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The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Flexible Bronchoscope is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.

The Flexible Bronchoscope (Model: BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) is intended to be used with the Portable Video Processor (cleared via K243497). The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy, and when used with the compatible video processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Bronchoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a push button for suction, a connector for suction tubing, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the video processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the video processor, optical fibers for transmitting illumination from the LED inside the handle, and the distal opening of the working channel. The Endoscope Connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection).

This document is an FDA 510(k) clearance letter for a Flexible Bronchoscope, indicating substantial equivalence to a predicate device. However, it does not contain the level of detail requested regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The provided text focuses on the physical and performance characteristics of the bronchoscope itself, its intended use, technological comparison to a predicate device, and various non-clinical tests (electrical safety, photobiological safety, mechanical/optical performance, biocompatibility, sterilization, shelf life, and package validation).

There is no mention of an AI component, an algorithm, or any study involving human readers, ground truth establishment, or performance metrics like sensitivity, specificity, or AUC. The "device performance" in this context refers to the bronchoscope's mechanical and optical functionality, not the diagnostic accuracy of an AI algorithm.

Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to answer based on the provided text, highlighting what is missing:

1. Table of acceptance criteria and reported device performance

The document does not present a formal table of "acceptance criteria" for a diagnostic algorithm with corresponding "reported device performance" in terms of clinical accuracy metrics (like sensitivity, specificity, AUC). Instead, it states that various non-clinical tests were performed to demonstrate compliance with recognized standards and that the device is "as safe, as effective, and performs as well as the legally marketed device identified above."

Below is a table summarizing the types of tests and the general conclusion, but without specific quantitative acceptance criteria or performance metrics related to diagnostic accuracy.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not applicable/Not mentioned. This document describes a medical device (bronchoscope) itself, not an AI algorithm performing a diagnostic task on a dataset. The "tests" mentioned are non-clinical engineering and biological safety tests, not tests on a dataset.
• Data Provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/Not mentioned.

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

• Not applicable. There is no mention of "ground truth" in the context of an AI algorithm's diagnostic performance for which experts would be needed. The "ground truth" for the non-clinical tests would be the established performance specifications and standards for a bronchoscope.

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

• Not applicable. As no expert ground truth establishment for a diagnostic AI is mentioned, no adjudication method would be relevant.

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. This document describes the clearance of a flexible bronchoscope, a physical medical device. It does not mention any AI component or a MRMC study.

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

• Not applicable. There is no mention of an algorithm in this document that would perform as a standalone device.

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

• Not applicable. Ground truth in the context of diagnostic AI is not mentioned. For the non-clinical tests, the "ground truth" is compliance with established engineering and safety standards.

8. The sample size for the training set

• Not applicable. There is no mention of an AI model or a training set.

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

• Not applicable. There is no mention of an AI model or a training set.

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UE BRONCHO Single-Use Bronchoscope: The UE BRONCHO Single-Use Bronchoscopes has been designed to be used with the UE Display, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The UE BRONCHO Single-Use Bronchoscopes is for use in a hospital environment. The UE BRONCHO Single-Use Bronchoscopes is single-use device designed for use in adults.

UE Display: The UE Display is reusable digital monitor, intended to display live imaging data from UE Medical visualization devices.

The bronchoscope system consists of UE BRONCHO Single-Use Bronchoscopes and UE Display. The UE BRONCHO Single-Use Bronchoscopes (the bronchoscopes) are sterile, single-use flexible video bronchoscopes available in three sizes (Slim, Regular, Large). The bronchoscopes have been designed to be used with the UE Display (reusable, non-sterile), endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The bronchoscope system is designed for use by adults in a hospital environment.

The provided FDA 510(k) clearance letter details the clearance of the UE BRONCHO Single-Use Bronchoscopes and UE Display. However, it does not contain specific acceptance criteria or details of a clinical study that demonstrates the device's performance against such criteria. The document explicitly states "Clinical study: Not applicable."

The clearance is based on non-clinical data, specifically performance testing and compliance with voluntary standards, which demonstrates substantial equivalence to a predicate device (Ambu® aScope™ 4 Broncho, Ambu® aView™ Monitor - K173727).

