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JEDMED's Ergo-Flex EF-N and EF-N Slim Laryngo-Nasopharyngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal cords.

This flexible scope is designed with the insertion tube with its bendable distal tip, the handle, the eyepiece and the focus ring. The handle incorporates the control lever to bend the distal tip and the connectors for the leakage tester and the fiber optic light-guide cable.

The provided document is a 510(k) premarket notification summary for the JEDMED Laryngo-Nasopharyngoscope EF-N and EF-N Slim. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of demonstrating equivalence through engineering and performance bench testing, rather than a clinical study with human subjects, ground truth, or expert consensus in the way those terms are typically used for AI/diagnostic devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of this nature, the "acceptance criteria" are typically defined by engineering specifications, safety standards, and performance characteristics compared to the predicate device. The "reported device performance" are the results of bench testing to demonstrate compliance with these criteria and equivalence.

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

• Sample Size for Testing: Not explicitly stated as a number of distinct devices for all tests. For example, "all tested scopes" for angulation implies multiple devices, but the exact number isn't quantified. For temperature testing, it refers to "4 different test sites" on the device.
• Data Provenance: The studies are bench tests and laboratory validations performed by the manufacturer, JEDMED Instrument Company, and Geneva Test Laboratory (for disinfection). This is not human data or clinical data; it's engineering and material testing. The country of origin of the data is implicitly the USA where JEDMED is located.

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

Not applicable in the typical sense for this device.

• There is no "ground truth" derived from human interpretation or clinical outcomes in the context of this 510(k) submission.
• The "acceptance criteria" are based on recognized standards (ISO, AAMI, IEC) and comparison to the predicate device's specifications. Compliance is measured via objective physical and chemical tests rather than expert consensus on a diagnostic outcome.
• The validation of reprocessing and biocompatibility would involve laboratory professionals and engineers.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous "test set" requiring adjudication by multiple readers or experts. Performance is measured against objective standards and specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a premarket notification for a medical device (an endoscope), not a diagnostic AI algorithm. The submission focuses on demonstrating substantial equivalence in design, materials, and safety/performance characteristics to a legally marketed predicate device.

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

Not applicable. This device is an endoscope, a tool used by a human clinician to visualize anatomical structures. It does not operate as an "algorithm only" or a "standalone" diagnostic system.

7. The Type of Ground Truth Used

Not applicable in the sense of expert consensus, pathology, or outcomes data for making diagnoses. The "ground truth" for this submission are:

• Established national and international standards for medical devices (e.g., ISO, AAMI, IEC).
• The engineering and performance specifications of the predicate device (Richard Wolf Medical Instruments Corp. flexible nasopharyngo-laryngoscope and flexible bronchoscope; K992526).
• Laboratory testing results (e.g., temperature measurements, cycle counts, chemical compatibility results).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As noted above, this is not an AI/machine learning device.

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