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Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords. They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy.

Flexible nasopharyngoscopes with or without a working channel are built of 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 fibre-optic light- guide cable.

The provided document, K070580, describes a 510(k) premarket notification for the XION Nasopharyngoscope models (EF-N, EF-NS, EF-N Slim, EF-N 14, EF-N 14S). This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the flexible nasopharyngo-laryngoscope and flexible broncho-scope from Richard Wolf Medical Instruments Corp. (K992526).

This type of submission focuses on comparing the new device's characteristics to a predicate device to establish that it is as safe and effective. It does not typically involve extensive clinical studies with acceptance criteria for device performance based on statistical measures of accuracy, sensitivity, or specificity in the way AI/ML software devices might. Instead, the "acceptance criteria" are the demonstration of substantial equivalence to the predicate device in terms of intended use, technological characteristics, and safety/effectiveness profiles.

Therefore, the answers below are framed within the context of a 510(k) substantial equivalence determination for a medical device, which differs significantly from studies proving performance for AI/ML algorithms.

Acceptance Criteria and Study to Prove Device Meets Criteria

The "acceptance criteria" in this context are primarily the demonstration that the XION Nasopharyngoscope is substantially equivalent (SE) to the predicate device in terms of its indications for use, technological characteristics, and safety and effectiveness. The "study" proving this is the 510(k) submission itself, which presents a comparison of the new device to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a 510(k) of a traditional medical device like an endoscope, "acceptance criteria" are not based on statistical performance metrics (like accuracy, sensitivity, specificity) but rather on alignment with the predicate device and relevant standards. The "reported device performance" is a comparison of specifications to the predicate device.

• Basic design and device material are the same.
• Some flexible nasopharyngoscopes have a fixed light cable instead of a removable one; some of them have a working channel (similar variations exist in predicate).

Differences to Predicate Device (minor):

• Sheath diameter: XION (2.8 - 4.1 mm) vs. Predicate (3.5 mm)
• Working length: XION (320 mm) vs. Predicate (300 mm)
• Bending angle (Up/Down): XION (130°) vs. Predicate (130°)
• Bending radius: XION (8 mm) vs. Predicate (Not specified, but assumed similar)
• Field of view: XION (80°) vs. Predicate (95°)
• Depth of field: XION (1 - 50 mm) vs. Predicate (3 - 50 mm)
• Weight: XION (230 - 320 g) vs. Predicate (Not specified, but assumed similar)
• Forceps channel diameter: XION (1.4 mm) vs. Predicate (1.1 mm)
• Control lever, light guide connector, leak tester connector, biopsy channel entry, eyepiece, body cover, suction valves, and focus ring are either compatible with or have similar functional/material descriptions to the predicate, with minor variations in specific construction details (e.g., specific coatings, compatibility with additional brands for connectors).

Conclusion: "The new technological characteristics have no influence on safety or effectiveness." |
| Safety and Effectiveness Profile | No new safety concerns or effectiveness questions raised compared to the predicate device. | Conclusion: "The submitted devices pose the same type of questions about safety and effectiveness as the compared devices." and "The submitted devices are substantially equivalent to the 510(k) devices sold by Richard Wolf Medical Instruments Corp." |

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

Not applicable. This is a 510(k) for a physical medical device (an endoscope), not an AI/ML software device. There is no "test set" in the sense of a dataset of images or clinical cases used to evaluate an algorithm's performance. The "test" is the comparison against the predicate device's established specifications and intended use.

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

Not applicable. There is no "ground truth" established by experts for a test set in this 510(k) submission. The ground truth for the safety and effectiveness of this type of device is based on accepted medical device manufacturing standards, preclinical testing (not detailed here but typically includes biocompatibility, sterilization, mechanical testing), and the proven safety and effectiveness of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described for performance evaluation in this 510(k) submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is not relevant for this type of medical device 510(k) submission, which focuses on substantial equivalence of a physical instrument rather than the performance of an interpretive algorithm.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No. This is not an AI/ML algorithm; it is a physical medical instrument.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established safety and effectiveness profile of the predicate device (Richard Wolf Medical Instruments Corp. K992526), alongside compliance with relevant performance standards and materials. The submission uses the predicate device's characteristics as the benchmark for comparison.

8. The Sample Size for the Training Set

Not applicable. There is no training set for an AI/ML algorithm in this 510(k) submission.

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

Not applicable. There is no training set mentioned in this 510(k) submission.

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