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Double Balloon Endoscope Model EN-840T: This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine and rectum. Never use this product for any other purposes.

Over-Tube TS-1214C: This product is intended to be used as an accessory with the FUJIFILM Double Balloon Endoscope cleared for use with an Over-tube is used to assist with the movement of the scope inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.

a. Double Balloon Endoscope Model EN-840T: The insertion portion of the device has a mechanism (hereinafter "the bends the tip from right to left and up and down, and a flexible tube (hereinafter") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the tip is arranged inside the insertion portion for inserting the surgical instrument. The insertion portion of the endoscopes comes into contact with the mucosal membrane. The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Balloon air feed outlet , Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, Objective lens, and Light guide. The bending portion is controlled by knobs on the control portion section to angulate the distal end to certain angles. The Flexible portion refers to the long insertion area between the Control portion (a part of Non-insertion portion). This portion contains light guides), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The class fiber bundles alow light to travel through the body cavity, thereby providing enough light to the CMOS sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction. The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connects the endoscopes to the light source.

b. Over-tube TS-1214C: The over-tube TS-1214C is introduced in the patient's anatomy with the pairing endoscope. TS-1214C is assembled over the outer diameter of endoscope. The endoscope and the over-tube are not advanced both at the same time, but alternatingly and successively. TS-1214C is provided sterile and single-patient use only. This accessory is a Class 2 device.

The provided text is a 510(k) Summary for a medical device (Double Balloon Endoscope EN-840T and Over-tube TS-1214C). It describes the device, its intended use, and a comparison to predicate devices, and lists various non-clinical tests performed to demonstrate substantial equivalence. However, it does not include information about specific acceptance criteria, reported device performance in a table, sample sizes, ground truth establishment, expert qualifications, or any human reader studies (MRMC or standalone AI performance).

Therefore, based on the provided text, I cannot answer most of your detailed questions about acceptance criteria and the study proving the device meets those criteria. The document focuses on regulatory compliance through substantial equivalence, primarily established through non-clinical testing against recognized standards.

Here's what can be extracted and what cannot:

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

• Cannot be extracted. The document mentions various tests were conducted (EMC, Electrical safety, Biocompatibility, Endoscope specific testing, Sterility, Field of view, Bending capability, Rate of suction, Working length, Diameter of forceps channel, Viewing direction, Resolution, LG output) and states "The subject device met performance specifications" or "Bench testing data demonstrated that the subject devices are substantially equivalent in performance." However, it does not provide specific numerical acceptance criteria or reported performance values in a table format.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be extracted. The document mentions "Bench testing data" and "Endoscope specific testing" but does not specify the number of samples or units tested for any of these non-clinical tests, nor the data provenance.

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 device is an endoscope and over-tube, which are hardware devices for visualization and intervention, not an AI system that requires expert-established ground truth for diagnostic accuracy. The testing described is non-clinical (electrical, mechanical, biocompatibility, sterility).

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

• Not applicable. As above, this is for non-clinical hardware testing, not diagnostic AI performance assessment requiring expert adjudication.

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. The document describes a traditional medical device (endoscope and over-tube) and its non-clinical testing for safety and effectiveness, based on substantial equivalence to predicate devices. There is no mention of AI or assistant features, nor any MRMC studies.

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

• No. This device is not an algorithm or AI system.

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

• Cannot be extracted and not applicable in the usual sense. For non-clinical tests, "ground truth" would correspond to the established measurement standards and specifications (e.g., a caliper for diameter, a force gauge for bending, a flow meter for suction rate, etc.). The document indicates these tests were performed according to recognized consensus standards (e.g., ISO, AAMI).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device requiring a training set.

In summary, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of the new endoscope and over-tube through engineering and biocompatibility testing against established standards and predicate devices. It does not contain the kind of performance data (e.g., sensitivity, specificity, AUC, or reader performance) typically associated with AI/ML-driven diagnostic devices.

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The Ancora-SB is an accessory to an endoscope. The Ancora-SB is intended for use with any standard endoscope that has an outer diameter of 9.0 - 9.4 mm and a working length of 1680 mm or greater. The Ancora-SB is intended for use with any standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 kPa (+2.6 kPa, -1.8 kPa). The device is indicated to ensure complete positioning of an endoscope in the small intestine by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment.

