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510(k) Data Aggregation
(28 days)
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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