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This instrument has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, EndoTherapy accessories such as an aspiration biopsy needle. This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.

The BF-UC190F has been designed to be used with the video system center, light source, documentation equipment, display monitor, and Endo Therapy accessories such as an aspiration biopsy needle. The BF-UC190F is intended for endoscopic real-time ultrasound imaging for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus. The BF-UC190F is a flexible video endoscope and a modification of the XBF-UC180F-DT8 which was previously cleared under K070983. The BF-UC190F consists of three parts: the control section, the insertion section, and the connector section.

The Olympus BF-UC190F Endoscopic Ultrasound Bronchofibervideoscope underwent several performance tests to demonstrate its substantial equivalence to the predicate device, the XBF-UC180F-DT8 (BF-UC180F), and confirm its safety and effectiveness.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria alongside performance data in a direct comparative format for each test. Instead, it states that various tests were conducted and the device conforms to or complies with relevant standards and guidance documents, implying that meeting these standards served as the acceptance criteria.

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

The document does not provide specific sample sizes for the test sets (e.g., number of units tested for thermal safety or mechanical durability, number of biological samples for biocompatibility). It generally states that "testing were conducted."

Data provenance is not explicitly mentioned in terms of "country of origin of the data" or "retrospective or prospective." All tests appear to be prospective bench tests performed by the manufacturer to validate the device's design and compliance with regulatory standards.

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

This information is not provided in the document. The testing described (e.g., electrical safety, EMC, biocompatibility, mechanical durability) are typically engineering and laboratory-based tests that do not involve "experts to establish ground truth" in the clinical sense (like radiologists marking images). Instead, the "ground truth" for these tests is established by the relevant engineering standards and regulatory requirements.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts assess the same data to establish a consensus ground truth. Since the performance data presented are primarily from bench and laboratory tests rather than clinical performance evaluations involving human interpretation, an adjudication method is not applicable and therefore not mentioned in the document.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device through technological comparison and various non-clinical performance tests, not on comparing reader performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-In-The-Loop)

A standalone (algorithm only) performance study was not conducted or reported. The device, an endoscope, is a physical instrument for real-time imaging and aspiration, designed to be used by a medical professional. There is no mention of an independent algorithm component for which "standalone performance" without human interaction would be relevant.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests is based on established engineering standards, regulatory guidance criteria, and design specifications. For example:

• Ultrasound output: Conformance to IEC 60601-2-37 limits.
• Reprocessing: Meeting efficacy requirements as outlined in FDA reprocessing guidance.
• Biocompatibility: Absence of adverse biological reactions as per ISO 10993-1.
• Software: Verification against software requirements specifications and cybersecurity guidelines.
• Electrical Safety/EMC: Conformity to IEC standards.
• Bench Performance (Thermal/Mechanical): Meeting predefined design requirements and durability targets.

There is no mention of clinical ground truth types like expert consensus, pathology, or outcomes data, as this is a pre-market submission focused on fundamental device safety and performance rather than clinical effectiveness.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The BF-UC190F is an endoscopic device, not an AI/Machine Learning algorithm that requires a "training set" of data. The "training" for such a device occurs during its design and development through iterative engineering, testing, and validation against established standards.

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

This information is not applicable as there is no "training set" in the context of this device. The "ground truth" for the device's development and validation (not a training set) involved adherence to engineering principles, scientific validation methods, and regulatory requirements (as outlined in point 7), established through industry standards, guidance documents, and internal design specifications.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Trans-esoph. (non-Card.), Airways and tracheobronchial tree.

OLYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE has been designed to be used with the SSD-Alpha5 (K041916) and SSD-Alpha10(K043196) diagnostic ultrasound systems (ALOKA CO.,LTD.), video system center, light source, documentation equipment, display monitor, and endo-therapy accessories such as aspiration blopsy needle. The subject device is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airway, tracheobronchial tree, esophagus, and surrounding organs.

The provided document (K070983) is a 510(k) premarket notification decision letter from the FDA for the Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the manner expected for a de novo device or a more complex AI-driven medical device.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details typical for an AI/ML device.