The Ancora-SB is a single-use, close-fitting sleeve that slides freely over a currently marketed standard endoscope having an outer diameter of 9.0 – 9.4 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the small intestine, by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment. The device is designed to be used with a Balloon Endoscopy System (BES) which includes a multi-channel endoscope, an endoscopy tower (light source, display monitor, recording equipment, etc.) and a balloon inflation unit (equipment that inflates or deflates by a push button control, inflation is to a stated maximum pressure and the pressure is maintained during active use when inflated).

The provided text is a 510(k) summary for the Ancora-SB device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe an acceptance criteria table with reported device performance or a study demonstrating the device meets such criteria using human reader data. Therefore, many of the requested items cannot be extracted from this document as they pertain to clinical or human-in-the-loop performance studies, which are not detailed here.

However, I can extract information regarding non-clinical testing performed to establish safety and effectiveness for substantial equivalence.

Here's a summary of what can be extracted based on the provided document:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a table of acceptance criteria linked to reported exact performance metrics for the device. It lists types of non-clinical tests that were performed to demonstrate safety and equivalence to the predicate device.

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

The document describes non-clinical bench testing and an animal study. For these types of studies, standard sample sizes for individual tests are typically used based on engineering principles and regulatory guidelines. The document does not specify these sample sizes. The data provenance is not mentioned beyond stating "GLP animal study" and "bench performance testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the studies described are non-clinical (bench and animal) and do not involve expert interpretation or ground truth establishment in the context of clinical scenarios, human readers, or expert consensus.

4. Adjudication method for the test set:

Not applicable, as this refers to clinical studies with human readers, which are not detailed in this document.

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 is mentioned. This document focuses on non-clinical testing for substantial equivalence. The device does not appear to be an AI-based diagnostic tool.

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

Not applicable, as the device is not an algorithm, but a physical accessory to an endoscope. Its performance is evaluated through bench and animal testing, not standalone algorithmic performance.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" would be established by the physical and mechanical properties being measured (e.g., dimensions, force, inflation time) as defined by engineering standards. For the animal study, the "ground truth" would be the observed physiological responses or effects in the animal model. Specific details on how this "ground truth" was established are not provided in the summary.

8. The sample size for the training set:

Not applicable, as this document does not describe an AI/ML device that requires a training set.

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

Not applicable, as this document does not describe an AI/ML device that requires a training set.

Summary of Non-Clinical Testing Performed (from Section: SUMMARY OF NON-CLINICAL TESTING):

The document states that the following non-clinical tests were performed to demonstrate safety and substantial equivalence:

• Biocompatibility testing: Per ISO 10993-1, -5, -10, and -23.
• Distribution testing: Per ASTM D4169-22.
• Shelf-life testing: Per ASTM F1980-21.
• Bench performance testing: Including:
  • Dimension inspection
  • Packaging inspection
  • Components and features inspection
  • Balloon compatibility and reliability
  • Overtube friction force and reliability
  • Balloon inflation time
  • Balloon anchor force
  • Joint strength
• GLP animal study.

Conclusion:

"The results of these tests indicate that the Ancora-SB is substantially equivalent to the predicate device."
"Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device."

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Endoscope EN-580T: This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine and rectum. Never use this product for any other purposes.

Over-tube TS-1314B: This product is used in combination with a FUJIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. This product is used to assist with the movement of the scopes inside the upper or lower digestive tract. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children.

Balloon BS-4: This product is used in combination with FUJIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is inserted into the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children.

Tube Kit TY-500D: This product is the tube kit used in combination with the compatible balloon controller in medical facilities. Do not use this product for any other purpose.

The endoscope EN-580T is inserted both perorally and transanally into the gastrointestinal tract during clinical use. The insertion of the device has a mechanism which bends the tip from right to left and up and down, and a flexible tube consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument.

The over-tube TS-1314B is introduced in the patient's anatomy with the pairing endoscope. TS-1314B is assembled over the outer diameter of endoscope. The endoscope and the over-tube are not advanced both at the same time, but alternatingly and successively. TS-1314B is provided sterile and single-patient use only.

