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The EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a 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 within the duodenum.

The EVIS EXERA III DUODENOSCOPE TJF-Q190V has been designed to be used with an video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. The TJF-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)." TJF-Q190V is also compatible with Olympus system "EVIS X1 Video System Center OLYMPUS CV-1500 (K222584)."

The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (CCD) chip which delivers images.

The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal.

There is an instrument channel located inside of the flexible insertion section. EndoTherapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion section to elevate endo therapy accessories for endoscopic treatment.

A sterile, single-use distal cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182, K202661 and K220587.

The provided 510(k) clearance letter for the Olympus TJF-Q190V Duodenoscope indicates that the clearance is based on adhesive modifications to the device. This implies that the acceptance criteria and the study proving the device meets these criteria would primarily relate to the durability and safety of the new adhesive material and its impact on the overall performance of the endoscope, particularly concerning reprocessing and material integrity.

However, the provided text does not contain the detailed information typically found in a clinical study report or a summary of non-clinical performance data that would explicitly list acceptance criteria and device performance in the format requested. The document states:

• "Verification/validation activities were performed subsequent to a risk assessment evaluation of the device modifications per the Olympus Quality Management System."
• "Results of the following testing demonstrate that the changes to the device do not adversely affect device performance: Performance Testing - Bench, Sterilization and Shelf-Life - Residual Toxicity of Reprocessing Chemicals, Biocompatibility Evaluation."
• "No clinical data were collected."

This means the clearance was based on non-clinical (bench) testing. Therefore, I cannot provide information on clinical performance metrics, multi-reader multi-case studies, or the establishment of ground truth by human experts, as these were not part of the submission for this particular change.

Given the limited information, I will infer the implied acceptance criteria based on the described non-clinical tests.

Implied Acceptance Criteria and Reported Device Performance

Based on the provided information, the acceptance criteria would be related to the non-clinical performance of the device with the new adhesive, ensuring it is equivalent or superior to the predicate device, especially concerning durability against reprocessing and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance (Inferred)

Study Proving Device Meets Acceptance Criteria:

The study involved non-clinical, bench-level verification and validation activities.

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

• Sample Size: Not explicitly stated. For bench testing, this would typically involve a defined number of devices or components subjected to various tests (e.g., durability cycles, chemical exposure). The exact number of units or test replicates is not provided in the summary.
• Data Provenance: The manufacturing site is Aizu Olympus Co., Ltd., Japan. The testing would have been conducted in a controlled lab environment. This was a retrospective evaluation of a design modification, and the data would be laboratory-generated.

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

• This question is not applicable as "No clinical data were collected." The "ground truth" for non-clinical bench testing would be defined by engineering specifications, material standards, and validated test methods, rather than expert human interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set:

• Not applicable. As no clinical data or human evaluations were involved for this specific submission.

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

• No, a MRMC study was not done. The document explicitly states, "No clinical data were collected." Therefore, there is no information on how human readers might improve with or without AI assistance, as AI is not mentioned and no human reading study was conducted.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a duodenoscope, a physical medical instrument, not an AI algorithm. There is no mention of a software algorithm or standalone performance in the context of AI.

7. Type of Ground Truth Used:

• For the non-clinical testing, the "ground truth" would be based on:
  • Engineering Specifications: Device design parameters, material specifications.
  • Regulatory Standards: ISO standards for biocompatibility (e.g., ISO 10993), sterilization, and other relevant performance standards for endoscopes.
  • Validated Test Methods: Established laboratory protocols for evaluating material durability, chemical resistance, and device functionality.
  • Predicate Device Performance Baseline: The performance characteristics of the legally marketed predicate device (K202661) served as a benchmark for substantial equivalence.

8. Sample Size for the Training Set:

• Not applicable. This submission focuses on a hardware modification (adhesive) to an existing device, not the development or training of a software algorithm.

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

• Not applicable. As there was no training set for a software algorithm.

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This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTberapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

The EVIS EXERA III DUODENOSCOPE TJF-Q190V has been designed 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 within the duodenum. The TJF-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)."

