(223 days)
FUJIFILM Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.
Never use this product for any other purposes.
FUJIFILM Endoscope Model EB-710P is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion is flexible and contains glass fiber bundles, several channels, and a complementary metal-oxide semiconductor (CMOS) image sensor in its distal end. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The channels in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation and rotation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart.
The provided text describes the 510(k) premarket notification for the FUJIFILM Endoscope Model EB-710P. It details the device, its intended use, comparison to predicate/reference devices, and performance data. However, the document does not describe an AI/ML-driven device or a study involving human readers and AI assistance.
Therefore, many of the requested criteria related to AI/ML performance, human reader studies, ground truth establishment for AI models, and sample sizes for training/test sets for AI are not applicable to this document. This document pertains to a traditional medical device (an endoscope) and its clearance based on substantial equivalence.
I will address the applicable criteria based on the information provided in the document.
Analysis of Acceptance Criteria and Device Performance (FUJIFILM Endoscope Model EB-710P)
This document describes the 510(k) premarket notification for a physical medical device, the FUJIFILM Endoscope Model EB-710P, not an AI or software-as-a-medical-device (SaMD) product. Therefore, the acceptance criteria and study described are for the physical performance and safety of the endoscope itself, primarily through bench testing and compliance with recognized standards, rather than clinical performance metrics of an AI model like sensitivity, specificity, or reader improvement.
The "acceptance criteria" here refer to meeting performance specifications and regulatory standards demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance specifications and states that the proposed device met them. It does not present a formal "acceptance criteria vs. reported performance" table in the way one might for an AI model's accuracy metrics, but rather as statements of compliance.
| Criterion/Test Type | Acceptance Standard/Method Used | Reported Device Performance |
|---|---|---|
| Resolution | For Proposed Device: At 2mm working distance: 0.08mm line pair readable; At 50mm working distance: 1.25mm line pair readable (on square wave chart). For Predicate Device: At 4mm working distance: 0.1mm line pair readable; At 100mm working distance: 1.6mm line pair readable. | Met performance specifications, demonstrating substantial equivalence to the predicate device. (The document states "The proposed device met performance specifications...Resolution...Optical and color performance of the proposed device was evaluated. In all cases, the proposed device demonstrated substantial equivalence to the predicate device.") |
| Cleaning, Disinfection, Sterilization | Validation in accordance with FDA guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015). | Validation performed in accordance with guidance. |
| Biocompatibility | Evaluated using ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Conducted in accordance with FDA guidance, "Use of International Standard ISO 10993-1..." (September 4, 2020). | Biocompatibility testing conducted successfully. |
| Software | Evaluated in accordance with IEC 62304:2006, FDA guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (May 11, 2005), and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 2, 2014). | Evaluated in accordance with standards and guidance documents. |
| Electrical Safety & EMC | Evaluated using ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010/AMD1:2013, and IEC 60601-2-18:2009. | Evaluated using specified standards. |
| Laser Safety & Photobiological Safety | Evaluated using IEC 60825-1:2007 and IEC 62471:2006. | Evaluated using specified standards. |
| Endoscope Specific Testing | Conducted according to ISO 8600-1:2015. | Conducted successfully. |
| Other Performance Specs | Field of view, Bending capability, Working length, Diameter of forceps channel, LG output, Rate of suction, Viewing direction. | The proposed device met performance specifications in these additional testing areas and demonstrated substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in the context of clinical studies for diagnostic accuracy, as it is a device clearance for an endoscope based on engineering and bench testing, and demonstrating substantial equivalence. The "test set" here refers to the physical units and materials used for various engineering and safety tests. No patient data or clinical imagery is referenced for performance testing in this document.
- Sample Size: Not applicable in the context of a clinical test set for AI/ML. The tests are performed on the device itself and components.
- Data Provenance: Not applicable in the context of clinical data. The tests are laboratory/bench tests on the device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth for an AI/ML model for diagnostic purposes is not relevant for the clearance of a physical endoscope itself. The "ground truth" for this device's performance would be the objective measurements and accepted standards in engineering and medical device testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where human readers interpret medical images, often to establish ground truth or evaluate reader performance. This is not describing such a study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document does not mention an MRMC study. MRMC studies are typically performed for AI-assisted diagnostic devices to assess how AI affects reader performance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's regulatory clearance is established by:
- Performance Specifications: The defined objective measurements and technical requirements for the endoscope's functions (e.g., resolution, field of view, bending capability).
- Consensus Standards: Adherence to recognized national and international standards for medical device safety, biocompatibility, electrical safety, software, and reprocessing (e.g., ISO, IEC, ANSI/AAM).
- Predicate Device Performance: The performance characteristics of the previously cleared predicate device, which the proposed device must be substantially equivalent to.
- Bench Testing Data: Direct measurements obtained from laboratory testing of the device.
8. The Sample Size for the Training Set
Not applicable. This is not describing an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process as defined for AI/ML.
§ 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.