The balloon BS-4 is attached to the balloon-compatible endoscope. The balloon air feed outlet should be contained inside BS-4. The accompanying fixing rubber is used to affix the scope balloon in place. The fixing rubbers are made specifically for BS-4 but should not be mixed with the fixing rubber of other scope balloons. BS-4 is provided sterile and single-patient use only.

The tube kit TY-500D consists of a set of two tubes connects the over-tube to the balloon controller by its air inlet. The other tube connects the same balloon controller to the endoscope by its balloon air feed inlet. TY-500D is only compatible with PB-30, cleared K153483. TY-500D is provided non-sterile. The tubes are not patient-contacting and reusable, but each filter is single-patient use only.

This document does not contain information about a study that proves the device meets specific acceptance criteria in the manner typically seen for AI/ML-driven devices. Instead, it describes a 510(k) premarket notification for updated medical devices (Endoscope and accessories) that aim to demonstrate substantial equivalence to previously cleared predicate devices.

The "acceptance criteria" here are inherent to the regulatory process of demonstrating substantial equivalence for traditional medical devices, focusing on safety and effectiveness compared to existing devices rather than a performance benchmark against a clinical gold standard using a specific test set.

Here's an breakdown based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of a table with specific numerical performance metrics (like sensitivity, specificity, AUC), the "acceptance criteria" are compliance with relevant safety and performance standards for medical devices, and the "reported device performance" is the successful completion of testing to demonstrate this compliance and substantial equivalence to predicate devices.

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

This document does not describe a "test set" in the context of AI/ML evaluation (e.g., a set of medical images or patient cases). The performance data cited refers to standard engineering and biological testing (sterility, biocompatibility, endoscope-specific tests). Therefore, information on sample size or data provenance for such a "test set" is not applicable or provided here.

3. Number of Experts Used to Establish the Ground Truth and Qualifications of Those Experts

Not applicable. Ground truth, in this context, would imply expert annotations or diagnoses on patient data. This document describes the substantial equivalence of physical medical devices and their components, not an AI/ML algorithm's diagnostic performance. Therefore, no experts were used to establish ground truth for a test set in this manner.

4. Adjudication Method for the Test Set

Not applicable, as there is no diagnostic "test set" to adjudicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance

No. This document does not pertain to AI or an AI-assisted device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This document does not pertain to an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is compliance with established international and FDA standards for medical device safety and performance. This is confirmed through laboratory testing for sterility, biocompatibility, and functional performance, rather than clinical outcomes or pathology data.

8. The Sample Size for the Training Set

Not applicable, as there is no AI/ML algorithm involved, and thus no "training set."

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

Not applicable, as there is no AI/ML algorithm and training set.

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Balloon BS-3 is intended to be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract at medical facilities under the management of physicians.

Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.

Balloon BS-3 is a pre-sterilized, single-use accessory used for fixing the endoscope in the body cavity. The device is fixed at the tip or bending portion of the endoscope and is inflated by filling air from the operation part of the endoscope with a special pump. The device is used for a natural opening of the human body to perform enlargement of a lumen, coelom or body cavity in order to enable and facilitate insertion of the endoscope.

This is a 510(k) summary for a medical device called "Balloon BS-3," an endoscopic accessory. The document does not describe an AI/ML device, therefore, the requested information about acceptance criteria and studies for an AI/ML device is not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Balloon BS-2) through comparison of technological characteristics and performance data related to sterility, biocompatibility, and inflation rate.

Here's an overview of the information provided in the document:

• Device Name: Balloon BS-3
• Intended Use: To be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract. Not for neonates, infants, or children.
• Predicate Device: Balloon BS-2 (K143556)

Performance Data and Conclusions:

The document states that the following tests were conducted:

• Sterility: Evaluated using ISO 11135:2014 and ASTM F1980-16.
• Biocompatibility: Evaluated using ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010.
• Comparative bench testing: Conducted on the subject and predicate devices to evaluate the rate of inflation.
• Additional evaluation: The subject device was additionally evaluated against ISO 8600-1:2015.

