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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:

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.

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The bronchoscope and EndoSheath® Technology are designed to be used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways.

The digital video processor is intended for use with the VSI flexible video scope.

The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to avver the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.

This 510(k) premarket notification (K091768) describes a device modification to a video bronchoscope system. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving new safety and effectiveness through extensive clinical performance studies. Therefore, much of the requested information regarding acceptance criteria, sample sizes for training/test sets, expert ground truth, and comparative effectiveness studies is not present in the provided document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. The submission does not detail a test set in the context of clinical performance data. Performance testing mentioned (electrical safety, thermal, EMC) likely involved engineering tests on the device itself, not a patient-based test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided. No ground truth for a test set is mentioned.

4. Adjudication method for the test set

• Not Applicable / Not Provided. No test set or adjudication method is described.

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. An MRMC comparative effectiveness study was not performed. This device is a bronchoscope, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No. This device is hardware (bronchoscope and video processor), not an algorithm.

7. The type of ground truth used

• Not Applicable / Not Provided. No ground truth in a clinical or diagnostic sense is mentioned. The "performance testing" refers to engineering and safety standards.

8. The sample size for the training set

• Not Applicable / Not Provided. No training set is mentioned as this is a hardware device modification, not an AI model.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided. No training set or ground truth for it is mentioned.

Summary of the Study Proving Device Meets Acceptance Criteria (Based on Provided Text):

The acceptance criteria for this device modification are primarily technical and material-based, focused on ensuring the modified device maintains the safety and performance characteristics of its predicate devices.

Study Description:

The study proving the device meets the acceptance criteria consisted of the following:

• Performance Testing: The subject device underwent and successfully passed electrical safety, thermal, and Electromagnetic Compatibility (EMC) testing requirements. These tests are standard engineering evaluations to ensure the device operates safely and as intended within its environment.
• Material Comparison: A comparison of patient contact materials in the endoscope confirmed they are identical to the materials used in the predicate device (Vision Sciences' TNE-5000, K072088). This demonstrates that the biological safety characteristics remain unchanged from an already cleared device.
• Technological Characteristics Comparison: The submission asserted substantial equivalence based on the subject device having "very similar material composition and working dimensions" and "identical viewing direction, image size, bending, reprocessing/sterilization method and working dimensions" to the predicate. It also uses the "same video processor" as other Vision Sciences' videoscopes.

Conclusion stated in the 510(k) Summary:

"Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video endoscopes with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use."

In essence, this 510(k) relies on demonstrating that the modified device is substantially equivalent to legally marketed predicate devices, with performance testing confirming adherence to relevant safety and performance standards for new hardware. It does not involve clinical studies with human readers or AI-driven diagnostic performance.

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