(37 days)
The Vision Sciences' Flexible ENT Scope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
The ENT-3000 Scope and BLS-1000 offers optimal portability for endoscopic viewing. LED based illumination provides bright white light for endoscopic viewing.
The provided document describes a Special 510(k) submission for a device modification, not a study evaluating AI performance or a comparative effectiveness study involving human readers. Therefore, much of the requested information regarding acceptance criteria, device performance, ground truth, and human reader studies is not available in the provided text.
This submission focuses on demonstrating substantial equivalence of a modified version of an existing device (Vision Sciences Model ENT-3000 Flexible Nasopharyngoscope with BLS-1000 Battery Powered LED) to its predicate device. The changes relate to an enhanced LED light source, requiring validation of safety and performance for this modification.
Here's what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a Special 510(k) for a device modification rather than a new AI or diagnostic device, the "acceptance criteria" discussed are primarily related to safety and performance standards for the modified physical device, specifically the light source. The document lists the following validation testing:
| Acceptance Criteria (Type of Testing) | Reported Device Performance |
|---|---|
| Light Output Testing | Included in Design Validation and Verification planning |
| Operating Temperature Testing | Included in Design Validation and Verification planning |
| Electrical Safety Testing | Included in Design Validation and Verification planning |
| Compliance to 21 CFR 820.30 Design Control requirements | Certified by Vision Sciences |
| Risk Analysis Procedure | Described by Vision Sciences |
Note: The document states that these tests were "included in Design Validation and Verification planning" but does not explicitly provide quantitative results or specific pass/fail values. The overall conclusion states the device has been shown to be "safe and effective for its intended use" based on these tests and comparison to predicate devices, implying these criteria were met.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. The document does not describe a clinical study with a "test set" in the context of an AI or diagnostic device. The testing mentioned (light output, operating temperature, electrical safety) would typically involve engineering tests on the physical device itself rather than data sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable / Not provided. As there's no clinical "test set" for diagnostic accuracy, there's no mention of ground truth established by experts.
4. Adjudication Method:
- Not applicable / Not provided. No adjudication method is mentioned as there's no diagnostic accuracy study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not mention any MRMC study or comparative effectiveness study involving human readers, with or without AI assistance. The device is a flexible endoscope, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. This is a physical medical device (an endoscope), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used:
- Not applicable / Not provided. Since there's no diagnostic performance study, no ground truth types (pathology, expert consensus, outcomes data) are mentioned. The "ground truth" for this type of submission generally relates to compliance with engineering standards and safety requirements.
8. Sample Size for the Training Set:
- Not applicable / Not provided. There is no "training set" in the context of an AI device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided. As there's no training set, this information is not relevant.
Summary of what is available about the study:
The submission is a Special 510(k): Device Modification.
The "study" involved Design Validation and Verification Planning, which included:
- Light output testing
- Operating temperature testing
- Electrical safety testing
- Compliance to 21 CFR 820.30 Design Control requirements
- Internal Risk Analysis procedure
The conclusion stated that "Based on the indications for use, technological characteristics, performance and electrical testing and comparison to predicate devices, the VSI ENT-3000 has been shown to be safe and effective for its intended use." This implies that the device successfully met the internal design validation and verification criteria for the modified components.
§ 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.