The overall conclusion is that "Bench testing demonstrates that the subject device is as safe and effective as the predicate device. Thus, Balloon BS-3 is substantially equivalent to the listed predicate device."

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To be attached to the distal end or the enteroscopes to facilitate endoscopic therapy, to be used for the following:

• . Keeping the suitable depth of the enteroscope's view field
• . Helping the endoscope with being inserted into the gastrointestinal tract

Not Found

The provided text is a 510(k) clearance letter for the Arc Enterocuff, which is an accessory to endoscopes. It outlines the regulatory approval for marketing the device. However, the document does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on regulatory compliance and the determination of substantial equivalence to predicate devices, rather than presenting a performance study report.

Therefore, I cannot provide the requested information from the given text.

To be clear:

• A table of acceptance criteria and the reported device performance: Not found in the document.
• Sample sized used for the test set and the data provenance: Not found in the document.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found in the document.
• Adjudication method: Not found in the document.
• Multi reader multi case (MRMC) comparative effectiveness study: Not found in the document.
• Standalone algorithm performance: Not applicable as this is a physical medical device (an enterocuff), not an AI algorithm.
• Type of ground truth used: Not found in the document.
• Sample size for the training set: Not applicable as this is a physical medical device.
• How the ground truth for the training set was established: Not applicable as this is a physical medical device.

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This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, and rectum.

FUJIFILM Double Balloon Endoscope EI-580BT is 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 complementary 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 and balloons. 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. All of these combinations were previously cleared in K143556 and K172916.

The provided text describes the regulatory clearance of the FUJIFILM Double Balloon Endoscope EI-580BT and outlines the performance data submitted to demonstrate substantial equivalence to a predicate device. However, it does not contain information related to a study proving the device meets specific acceptance criteria based on human-in-the-loop performance, AI assistance, or an algorithm's diagnostic accuracy.

The performance data mentioned in the document focuses on:

• Electrical safety: Compliance with standards like ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, etc.
• Biocompatibility: Compliance with ISO 10993 standards.
• Endoscope specific testing: Compliance with ISO 8600 standards.
• Cleaning, high-level disinfection, and sterilization: Compliance with AAMI TIR standards and FDA guidance.
• Usability testing: Compliance with IEC 62366-1:2015.
• Bench testing: Validation of features like "Advanced Force Transmission" and "Adaptive Bending," and performance specifications for field of view, bending capability, rates of air/water/suction, working length, channel diameter, viewing direction, resolution, and LG output.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving the device meets these criteria in the context of diagnostic accuracy, human-in-the-loop performance, AI assistance, or algorithm-only performance, as this information is not present in the provided text.

The document pertains to the clearance of an endoscope, which is a medical instrument for direct visualization, not an AI or image-analysis diagnostic device. The "performance data" discussed are engineering and safety specifications typical for such a device, not metrics like sensitivity, specificity, AUC, or reader performance improvement often associated with AI/diagnostic software.

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EN-580T, EN-450P5/20 and EN-450T5 are intended for the upper and lower digestive tracts. Specifically, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum.

EC-450B15 is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestines. It is intended for observation, diagnosis, and endoscopic treatment.

FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 are comprised of three general sections: a control portion, an insertion and an umbilicus. The control portion controls 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 complementary 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 pluqged 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.

The document describes the regulatory submission for FUJIFILM Double Balloon Endoscopes, focusing on modifications made to existing devices. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Performance Data" section (pages 4-5).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that a series of performance tests were conducted to ensure the modified devices perform equivalently to the predicate devices. The acceptance criteria were "pre-defined," and in all cases, the devices met these criteria. However, the specific quantitative acceptance criteria for each test and the precise reported device performance values are not explicitly detailed in the provided text. Instead, a list of tested parameters is given.

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

The document does not explicitly state the sample size (number of devices or tests performed) for the performance testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these performance studies.

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

This information is not applicable and not provided in the document. The performance tests described (e.g., field of view, bending capability, electrical safety, biocompatibility) are objective engineering and material science evaluations, not assessments requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. The performance tests described are objective and do not involve adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of modified endoscopes to predicate devices through technical and physical performance metrics, not on evaluating human reader performance with or without AI assistance.