Therefore, I cannot populate the requested table and answer questions 2-9 with the provided text. The document refers to "bench performance testing" which includes optical performance, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range, and frame rate, comparing these aspects with the predicate device. However, it does not specify quantitative acceptance criteria for these tests nor provide the reported device performance against such criteria in the detail requested.

Here's an attempt to populate the table and address the questions based only on the information available in the provided text. Where information is missing, it will be stated as "Not provided in the text."

1. Table of Acceptance Criteria and Reported Device Performance

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

Not provided in the text. The document refers to "bench performance testing" which typically uses a limited number of physical units or simulated conditions, rather than a "test set" of patient data as might be relevant for AI/ML devices. No human patient data was used for testing.

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

Not applicable, as no clinical study or expert-based ground truth establishment for a test set is mentioned. The testing was non-clinical bench testing.

4. Adjudication method for the test set

Not applicable, as no clinical study involving expert interpretation or adjudication is mentioned.

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 explicitly states "Clinical study: Not applicable." Therefore, an MRMC study was not performed. This device is a bronchoscope system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a bronchoscope system. While it has software and display capabilities, it is not an algorithm that performs a diagnostic or analytical function independently of a human operator, and no standalone performance study in this context was mentioned.

7. The type of ground truth used

For the non-clinical bench tests (e.g., optical performance, physical dimensions, electrical safety), the "ground truth" would be established by direct physical measurements, adherence to engineering specifications, and compliance with recognized international standards (e.g., ISO 8600, IEC 60601 series, ISO 10993 series). There is no "ground truth" in the clinical sense (e.g., pathology, outcomes data, expert consensus) as no clinical studies were performed.

8. The sample size for the training set

Not applicable. This device is a bronchoscope system and not an AI/ML device that requires a training set of data for model development.

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

Not applicable, as no training set was used.

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The Vathin®H-SteriScopeTM single-use flexible video bronchoscope has been designed to be used with the Vathin display unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree in patients.

The Vathin® Video Bronchoscope System is for use in a hospital environment.

The Vathin®H-SteriScopeTM single-use flexible video bronchoscope is a single-use device designed for use in adults, with the BCV1-02 and BCV1-C2 also designed for pediatric use (BCV1-02: 6 months to 6 years; BCV1-C2: 6 years and older).

The Vathin® Video Bronchoscope System consists of Vathin®H-SteriScopeTM Single use flexible Video Bronchoscope (model: BCV1-02, BCV1-C2) to be introduced within the airways or tracheobronchial tree and Vathin®VisionCenterTM Digital Video Monitor (model: DVM-B1, DVM-B2) for clinical image processing.

The Vathin®H-SteriScopeTM Single-use flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Vathin®VisionCentereTM Digital Video Monitor provides power and processes the images for medical electronic endoscope.

Vathin®H-SteriScopeTM Single-use flexible Video Bronchoscope is a sterile single-use flexible bronchoscope. Vathin®H-SteriScopeTM Digital Video Monitor is a reusable monitor.

I regret to inform you that the provided FDA 510(k) clearance letter and accompanying 510(k) Summary for the Vathin® Video Bronchoscope System do not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving device performance as it relates to AI/software functionality.

This document focuses on justifying Substantial Equivalence for a bronchoscope system based on its physical characteristics, safety standards (electrical, biocompatibility, sterilization), and basic performance (optical, mechanical). It mentions "Software verification and validation" in Section 7.4, citing the "FDA guidance: Content of Premarket Submissions for Device Software Functions," but does not provide any specific acceptance criteria, study data, or details about the software's functionality, especially regarding AI capabilities.

Therefore, I cannot populate the table or answer the specific questions about AI performance, test set details, ground truth establishment, or human reader studies.

Here's why the document is insufficient for your request:

• No AI/Algorithm Claims: The document describes a video bronchoscope and its display unit. It doesn't mention any AI or advanced algorithmic functions (e.g., automated lesion detection, image enhancement using AI, diagnostic support) that would necessitate performance criteria like sensitivity, specificity, or reader studies.
• Focus on Hardware/System Performance: The performance data section (7.1-7.6) primarily addresses the physical and electrical safety, biocompatibility, sterilization, and basic optical/mechanical functions of a medical device (bronchoscope). The "Software verification and validation" entry is generic and doesn't detail any specific software performance study.
• Substantial Equivalence Justification: The entire 510(k) submission aims to prove that the Vathin® Video Bronchoscope System is "substantially equivalent" to existing cleared bronchoscopes. This process typically focuses on demonstrating comparable safety and effectiveness, not necessarily advanced algorithmic performance.

