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EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F: 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.
Single Use Biopsy Forceps FB-433D: The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope.

EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F: The BF-MP190F 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-MP190F is indicated for use within the airways and tracheobronchial tree. The BF-MP190F is a flexible video endoscope used for endoscopic diagnosis and treatment within the respiratory organs and a modification of the BF-Q190 which was previously cleared under K121959. The BF-MP190F has been designed to be applicable for diagnosis and treatment in the peripheral portion of the tracheobronchial trees compared to the predicate model. The basic principle, the user interface and operation for the bronchoscopic procedure of the BF-MP190F is identical to the predicate BF-Q190.
Single Use Biopsy Forceps FB-433D: The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope. Identical to the predicate device, the subject device is inserted into the channel of an endoscope to collect tissue with the pair of forceps which is equipped at the distal end of the subject device. Then users withdraw the subject device from the channel and collect samples.

The provided text describes a 510(k) premarket notification for an Olympus bronchoscope (BF-MP190F) and single-use biopsy forceps (FB-433D). The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing, rather than presenting a study where a device's performance is measured against predefined acceptance criteria. Therefore, the requested information, which pertains to such a performance study and acceptance criteria specific to an AI/algorithm-based device, is largely not available in this document.

Here's an analysis of what information is available or implied, and what is not:

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

• Not Available. The document does not describe specific numerical acceptance criteria or performance metrics for the device (e.g., sensitivity, specificity, accuracy). Instead, it lists various non-clinical tests conducted to demonstrate safety and effectiveness. The acceptance criteria for these tests are generally implied to be "meeting established in-house criteria" or compliance with specific ISO/ASTM standards (e.g., ISO 14971 for risk analysis, ISO 10993 for biocompatibility, etc.). These are related to manufacturing and safety, not diagnostic or clinical accuracy.

2. Sample sized used for the test set and the data provenance

• Not Available. The document outlines a series of non-clinical tests (e.g., thermal safety, mechanical durability, forceps operation, dimension, package integrity, software validation, EMC, electrical safety, reprocessing validation, sterilization validation, shelf-life testing). These typically involve a small number of physical samples of the devices themselves, performed in a lab setting, rather than a "test set" of clinical data with human subjects or patient samples. The concept of "data provenance" (country of origin, retrospective/prospective) is not applicable here as it's not a clinical performance study.

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

• Not Applicable/Not Available. Since this is a non-clinical evaluation of hardware and accessories, there is no "ground truth" establishment in the sense of expert clinical diagnosis or interpretation. The tests assess the physical and functional characteristics of the device against engineering specifications and safety standards.

4. Adjudication method for the test set

• Not Applicable/Not Available. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus on clinical ground truth, which is not part of this device's evaluation as described.

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 document describes a bronchoscope and biopsy forceps, which are physical medical instruments. It does not describe an AI or algorithm-driven device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

• Not Applicable. As mentioned above, this document does not concern an algorithm-driven device.

7. The type of ground truth used

• Not Applicable/Not Available. For the non-clinical tests performed, "ground truth" would be established by objective measurements and compliance with engineering specifications, safety standards, and performance test protocols (e.g., a "thermal safety test" would have an objective temperature limit). It does not involve expert consensus, pathology, or outcomes data in the context of clinical performance.

8. The sample size for the training set

• Not Applicable. This document does not pertain to an AI/machine learning device that would require a training set.

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

• Not Applicable. This document does not pertain to an AI/machine learning device that would require a training set.

Summary based on the provided text:

The submission focuses on demonstrating substantial equivalence of a new bronchoscope and biopsy forceps to previously cleared predicate devices, primarily through engineering and safety evaluations. The modifications include changes in the bronchoscope's CCD unit position, outer diameter, instrument channel size, optical properties, and materials, as well as additional sterilization methods. For the biopsy forceps, changes relate to compatible devices, maximum diameter and length, and cup size/material.

The "study" in this context refers to a series of non-clinical tests designed to verify that these modifications do not raise new safety or effectiveness concerns and that the devices comply with relevant international standards.

