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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 Single Use Aspiration Needle NA-201SX-4021 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

The Single Use Aspiration Needle NA-201SX-4022 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

The Olympus Single Use Aspiration Needle NA-201SX-4021 and NA-201SX-4022 are designed for use with ultrasound endoscopes for ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. These devices are single-use, disposable, sterile (Ethylene Oxide) needles available in two models with different specifications:

• NA-201SX-4021:

• Working Length: 700mm
• Maximum Insertion Portion Diameter: 1.9mm
• Needle Width: 21G
• Normal Needle Length: 20mm
• Maximum Needle Length: 40mm

• NA-201SX-4022:

• Working Length: 700mm
• Maximum Insertion Portion Diameter: 1.8mm
• Needle Width: 22G
• Normal Needle Length: 20mm
• Maximum Needle Length: 40mm

Both models feature an adjustable sheath length and are intended for single use.

This document is a 510(k) clearance letter for a physical medical device (Single Use Aspiration Needle), not an AI/Software-as-a-Medical-Device (SaMD). Therefore, the requested information pertaining to AI/SaMD performance evaluation criteria (such as test set size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable and is not present in the provided document.

The document discusses the substantial equivalence of the new aspiration needles to a predicate device based on their physical and functional characteristics. The performance data section refers to bench testing of physical attributes, not computational performance or diagnostic accuracy.

Therefore, I cannot provide the requested information as it relates to AI/SaMD. I can, however, extract the acceptance criteria and reported device performance for the physical device based on the provided text.

Acceptance Criteria and Reported Device Performance (Physical Device)

This section summarizes the performance data for the Single Use Aspiration Needle (NA-201SX-4021 and NA-201SX-4022), based on the provided FDA 510(k) summary. These criteria relate to the physical and functional performance of the device, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/SaMD specific questions:

As stated previously, the provided document is for a physical medical device (Single Use Aspiration Needle), not an AI/SaMD device. Therefore, the following information is not applicable and not provided in the source text:

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was physical bench testing, not data-driven AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established by engineering specifications and direct measurement, not expert review of AI outputs.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This applies to AI-assisted diagnostic or interpretive systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical needle refers to its engineered specifications and expected mechanical/biological performance, verified through bench testing.
8. The sample size for the training set: Not applicable. This applies to machine learning models.
9. How the ground truth for the training set was established: Not applicable. This applies to machine learning models.

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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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The ULTRASONIC PROBE UM-S20-17S has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.

The ULTRASONIC PROBE UM-S20-20R has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.

The Ultrasonic Probes have been designed to be used with an Olympus Endoscopic Ultrasound Center, a Probe Driving Unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the of the upper airways and tracheobronchial tree and surrounding organs.

Ultrasonic Probes UM-S20-17S and UM-S20-20R are designed to be used in conjunction with bronchoscopes. The Probes are inserted into the patient through a channel of the endoscope.

The Ultrasonic Probes consist of an insertion tube and a connector section. The connector section is connected to the Probe Driving Unit and the Probe Driving Unit is connected to the Ultrasound Center.

The Ultrasonic Probe sends and receives electrical signals to and from the Ultrasound Center through the Probe Driving Unit. The Probes use a 20MHz frequency piezoelectric transducer and produce B-mode scan. They produce 360-degree mechanical/radial sonograms.

The transducer is built into the insertion tube at the tip of the Probe. The transducer is rotated by the Probe Driving Unit within the insertion tube.

The transducer converts the electrical signal to the ultrasound wave, sends it to the object, receives the reflected wave from the object and converts it to the electrical signal. The electrical signal is input to the Endoscopic Ultrasound Center and the ultrasound image is generated by the Endoscopic Ultrasound Center.

UM-S20-17S and UM-S20-20R use direct contact method only.

The Subject devices submitted for clearance each include one (1) major component: the Ultrasonic Probe, which is packaged with a Probe Holder (MH-245) and a Water-resistant Cap (MH-244).

The provided FDA 510(k) clearance letter for the Olympus Ultrasonic Probes (UM-S20-17S and UM-S20-20R) details the acceptance criteria and the study that proves the device meets those criteria. However, it's crucial to note that this document pertains to ultrasonic probes (hardware) and does not involve Artificial Intelligence (AI). Therefore, many of the typical elements related to AI/ML device testing (e.g., training set, ground truth experts, MRMC studies, standalone algorithm performance) are not applicable or described in this type of submission.

