(11 days)
The scope is indicated for use during flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
The VSI Flexible ENT Scope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
The device described in this 510(k) consists of modified flexible fiberoptic ENT scope. The scope has been modified to replace the integral light guide cable with a battery-powered LED light source (with accessory recharger).
The provided text describes a Special 510(k) Premarket Notification for a device modification, focusing on a change in the light source of an existing ENT scope. As such, the submission primarily addresses safety and effectiveness through design control, risk analysis, and validation testing, rather than comparative performance studies against specific acceptance criteria in the manner you've requested for typical AI/ML device evaluations.
Therefore, many of the requested points regarding acceptance criteria, study types, ground truth, and expert involvement are not applicable to this particular 510(k) submission, as it relates to a physical device modification rather than an AI/ML algorithm.
Here's the information that can be extracted or deduced from the provided documents, along with explanations for the unanswerable points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Performance of Modified Scope | - Certification of compliance to 21 CFR 820.30 Design Control requirements. |
| - Description of internal Risk Analysis procedure. | |
| - Validation testing conducted for: | |
| - Light output | |
| - Operating temperature | |
| - Scope leak testing | |
| - Reprocessing effects analysis | |
| - Electrical safety testing | |
| Substantial Equivalence to Predicate Devices | - The FDA determined the device to be substantially equivalent to legally marketed predicate devices (K942265 – Flexible ENT Scope and K990354 – Modified EndoSheath® for Flexible ENT Scope). |
| Intended Use | - The modified VSI Flexible ENT Scope is "safe and effective for its intended use" (flexible endoscopic examination of the upper airway, vocal chords, and/or nasal passages). |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a physical device modification (changing an integral light guide cable to a battery-powered LED light source). It does not appear to involve a "test set" of patient data for evaluating diagnostic performance in the way an AI/ML device would. The "validation testing" mentioned refers to engineering and safety performance tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. There's no indication of clinical "ground truth" establishment in this context, as it's not a diagnostic AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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. This is not an AI-assisted device. The submission is for a modification to a flexible ENT scope's light source.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For the device modification, the "ground truth" for proving safety and performance would be established through engineering specifications, test standards, and regulatory compliance (e.g., electrical safety standards, leak test pass/fail criteria). There is no clinical "ground truth" needed for diagnostic accuracy in this context.
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. See point 8.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.