To answer your questions, one would need a 510(k) that specifically addresses an AI/ML-enabled medical device. Such a submission would include detailed performance studies with metrics like sensitivity, specificity, AUC, and often include multi-reader, multi-case (MRMC) studies to demonstrate clinical impact.

If you had provided a 510(k) document for an AI-powered device, the table and answers would look something like this (conceptual example):

Conceptual Example - This section is not based on the provided document as it does not contain the necessary information.

For an AI-powered medical device, the acceptance criteria and study proving its performance would be detailed as follows:

1. Acceptance Criteria and Reported Device Performance

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EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XP190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-P190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

The EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-XP190, OLYMPUS BF-P190, and BF-XT190) and BRONCHOVIDEOSCOPE BF-H1100 and BF-1TH1100 are used for endoscopic diagnosis and treatment within the respiratory organs. These endoscopes consist of three parts: the control section, the insertion section, and the connector section.

The provided FDA 510(k) clearance documentation for the Olympus Bronchovideoscopes (K250862) primarily demonstrates substantial equivalence based on technological characteristics and bench testing. It does not contain information about comparative effectiveness studies (like MRMC studies for AI devices), expert ground truth establishment, or typical performance metrics associated with AI/software-as-a-medical-device (SaMD) clearances.

This submission focuses on:

• Technological Equivalence: Showing that the devices (BF-XP190, BF-P190, BF-XT190, BF-H1100, and BF-1TH1100) are fundamentally the same as their predicates, with the primary change being compatibility with a new video system center (CV-1500) and updated labeling related to laser/high-frequency/APC systems.
• Bench Testing: Verification of physical and imaging performance parameters (e.g., thermal safety, color performance, resolution, noise, video latency) to ensure they meet specifications, particularly when combined with the new video system.
• Animal Testing: To assess the imaging modes (WLI, NBI, TXI, BAI-MAC) with the new video processor.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) is not present in this document. The document explicitly states that "Software Testing and Cybersecurity" was "not performed" due to "no design, material, sterilization, reprocessing, packaging, shelf life, or software changes" (Page 29). This implies that the device itself is a hardware endoscope, and any software associated with it is considered an intrinsic part of its established functionality, not a new or significantly changed software component requiring a separate performance study with clinical endpoints or AI evaluation.

The "acceptance criteria" here relate to the successful completion of the listed bench (and limited animal) tests, demonstrating that the new combination (endoscope + CV-1500) functions as intended and safely, similar to the predicate combinations.

Below is a table summarizing the "acceptance criteria" and "reported device performance" as derived from the document's comparison tables and performance data section, which are primarily about technical specifications and functional verification, not software/AI performance metrics.

Acceptance Criteria and Reported Device Performance (Summary based on provided text)

Since this 510(k) is for existing endoscopes with a new video system and updated labeling, the "acceptance criteria" are implied by the extensive comparison tables (Tables 1-5) which show the subject devices having nearly identical technical specifications to their predicate devices, and the successful completion of specified bench and animal testing. The performance data section doesn't list specific quantitative acceptance criteria for each test but rather states that tests were conducted to "ensure that the subject device performs as intended and meet design specifications."

Study Details (based on provided text)

The document describes performance testing rather than a comparative clinical study for AI/software-as-a-medical-device.

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

   • See table above. The acceptance criteria are largely implied by the equivalence to the predicate devices in terms of physical, optical, and functional characteristics, and the successful completion of specified bench and animal tests. Quantitative metrics for these tests are not provided in this summary but would have been part of the full submission.

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

   • Test set sample size: Not specified. The document mentions "bench testing" and "animal testing." For bench tests, it typically refers to a small number of devices or engineered test setups. For animal testing, the number of animals or studies is not provided.
   • Data provenance: Not specified. It can be inferred that the testing was conducted by or on behalf of Olympus Medical Systems Corp. in Japan, given the manufacturing site and submitter location. It does not state if the data is retrospective or prospective, or from which country/region the "animal" data would originate.