The "studies" described here are non-clinical performance tests (bench testing), demonstrating the safety and effectiveness of the physical medical device by comparing its characteristics and performance to a legally marketed predicate device.

Acceptance Criteria and Device Performance for Olympus Ultrasonic Probes

The acceptance criteria for these ultrasonic probes are predominantly based on meeting the performance specifications of the predicate and reference devices, and complying with established medical device standards for safety and functionality. The "reported device performance" indicates that the subject devices met all the acceptance criteria through various non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

• Frequency: 20 MHz (matching Reference Device UM-3R)
• Axial Resolution: 2mm or less (matching Reference Device UM-3R)
• Lateral Resolution: 2mm or less (matching Reference Device UM-3R)
• Frame Rate: 6.67rps (matching Reference Device UM-3R)
• Scanning Field of View: 360° (matching Reference Device UM-3R)
• Display Mode: B-mode (matching Predicate and Reference Devices) | All acoustic output parameters passed/met the specified criteria and standards. |
  | Durability | Demonstrated adequate operational lifespan and resistance to wear and tear. Specific quantitative thresholds are not detailed but are implied by "Durability" testing. | Testing passed/met acceptance criteria. |
  | Measurement Accuracy | Verified the accuracy of measurements obtained using the ultrasonic probes. Specific accuracy metrics are not detailed but are implied by "Measurement Accuracy" testing. | Testing passed/met acceptance criteria. |
  | Human Use Factors | Compliance with FDA Guidance Documents: Applying Human Factors and Usability Engineering to Medical Devices (Feb 3, 2016). Ensures safe and effective use by healthcare professionals. | Testing passed/met acceptance criteria. |
  | Biocompatibility | Compliance with ISO 10993 series (ISO 10993-1, -5, -10, -12, -17, -18, -23). Ensures materials are safe for patient contact. | Testing passed/met acceptance criteria. |
  | Reprocessing Validation | Compliance with ISO 17664-1, AAMI TIR12, ANSI AAMI ST98, ANSI AAMI ST58, ISO 11135, ISO 11138-2. Ensures safe and effective cleaning and sterilization through methods like ETO. | Testing passed/met acceptance criteria. |
  | Electrical Safety/EMC | Compliance with IEC 60601-1, IEC ES60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, IEC TR 60601-4-2. Ensures electrical safety and electromagnetic compatibility. | Testing passed/met acceptance criteria. |

Study Details (Applicable to Non-AI Hardware Verification)

As this is a hardware device 510(k) submission, the study methodology focuses on non-clinical performance data and bench testing rather than clinical trials with human subjects or AI-specific assessment methods.

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

• Sample Size: The document does not specify a "sample size" in terms of cases or patients, as the testing was non-clinical (bench testing). The "test set" in this context refers to the manufactured probes themselves and the conditions under which they were tested (e.g., phantom models for acoustic output, simulated use for durability, material samples for biocompatibility).
• Data Provenance: The tests were conducted internally by Olympus Medical Systems Corporation and its manufacturing site, SHIRAKAWA OLYMPUS CO., LTD. in Japan. The data is from bench testing and in-house validation, not from real-world patient data (retrospective or prospective). The manufacturing site is in Japan.

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

• This concept is not applicable to this type of hardware 510(k) submission. "Ground truth" for these tests is established by adhering to widely accepted international standards (ISO, IEC, AAMI) and FDA guidance documents for medical device performance, safety, and manufacturing. These standards define the measurable physical and electrical properties that the device must meet. The experts involved would be engineers, quality control specialists, and regulatory affairs personnel responsible for designing, manufacturing, and testing the probes to these standards.

4. Adjudication Method for the Test Set:

• This concept is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations of medical images or data, which is relevant for AI image analysis or clinical trials. For hardware testing, "adjudication" is replaced by adherence to established test protocols, measurement equipment calibration, and standard-defined pass/fail criteria.

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

• No, an MRMC comparative effectiveness study was not performed. MRMC studies are used to assess the impact of AI on human reader performance, which is not relevant for this non-AI hardware device. The equivalence claim for this device is based on technical specifications and non-clinical performance data compared to a predicate device.

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

• No, a standalone algorithm performance test was not done. This device is a physical diagnostic ultrasonic transducer, not a software algorithm. Its "performance" refers to its ability to generate images when connected to an ultrasound center, which is then interpreted by a human operator.