The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (CCD) chip which delivers images.

The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal.

There is an instrument channel located inside of the flexible insertion section. EndoTherapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion to elevate EndoTherapy accessories for endoscopic treatment.

A sterile, single-use Distal Cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182 and K202661.

This document K220587 is a 510(k) Premarket Notification from Olympus Medical Systems Corp. regarding the EVIS EXERA III Duodenovideoscope Olympus TJF-Q190V.

Based on the provided document, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, AUC). This document primarily addresses the substantial equivalence of device modifications to an existing predicate device, focusing on bench testing, sterilization, biocompatibility, and human factors.

The document explicitly states: "No clinical data were collected."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it does not exist within this document for this specific device clearance.

Here's a breakdown of why each requested point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document discusses "performance testing bench," "sterilization validation," "shelf-life testing," "biocompatibility evaluation," and "human factors evaluation" as verification activities, but it does not specify quantitative acceptance criteria or reported performance metrics (like sensitivity, specificity, etc.) for the duodenoscope's diagnostic or therapeutic function.
2. Sample sizes used for the test set and the data provenance: Not applicable in the context of a clinical performance study. The tests mentioned are engineering and safety validations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with "ground truth" (e.g., disease presence) was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 pertains to a medical imaging device (endoscope), not an AI/ML-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study was performed.
8. The sample size for the training set: Not applicable, as no AI/ML component is discussed.
9. How the ground truth for the training set was established: Not applicable.

Summary from the document:

The 510(k) submission for the Olympus TJF-Q190V Duodenovideoscope focuses on design modifications to a sterile, single-use Distal Cover (MAJ-2315) used with the duodenoscope and labeling updates. The core duodenoscope device itself (TJF-Q190V) and the distal cover were previously cleared under K193182 and K202661. This submission aims to demonstrate that these specific modifications do not adversely affect device performance and that the device remains substantially equivalent to its predicate.

The non-clinical performance data summarized includes:

• Performance Testing Bench
• Sterilization Validation and Shelf-Life Testing
• Biocompatibility Evaluation
• Human Factors Evaluation

The conclusion is that the modified Distal Cover MAJ-2315 raises no new issues of safety and effectiveness and the device is substantially equivalent to the predicate device.

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This instrument has been designed 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 within the duodenum.

The TJF-Q190V has been designed 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 within the duodenum. The TJF-0190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)".

The subject device consists of flexible insertion section, control section and endoscope connector section with equipped CCD chip which delivers images.

The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both the white light for the normal observation and the narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces electrical signal to video signal.

There is an instrument channel entirely inside of the flexible insertion section. Endo Therapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion to elevate EndoTherapy accessories for endoscopic treatment.

The TJF-Q190V consists of a single-use distal cover, MAJ-2315 which has been designed to be attached to OLYMPUS TJF-O190V to cover the distal end of the insertion tube and around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously 510(k) cleared via premarket notification, K193182.

The following new reprocessing accessory has also been designed for use with TJF-O190V:

CONNECTING TUBE MAJ-2358

The MAJ-2358 has been designed to be used when reprocessing TJF-Q190V using the Olympus endoscope reprocessor.

The MAJ-2358 is a connecting tube to connect Olympus endoscope reprocessor and TJF-O190V. The endoscope side connector is attached to the distal end of the endoscope to directly deliver fluid to the elevator area.

This document (K202661) is a 510(k) premarket notification for a medical device, the Evis Exera III Duodenovideoscope Olympus TJF-Q190V, and its associated reprocessing accessory, the Connecting Tube MAJ-2358. The core of the submission is to demonstrate that the redesigned duodenoscope and new reprocessing accessory are substantially equivalent to a previously cleared predicate device.

The provided text does not contain information about a study that proves the device meets specific performance acceptance criteria in terms of clinical performance (e.g., diagnostic accuracy, sensitivity, specificity, or human expert performance improvement with AI). Instead, the performance data provided focuses on:

• Reprocessing validation testing: Ensuring the device can be properly reprocessed for safe reuse.
• Bench testing: Verifying the device and its accessories meet design specifications and perform as intended.
• Risk analysis: Assessing potential risks associated with the new connecting tube.

