(88 days)
The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor.
The endoscope is intended for use in a hospital environment. It is designed for use in adults.
The Ambu® aScope™ 4 RhinoLaryngo Intervention is a sterile single use flexible endoscope for examination of the nasal lumens and upper airway anatomy.
Ambu® aScope™ 4 RhinoLaryngo Intervention has the following physical and performance characteristics:
Maneuverable tip controlled by the user
Flexible insertion cord
Camera and LED light source at the distal tip
Working Channel
Sterilized by Ethylene Oxide
For single use
The acceptance criteria and the study proving the device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a dedicated table format. However, it indicates qualitative acceptance criteria by stating that "All tests were passed" for various performance characteristics when compared to recognized consensus standards and internal performance tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformity to ISO 8600-1, ISO 8600-3, ISO 8600-4 | Result: All tests were passed. |
| Performance tests for Bending Endurance and Angle | Result: All tests were passed. |
| Performance tests for Image Sharpness and Resolution | Result: All tests were passed. |
| Performance tests for Length of Insertion Cord | Result: All tests were passed. |
| Performance tests for Suction Capability | Result: All tests were passed. |
| Shelf life (Performance test, Sterile Packaging Integrity) on finished, sterilized, and aged products | Result: All tests were passed. |
| Biocompatibility in compliance with ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity) | Result: All tests were passed. |
| Electromagnetic Compatibility in compliance with IEC 60601-1-2 | Result: All tests were passed. |
| Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18 | Result: All tests were passed. |
| Substantial Equivalence to Predicate Device (Olympus XENF-TP (K013591)) | "Based on the indication for use, technological characteristics, performance data and comparison to predicate device it has been concluded that the functionality and intended use of Ambu® aScope™ 4 RhinoLaryngo Intervention is substantially equivalent to the predicate device. It is concluded that Ambu® aScope™ 4 RhinoLaryngo Intervention is as safe and as effective and perform as well as the predicate device." |
2. Sample size used for the test set and the data provenance:
The document describes bench testing for various performance parameters, shelf-life, and biocompatibility. It also references conformity to ISO standards. However, it does not provide specific sample sizes for these tests. The data provenance is internal to the manufacturer ("Performance test reports," "Biocompatibility test reports") and relates to the device design and manufacturing process. There is no indication of clinical test sets with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The reported studies are primarily bench tests and conformity assessments, not clinical studies requiring expert ground truth establishment from patient data.
4. Adjudication method for the test set:
Not applicable. The reported studies are bench tests and conformity assessments, not clinical studies requiring expert adjudication of patient results.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical endoscope, and the submission focuses on its safety and performance characteristics compared to a predicate device, not on AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone algorithm performance study was not mentioned. The device is a physical endoscope for direct human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the reported studies appears to be based on:
- Established engineering principles and metrology: For performance tests like bending endurance, image sharpness, length, and suction.
- Recognized consensus standards: ISO 8600 series for optics, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC. These standards define criteria against which the device performance is measured.
- Predicate device characteristics: For demonstrating substantial equivalence, the technological characteristics of the predicate device (Olympus XENF-TP) serve as a comparative reference.
8. The sample size for the training set:
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
§ 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.