7. The Type of Ground Truth Used:

• The "ground truth" for this hardware device is defined by engineering specifications, physical measurements, and compliance with national and international medical device standards. For example, acoustic output parameters are measured against specific limits defined in IEC standards, and biocompatibility is confirmed by testing against ISO 10993. There is no "expert consensus" on imaging findings, pathology, or outcomes data used as ground truth for this device's clearance.

8. The Sample Size for the Training Set:

• This concept is not applicable. There is no "training set" as this is not an AI/ML device that requires machine learning.

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

• This concept is not applicable as there is no training set.

In summary, the FDA 510(k) clearance for the Olympus Ultrasonic Probes is based on a comprehensive set of non-clinical, bench-level performance tests demonstrating technical equivalence to a predicate device and compliance with relevant safety and performance standards for diagnostic ultrasonic transducers. It does not involve AI/ML components or associated clinical study designs like MRMC or standalone algorithm performance assessment.

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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 CYTOLOGY BRUSH BC-202D/203D Series is intended to be used to collect tissue specimens in the tracheobronchial tree in combination with a bronchoscope.

The DISPOSABLE CYTOLOGY BRUSH BC-202D-1210/2010/3010/5010, BC-203D-2006 have been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. The Subject Device (SD) is inserted into the bronchoscope through a biopsy valve to reach the target area, where, by rubbing the brush on the target area, specimens or cells can be collected. The Subject Device is then withdrawn from the bronchoscope channel with the collected samples.

The Subject Device consists of:

• Handle
• Insertion portion

The handle consists of a ring and a grip. The insertion portion consists of a plastic tube, stainless steel wire, nylon brush (length 6mm or 10mm, diameters 1.2 – 5 mm) and stainless steel distal tip. The grip is attached to the tube and the ring is attached to the wire. The user can move the brush at the tip of the wire back and forth by holding the grip and moving the ring back and forth. The distal tip is designed to prevent damage to the inside of the tube and/or bronchial wall.

This document is a 510(k) clearance letter for a medical device, specifically a disposable cytology brush. It is not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies for AI/ML performance (e.g., sample size for test/training sets, expert consensus, MRMC studies, standalone algorithm performance, effect size of human reader improvement with AI) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through:

• Biocompatibility testing: Ensuring the materials are safe for human contact.
• Performance testing (Bench/Non-Clinical): Evaluating the physical and mechanical performance of the brush.
• Sterilization and Shelf Life Testing: Confirming the device remains sterile and functional over its stated shelf life.

Here's how the provided information relates to the performance acceptance criteria and proof for this medical device:

Acceptance Criteria and Device Performance for Disposable Cytology Brush

For this medical device, substantial equivalence is proven by meeting established performance specifications through non-clinical (bench) testing, biocompatibility testing, and sterilization/shelf life validation. There are no AI-specific acceptance criteria or studies mentioned as this is a physical medical device, not an AI/ML software device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each bench test. For these types of physical device tests, sample sizes are typically determined by established standards (e.g., ISO, ASTM) and statistical validity for mechanical testing (e.g., n=30, or as per specific test method requirements).
• Data Provenance: The tests are explicitly described as "Non-Clinical (Bench) Performance Testing" and "Biocompatibility Testing." This means the data comes from laboratory experiments and material testing, not human or observational data. There is no mention of country of origin for the data; it would be generated in the manufacturer's or contracted test labs. All tests are inherently "prospective" in the sense that they are conducted specifically to validate the device's performance.

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

• Not applicable. This is a physical medical device. Ground truth for its performance is established by objective engineering measurements, material science principles, and biological safety standards (e.g., ensuring a certain tensile strength, confirming sterility, testing for cytotoxicity per ISO standards). It does not involve human expert interpretation of images or patient data in the way an AI/ML device would.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Testing results are pass/fail based on predetermined numerical or qualitative specifications from recognized standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is not an AI/ML device used for diagnostic interpretation. Therefore, there is no human reader component to improve or compare against.

6. Standalone (Algorithm Only) Performance

• Not applicable. There is no algorithm or software for standalone performance evaluation. The device is a physical tool.

7. Type of Ground Truth Used

• Bench Test Specifications: The "ground truth" for this device's performance lies in its ability to meet predefined engineering specifications (e.g., force measurements, cyclical durability, material integrity) and biological safety standards (e.g., absence of toxicity, successful sterilization). This is determined through standardized laboratory testing methods rather than expert consensus on clinical cases or pathology.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML algorithm that learns from data.

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

• Not applicable. See point 8.

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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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