(120 days)
The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures.
The asap ENT endoscope is reusable.
The asap ENT endoscope is of the rigid type with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap ENT endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
This document is a 510(k) summary for a Sinuscope device and focuses on establishing substantial equivalence to a predicate device rather than presenting a study related to acceptance criteria for a new, breakthrough AI-driven medical device. Therefore, much of the requested information regarding AI device studies cannot be found or inferred from the provided text.
Here is the information that can be extracted or inferred based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
There is no explicit table of acceptance criteria with reported device performance in the context of a new efficacy study for this device. The document primarily focuses on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Voluntary Standard Compliance: | |
| IEC 60601-2-18 | Complies |
| DIN 58105, part 1 and 2 | Complies |
| DIN 17442 (medical steel) | Complies |
| DIN 980 | Complies |
| Biocompatibility: | |
| Materials of same specifications as predicate devices | Ensured (conforms to applicable ISO standards) |
| Sterilization: | |
| Ability to repeatedly adequately sterilize | Confirmed by validation protocol |
| Substantial Equivalence to Predicate Device (K981751): | |
| Specifications and intended use | Same |
| Design or conditions of intended use | No significant differences |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document describes a traditional medical device (sinuscope) being reviewed for substantial equivalence, not an AI/ML device undergoing performance testing with a specific test set of data. Therefore, there is no test set of patient data, nor is there data provenance in the context of an AI study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As described in point 2, there is no test set of data requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described in point 2, there is no test set of data requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
Not applicable. Ground truth for an AI device is not relevant here. The "ground truth" in this 510(k) context is the established safety and effectiveness of the predicate device (Sinuscope K981751), which the current device aims to be substantially equivalent to by meeting similar specifications and performance.
8. The Sample Size for the Training Set
Not applicable. This document is not describing an AI model, and therefore, there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As described in point 8, there is no training set for which ground truth would need to be established.
Summary of the Study (as described in the document):
The "study" described in this 510(k) pertains to demonstrating substantial equivalence to an already legally marketed predicate device (Sinuscope, K981751). The core of this demonstration relies on:
- Comparison of specifications and intended use: The document states that the specifications and intended use of the new asap ENT endoscope are "the same" as the predicate.
- Comparison of design and conditions of intended use: It states "no significant differences."
- Material comparison: The device is constructed of materials of "the same specifications" as the predicate to ensure biocompatibility and conforms to applicable ISO standards.
- Sterilization validation: The ability to repeatedly adequately sterilize the device was "confirmed by validation protocol."
This is a traditional medical device submission, not a study involving AI/ML performance. The "acceptance criteria" are compliance with relevant voluntary standards and demonstrating that the device is as safe and effective as the predicate, based on design, materials, and validated processes (like sterilization).
§ 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.