, it relies on demonstrating substantial equivalence to previously cleared devices.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or quantitative performance metrics are stated in this 510(k) submission. The device's "performance" is demonstrated through a comparison of its specifications and functions to those of predicate devices.
| Feature/Parameter | Acceptance Criteria (Not Explicitly Stated - Implied by Predicate Equivalence) | Reported Device Performance (Model 500P) |
|---|---|---|
| Probes | Equivalent to predicate devices (2mHz PW, 5mHz CW, and additional 4mHz CW, 8mHz CW) | 2 mHz PW, 5 mHz CW, 4 mHz CW, 8 mHz CW |
| Doppler Type | Bi-Directional | Bi-Directional |
| Frequency Ranges | Equivalent to predicate devices (e.g., 1, 2, 5, 10, 20 kHz, 0, 20, 40% offset) | 1, 2, 5, 10, 20 kHz (frequency ranges), 0, 20, 40, 50% (frequency offset) |
| Time/Frequency Calipers | Present and functional | YES |
| Storage of Spectral Data | Equivalent capacity to predicate devices (e.g., 104 seconds) | 2 hours |
| Calculations | Same parameters as predicate devices (Peak, Mean, Pulsatility Index, Resistance Index, Systolic/Diastolic Ratio) | Peak, Mean, Pulsatility Index, Resistance Index, Systolic/Diastolic Ratio |
| Annotation | Equivalent to predicate devices (Date, Vessel I.D., Patient I.D., printed report) | Date, Vessel I.D., Patient I.D., plus printed Patient Report with waveforms |
| Monitoring Mode | Present and functional, equivalent to predicate devices | YES |
| HITS (Emboli Detection) | Present and functional, equivalent to predicate devices | YES |
Note: The "acceptance criteria" here are implied by the claim of substantial equivalence to predicate devices. The "reported device performance" is a listing of the device's features and specifications, which are implicitly claimed to be "as good as" or "equivalent to" the predicate devices in terms of safety and effectiveness. The 500P often meets or exceeds the predicate in terms of features (e.g., more probes, longer data storage, additional report features, monitoring mode, HITS).
2. Sample Size Used for the Test Set and Data Provenance
The submission states: "The Model 500P Transcranial and Vascular Doppler has been subjected to extensive safety, performance testing, and validation before release. Final testing of the 500P included qualitative performance tests designed to ensure that the device met all of its functional specifications."
- Sample Size for Test Set: Not specified. The submission refers to "extensive safety, performance testing, and validation" which were "qualitative performance tests." This suggests a series of engineering tests rather than a clinical study with a patient sample size.
- Data Provenance: Not specified, but likely internal (Multigon Industries, Inc.) testing data. No mention of country of origin for any clinical data or whether it was retrospective or prospective, as no clinical study with patient data appears to have been conducted as part of this submission for substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission does not describe a clinical study where ground truth would be established by experts. The "testing" referred to appears to be engineering and functional validation against internal specifications and industry standards, not a diagnostic accuracy study.
4. Adjudication Method for the Test Set
Not applicable. As no clinical study against ground truth established by experts is described, there's no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this submission. The submission focuses on demonstrating substantial equivalence in specifications and features, not on the improvement of human readers with or without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
Yes, the device's functional performance was evaluated in a "standalone" manner, in that its features and specifications were tested qualitatively. However, this is not in the context of an "algorithm" or AI in the modern sense, but rather the performance of the Doppler system itself. The submission states, "Final testing of the 500P included qualitative performance tests designed to ensure that the device met all of its functional specifications." This implies testing the device on its own to confirm it performs as designed.
7. Type of Ground Truth Used
The "ground truth" for the internal performance and safety testing appears to be based on:
- Engineering specifications and functional requirements: Ensuring the device's components (probes, display, storage, calculations, monitoring, HITS) work as intended according to design.
- Compliance with industry and safety standards: UL 2601-1, AIUM/NEMA UD 2, UD 3, IEC60601-1-2, IEC60601-2-37.
There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient diagnoses) being used for performance testing in this 510(k) submission.
8. Sample Size for the Training Set
Not applicable. This device is a hardware/software system for Transcranial and Vascular Doppler, not a machine learning model that requires a "training set" of data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as above.
In summary: This 510(k) submission is a "traditional" substantial equivalence application for a medical device (a Doppler system). It establishes equivalence by comparing its technical specifications and functionalities to existing, legally marketed predicate devices, rather than through de novo clinical studies with pre-defined quantitative acceptance criteria and ground truth derived from patient data. The "tests" mentioned are qualitative performance tests and compliance with safety standards, not clinical trials.
§ 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.