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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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This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize, or to perform electrosurgical hemostasis within the tracheobronchial tree.

The product is only intended for adult populations.

Single Use Hot Biopsy Forceps FD-231 has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize, or to perform electrosurgical hemostasis within the tracheobronchial tree.

The Single Use Hot Biopsy Forceps FD-231consists of a handle and insertion portion. Fenestrated cups in the distal end of insertion are activated in the open and closed position by maneuvering the slider in the handle.

During operation, insertion will be inserted into endoscopes. Once the tissue is held by the cups. the tissue is subjected to high frequency electric current transmitted from plug which allows for collecting tissue. Once the tissue is touched by closed cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for cauterization and hemostasis.

By means of high frequency electric current passing through the tissues between electrical plate attached on patient`s skin and the cups, heat will be produced from electricity resistance by the tissue and the heat will be utilized for collecting tissue, cauterization and hemostasis.

This document is a 510(k) summary for the Olympus Single Use Hot Biopsy Forceps FD-231. It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to acceptance criteria and device performance:

**The document does not describe: **

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes. This document focuses on the design and safety aspects of a medical device (hot biopsy forceps), not a diagnostic algorithm. Therefore, typical metrics like sensitivity, specificity, or AUC, as would be relevant for an AI/ML-based diagnostic device, are not applicable here.
• Sample size used for a "test set" in the context of diagnostic performance. The "tests" here are engineering and safety validations.
• Data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Effect size of human readers improving with AI vs. without AI assistance.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, this document describes:

The document describes non-clinical testing to demonstrate the safety and effectiveness of the device, focusing on substantial equivalence to a predicate device. The acceptance criteria in this context are established by engineering standards and internal risk analysis, rather than diagnostic performance metrics.

Here's what can be extracted regarding acceptance criteria and performance, as appropriate for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Validation)

While not presented in a formal table with pass/fail remarks for each test, the document lists the types of non-clinical tests performed and implies that the device met the criteria for each, as it received 510(k) clearance.

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

• Sample Size: Not explicitly stated as a number of devices/units for each test. However, the performance of these tests (e.g., biocompatibility) typically involves a sufficient number of samples as dictated by the relevant standards.
• Data Provenance: The device is manufactured by Aomori Olympus Co., Ltd. in Japan. The tests are non-clinical (laboratory/bench testing) and performed according to international standards (ISO, ASTM, IEC, AAMI/ANSI). The data's "provenance" here refers to the engineering validation processes, likely conducted at the manufacturer's or qualified testing facilities. Retrospective/prospective is not applicable as this is not clinical performance data.

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

• Not Applicable. This is not a study assessing diagnostic "ground truth" established by human experts. The "ground truth" for the non-clinical tests are the objective measurements and adherence to specified engineering and safety parameters outlined in the standards.

4. Adjudication Method for the Test Set:

• Not Applicable. No human interpretation or adjudication of diagnostic images is involved. The "test set" here refers to the physical devices undergoing engineering and safety validation, with acceptance being based on meeting quantitative criteria from standards.

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

• No. This type of study is for evaluating the impact of a diagnostic AI on human reader performance. This device is a surgical instrument, not a diagnostic AI.

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

• Not Applicable. There is no algorithm or AI component to this device. Its performance is purely mechanical and electrical, measured through non-clinical bench testing.

7. The Type of Ground Truth Used:

• Engineering Specifications and Standard Requirements: The "ground truth" for this device's performance acceptance is its adherence to a robust set of international and industry standards (e.g., ISO, IEC, AAMI/ANSI, ASTM) covering electrical safety, biocompatibility, sterilization, packaging, and functional mechanical properties. These standards define the acceptable range or threshold for specific measurements.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no training set.

In summary, this document demonstrates regulatory clearance for a medical device (hot biopsy forceps) based on non-clinical engineering and safety testing, showing substantial equivalence to a predicate device. It explicitly states that:

• Validation from non-clinical testing demonstrated that the differences (compatible endoscope/accessories, electrical specification, material composition/configuration of handle/insertion) do not raise further problems on safety or effectiveness.
• "The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment" (based on ISO 14971).
• The conclusion is that the device "does not demonstrate any significant changes in intended use and technical characteristics that could affect the safety or effectiveness of the device."

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