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

   • Not applicable / Not specified. This type of information is typically provided for studies evaluating AI algorithms or diagnostic accuracy, where human experts establish a ground truth for imaging interpretation. The present submission is for a hardware endoscope system, and its performance evaluation relies on engineering specifications and functional testing, not expert interpretation of diagnostic images.

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

   • Not applicable / Not specified. Adjudication methods are relevant for human reader studies or expert ground truth establishment, which are not detailed here.

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, not performed / Not applicable. This submission is not for an AI companion diagnostic or an AI-software-as-a-medical-device. It's for an endoscope system. The document explicitly lists "Software Testing and Cybersecurity" and "Clinical" as "not performed" because there were no fundamental software changes beyond integration with a new video system, which itself does not constitute an AI component in the context of this 510(k) summary. The NBI, RDI, TXI, and BAI-MAC modes are imaging enhancements, not AI algorithms.

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

   • Not applicable. This relates to AI/software performance, which is not the focus of this 510(k).

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

   • Not applicable. For this device (endoscope), ground truth typically relates to engineering specifications (e.g., accurate measurements, clear image quality as determined by reproducible test patterns, proper functionality of mechanical parts). For the animal testing of imaging modes, the "ground truth" would be the direct observation of the animal's internal anatomy via the endoscope itself and comparison to expected/known characteristics, not an independent "pathology" or "outcomes" ground truth in a diagnostic sense.

8. The sample size for the training set:

   • Not applicable. This submission is not for an AI system that requires a "training set."

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

   • Not applicable. As above, no AI training set is described.

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a. Endoscope Model EB-710P
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.

b. Processor EP-8000
The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.

This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals.

It is used for endoscopic observation, diagnosis and treatment.

a. Endoscope Model EB-710P
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 portion 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.

b. Processor EP-8000
FUJIFILM Video Processor EP-8000 is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.

FUJIFILM Video Processor EP-8000 relays the image from an endoscope to a video monitor. The projection can be either analog or digital at the user's preference. The processor employs fiber bundles to transmit light from four LED lamps (Violet, Blue, Green, and Amber), with a total power of 79.2W lamps, to the body cavity.

The device is AC operated at a power setting of 100-240V/50-60Hz/ 3.0-1.5A. The processor is housed in a steel-polycarbonate case measuring 395×210×515mm

The provided FDA 510(k) clearance letter pertains to the FUJIFILM Endoscope Model EB-710P and Processor EP-8000. It details the substantial equivalence of these devices to their predicates based on non-clinical testing.

However, the provided text does not contain information about acceptance criteria or a study that uses a test set to prove the device meets those criteria.

The document primarily focuses on:

• Product identification: Device names, regulation numbers, product codes.
• Regulatory details: FDA clearance status, general controls, and compliance requirements.
• Substantial equivalence justification: Comparison of intended use, technological characteristics, and principles of operation between the new devices and their predicates.
• Non-clinical testing: A list of engineering tests performed (e.g., electrical safety, software validation, color and optical performance, image quality assessments like reproduction, geometric distortion, resolution, depth of field, ISO-SNR, dynamic range, intensity uniformity, and field of view).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided FDA clearance letter.

To answer your request, I would need a document (e.g., a summary of safety and effectiveness, or a clinical study report) that explicitly defines:

1. Acceptance criteria: Quantitative thresholds or qualitative statements that define successful device performance.
2. Reported device performance: The actual outcomes measured during the study.
3. Test set details: Sample size, data provenance, ground truth establishment (experts, adjudication, type of ground truth).
4. Training set details: Sample size, ground truth establishment.
5. MRMC study information: If applicable, whether human readers improved with AI assistance and by how much.
6. Stand-alone algorithm performance: If an algorithm-only study was conducted.

The provided document only states that "EP-8000 demonstrated substantial equivalence to VP-7000 and BL-7000 in Image performance and color reproduction" for the listed non-clinical tests, implying that the new device performed as well as the predicate for these specific engineering parameters, but it does not provide the specific performance values or the acceptance thresholds for these parameters. It also makes no mention of AI assistance or human reader studies.