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

No, a standalone (algorithm-only) performance study was not done. This device is an endoscope, a physical instrument, and does not involve AI algorithms for diagnosis or analysis.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests was based on established engineering specifications, consensus standards (e.g., ISO, AAMI, IEC), and regulatory guidance documents. For instance, electrical safety was measured against specific IEC standards, and biocompatibility against ISO standards. The validation of reprocessing instructions was performed in accordance with FDA guidance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. The studies described are performance tests of physical devices against pre-defined specifications, not machine learning model training.

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

This information is not applicable and not provided for the reason mentioned above.

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The Fujifilm Double Balloon Endoscopes are intended for the upper and lower digestive tracts. Specifically, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum.

The Fujifilm Double Balloon Endoscopes, Models EN-530T and EN-580T and related accessories consist of double balloon endoscopes (models EN-530T and EN-580T), a hood (model DH-17EN), a balloon (model BS-2), an over-tube (model TS-13140), and a balloon controller (model PB-20).

The endoscopes are comprised of three general sections; an operation section, an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion contains glass fiber bundles, several channels and a charged couple device (CCD) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the gastrointestinal cavity. This provides adequate light to the CCD image sensor to capture an image and display it on the monitor. The endoscope also contains several channels such as an air/water channel, a suction channel, a balloon channel and a forceps channel. The balloon controller is used to inflate or deflate the balloons on the distal end of the endoscope and on the over-tube through the balloon channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps for endoscopic procedures. The umbilicus section consists of electronic components needed to operate the endoscope when plugged to the video processor and the light source. The subject models are used in combination with Fujifilm's video processor, light source and peripheral devices (water tank, endoscope accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, and cart). The hood is an optional accessory that is attached to the distal end of the endoscopes and is intended to maintain the field of view during the endoscopic procedure.

The minor modifications to the endoscopes were made for the purpose of overall product enhancement and general technological advancement.

This 510(k) summary describes an endoscopic device, and as such, it does not fit the typical format for AI/ML device evaluations. Therefore, many of the requested bullet points, such as MRMC studies, effect size, and specific ground truth details for AI models, are not applicable.

However, based on the provided document, I can extract the following information about the device's performance evaluation against established criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance specifications that were tested, comparing the subject devices (EN-530T and EN-580T) to predicate devices (EN-450P5/20 and EC-450BI5). The statement "Subject devices met performance specifications of the following additional testing" implies that the new devices achieved acceptable performance for each listed criterion.

Additional Performance Tests for which "Subject devices met performance specifications":

• Time for inflation
• Operating pressure
• Frictional resistance
• Bending capability
• Rate of air supply
• Rate of water supply
• Rate of suction
• Viewing direction
• Pump air feed pressure
• Pump air evacuation pressure
• Pump air flow rate

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

The document states that "Bench testing data demonstrated that the subject endoscopes have substantially equivalent performance to the predicates." However, it does not specify the sample size for this bench testing.
The data provenance is internal bench testing conducted by the manufacturer, Fujifilm Medical Systems, U.S.A., Inc. It is retrospective in the sense that it's testing against established specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The performance tests appear to be objective measurements based on engineering and performance specifications, rather than expert interpretation of images or clinical outcomes.

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

This information is not provided and is generally not applicable to bench testing of endoscopic devices which relies on objective measurements against engineering 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:

This is not applicable as the device is an endoscope and not an AI/ML-driven diagnostic tool that assists human readers.

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

This is not applicable as the device is an endoscope and not an AI/ML algorithm.

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

The "ground truth" for the performance specifications is based on pre-defined engineering and functional specifications and measurements as outlined by relevant consensus standards (e.g., ISO 8600 series) and the manufacturer's internal criteria. For example, resolution is measured by recognizing a pitch chart at a specific distance.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device requiring a training set in that context.

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

This is not applicable as this is not an AI/ML device requiring a training set.

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This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with an Olympus video system center, light source, balloon control unit, splinting tube, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopic diagnosis and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral anal insertion.

