Search Results

FUJIFILM Bronchoscopes EB-580S and EB-580T are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

FUJIFILM Bronchoscopes EB-580S and EB-580T are comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control the angulation of the endoscope. This portion also controls the flexibility of the distal end in 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 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 into the video processor and light source. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K122535.

EB-580S and EB-580T can be used with Video Processor VP-7000 and Light Source BL-7000. However, LCI, FICE, and BLI imaging modes are not compatible with the subject devices.

This document describes the performance testing for the FUJIFILM Bronchoscopes EB-580S and EB-580T.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of units tested for electrical safety, biocompatibility, or endoscope-specific metrics). However, the performance data presented is based on bench testing. This indicates that the data provenance is from prospective testing conducted by the manufacturer, likely in a controlled laboratory environment. The country of origin of the data is not specified directly for the testing, but the submitter is FUJIFILM Corporation, located in Japan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the involvement of experts to establish a "ground truth" for the performance testing. The evaluation appears to be based on adherence to established consensus standards and the manufacturer's internal performance specifications. For device performance in terms of physical and electrical characteristics, the "ground truth" is typically defined by the technical specifications outlined in the standards themselves or by engineering design specifications, rather than by expert clinical interpretation.

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing involves objective measurement against engineering standards and specifications rather than subjective interpretation by multiple human assessors.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was mentioned. The submission is for a medical device (bronchoscope) and focuses on its compliance with safety and performance standards, not on evaluating the improvement of human readers with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device described is a physical medical instrument (bronchoscope), not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing was based on:

• Consensus Standards: International and national standards for electrical safety (e.g., IEC 60601 series), biocompatibility (e.g., ISO 10993 series), endoscope specifics (e.g., ISO 8600 series), and reprocessing (e.g., AAMI TIR series).
• Manufacturer's Performance Specifications: Internal design and functional requirements for physical parameters like field of view, working length, bending capability, resolution, etc.

8. The Sample Size for the Training Set

This section is not applicable. The document describes a physical medical device (bronchoscope), not a system involving a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as above.

Ask a specific question about this device

The FUJIFILM Bronchoscope Model EB-530P is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

The FUJIFILM Bronchoscope Model EB-530P is comprised of three general sections: a control/ operating section, an insertion and an umbilicus. The control/operating section controls the angulation (up/down) of the distal end of the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary charged 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 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 subject device is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K122535.

The provided document is a 510(k) premarket notification for a medical device, the FUJIFILM Bronchoscope Model EB-530P. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria for a new clinical indication.

The document does not describe acceptance criteria in the way one would typically find for a medical device that uses artificial intelligence (AI) or requires a clinical performance study with defined metrics like sensitivity, specificity, or accuracy. It's a bronchoscope, which is a physical instrument for observation, diagnosis, and endoscopic treatment.

Therefore, many of the requested bullet points, such as those related to AI performance, ground truth, expert adjudication, and MRMC studies, are not applicable to this type of device submission.

However, I can extract information related to performance testing and comparison to the predicate device, which serves as the basis for the FDA's substantial equivalence determination.

Based on the provided document, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the typical sense of clinical performance metrics. Instead, the "acceptance" is implicitly that the device performs functionally as intended and safely, similar to or better than the predicate device.
   • Reported Device Performance: The document lists several characteristics and states implicitly that the device "met performance specifications" or "has substantially equivalent performance" to the predicate. The "Performance Data" section (page 4) lists the types of tests conducted:
     • Electrical safety
     • Biocompatibility
     • Cleaning, high-level disinfection, and EO sterilization reprocessing validation
     • Endoscope specific testing (ISO standards)
     • Additional testing: Field of view, Bending capability, Rate of suction, Working length, Diameter of forceps channel, Viewing direction, LG Output.

   Table (Reconstructed from "Performance Data" and "Table 7.1: Comparison"):

   Acceptance Criteria Category/Characteristic	Device Performance (How it meets "acceptance")	Unclear if specific quantitative thresholds were used beyond "met specifications" or "comparable to predicate."
   Electrical Safety	Evaluated using ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.	Implied "met standards."
   Biocompatibility	Evaluated using ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.	Implied "met standards" and "material changes...raise no new concerns."
   Reprocessing Validation	Cleaning, high-level disinfection, and EO sterilization were performed.	Implied "validated reprocessing instructions."
   Endoscope Specific Testing	Conducted using ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.	Implied "met standards."
   Field of View	120 degrees (Same as predicate)	Implicitly, "Same as predicate device" means it meets performance.
   Bending Capability (Up)	180 degrees (Same as predicate)	Implicitly, "Same as predicate device" means it meets performance.
   Bending Capability (Down)	130 degrees (Same as predicate)	Implicitly, "Same as predicate device" means it meets performance.
   Rate of Suction	"Met performance specifications"	Not quantified in document.
   Working Length	600mm (Same as predicate)	Implicitly, "Same as predicate device" means it meets performance.
   Diameter of Forceps Channel	1.2mm (Predicate: 2.0mm)	Although different, implied "met performance specifications" for the new design without raising safety/effectiveness issues.
   Viewing Direction	Forward/ 0 degree (Same as predicate)	Implicitly, "Same as predicate device" means it meets performance.
   LG Output	"Met performance specifications"	Not quantified in document.
   Distal End Diameter	3.8mm (Predicate: 4.9mm)	Different, but considered "minor dimensional differences" that "raise no new issues of safety or effectiveness."
   Flexible Portion Diameter	3.8mm (Same as predicate for proposed, but 4.9mm for predicate)	Different, but considered "minor dimensional differences."
   Maximum Insertion Diameter	4.2mm (Predicate: 5.9mm)	Different, but considered "minor dimensional differences."
   Total Length	890mm (Predicate: 870mm)	Different, but considered "minor dimensional differences."

2. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not specified quantitatively for any of the performance tests (e.g., how many bronchoscopes were tested for bending capability). These are likely bench tests of physical characteristics.
   • Data Provenance: The tests are "bench testing data" (page 7), implying laboratory testing of the device itself, not clinical data from patients. No country of origin for data is specified, as it's not typical patient data. The tests are prospective as they are conducted for the specific submission.

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):

   • Not Applicable. This is a physical bronchoscope, not an AI or diagnostic imaging device that requires expert ground truth establishment for clinical performance. The "ground truth" for its physical specifications comes from engineering measurements and adherence to international standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable. No human adjudication of results in the sense of clinical interpretation is described. Physical and electrical tests are verified against defined standards and specifications.

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:

   • Not Applicable. This is not an AI device or a diagnostic device where human perception is assisted by AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. There is no algorithm mentioned in this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. For a physical device like a bronchoscope, the "ground truth" for performance is based on engineering specifications, physical measurements, and adherence to established international standards (e.g., ISO, IEC).

8. The sample size for the training set:

   • Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

   • Not Applicable. As above, no training set for an AI/ML algorithm is involved.

Ask a specific question about this device