(198 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™ RLS Slim is a sterile single use flexible endoscope for examination of the nasal lumens and upper airway anatomy.
Ambu® aScope™ RLS Slim 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
• Sterilized by Ethylene Oxide
• For single use
The provided text describes the "Ambu® aScope™ RLS Slim" device, which is a sterile, single-use flexible endoscope. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity). Instead, it lists various performance tests and regulatory compliances that the device underwent, with the universal result being "All tests were passed."
Here's a table summarizing the reported device performance based on the provided "Performance Data - Bench" section:
| Acceptance Criteria (Test Category) | Reported Device Performance |
|---|---|
| Declaration of conformity to recognized consensus standards | |
| ISO 8600-1 (Optics and optical instruments - Medical endoscopes and certain accessories) | All tests were passed. |
| ISO 8600-3 (Optics and optical instruments - Medical endoscopes and certain accessories) | All tests were passed. |
| ISO 8600-4 (Optics and optical instruments - Medical endoscopes and certain accessories) | All tests were passed. |
| Performance test reports | |
| Length and diameters of insertion cord | All tests were passed. |
| Bending angle, endurance and radius | All tests were passed. |
| Manipulator bending force | All tests were passed. |
| Image Sharpness | All tests were passed. |
| Shelf life documentation | |
| Performance test of Ambu® aScope™ RLS Slim Sterile Packaging Integrity (on finished, sterilized and aged products) | All tests were passed. |
| Biocompatibility tests (in compliance with ISO 10993-1) | |
| Cytotoxicity (ISO 10993-5) | All tests were passed. |
| Sensitization (ISO 10993-10) | All tests were passed. |
| Intracutaneous reactivity test (ISO 10993-10) | All tests were passed. |
| Electromagnetic Compatibility and Electrical Safety | |
| Electromagnetic Compatibility (in compliance with IEC 60601-1-2) | All tests were passed. |
| Electrical Safety (in compliance with IEC 60601-1 and IEC 60601-2-18) | All tests were passed. |
2. Sample size used for the test set and the data provenance:
The document mentions "Performance test reports" for various physical and performance characteristics, shelf life, and biocompatibility, but does not specify the sample size for any of these tests.
Regarding data provenance, the tests were conducted to document the performance of the Ambu® aScope™ RLS Slim. It is implied these are pre-market tests performed by the manufacturer (Ambu A/S in Denmark, with contact details provided). There is no explicit mention of the country of origin of the data beyond the manufacturer's location, nor is it specified if the tests were retrospective or prospective, though performance tests are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts in the context of establishing ground truth for the performance tests. The tests described are primarily focused on the physical, mechanical, and safety characteristics of the device itself (e.g., bending angle, image sharpness, sterility) rather than a diagnostic performance where expert interpretation would typically establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Since experts were not mentioned as being used to establish ground truth for a diagnostic performance test, there is no mention of an adjudication method. The tests described appear to be objective measurements against predefined specifications or standards.
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 MRMC comparative effectiveness study was done or mentioned. This device is a flexible endoscope for visualization, not an AI-powered diagnostic tool, so such a study would not be applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone performance study of an algorithm was done. This device is a physical endoscope and does not contain artificial intelligence algorithms for standalone performance evaluation by itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests performed appears to be based on objective measurements against recognized industry standards and internal specifications. For example:
- ISO 8600-1, ISO 8600-3, ISO 8600-4 for optical instruments.
- IEC 60601-1-2 for electromagnetic compatibility.
- IEC 60601-1 and IEC 60601-2-18 for electrical safety.
- ISO 10993-1, ISO 10993-5, ISO 10993-10 for biocompatibility.
- Internal specifications for physical characteristics like length, diameter, bending angle, manipulator force, and image sharpness.
There is no mention of ground truth established by expert consensus, pathology, or outcomes data, as these are typically associated with diagnostic accuracy claims.
8. The sample size for the training set:
Not applicable. This device is a traditional medical device (an endoscope), not a machine learning or AI algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set mentioned, there is no discussion of how its ground truth was established.
§ 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.