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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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This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy 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.

This EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The BF-XT190 is indicated for use within the airways and tracheobronchial tree. The BF-XT190 is a video scope used for the endoscopic diagnosis and treatment within the respiratory organs and modification of the BF-MP190F which was previously cleared under K172726.

The provided text describes a 510(k) premarket notification for the EVIS EXERA III Bronchovideoscope Olympus BF-XT190. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical or analytical performance.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, and detailed study information are not present in the provided text, as this type of submission relies on comparisons to an already cleared device and bench testing for new features.

Here's an analysis based on the information available:

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

The document does not provide a table of acceptance criteria with corresponding performance metrics for clinical or analytical performance. Instead, it lists the types of performance testing conducted to support substantial equivalence.

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

• Sample Size for Test Set: Not specified for any of the performance tests. The nature of these tests (e.g., biocompatibility, electrical safety) typically involves a specific number of units/samples for testing, but these numbers are not detailed in this summary.
• Data Provenance: Not explicitly stated. The company, Olympus Medical Systems Corp., is based in Tokyo, Japan, and the contact person is in the USA. However, the location where the tests were physically performed is not provided. The document implies these are internal validation tests, not clinical studies with patient data.
• Retrospective or Prospective: Not applicable as no clinical or patient data study is mentioned.

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

Not applicable. The ground truth concept, typically involving expert consensus on patient cases for diagnostic devices, is not relevant here as no clinical or patient data study was conducted. The performance testing described relates to the device's physical, electrical, and functional characteristics.

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

Not applicable. No expert adjudication process is described as there is no clinical or image-based test set requiring expert interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a bronchoscope, not an AI-assisted diagnostic tool. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence."

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

Not applicable. This device is a bronchoscope, not an algorithm or AI system.

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

The concept of "ground truth" as it applies to diagnostic or prognostic data is not relevant to the performance tests described. For bench tests, the "ground truth" would be the established engineering specifications, international standards (e.g., ISO, IEC), and regulatory guidelines (e.g., FDA guidance documents) against which the device's performance is measured. For example:

• For biocompatibility: Adherence to ISO 10993-1.
• For electrical safety: Compliance with ANSI/AAMI ES 60601-1 and IEC 60601-2-18.
• For software: Compliance with FDA software guidance.

8. The sample size for the training set

Not applicable. This device is a bronchoscope, not an AI/ML system that requires a training set.

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

Not applicable. No training set is mentioned as it is not an AI/ML device.

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