(147 days)
This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen.
This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen.
ENF-GP2 is mainly consisted of four functional parts:
- eyepiece section that observes endoscopic images
- control section that operates endoscope such as controlling angulation to guide insertion and observation
- connector section that links with light source -
- insertion section that goes through and contacts with nasal and nasopharyngeal lumen under light guide.
When observing nasal or nasopharyngeal lumen, the light emitted from light source comes into fiberscope via apparatus on connector section and is eventually transmitted and released from examination light outlet in the distal end to supply light by optical fiber bundles. Subsequently the enlighten image reflexed into objective lens is grasped and sent to evepiece section by image fiber bundles, and observer can observe the image in eyepiece section or alter the imaging position by means of operations on control section, such as manipulation by UP/DOWN angulation control lever to adjust the bending section. Each section works collectively to perform observation within nasal and nasopharyngeal lumen.
The provided text describes a 510(k) premarket notification for the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2, asserting its substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo clinical or standalone performance studies against predefined acceptance criteria for novel claims.
Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning standalone diagnostic performance, multi-reader multi-case studies, and detailed ground truth data for training/test sets, is not present in this document. The document details bench and reprocessing validation tests for the device itself, rather than its diagnostic performance in a clinical setting against specific analytical or clinical performance metrics.
Here's an analysis of the provided text based on your request, highlighting what is and isn't available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with "acceptance criteria" for diagnostic performance and "reported device performance" against those criteria in the context of an AI/algorithm-driven device. Instead, it describes performance testing focused on device safety and functionality.
| Acceptance Criteria Type | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Reprocessing Validation | As recommended by "Guidance for Industry and Food and Drug Administration Staff, 'Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling'". | Conducted and documentation provided. |
| Biocompatibility | In accordance with FDA's Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process'". | Conducted. |
| Electrical Safety | Compliance to ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC60601-2-18:2009. | Performed to verify compliance. |
| Thermal Safety | Compliance to "PROTECTION AGAINST EXCESSIVE TEMPARATURES AND OTHER SAFETY HAZARDS" of IEC 60601-2-18:2009-08. | Performed to verify compliance. |
| Mechanical Durability | Safety and effectiveness considering the supposed usage and operating environment. | Performed to verify safety and effectiveness. |
| Optical Performance | Safety and effectiveness from optical perspective. | Performed to verify safety and effectiveness. |
| Risk Analysis | In accordance with established in-house acceptance criteria based on ISO 14971:2007 and human factors validation in accordance with FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices". | Conducted, and design verification tests and acceptance criteria were identified and performed as a result. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document refers to testing of the physical medical device (fiberscope), not an AI/algorithm where a "test set" of data would be used for performance evaluation.
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)
This information is not available in the provided text. No ground truth establishment for a diagnostic test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. No test set adjudication is mentioned.
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 performed. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence." This device is a fiberscope, not an AI-assisted diagnostic tool discussed in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/available for this device submission. The device is a physical rhinopharyngoscope, not a standalone AI algorithm. The performance tests mentioned in the document relate to the physical and functional aspects of the scope itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided text. Ground truth, in the context of diagnostic performance, is not discussed for this device.
8. The sample size for the training set
This information is not applicable/available for this device submission. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable/available for this device submission. There is no mention of a "training set" or its ground truth establishment.
§ 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.