Indications for Use of the Components are as follows:

SIF-Q180 (SMALL INTESTINAL VIDEOSCOPE)

This instrument has been designed to be used with an Olympus video system center, light source, single use splinting tube, balloon control unit, documentation equipment, video monitor, endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract (including the esophagus, stomach, duodenum, colon, and small intestine) by either oral and anal insertion.

OBCU (BALLOON CONTROL UNIT)

This balloon control unit has been designed for inflating and deflating the balloon attached to the distal end of a single use splinting tube in order to assist the insertion of an Olympus -designated small intestinal endoscope.

The subject device, Small Intestinal Videoscope system, is designed for endoscopy and endoscopic surgery within the small intestine. This system is composed of Small Intestinal Videoscope, Single Use Splinting Tube, and Balloon Control Unit and its accessories. The subject system is compatible with NBI observation which utilizes narrow-band spectrum to enhance contrast of the surface structure and fine capillary patterns of the mucous membranes. Also, the subject system utilizes a balloon attached to the splinting tube to facilitate advancement of the endoscope well within the small intestine.

This 510(k) summary for the Olympus Small Intestinal Videoscope System (K071254) does not contain the information requested about acceptance criteria, device performance, statistical studies, or ground truth establishment.

The document is a premarket notification for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device. It addresses:

• General Information: Applicant, manufacturer, official correspondent.
• Device Identification: Trade name, common name, regulation number, regulation name, regulatory class, product code.
• Predicate Device Information: Details of the device it's being compared against.
• Device Description: A brief overview of the system components and their function.
• Indications for Use: The medical conditions and procedures for which the device is intended.
• Comparison of Technological Characteristics: How the new device is similar to and different from the predicate device, highlighting features like NBI observation and balloon technology.
• Conclusion: A statement that the device does not incorporate significant changes that would affect safety and effectiveness compared to the predicate.
• FDA Correspondence: The official letter from the FDA determining substantial equivalence, including regulatory compliance reminders.

The document does NOT provide:

1. Acceptance criteria or reported device performance data: There is no table detailing specific performance metrics (e.g., image resolution, depth of field, illumination, insertion success rates, diagnostic accuracy) or acceptance thresholds for these metrics.
2. Details of any study: No information is given about sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set details. This is typical for a 510(k) submission where substantial equivalence is demonstrated through technological comparison rather than efficacy or performance studies against specific criteria.
3. Type of ground truth used: Since no study is described, no ground truth information is available.

Summary of missing information:

• Acceptance Criteria & Device Performance: Not reported.
• Sample Size (Test Set) & Data Provenance: Not reported, as no study is detailed.
• Number & Qualifications of Experts: Not reported.
• Adjudication Method: Not reported.
• MRMC Comparative Effectiveness Study: Not reported.
• Standalone Performance Study: Not reported.
• Type of Ground Truth: Not reported.
• Sample Size (Training Set): Not reported.
• Ground Truth for Training Set: Not reported.

In essence, this document establishes market clearance based on substantial equivalence to a previously cleared device, focusing on its intended use, design, and technological characteristics, rather than new clinical performance data or specific acceptance criteria.

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The NaviAid ™ BGE device is an accessory to an endoscope and is intended to ensure complete positioning of a standard endoscope in the small intestine (i.e., an endoscope that is 10-13 mm in diameter and is used for standard intestinal endoscopic visualization).