Here's why and what information can be extracted/inferred:

• Type of Device: The device is an ultrasonic broncho-fibervideoscope, which is a hardware device for endoscopy with integrated ultrasound capabilities. It's not an AI/ML diagnostic software.
• Regulatory Pathway: The 510(k) pathway demonstrates substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, fundamental technological characteristics, and safety and effectiveness as the predicate, or that any differences do not raise new questions of safety or effectiveness. Formal clinical studies with performance metrics against acceptance criteria are often not required if engineering and non-clinical bench testing are sufficient to support equivalence.
• Date: The document is dated 2017, predating widespread FDA guidance and requirements for AI/ML device performance studies outlining the specific details you've asked for.

Based on the available document, here's what can be stated about the device and its assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) for a diagnostic output. Instead, the "performance" demonstrated for a 510(k) device like this typically involves:

• Bench Testing: Verification of technical specifications (e.g., ultrasound frequency, imaging depth, image quality, mechanical dimensions, electrical safety, biocompatibility, sterilization efficacy).
• Verification and Validation (V&V): Ensuring the device meets its design inputs and intended use through various tests.

The document implicitly "accepts" the device's performance by finding it substantially equivalent to the predicate devices. This means its performance is considered comparable and safe/effective for its intended use.

No explicit table of acceptance criteria or numerical performance results (e.g., sensitivity, specificity, AUC) are provided in this regulatory letter. The letter is a communication of regulatory decision, not a detailed study report.

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

• Test Set Sample Size: Not applicable in the context of typical AI/ML performance studies. For a hardware device, V&V tests would use units of the device itself and potentially phantoms or in-vivo animal models (not specified in this letter).
• Data Provenance: Not applicable in the AI/ML sense. The "data" here would be the results of engineering tests, not patient data for algorithm training/testing.

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

• Experts: Not explicitly stated. For a physical device, ground truth during testing would likely be established through engineering measurements, expert medical assessment of image quality (e.g., by radiologists, pulmonologists, gastroenterologists familiar with endoscopic ultrasound), and potentially histological evaluation if biopsy results were part of functional testing (again, not detailed here).
• Qualifications: Not specified within the letter.

4. Adjudication Method:

• Adjudication Method: Not applicable or specified for this type of device and regulatory submission.

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

• MRMC Study: No, this type of study is not mentioned as having been conducted or required for this 510(k) submission. MRMC studies are typically used to assess the impact of diagnostic aids (like AI) on physician performance. The device itself is a diagnostic tool, not an AI aid to another diagnostic process.

6. Standalone Performance:

• Standalone Performance: Not applicable in the context of an AI algorithm. The performance of the device (XBF-UC180F-DT8) and its associated ultrasound system (ALOKA SSD-Alpha 5/10) is its standalone performance as a diagnostic imaging system. The letter doesn't isolate specific performance metrics outside of the combined system's functionality.

7. Type of Ground Truth Used:

• Ground Truth: For a traditional diagnostic imaging device like this, ground truth in V&V trials would typically involve:
  • Phantom studies: Known physical properties measured by other means.
  • Pathology/Histology: For biopsy capabilities.
  • Clinical correlation: Experienced clinician interpretation or follow-up.
  • Engineering specifications: Meeting design requirements.
    The document doesn't specify which ground truth methods were primarily used for the 510(k) submission.

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

In summary, the provided FDA 510(k) letter for the Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope is a regulatory outcome document demonstrating substantial equivalence. It does not contain the detailed performance study information that would be found in a submission for an AI/ML-driven diagnostic device.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraluminal ultrasound for upper airways and tracheobronchial tree.

This subject device has been designed to be used with an OLYMPUS endoscopic ultrasound center, light source, documentation equipment, display monitor, endotherapy accessories and other ancillary equipment for endoscopic ultrasonic imaging of the upper airways and trancheobronchial tree.

The provided text is a 510(k) summary for the Olympus BF Type UM40 Ultrasonic Bronchofiberscope. It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for regulatory approval. It mentions the intended use, device description, and technological characteristics, but it does not delve into performance metrics, test sets, ground truth establishment, or statistical analyses typically found in a study proving acceptance criteria.

Therefore, I cannot populate the requested table or sections regarding acceptance criteria and study details based on the provided text. The document is a regulatory submission for market clearance, not a scientific study report.

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