Therefore, many of the requested details, particularly those related to AI/human reader performance studies, ground truth establishment for clinical data, and effect sizes of AI assistance, are not applicable to this document as it describes a conventional medical device rather than an AI-powered one.

However, based on the provided text, I can extract information related to the device's technical acceptance criteria and the type of studies performed for regulatory clearance.

Acceptance Criteria and Device Performance (Based on provided text)

Since this is not an AI/diagnostic device, the acceptance criteria are related to cleaning, functionality, and safety.

Study Details (Applicable to this type of device and submission)

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify sample sizes for the reprocessing validation, bench testing, risk analysis, or human factors studies. These would typically be detailed in the full test reports referenced by the submission, not in the summary document.
   • Data Provenance: Not explicitly stated for specific tests, but the manufacturing site is Aizu Olympus Co., Ltd., Japan, implying tests likely occurred within Olympus's development and testing infrastructure, which could be global. The submission is to the U.S. FDA. The design and validation studies generally reflect prospective testing of the device against its specifications and reprocessing protocols.

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

   • Not applicable in the context of clinical expert review for diagnostic accuracy. For reprocessing validation, experts would be microbiologists or reprocessing specialists. For human factors, they would be end-users (e.g., nurses, technicians, physicians) representative of the target user population. The specific number and qualifications are not disclosed in this summary but would be part of the underlying test reports.

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

   • Not applicable for clinical diagnostic adjudication. For technical validation (reprocessing, bench tests), "adjudication" wouldn't be in the sense of resolving differing clinical interpretations. Pass/fail criteria are established based on engineering specifications, regulatory standards (e.g., AAMI TIR30 for reprocessing), and risk analysis results. Human factors studies would assess usability and potential for error, which might involve qualitative and quantitative data but not a clinical adjudication model.

4. 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. This device is a duodenoscope, an imaging and interventional tool. It is not an AI-powered diagnostic device, nor does it claim to assist human readers in image interpretation or diagnostic performance in the way an AI algorithm would.

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

   • No. This is a hardware device.

6. The type of ground truth used:

   • Not a clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for these tests would be:
     • Reprocessing: Sterility, absence of bioburden, and functional integrity after multiple reprocessing cycles, confirmed by laboratory methods.
     • Bench Testing: Engineering specifications (e.g., dimensional accuracy, image quality parameters, durability, fluid flow rates in channels), confirmed by measurements and functional checks.
     • Risk Analysis/Human Factors: Identification of potential hazards and user errors, and confirmation that controls mitigate risks to an acceptable level.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that uses a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. (See point 7)

In summary: The provided document is a regulatory clearance for a medical device (a duodenoscope) and a reprocessing accessory. The acceptance criteria and supporting studies are focused on the device's physical and functional performance, reprocessing efficacy, safety, and human factors, rather than clinical diagnostic performance enhancements or AI assistance.

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This instrument has been designed 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 within the duodenum.

The TJF-Q190V has been designed 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 within the duodenum. The TJF-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)".

The subject device consists of flexible insertion section, control section and endoscope connector section with equipped CCD chip which delivers images.

The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both the white light for the normal observation and the narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces electrical signal to video signal.

There is an instrument channel entirely inside of the flexible insertion section. Endo Therapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion to elevate EndoTherapy accessories for endoscopic treatment.

The TJF-Q190V consists of a single-use distal cover, MAJ-2315 which has been designed to be attached to OLYMPUS TJF-O190V to cover the distal end of the insertion tube and around the forceps elevator. MAJ-2315 is to be discarded after clinical use.

The following new reprocessing accessory has also been designed for use with TJF-Q190V:

DISTAL END FLUSHING ADAPTER MAJ-2319

The MAJ-2319 was designed to flush the distal end of the endoscope with reprocessing fluids.

