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The subject devices are designed to be used with an Olympus bronchoscope for the collection of bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents.

Mucus Collection Probes, BC-401C and BC-402C, have been designed to be used with an Olympus endoscope to collect bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents. Single use.

This response is based on the provided text.

The information provided describes a 510(k) premarket notification for the Olympus Mucus Collection Probe BC-401C, BC-402C. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and a detailed study design as might be seen for novel devices. Therefore, much of the requested information (e.g., specific acceptance criteria for performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone algorithm performance) is not typically included or required in a 510(k) premarket notification for a device of this nature.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria or reported device performance metrics are provided in the document. The submission asserts substantial equivalence based on the intended use, method of operation, materials, and design being similar to the predicate device.

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

Not applicable. The document does not describe a clinical performance study with a test set. The review is based on a comparison to a predicate device, focusing on design, intended use, and operational similarities.

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

Not applicable, as no test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set:

Not applicable.

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

No MRMC study was performed or is mentioned in the provided text.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable, as this is a physical medical device (mucus collection probe), not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable, as no performance study requiring ground truth is described.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and there is no mention of an algorithm or training set.

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

Not applicable.

Study Proving Acceptance Criteria:

The "study" or justification for meeting acceptance criteria in this 510(k) submission is primarily a comparison to a predicate device. The key statement from the document is:

"When compared to the predicate device, the subject device does not add any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness."

This statement serves as the basis for FDA's determination of substantial equivalence, which is the "acceptance criteria" for a 510(k) clearance in this context. The detailed comparison table in section {1} highlights the similarities and minor differences (e.g., maximum diameter, brush diameter, fiber rod presence) between the subject devices (BC-401C/402C) and the predicate device (BC-14C/15C/16C). The argument is that these differences do not raise new questions of safety or effectiveness.

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The BF Type 240 Bronchovideoscopes have been designed to be used with an Olympus EVIS CV- 200 video system center, light source, documentation equipment, video monitor, Endo-Therapy accessories, electrocautery devices, electrosurgical unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

The BF Type 240 Bronchovideoscopes have been specifically designed to be used with the recommended electrocautery devices for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

Olympus offers three models: BF-240, BF-P240, and BF-1T240 of Bronchovideoscopes. They are specifically designed to be used in conjunction with the EVIS 200 Video System which was cleared in 510(k) # K931154 and recommended electrocautery devices.

All other characteristics such as optical, product specifications, material, intended use, and indications for use of the BF-240 Bronchovideoscopes remains unchanged except the modifications identified earlier in this section.

Olympus currently markets EVIS BF Type 200Bronchvideoscopes, its associated accessories and ancillary equipment, which were cleared for marketing in 510(k) # K931154. The BF Type 240 Bronchoviseoscopes are substantially equivalent to the BF Type 200 Bronchvideoscopes in design, specifications, materials, intended use, and method of use except the BF-240 allows the user to use the electrocautery devices such as electrosurgical snares and coagulation electrodes during the endoscopic procedure.

Acceptance Criteria and Study for Olympus BF Type 240 Bronchovideoscopes

This document describes the acceptance criteria and the study that demonstrates the Olympus BF Type 240 Bronchovideoscopes meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not contain information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective or prospective) for demonstrating the device's performance against clinical endpoints. The submission primarily focuses on substantial equivalence to a predicate device and compliance with safety standards.

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

This information is not provided in the submitted summary. The summary does not describe a study involving expert-established ground truth for clinical performance.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as there is no mention of a clinical test set requiring adjudication in this summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the provided summary. This device is an endoscope, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study for an algorithm was not performed, nor is it applicable, as the device is a medical instrument (bronchovideoscope), not an algorithm or AI system.

7. The Type of Ground Truth Used

The primary "ground truth" used for this submission is the predicate device's established safety and effectiveness and the Voluntary Safety Standards IEC 601-1 and IEC 601-2-18. The submission asserts that the new device meets these safety standards and is substantially equivalent to the predicate, implying that the predicate's performance serves as a benchmark for the new device's expected function. There is no mention of a separate clinical ground truth (e.g., pathology, outcomes data) for the BF Type 240.

8. Sample Size for the Training Set

This information is not applicable/not provided. Bronchovideoscopes are medical devices, not AI models that require training sets.

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

This information is not applicable/not provided, as the device is not an AI model requiring a training set with established ground truth.

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The Olympus EVIS BF Type 200 Series video bronchoscopes have been designed for endoscopic diagnosis and treatment within the airways, including the tracheobronchial tree.

Olympus intends to offer three modified BF-200, and BF-1T200 models of video bronchoscopes to be used in conjunction with the EVIS 200 video system center. These video bronchoscopes are identical to the legally marketed video bronchoscopes, which were cleared for marketing through 510(k) # K931154, except for the insertion tube's outer coating material.

All characteristics such as design, construction, optical characteristics, mechanical specifications, electrical and thermal characteristics, intended use, method of use, and application sites remains unchanged.

The provided document pertains to a 510(k) summary for the Olympus EVIS 200 Video Endoscopy System, specifically referencing the Olympus EVIS BF 200 Series Video Bronchoscopes. This document is a pre-market notification to the FDA for a medical device that is substantially equivalent to a predicate device already on the market.

Crucially, the provided text describes a modification to an existing device (a change in the insertion tube's outer coating material) rather than a study demonstrating performance against acceptance criteria for a new device or an AI-powered diagnostic tool.

Therefore, none of the requested information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details can be extracted from this document, as it is not relevant to this type of regulatory submission.

The document explicitly states: "All characteristics such as design, construction, optical characteristics, mechanical specifications, electrical and thermal characteristics, intended use, method of use, and application sites remains unchanged." This indicates that no new performance studies were required or conducted for this specific 510(k) submission, as the fundamental performance of the device is considered identical to its predicate.

In summary, the provided text does not contain the information required to answer the questions about acceptance criteria and study details because it describes a minor modification to an already cleared device, not a new performance study.

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The EVIS 140 System is specifically designed for endoscopic diagnosis, treatment, and photo and video documentation in combination with Olympus endoscopes, various accessories and ancillary equipment within the upper and lower digestive tract including esophagus, stomach, pancreatic duct, biliary duct, duodenum, small intestine, rectum and colon.

Olympus EVIS 140 System, associated endoscope, and ancillary equipment and endoscopic accessories

This document is a 510(k) summary for the Olympus EVIS 140 Video Endoscopy System, submitted in 1996. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Identification: Name, common name, classification name, predicate devices.
• Contact Information: For the submitter.
• Intended Use: Highlighting its use for endoscopic diagnosis, treatment, and documentation in various parts of the digestive tract.
• Claim of Substantial Equivalence: Stating that its intended use is identical to a previously cleared device (Olympus EVS System) and therefore "does not raise any questions regarding the safety of the subject device."

Therefore, I cannot provide the requested table and study details based on the provided text. The prompt asks for information that is simply not present in this 510(k) summary. This type of regulatory submission from 1996 usually relies on demonstrating substantial equivalence to a predicate device rather than providing extensive performance studies against specific acceptance criteria in the way more modern AI/software device submissions do.

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