(186 days)
The ENT Nasopharyngoscope EES 100 is a sterile, single-use, and flexible device intended to be operated with its compatible display (EVS 100) for endoscopic procedures within nasal lumens and upper airway anatomy. The Video Box EVS 100 is intended to provide visualization via the connected tablet. The Nasopharyngoscope is intended for use in a hospital environment. It is designed for adult use.
ENT Nasopharyngoscope and Accessories contain nasopharyngoscope (model name: EES 100) and image transfer system (Video Box, model name: EVS 100A). EES 100 is a single-use, flexible, sterile nasopharyngoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected Video Box (EVS 100A). EVS 100A is attached on a tablet. The live imaging or snapshot will present directly on the tablet. The function of Nasopharyngoscope is to provide live imaging of the nasal tissue, including tissue appearance recording, snapshot, vertical flip and horizontal flip. The device does not provide any instruction for diagnosis nor treatment.
This document does not describe the acceptance criteria and a study that proves the device meets those criteria in the way typically seen for AI/ML devices. Instead, it is a 510(k) premarket notification for a medical device called the "ENT Nasopharyngoscope and Accessories" which outlines its substantial equivalence to a predicate device.
Therefore, many of the requested fields related to AI/ML device studies (like sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this document, as this device does not appear to be an AI/ML product.
Here's a breakdown of what can be extracted from the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a table format with corresponding device performance for specific claims, as would be common for AI/ML device studies. Instead, it focuses on demonstrating substantial equivalence to a predicate device through conformity to various engineering and safety standards, and through similar technical specifications.
The "acceptance criteria" are implied by adherence to these standards and the similarity to the predicate. The "reported device performance" is essentially the statement that the device meets these standards and has comparable specifications.
| Category | Acceptance Criteria (Implied by Standards/Predicate) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformity to IEC 60601-1 | Device meets requirements of IEC 60601-1. |
| Electromagnetic Compatibility | Conformity to IEC 60601-1-2 | Device meets requirements of IEC 60601-1-2. |
| Sterilization Validation | Conformity to ISO 11135 | Sterilization validated per ISO 11135. |
| Package Integrity | Conformity to ISO 11607-1 | Package integrity tested per ISO 11607-1. |
| EO/ECH Residue | Conformity to ISO 10993-7 | EO/ECH residue tested per ISO 10993-7. |
| Transportation Test | Conformity to ASTM D4169-16 | Transportation tested per ASTM D4169-16. |
| Aging Test | Conformity to ASTM F1980-16 | Aging tested per ASTM F1980-16. |
| Sterility Test | Conformity to ISO 11737-1 | Sterility tested per ISO 11737-1. |
| Risk Management | Conformity to ISO 14971, EN ISO 14971, MDR 2017/745 | Risk management performed per specified standards. |
| Light Hazards | Conformity to IEC 62471 | Device meets requirements of IEC 62471. |
| Biocompatibility | Conformity to ISO10993-5 and ISO10993-10 | Biocompatibility tested per specified standards. |
| Optical Specification | Comparable to predicate (FOV 85°, DOV 0°, DOF 6-50 mm) | FOV: 90°, DOV: 0°, DOF: 7-50 mm (differences deemed not significant). |
| Mechanical Specification | Comparable to predicate (Bending angle 130°, Length 300mm, OD 3.5mm) | Bending angle: 130°, Length: 300mm, OD: 3.6mm (differences deemed not significant). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is hardware-focused, and the testing described consists of non-clinical, bench tests against recognized standards rather than a clinical "test set" in the context of an AI/ML algorithm. No data provenance for software performance is discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device that requires expert-established ground truth for its performance assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no diagnostic test set requiring adjudication.
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. This is not an AI/ML device, so no MRMC study, AI assistance, or effect size is discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an endoscopic instrument and not an algorithm. Its function is to provide live imaging which is interpreted by a human user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of AI/ML. The "ground truth" for this device's performance is its adherence to established engineering and safety standards (e.g., IEC, ISO, ASTM) and its ability to provide clear visualization, confirmed through bench testing and usability testing, as opposed to diagnostic accuracy evaluated against pathology or expert consensus.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, therefore, there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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.