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510(k) Data Aggregation
(241 days)
FUJIFILM Endoscope Model EI-740D/S
FUJIFILM Endoscope Model EI-740D/S is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Never use this product for any other purposes.
FUJIFILM Endoscope Model EI-740D/S is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. 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 CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processor, FUJIFILM's light sources and peripheral devices such as monitor, printer, foot switch, and cart.
This document is a 510(k) summary for the FUJIFILM Endoscope Model EI-740D/S, seeking to prove substantial equivalence to a predicate device (Endoscope Model EI-740D/S, K210162). The focus of this submission is on demonstrating safety and performance equivalence, primarily through reprocessing validation and electrical/photobiological safety.
Therefore, the information typically found in a clinical study for an AI/ML powered device, which would include detailed acceptance criteria for diagnostic performance, sample sizes, expert adjudication, and ground truth establishment, is not present in this document.
The document details the following regarding the device and its validation:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on the equivalence of the proposed device to the predicate device, especially concerning reprocessing validation and safety standards, rather than diagnostic performance criteria in the context of an AI/ML algorithm.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Reprocessing Validation | The proposed device was adopted into the cleaning, disinfection, and sterilization validation of the predicate device. Performed in accordance with FDA guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Label1ng, issued March 17, 2015." Delayed reprocessing instructions were validated. |
| Oxygen Saturation Measurement (OXEI mode) | The proposed device was adopted into the StO2 measurement testing performed on the EX-0 Oxygen Saturation Image Processor paired with the Endoscope Model EG-740N (K203717). |
| EMC and Electrical Safety | Evaluated using standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2014, and IEC 60601-2-18:2009. |
| Photobiological Safety | Evaluated using the standard: IEC 62471:2006. |
| Biocompatibility and Performance Testing | The proposed device can be adopted into the biocompatibility and performance testing of the predicate device (K210162) due to no modification in material construction, patient contact type/duration, or other technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance:
This document does not provide information on a "test set" in the context of an AI/ML diagnostic study. The performance evaluation is based on technical and safety validations rather than a clinical outcome study with a patient data test set.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable, as this is a 510(k) submission for an endoscope demonstrating substantial equivalence, not an AI/ML diagnostic study requiring expert ground truth establishment for clinical performance.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or reported in this 510(k) summary. The device is an endoscope, not an AI-powered diagnostic tool for which MRMC studies are typically performed to assess human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a medical device (endoscope), not a standalone AI algorithm.
7. Type of Ground Truth Used:
The "ground truth" in this context refers to established engineering and medical device standards for safety and performance (e.g., successful reprocessing, adherence to electrical safety standards). There is no "ground truth" derived from patient outcomes or expert consensus on disease diagnosis for an AI algorithm.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
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(78 days)
Endoscope Model EI-740D/S
FUJIFILM Endoscope Model EI-740D/S is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
FUJIFILM Endoscope Model El-740D/S is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the anqulation of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.
This document is an FDA 510(k) summary for a medical device, specifically an endoscope (FUJIFILM Endoscope Model EI-740D/S). It is not a study proving the device meets specific performance criteria related to the type of AI/ML evaluation detailed in your request.
The provided text describes a substantial equivalence determination for a traditional medical device (an endoscope) to a predicate device. This process primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing, biocompatibility, electrical safety, software validation, and adherence to relevant standards. It does not involve clinical effectiveness studies or AI/ML performance evaluations such as those measured by sensitivity, specificity, or AUC, as these would be required for AI/ML-driven diagnostic devices.
Therefore, I cannot directly extract the specific information you requested in bullet points 1-9 from this document, as it outlines a different type of device clearance process.
Here's why each point cannot be addressed from the given text:
- Table of acceptance criteria and reported device performance: The document mentions "Additional performance specifications were evaluated against pre-defined acceptance criteria" but does not provide a table with specific criteria or values. The performance data section focuses on compliance with various safety and compatibility standards rather than diagnostic performance metrics (e.g., sensitivity, specificity).
- Sample size and data provenance: This information is not relevant or included for a traditional device's 510(k) submission focused on substantial equivalence to a predicate, as there are no "test sets" in the context of AI/ML validation here.
- Number of experts and qualifications for ground truth: Not applicable. There is no AI/ML component requiring ground truth establishment by experts for diagnostic performance.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This is for AI-assisted human reading, which is not what this endoscope's submission is about.
- Standalone (algorithm only) performance: Not applicable. This is not an AI/ML diagnostic algorithm.
- Type of ground truth used: Not applicable. No diagnostic ground truth as required for AI/ML validation is discussed.
- Sample size for training set: Not applicable. No AI/ML model training is described.
- How ground truth for training set was established: Not applicable.
In summary, the provided document is for a traditional endoscope's 510(k) clearance, not for an AI/ML-enabled diagnostic device. Therefore, the detailed AI/ML-specific performance metrics and study design elements you asked for are not present.
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