(107 days)
The Single-use Flexible Rhinolaryngoscope is designed to be used with the Digital Video Monitor, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Vathin® Video Rhinolaryngoscope System is for use in a hospital environment.
The Vathin® Video Rhinolaryngoscope System consists of Single-use flexible Rhinolaryngoscope (eight models shown in below) and Digital Video Monitor (model: DVM-A1, DVM-A2, DVM-B1, DVM-B2) for clinical image processing and display.
The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.
Single-use flexible Rhinolaryngoscope is a sterile single Rhinolaryngoscope. Digital Video Monitor is a reusable monitor.
The light emitted by the LED cold light source of the Single-use flexible Rhinolaryngoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Digital Video Monitor via the encoding circuit. The Digital Video Monitor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.
Single-use flexible Rhinolaryngoscope 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 differences between the Single-use flexible Rhinolaryngoscope models are as follow:
- . Have or haven't working channel
- . Working channel inner diameter
- . Insertion tube outer diameter
- . The length of insertion tube
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information:
Device: Vathin® Video Rhinolaryngoscope System (includes Single-use Flexible Rhinolaryngoscope and Digital Video Monitor)
1. A table of acceptance criteria and the reported device performance
The provided document describes the device's technical specifications and reports that all evaluation acceptance criteria were met for the non-clinical tests. However, it does not explicitly state numerical acceptance criteria for each performance parameter, nor does it provide a direct comparison table of "acceptance criteria vs. reported performance" in a quantitative manner. Instead, it lists the tests performed and implies compliance.
Below is a table summarizing the reported device performance characteristics where numerical values are given, and notes where general compliance is stated without specific numerical acceptance criteria.
| Feature | Reported Device Performance | Acceptance Criteria (Implied / Stated) |
|---|---|---|
| Rhinolaryngoscope | ||
| Field of View (degree) | 110° | Not explicitly stated, but "larger (than predicate) is beneficial" |
| Direction of View (degree) | 0° | Not explicitly stated |
| Bending Angle (degree) | Up: 210°, Down: 210° | Not explicitly stated, but "larger (than predicate) means more flexibility" |
| Max Insertion Portion Width (mm) | RL-S1800, etc.: 3.2; RL-S1E00, etc.: 5.0 | Not explicitly stated, but "smaller (than predicate) for easier patient entry" |
| Min Insertion Channel Width (mm) | RL-S1800, etc.: 0; RL-S1E00, etc.: 2.2 | Not explicitly stated, but "larger (than predicate) is more convenient for doctors" |
| Working Length (mm) | 300 | "Meets the needs of clinical use," considered substantially equivalent to predicate's 350mm |
| Illumination Source | LED | Same as predicate |
| Single-Use | Yes | Same as predicate |
| Biocompatibility | No Cytotoxicity, No Irritation to Skin, No significant evidence of sensitization, No pyrogen | All evaluation acceptance criteria were met (based on ISO 10993-1) |
| Sterilization | EO | Same as predicate |
| Digital Video Monitor | ||
| Max. Resolution | 1280 x 800 | Not explicitly stated, but higher than reference device's 800x480 |
| Display Type | 12.1" touch screen | Not explicitly stated, but different from reference device's 8.5" colour TFT LCD |
| USB Connection | A-type | Same as reference device |
| Video Output | HDMI/USB 2.0 | Different from reference device's RCA connection |
| Image/Video Capture | Yes | Same as reference device |
| Electrical Safety / EMC | System complies with standards | IEC 60601-1, IEC60601-2-18 for safety; IEC 60601-1-2 for EMC |
| Other Performance Tests | All "evaluation acceptance criteria were met" | (Tests listed in Section VII: Appearance, dimensions and weight, Functional performance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document comprehensively lists various non-clinical tests conducted (Biocompatibility, Electrical Safety/EMC, Performance testing including Appearance, Dimensions, Weight, and Functional Performance). However, it does not specify the sample size used for any of these test sets, nor does it provide information on the country of origin of the data or whether the studies were retrospective or prospective. These were non-clinical, bench-top tests.
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)
The document describes non-clinical, bench-top testing. For such tests, the "ground truth" is typically established by industry standards, engineering specifications, and validated measurement methods, rather than by human expert consensus or qualifications in the medical sense for diagnostic performance. Therefore, no information on the number or qualifications of experts for establishing ground truth is provided or relevant in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since the study described involves non-clinical engineering and performance testing, rather than human interpretation of medical data, the concept of an "adjudication method" (like 2+1 or 3+1 for resolving discrepancies in expert interpretations) is not applicable and not 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 MRMC comparative effectiveness study was mentioned or performed. This submission is for a medical device (endoscope system) and not an AI-powered diagnostic tool. The focus is on the substantial equivalence of the hardware's performance and safety.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned or performed. This device is a physical Rhinolaryngoscope and Digital Video Monitor, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests conducted:
- Biocompatibility: Ground truth was established by adherence to ISO 10993-1:2018 standards and validated laboratory tests (Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity).
- Electrical Safety and Electromagnetic Compatibility (EMC): Ground truth was established by compliance with international standards (IEC 60601-1, IEC60601-2-18, IEC 60601-1-2).
- Performance Testing (Appearance, Dimensions, Weight, Functional Performance): Ground truth was established by engineering specifications and validated measurement methods as defined in the test protocols (e.g., measuring angles, lengths, diameters, image quality parameters).
8. The sample size for the training set
Not applicable. This submission describes a hardware medical device, not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used.
§ 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.