The MAJ-2319 can be attached to the distal end of the endoscope during the manual cleaning and disinfection process to flush the distal end with reprocessing fluids. The reprocessing fluid is flushed through the MAJ-2319 to the distal end using a syringe.

The provided text describes a 510(k) premarket notification for the "Evis Exera III Duodenovideoscope Olympus TJF-Q190V." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for an AI algorithm.

Therefore, the information requested in points 1-9 is largely not applicable or directly available in the provided text, as this is a submission for a traditional medical device (an endoscope), not an AI-powered diagnostic tool.

Here's why and what can be extracted:

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

• Not Applicable in the traditional sense for an AI study. The document lists various performance data categories (sterilization, reprocessing, biocompatibility, software V&V, electrical safety, bench testing, risk analysis), but these are for the mechanical and electrical functionality of the endoscope itself, and its accessories, not for an AI's accuracy metrics. There are no specific "acceptance criteria" for metrics like sensitivity, specificity, accuracy, etc., for an AI algorithm, because this device does not contain one.

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. There is no "test set" for an AI algorithm. The performance testing refers to physical tests on the endoscope and its accessories.

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 ground truth establishment for an AI algorithm is mentioned.

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

• Not Applicable. No test set or adjudication for an AI algorithm is mentioned.

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 is a hardware device (endoscope), not an AI-assisted diagnostic tool. No human reader studies are mentioned.

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

• Not Applicable. No AI algorithm is integrated into this device.

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

• Not Applicable. There is no AI algorithm that requires ground truth in this submission. The "ground truth" for the device's functionality would be adherence to engineering specifications and regulatory standards.

8. The sample size for the training set

• Not Applicable. No AI training set is mentioned.

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

• Not Applicable. No AI training set or ground truth establishment process is mentioned.

Summary of Relevant Performance Data from the Document (as it pertains to a non-AI device):

The document details various performance data provided in support of the substantial equivalence determination for the Olympus TJF-Q190V Duodenovideoscope. These studies demonstrate the safety and effectiveness of the traditional medical device and its accessories, not an AI component.

Here's a breakdown of the performance data categories:

• 1) Sterilization/Shelf life testing:

  • Description: Conducted for the MAJ-2315 (Single Use Distal Cover) in accordance with FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510k) Submissions for Devices Labeled as Sterile." Accelerated aging was performed per ASTM F1980-16, with real-time aging for three years planned.

• 2) Reprocessing validation testing:

  • Description: Reprocessing instructions and method validation for the TJF-Q190V were conducted and documented as recommended by FDA guidance "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling." This includes the MAJ-2319 (Distal End Flushing Adapter).

• 3) Biocompatibility testing:

  • Description: Performed for the TJF-Q190V and MAJ-2315 according to FDA guidance and ISO 10993-1. Specific tests included:
    • Cytotoxicity Study Using the Colony Assay
    • Intracutaneous Study in Rabbits
    • Guinea Pig Maximization Sensitization Test

• 4) Software verification and validation testing:

  • Description: Conducted for the TJF-Q190V software, following FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."

• 5) Electrical safety and electromagnetic compatibility (EMC):

  • Description: Tested on the TJF-Q190V. The system complies with:
    • AAMI ANSI ES60601-1: 2005/(R)2012 and A1:2012
    • IEC 60601-2-18: Edition 3.0 2009-08 (for safety)
    • IEC 60601-1-2: Edition 4: 2014-02 (for EMC)

• 6) Performance testing - Bench:

  • Description: Conducted for the TJF-Q190V and its accessories to ensure it performs as intended and meets design specifications. This included:
    • Thermal Safety test
    • Mechanical durability test
    • Performance testing for MAJ-2315
    • Photobiological safety test
    • Accidental Physical Impact testing on distal tip

• 7) Performance testing - Animal:

  • Description: No animal study was performed.

• 8) Performance testing - Clinical:

  • Description: No clinical study was performed.

• 9) Risk analysis:

  • Description: Conducted according to ISO 14971:2007 and human factors validation per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." This risk analysis helped identify and perform design verification tests and their acceptance criteria.

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