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The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade).

The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade). The Balloon Catheter is inserted into the instrument channel of compatible bronchoscopes and advanced to the target area, where medical fluid or saline solution are injected, or the balloon is inflated to allow for hemostasis (tamponade). When the procedure is completed, the balloon is deflated, and the catheter is removed from the patient.

The Balloon Catheter is provided sterile and is constructed of a natural rubber latex inflatable balloon, polyethylene tube, branch, irrigation port, air feed cap, and stopcock. The inflatable balloon has a maximum diameter of O 11 mm after inflation.

The provided document is a 510(k) clearance letter and summary for a medical device (Disposable Balloon Catheter B5-2C). It does not contain any information about acceptance criteria and associated study results for an AI/ML powered device.

The document describes the device, its intended use, comparison to a predicate device, and various performance testing. However, these tests are standard for a physical medical device (biocompatibility, bench testing for physical properties like balloon diameter, strength, etc.) and do not involve AI/ML performance metrics such as sensitivity, specificity, or the involvement of expert readers for ground truth establishment.

Therefore, I cannot provide accurate answers to the questions based on the provided text, as the information regarding acceptance criteria and studies for an AI-powered device is not present.

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The DISPOSABLE BIOPSY FORCEPS FB-211D/221D/231D/241D are intended to be used to collect tissue within the tracheobronchial tree in combination with a bronchoscope

The Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, and FB-241D (also known as "EndoJaw") have been designed to collect tissue within the tracheobronchial tree in combination with a flexible bronchoscope. The Disposable Biopsy Forceps are inserted into the channel of a bronchoscope to collect tissue by biting the surface of the lesion with a pair of forceps located at the distal end of the device. The Disposable Biopsy Forceps are withdrawn from the channel and the tissue sample is collected.

The Disposable Biopsy Forceps consists of a handle and an insertion portion. The handle consists of a handle body and slider. The insertion portion consists of a sheath, metallic coil (operating wire), cups, and forceps cap. The slider is connected to the operating wire in the insertion portion and the cups are opened/closed by advancing/retreating the slider with the function of the connection parts. The subject device is available in multiple distal end cup shapes; FB-211D – Alligator jaw-step, FB-221D – Alligator jaw-step with needle, FB-231D – Oval type, and FB-241D – Oval type with needle.

This response is based solely on the provided FDA 510(k) Clearance Letter for the Olympus Disposable Biopsy Forceps.

Analysis of the Provided Document:

The provided document is an FDA 510(k) Clearance Letter for a medical device: Disposable Biopsy Forceps. This type of clearance is for devices that are "substantially equivalent" to legally marketed predicate devices. The key takeaway from this document is that the clearance is based on comparing the new device to a predicate device through non-clinical bench testing, not on clinical performance studies involving human subjects or AI-assisted diagnostic accuracy.

Therefore, the questions regarding ground truth, expert adjudication, MRMC studies, standalone algorithm performance, and sample sizes for training/test sets related to diagnostic accuracy (which would be typical for an AI/software as a medical device) are not applicable to this specific 510(k) clearance documentation.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications tested during the non-clinical bench testing to demonstrate substantial equivalence to the predicate device.

Responses based on the provided FDA 510(k) Clearance Letter:

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

The document states: "All test samples passed pre-defined acceptance criteria." However, the specific quantitative acceptance criteria for each test and the detailed reported performance metrics are not explicitly provided in this summary. The document only lists the types of performance tests conducted.

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

• Sample Size: The document mentions "All test samples" but does not specify the numerical sample sizes used for each of the non-clinical bench tests.
• Data Provenance: The tests were conducted by Olympus. The document does not specify country of origin for data as this is a device clearance based on manufacturing and performance testing, not patient data from clinical studies. The testing was prospective in the sense that the tests were designed and executed to evaluate the new device.

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

This question is not applicable as this 510(k) clearance is for a physical medical device (biopsy forceps) and is based on engineering performance demonstration through non-clinical bench testing, not on clinical diagnostic accuracy or interpretation of medical images/data (which would require expert ground truth).

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

This question is not applicable for the reasons stated in point 3. Adjudication methods are relevant for subjective image interpretation or clinical outcomes, not for objective bench test measurements of a physical device.

