(141 days)
EB-530US is intended for the observation, diagnosis, and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with a FUJIFILM ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.
FUJIFILM Ultrasonic Endoscope EB-530US is an ultrasonic bronchoscope that emits ultrasound waves and scans the reflected signals to provide ultrasonic images when used in combination with an ultrasonic processor.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Parameter | Reported Device Performance | Study Type |
|---|---|---|---|
| Electrical Safety | ANSI/AAMI ES 60601-1:2012 | Met pre-defined criteria | Non-clinical |
| IEC 60601-1-2:2007 | Met pre-defined criteria | Non-clinical | |
| IEC 60601-1-6:2013 | Met pre-defined criteria | Non-clinical | |
| IEC 60601-2-18:2009 | Met pre-defined criteria | Non-clinical | |
| IEC 60601-2-37:2015 | Met pre-defined criteria | Non-clinical | |
| Biocompatibility | ISO 10993-1:2009 | Met pre-defined criteria | Non-clinical |
| ISO 10993-5:2009 | Met pre-defined criteria | Non-clinical | |
| ISO 10993-10:2010 | Met pre-defined criteria | Non-clinical | |
| Storage & Transportation | Expanded temperature range (-20°C to 60°C) | Validated | Non-clinical |
| Expanded humidity range (10 to 85% RH) | Validated | Non-clinical | |
| Performance Testing | Field of view | Met pre-defined criteria | Non-clinical |
| Forceps channel diameter | Met pre-defined criteria | Non-clinical | |
| Axial resolution | Met pre-defined criteria | Non-clinical | |
| Bending capability | Met pre-defined criteria | Non-clinical | |
| Viewing direction | Met pre-defined criteria | Non-clinical | |
| Lateral resolution | Met pre-defined criteria | Non-clinical | |
| Suction rate | Met pre-defined criteria | Non-clinical | |
| Resolution | Met pre-defined criteria | Non-clinical | |
| Penetration depth | Met pre-defined criteria | Non-clinical | |
| Working length | Met pre-defined criteria | Non-clinical | |
| LG output | Met pre-defined criteria | Non-clinical |
2. Sample size used for the test set and the data provenance
The document does not specify human clinical trials or a "test set" in the context of patient data. The performance testing appears to be entirely non-clinical (engineering and laboratory tests), likely using a sample of the manufactured device itself or components. Therefore, information about human data provenance is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported performance testing is non-clinical and does not involve expert evaluation for ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication by experts is described.
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, and the device is an ultrasonic endoscope, not an AI-assisted diagnostic tool. Therefore, the effect size of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not an AI algorithm. The device is a medical instrument. Therefore, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" would be established by objective measurements against engineering specifications, calibrated instruments, and established safety and performance standards (e.g., IEC standards for electrical safety, ISO standards for biocompatibility).
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.