The NaviAid™ BGE affords deep access into the small intestine, while maintaining all the advantages of an endoscopic procedure, such as back-and-forth navigation, stopping propagation if needed, real-time operation, video imaging, working channel including biopsy and treatment. The NaviAid™ Balloon Guided Endoscopy (BGE) system comprises an accessory kit containing the disposable balloon system and an air supply control unit for inflating and deflating the balloon system. The role of the Balloon Guided Endoscopy (BGE) disposable accessory kit is to facilitate advancement of a standard endoscope deeper into the small intestine. The NaviAid™ BGE system "upgrades" standard endoscopes to a double balloon endoscopy system. The NaviAid™ BGE accessory kit includes two balloons - the Guiding Balloon for Small Intestine ("GBS") and the Stabilizing Balloon ("SB"). Both balloons are inflated by ambient air. The Air Supply Unit ("ASU") operates and controls the inflation and deflation of the two balloons through two foot-pedals. Each balloon is connected to a dedicated tube that runs along the endoscope, and is connected at its proximal (user) end to the ASU. The balloon tubes are attached to the endoscope with clips and silicon bands. The NaviAid™ BGE accessory kit is mounted (deflated) on the tip of the endoscope, and is inserted with the endoscope into the gastrointestinal tract of the patient. The SB is the proximal balloon that is used to anchor the endoscope (near its tip) to the intestinal wall. The GBS is the distal balloon that can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the GBS inflation tube at its proximal side, outside the patient body. When the GBS balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip (now with a deflated balloon) is advanced, and the GBS inflation tube serves as a "guidewire" that leads the endoscope as it is pushed towards the GBS anchoring location. The sequence of inflation and deflation of the balloons enables "pleating the small intestine on to the endoscope" or forming a rail on which the endoscope can be guided and advanced towards the GBS anchoring location. The balloons and tubes do not compromise the endoscope's flexibility, although its field of view may be reduced by up to 8%. Additionally, the balloons do not significantly compromise the maneuverability of the endoscope's tip and do not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. The NaviAid BGE accessory kit is disposable and intended for single use, while the ASU is re-usable.

The provided document describes the NaviAid™ BGE device and its non-clinical performance tests to demonstrate substantial equivalence to a predicate device, the Fujinon Double Balloon Endoscopy System. There is no information regarding a study defining acceptance criteria, and then proving the device meets that criteria. The document states "Clinical Performance Data: Not Applicable".

Here's an analysis of the provided information as it relates to your questions:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists several non-clinical performance tests conducted without specifying quantitative acceptance criteria or detailed results for each. The conclusion drawn is that "The non-clinical tests demonstrated that the NaviAid™ BGE device meets its design and performance specifications."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document focuses on non-clinical tests rather than clinical studies with test sets of patient data.

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)

This information is not applicable as no clinical study with a "test set" and "ground truth" established by experts is described.

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

This information is not applicable as no clinical study with a "test set" requiring adjudication 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 such study was done. The device is an accessory to an endoscope, not an AI-powered diagnostic tool, and the document explicitly states "Clinical Performance Data: Not Applicable".

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

This is not applicable. The NaviAid™ BGE device is a physical accessory used with a human-operated endoscope, not a standalone algorithm.

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

This is not applicable as no clinical study generating "ground truth" is described. The "ground truth" for the non-clinical tests would have been the engineering specifications and test protocols designed to ensure the device functions as intended.

8. The sample size for the training set

This is not applicable as there is no mention of a "training set" for an algorithm. The device is a physical medical accessory, not an AI model.

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

This is not applicable as there is no "training set."

Summary of available information related to acceptance criteria and performance:

The document lists the following non-clinical performance tests conducted on the NaviAid™ BGE device:

• Electrical & Mechanical Safety Testing (IEC 60601-1)
• Electromagnetic Compatibility Testing (IEC 60601-1-2)
• Software Validation (IEC 60601-1-4 & FDA Guidelines)
• Biocompatibility Testing (ISO 10993)
• ASU Test
• Bond Strength Test
• Air Leakage Test
• Balloon Burst Pressure Test
• GBS Inflation Tube & Bending Radius Test
• Endoscope Flexibility & Insertion Test
• Components Degradation Test
• Endoscope Diameter Test
• GBS Inflation/Deflation Cycle Test
• ASU Connections
• Disposables Mounting Testing
• In-Vitro Validation Test
• Packaging Validation

The document concludes that "The non-clinical tests demonstrated that the NaviAid™ BGE device meets its design and performance specifications." It also states, "Furthermore, the tests showed that the NaviAid™ BGE device is easy to use and user friendly and does not cause damage to the intestine."

Essentially, the "acceptance criteria" here are implied to be the successful completion and passing of these various non-clinical engineering and safety standards/tests. The "study that proves the device meets the acceptance criteria" is the execution of these listed non-clinical tests, with the reported device performance being that it "meets its design and performance specifications."

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