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 question is not applicable as the clearance is for a physical biopsy forceps and does not involve AI or human readers for diagnostic interpretation.

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

This question is not applicable as the clearance is for a physical biopsy forceps and does not involve an algorithm.

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

This question is not applicable as the device is cleared based on non-clinical performance characteristics (e.g., insertion, withdrawal, force of jaws, sterility, shelf-life) which are evaluated against predefined engineering specifications and physical measurements, not against clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This question is not applicable as this is a physical medical device clearance, not an AI/machine learning device that requires a "training set."

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

This question is not applicable for the reasons stated in point 8.

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The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.

The Bronchoscope System comprises two components: (1) a Portable Video Processor (model: EA101) and (2) a compatible Flexible Bronchoscope (model: BS41H-12EU, BS41H-12US, BS46H-17EU, BS46H-17US, BS50H-20EU, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US).
The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope. The Portable Video Processor consists a 13.3" LCD touch screen. It is powered through a Lithium-ion battery or a separate power adaptor.
The Flexible Bronchoscope has following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• CMOS Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use
  Portable Video Processor has following physical and performance characteristics:
• Displays the image from the Flexible Bronchoscope on the built-in screen.
• Can be connected to an external monitor.
• Non-sterile Reusable device.

The provided 510(k) clearance letter and summary for K243497 indicate that the device in question is a Flexible Bronchoscope System. This submission appears to be a change to an already cleared flexible bronchoscope (K211169) to make it compatible with a new Portable Video Processor (EA101).

Crucially, there is no mention of any AI or machine learning component in the device description, indications for use, or the non-clinical and/or clinical tests summary. The document describes standard performance testing for medical devices, focusing on electrical safety, EMC, photobiological safety, optical performance, biocompatibility, sterilization, shelf life, and package validation. Software verification and validation are mentioned in the context of IEC 62304, which covers medical device software lifecycle processes, but this does not imply AI.

Therefore, many of the questions related to AI-specific acceptance criteria, study methodologies (like MRMC studies, standalone AI performance), ground truth establishment for AI training/testing sets, and expert involvement for AI adjudication are not applicable to the information provided in this document.

The document does provide information relevant to the overall device's performance validation, which can be presented as acceptance criteria and proof for a non-AI medical device.

Non-AI Device Acceptance Criteria and Study Proof

Since the device described is not an AI/ML device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of regulatory clearance for a traditional medical device rather than for AI performance. The studies performed are primarily bench testing and phantom/component level evaluations to demonstrate substantial equivalence to the predicate device and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are typically defined by compliance with recognized standards and demonstration of equivalent performance to a predicate device. The "reported device performance" is the evidence presented to show this compliance.

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

• Test Set Sample Sizes: Not explicitly stated as "sample sizes" in the manner of a clinical trial. For bench testing (electrical safety, EMC, optical, biocompatibility, sterilization, shelf life, packaging), samples of the device and/or its components were tested to meet specific standard requirements. For example, biocompatibility involves testing material extracts, and sterilization validation involves processing batches of devices. The exact number of units tested for each specific bench test is not detailed in this summary.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. Given the applicant is in Shanghai, China, it is highly likely the testing was conducted in China. These were non-clinical bench tests, not clinical studies collecting patient data, so "retrospective or prospective" doesn't directly apply in the typical sense.

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

• Not applicable in the context of AI/ML ground truth. For traditional device validation, "ground truth" is established by the specifications in recognized consensus standards (e.g., ISO, ASTM, IEC) and the performance characteristics of the predicate device. Expert involvement would be in the form of engineers, test technicians, and quality assurance personnel who perform and verify the tests according to established protocols and standards. Their qualifications are inherent in their professional roles, but not quantified as "number of experts" for ground truth establishment as would be done for clinical image annotation.

4. Adjudication Method for the Test Set

• Not applicable in the context of AI/ML adjudication. For traditional device testing, the "adjudication" is compliance with objective, measurable parameters defined by standards. Test results either meet the specified limits/criteria or they do not. QA processes would review and approve test reports, but there isn't a human "adjudication" process in the way it's used for clinical data interpretation differences.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is not an AI/ML device. MRMC studies are typically performed for imaging devices or AI algorithms where human interpretation is involved and needs to be evaluated for improvement with or without AI assistance. This device is a bronchoscope system for visualization and intervention, not for diagnostic image interpretation by humans that would necessitate an MRMC study.