This submission is a traditional 510(k) for a physical medical device, not an AI/ML-driven device, so many of the requested categories related to algorithm performance, training data, and expert review of clinical cases are not applicable.

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This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopic surgery within the biliary tract and pancreatic duct in conjunction with DUODENOSCOPE with an instrument channel with a minimum diameter of ¢ 4.2mm.

The XCHF-BP160F Choledochoscope is basically identical to the predicate device, OES Transduodenal Choledochofiberscope CHF type B20 except that the subject device is equipped with the high resolution CCD in the control section, in addition to the fiber bundle in the insertion tube. Images are transmitted through the fiber bundle and converted by the CCD in the control section to video signals. This is a hybrid technology and substantially equivalent to another Olympus predicate device, Olympus bronchoscope, model BF type XP160F(K033225).

The XCHF-BP160F Choledochoscope is used in conjunction with the TJF-duodenoscope with an instrument channel with a minimum diameter of ¢ 4.2mm, such as Olympus TJF type 100. TJF type 140, TJF type 160F/VF and TJF type M20 duodenoscopes. The XCHF-BP160F Choledochoscope is safety and effectively delivered through the upper gastrointestinal (G) tract to the Papilla of Vater) by traveling through the instrument channel of the TJF-duodenoscopes. At this point, XCHF-BP160F Choledochoscope can directly observe the billiary tract or pancreatic duct.

The provided document is a 510(k) premarket notification for the Olympus Choledochoscope Model XCHF-BP160F. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive original studies.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not typically included in a 510(k) summary for a device like this. The submission primarily relies on the established safety and effectiveness of the predicate devices and demonstrates that the new device does not introduce new risks or questions of effectiveness.

Here's a breakdown based on the information available and the nature of a 510(k) submission for this type of device:

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

• Acceptance Criteria: The document does not explicitly list quantitative acceptance criteria in the format typically seen with performance studies (e.g., minimum sensitivity, specificity, accuracy). Instead, acceptance is based on demonstrating substantial equivalence to predicate devices and adherence to voluntary safety standards.

• Reported Device Performance:

  • Imaging System: CCD (compared to Optical fiber bundle for primary predicate, and CCD for secondary predicate). This is a technological characteristic, not a performance metric in the traditional sense, but it upgrades the imaging capability.
  • Insertion diameter: ϕ 2.9 – 3.7mm (smaller than primary predicate's ϕ 4.5mm).
  • Channel diameter: ϕ 1.2mm (smaller than primary predicate's ϕ 1.7mm, same as secondary predicate's ϕ 1.2mm).
  • Angulation (U / D): U=70°, D=70° (different from predicates' ranges).
  • Compliance with Standards: Meets IEC60601-1:1998+ Amendment 1:1991+Amendment 2:1995, IEC 60601-1-1:2000 and IEC60601-2-18: 1996+ Amendment1:2000.
  • Non-clinical Tests Performed: Thermal safety, optical performance, reprocessing, mechanical durability, mechanical safety, risk analysis. (No specific quantitative results are provided in this summary).
  • Biocompatibility: Patient contacting materials completed biocompatibility studies with the predicate device.

  No specific metrics like sensitivity, specificity, or inter-reader agreement are reported as this is not a diagnostic algorithm.

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

• Not applicable. The document states, "Therefore, no clinical tests have been conducted on this device." The evaluation is based on non-clinical tests and comparison to predicate devices, not on a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set or ground truth established by experts for performance evaluation was conducted.

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

• Not applicable. No clinical test set.

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 device is a choledochoscope, which is an imaging and interventional tool, not an AI-powered diagnostic device. Therefore, MRMC studies or AI assistance effect sizes are not relevant here.

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

• Not applicable. This is a medical instrument, not a standalone algorithm.

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

• Not applicable. As no clinical studies were performed for this 510(k) submission, there was no ground truth established using patient data. The "ground truth" for the non-clinical tests would be the established industry standards and manufacturer's specifications for design, materials, and safety.

8. The sample size for the training set

• Not applicable. This is a medical instrument, not an AI/ML device that requires a training set.

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

• Not applicable. This is a medical instrument; there is no training set as understood in the context of AI/ML.

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