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510(k) Data Aggregation
(69 days)
DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE
The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the upper airway, vocal chords, and/or nasal passages.
The VSI EndoSheath for use with the VSI Model E-F100 Nasopharyngoscope consists of a sterile, disposable, protective sheath which covers the pation of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.
This looks like a 510(k) summary for a medical device, specifically an EndoSheath for a nasopharyngoscope. This type of document generally focuses on demonstrating substantial equivalence to a predicate device through performance testing and does not typically involve the kinds of studies (e.g., studies with human readers, ground truth consensus panels) that are common for AI/ML-based diagnostic devices.
Therefore, many of the requested fields cannot be directly answered from the provided text as they are not applicable to this type of device and submission.
Here's an analysis based on the provided text, addressing what can be extracted and noting what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "Functional and Burst Test", "Scope Angulation", etc., as tests performed, implying these are the areas where the device needs to perform adequately. However, specific quantitative acceptance criteria (e.g., "burst pressure must be > X psi") and the corresponding quantitative performance results were not provided in the summary. The summary only states that these tests were performed and implies satisfactory results based on the "Conclusion" statement.
| Test Performed | Acceptance Criteria (Not Explicitly Stated Quantitatively in Summary) | Reported Device Performance (No Quantitative Data Provided) |
|---|---|---|
| Functional and Burst Test | Implied to meet functional/burst requirements | Implied acceptable |
| Scope Angulation (With and Without Sheath) | Implied that sheath does not unduly impede angulation | Implied acceptable |
| Scope OD (With and Without Sheath) | Implied that sheath does not unduly increase OD | Implied acceptable |
| Sheath Longitudinal and Radial Strain when Loaded on Scope | Implied that sheath withstands strain without failure | Implied acceptable |
| Light Transmittance | Implied adequate light transmission for visualization | Implied acceptable |
| Field of View | Implied that sheath does not unduly obstruct field of view | Implied acceptable |
| Scope Resolution (With and Without Sheath) | Implied that sheath does not unduly degrade resolution | Implied acceptable |
| Biocompatibility Tests: | ||
| Irritation | Implied to be non-irritating | Implied acceptable |
| Sensitization | Implied to be non-sensitizing | Implied acceptable |
| Cytotoxicity | Implied to be non-cytotoxic | Implied acceptable |
| Acute Systemic Toxicity | Implied to be non-toxic systemically | Implied acceptable |
| Hemolysis | Implied to cause no undue hemolysis | Implied acceptable |
| Implantation | Implied to be suitable for contact without adverse effects | Implied acceptable |
| Microbial Barrier Testing: | ||
| Live Polio Virus | Implied to be an effective barrier against virus | Implied acceptable |
| Phi X 174 Bacteriophage | Implied to be an effective barrier against bacteriophage | Implied acceptable |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document only lists the types of tests performed ("in vitro functional tests," "biocompatibility data," "microbial barrier testing"). It does not mention the number of units or samples tested for each.
- Data Provenance: Not applicable. These are in-vitro, engineering, and laboratory tests on physical components, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical sterile sheath. Ground truth establishment by clinical experts (like radiologists for imaging devices) is not relevant for its safety and performance claims outlined here. The tests are direct measurements of physical and biological properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As there are no human-read interpretations or clinical assessments, an adjudication method for a test set is not relevant.
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:
- Not Applicable. This is not an AI/ML diagnostic device. It's a sterile, disposable protective sheath for an endoscope. No MRMC study involving human readers or AI assistance was performed or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Ground truth in the context of diagnostic performance (e.g., for AI) is not relevant here. The "ground truth" for the tests performed are the physical and chemical standards and methods used in laboratories (e.g., a burst test's "ground truth" is whether it burst at a certain pressure or not; a biocompatibility test's "ground truth" is whether a cytotoxic effect was observed).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this device.
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