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

• No. This is not an AI/ML device. Standalone performance is relevant for AI algorithms. The performance of this device is assessed through its physical, electrical, and optical properties as a medical instrument.

7. The Type of Ground Truth Used

• For this traditional medical device, "ground truth" equates to compliance with recognized industry standards and the specifications / validated performance of the predicate device. For example:
  • Electrical Safety: Ground truth is defined by the limits and test methods of IEC 60601-1.
  • Biocompatibility: Ground truth is established by the accepted biological responses defined in ISO 10993 series.
  • Optical Performance: Ground truth is established by the parameters defined in ISO 8600 and comparative measurements against the predicate device.

8. The Sample Size for the Training Set

• Not applicable. This device does not use an AI/ML model; therefore, there is no "training set."

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

• Not applicable. As there is no AI/ML model or training set, this question is not relevant.

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The Insighters(TM) Single-use Bronchoscope System provides images for the observation, diagnosis and treatment of trachea, bronchus and lung area.

It is indicated for diseases of the trachea and bronchi other than contraindications.

The Insighters(TM) Single-use Bronchoscope System is generally in-hospital use.

The Insighters(TM) Single-use Bronchoscope System is for use by trained clinicians/physicians only.

The Single-use Flexible Video Bronchoscope (Insighters™ Single-use Bronchoscope System) consists of an Single-use Bronchoscope (iS-B12A/ iS-B22A/iS-B26A) and an Insight Workstation(iS-PF1) which is a compatible displaying unit.

The Single-use Bronchoscope consists of an insertion part (including the head end part, a bending part, and Main Hose part) and an operation part (including an electrical interface, a suction interface, a suction button, and clamp channel interface). It comes in 3 models: iS-B12A, iS-B22A, iS-B26A. The differences among the different models are only in size. This product is sterilized by ethylene oxide, single use, disposable, body orifices invasive and short-term use device.

The Insighters™ Insight Workstation (iS-PF1) consists of a display host and accessories: Power adaptor (model PH50-12), Connection Cable. The Insight workstation supports connection with Single-use bronchoscope by Connection Cable. It can supply power and processes the images for medical electronic endoscope. It is a reusable monitor and no contact with the patient.

The Insighters™ Single-use Bronchoscope System is to provide images for the observation, diagnosis and treatment of trachea, bronchus and lung area.
This product is a portable electronic endoscope. It has the characteristics of clear image, small size, light weight, easy to carry, flexible operation, easy to learn and use, etc.
This product contains a working channel, which is convenient for use after insertion of endoscopic accessories.
The applied part of this product is the insertion part of the Single-use Bronchoscope.
Single use application of this product minimises the risk of cross-contamination of the patient.

There appears to be a misunderstanding of the provided FDA 510(k) clearance letter. The document details the clearance of a Single-use Flexible Video Bronchoscope and an accompanying Insight Workstation.

Crucially, this document does NOT describe an AI/ML-driven medical device, nor does it present any studies proving the device meets acceptance criteria related to AI/ML performance. The "Insight Workstation" mentioned is a display unit, not an AI component.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving an AI device meets those criteria, as the provided document pertains to a traditional medical device (a bronchoscope) and makes no mention of AI or machine learning.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Ambu® aScope™ 4 Broncho Family) based on:

• Identical indications for use, patient population, and environment of use.
• Similar technological characteristics (flexible scope, working length, illumination, color performance, image/video capture, single-use, EO sterilization, shelf life, packaging).
• Non-clinical performance testing (electrical safety, EMC, optical performance, bending angle, aging, sterile packaging integrity, thermal safety, reliability, usability, chemical properties, photobiological safety, mechanical performance, color performance).
• Biocompatibility testing.

The document explicitly states: "Based on the similarities of the device specifications, intended use, indications for use between the Single-use Flexible Video Bronchoscope and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification." This means there are no clinical studies or AI performance studies to discuss within the scope of this FDA clearance letter.

To provide the requested information, a document describing the clearance of an AI/ML-based medical device would be required.

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