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510(k) Data Aggregation
(65 days)
The proposed VSI Model S-V200 Color Video Sigmoidoscope is intended for use to examine the lower bowel tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath consists of a reusable video sigmoidoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the air, water and suction/biopsy channels. The sheath is removed and disposed of following each procedure.
The provided text describes a 510(k) summary for the Vision-Sciences Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath. However, it does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document focuses on device description, indications for use, and a brief mention of two performance tests. It explicitly states that no biocompatibility data was presented. More importantly, it does not provide any specific acceptance criteria (e.g., numerical thresholds for resolution or angulation) nor does it report the actual device performance metrics against such criteria.
Therefore, I can only provide information based on what is available in the text.
Here's the information that can be extracted or inferred, and the parts that cannot be answered from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required for Approval) | Reported Device Performance (Achieved) |
|---|---|
| Scope Angulation/Cycle Testing: No specific numerical acceptance criteria are provided in the document. | The document states "Performance testing was presented in support of this submission" for "Scope Angulation/Cycle Testing (with and without EndoSheath)." However, no numerical results or a statement of meeting an unstated criterion are provided. It only implies the test was performed. |
| Scope Resolution: No specific numerical acceptance criteria are provided in the document. | The document states "Performance testing was presented in support of this submission" for "Scope Resolution (with and without EndoSheath)." However, no numerical results or a statement of meeting an unstated criterion are provided. It only implies the test was performed. |
| Biocompatibility: No specific acceptance criteria are mentioned, but implicitly, a device intended for internal use would typically require biocompatibility. | The document explicitly states: "No biocompatibility data was presented in support of this Premarket Notification." This indicates that while it might be an implicit criterion for such a device, no data was provided in this submission to address it. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any of the tests mentioned (Angulation/Cycle Testing, Resolution).
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: The performance tests mentioned (Angulation/Cycle Testing, Resolution) are objective engineering/physical performance tests of the device itself, not diagnostic performance tests involving human interpretation or clinical data. Therefore, "ground truth" in the clinical diagnostic sense with expert consensus is not relevant for these specific tests.
4. Adjudication method for the test set
- Not Applicable: As explained above, these were physical device performance tests, not clinical diagnostic studies requiring adjudication of output.
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
- No: The document does not mention any MRMC study. The device is a sigmoidoscope, which is an optical instrument for direct examination, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: The device described is a physical instrument (sigmoidoscope), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the clinical sense: For the Angulation/Cycle and Resolution tests, the "ground truth" would be established by validated engineering standards and measurement equipment. The document does not detail these standards or measurements.
8. The sample size for the training set
- Not Applicable: This is a physical device, and the mentioned tests are physical performance validations, not related to machine learning models that require training sets.
9. How the ground truth for the training set was established
- Not Applicable: As above, this information is irrelevant for the type of device and tests described.
Summary of Limitations from the Provided Text:
The provided 510(k) summary is very high-level regarding performance testing. It indicates that tests were performed ("Scope Angulation/Cycle Testing" and "Scope Resolution"), but it lacks crucial details such as:
- Specific numerical acceptance criteria.
- The actual quantitative results of these tests.
- The methodology of these tests (e.g., how resolution was measured, how many cycles were performed).
- Sample sizes for these tests.
- Any details about clinical performance, given that it focuses on physical characteristics.
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