(60 days)
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:
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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.
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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
- Description: Performed for the TJF-Q190V and MAJ-2315 according to FDA guidance and ISO 10993-1. Specific tests included:
-
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."
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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)
- Description: Tested on the TJF-Q190V. The system complies with:
-
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
- Description: Conducted for the TJF-Q190V and its accessories to ensure it performs as intended and meets design specifications. This included:
-
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.