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510(k) Data Aggregation
(28 days)
MULTIGON INDUSTRIES, INC.
The Model 500H Doppler Guided Proctoscope is used to detect blood vessels supplying hemorrhoids and for performing HAL ( Hemorrhoid Arterial Ligation) for Class II and Class III hemorrhoids. It is to be used by physicians in hospitals, clinics, and physician's offices by prescriptions or doctor's orders.
The model 500H Doppler guided proctoscope consists of two parts . The first part is a Doppler probe in a proctoscope that are used integrally with each other and are not intended to be used separately. The Doppler guided proctoscope has a removable fiber optic light pipe, and a removable 8 mHz CW Doppler probe. The second part is a combination 8 mHz continuous wave (CW) Doppler detector with loudspeaker and a light source. The Doppler guided proctoscope is inserted in the rectum and rotated until one of the branches of the hemorrhoidal artery is located. The artery is located when the user hears the classical arterial blood flow sound. The Doppler guided proctoscope is rotated such that the arterial sound is maximized thus insuring that the hemorrhoidal artery is under the Doppler probe and in the Doppler guided proctoscope's rectangular slit. The physcician or surgeon can then ligate the artery . The Doppler guided proctoscope is then rotated until the next hemorrhoidal artery branch is detected. The process is repeated until all detected hemorrhoidal arteries are located and ligated. After ligation the Doppler guided proctoscope can be rotated 360 degrees to make sure that all of the hemorrhoidal arterial branches have been ligated.
The provided text describes a 510(k) submission for the Multigon Industries, Inc. Model 500H Doppler Guided Proctoscope. It does not contain a study with acceptance criteria and a detailed analysis of the device's performance against those criteria in a clinical setting.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards. The "Test Data" section is very brief and high-level, stating:
"The Model 500H Doppler guided proctoscope has been subjected to extensive safety, performance testing, and validation before release. Final testing of the 500H included various performance tests designed to ensure that the device met all of its functional specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards."
This statement confirms that testing was done, but does not provide the specific acceptance criteria or the reported device performance in a way that can be tabulated.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Specifications: | "met all of its functional specifications" |
| Safety Standards: Compliance with: | "complies with applicable industry and safety standards" |
| * UL 2601-1 Safety Requirements for Medical Equipment | Not explicitly stated but implied by compliance statement. |
| * AIUM/NEMA UD 2 Standard for Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment | Not explicitly stated but implied by compliance statement. |
| * AIUM/NEMA UD 3 Standard for Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment | Not explicitly stated but implied by compliance statement. |
| * IEC 1157 Declaration of Acoustic Power | Not explicitly stated but implied by compliance statement. |
| * IEC60601-1-2 | Not explicitly stated but implied by compliance statement. |
| * IEC60601-2-37 | Not explicitly stated but implied by compliance statement. |
| Acoustic Output: | |
| * MI Limit (X) | 0.089 |
| * Ispta.3 (mW/cm squared) Limit (X) | 19.1 |
| * Mean MI value | 0.0075 |
| * Mean Ispta.3 (mW/cm squared) value | 13.5 |
| * Std. Dev. (Sx) MI | 0.0003 |
| * Std. Dev. (Sx) Ispta.3 (mW/cm squared) | 1.3 |
Note: The "acceptance criteria" for functional specifications and general safety are stated broadly as "met" and "complies with." Specific numerical targets for these (beyond acoustic output) are not provided in this document. The acoustic output section provides specific limits and measured values for the 500H, which are implicitly the acceptance criteria met by the device.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not specified for functional or safety tests. For acoustic output, "Three probes were tested."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing appears to be internal validation by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Adjudication Method: Not specified.
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
- MRMC Study: No, this document does not describe a MRMC comparative effectiveness study. This device is a guided proctoscope, not an AI-assisted diagnostic imaging interpretation device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a physical instrument (proctoscope with a Doppler probe) used by a physician, not an algorithm. The document explicitly states "The 500H has no software or firmware associated with it."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified in detail for the functional and safety tests. For the acoustic output, the ground truth is the measured physical values against established standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware instrument and does not involve a training set in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
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(30 days)
MULTIGON INDUSTRIES, INC.
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.
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