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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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The flexible ENT videoscopes with digital video processor and disposable sheath systems are intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The flexible ENT videoscope with EndoSheath® System is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.

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 cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.

The provided text describes a Special 510(k) Premarket Notification (K072073) for a modified medical device, the "Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Systems." This type of submission is for modifications to previously cleared devices under the FDA's "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."

The document does not contain the detailed acceptance criteria or a specific study that quantifies device performance against those criteria in a way that typically applies to AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices through design control requirements and general V&V activities.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in the format of a table. For a Special 510(k) of this nature, the "acceptance criteria" are implied to be adherence to design control requirements and successful completion of verification and validation (V&V) activities to ensure the modified device remains safe and effective and substantially equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text refers to "comprehensive Design Validation and Verification" but does not specify the sample sizes for any testing (e.g., number of endoscopes tested, number of sheaths, duration of functional tests). The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The assessment appears to be based on engineering and performance testing rather than clinical evaluation requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a device modification and the V&V activities described, it's unlikely that a clinical adjudication method like 2+1 or 3+1 would have been applied in this context. The V&V would likely involve objective measurements and engineering assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted or reported in this document. This submission is for device modification, focusing on engineering validation and substantial equivalence, not a clinical effectiveness study of human readers with vs. without AI assistance. The device in question is an endoscope system, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This concept does not apply to the device described. This is a medical imaging and intervention device (flexible endoscope with a video processor and disposable sheaths) that is inherently used with a human-in-the-loop (a clinician). It does not involve an AI algorithm operating in a standalone capacity.

7. Type of Ground Truth Used

Based on the description of "V & V activities, including biocompatibility testing, scope/sheath/processor system functional and performance testing, and software validation," the "ground truth" would be established by:

• Engineering specifications and standards: For functional and performance testing (e.g., image resolution, light output, flexibility, durability).
• Biocompatibility standards: For material safety with patient contact.
• Software requirements specifications: For software validation.
  The document does not mention the use of expert consensus, pathology, or outcomes data as "ground truth" for the device's performance, as it's not an AI diagnostic device.

8. Sample Size for the Training Set

This information is not applicable and not provided. The device is an endoscope system, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reason as above (not an AI/ML algorithm requiring a training set).

Summary of Missing Information:

It's important to reiterate that much of the information requested (sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically associated with the evaluation of AI/ML-driven diagnostic or assistive devices. The provided document describes a "Special 510(k)" for a device modification to a flexible endoscope system, which focuses on demonstrating continued safety and effectiveness and substantial equivalence through engineering V&V rather than large-scale clinical performance trials or AI model validation.

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