(266 days)
The EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. The CV-1500 Video System Center is compatible with scopes within the EVIS 190 and 1100 families.
The BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, 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.
The BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, 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.
The CV-1500 video system center is indicated to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, and be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product also functions as a pump to supply air through the endoscope, a light source to the endoscope, and a controller/monitor of ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis.
RDI (Red Dichromatic Imaging) observation: RDI is optical-digital observation using red dichromatic narrow band light and green illumination light to enhance visibility of bleeding points in the endoscopic image due to the difference in light absorption.
TXI (TeXture and color enhancement Imaging): TXI emphasizes tonal changes, patterns, and image outlines. It also corrects the brightness of dark areas.
BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast): BAI-MAC maintains the brightness of the bright part of the endoscopic image and corrects the brightness of the dark part of the endoscopic image.
The BF-H1100 and BF-1TH1100 endoscopes consist of three parts: the control section, the insertion section, and the connector section. The endoscope receives the illumination light from light guide connector connected to the video system center (CV-1500). The illumination light is transferred to the distal end through the optical fiber bundle inside of the endoscope and illuminates the inside of the patient body through the illumination lens at the distal end.
The endoscope receives the reflected light from the inner lumen of a patient by objective lens at the distal end. The built-in charge-coupled device (CCD) at the distal end converts the light to the electrical signal, and the signal is sent to the video system center via the electrical cable and the video connector of the endoscope. The endoscope transfers the image signal and displays the observation image on the screen.
This FDA 510(k) summary focuses on establishing substantial equivalence for the EVIS X1 Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, and Bronchovideoscope Olympus BF-1TH1100 to their predicate devices. The listed performance data describes various bench tests and an animal study conducted. However, this document does not detail specific acceptance criteria or report device performance against those criteria in a tabular format. It also explicitly states that "No clinical study was performed to demonstrate substantial equivalence." Therefore, a comprehensive answer for all your requested points cannot be extracted from this particular document.
Here's what can be inferred and what information is missing:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document in a tabular format. The document states that "The design verification tests and the acceptance criteria were identified and performed as a result of the risk management," and lists various performance tests (e.g., Thermal Safety, Durability, Resolution, Depth of Field, RDI, TXI and BAI-MAC performance). However, it does not provide the specific acceptance thresholds for these tests or the quantitative results achieved by the device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The document does not specify sample sizes for the bench tests.
- Animal Study: An "animal study" was performed for CV-1500 to confirm WLI, NBI, TXI, and BAI-MAC performance. The document does not specify the sample size (e.g., number of animals) or the country of origin for this study. It is implicitly a prospective study in an animal model.
- Clinical Study: "No clinical study was performed to demonstrate substantial equivalence." Therefore, there is no human test set or associated provenance.
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)
This information is not provided as there was no clinical study involving human readers or expert-established ground truth mentioned in this 510(k) summary for device performance evaluation. For the animal study, the ground truth establishment method and expert involvement are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there was no clinical study involving human readers discussed in this 510(k) summary. For the animal study, the adjudication method is not detailed.
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
No MRMC comparative effectiveness study was done involving human readers or AI assistance, as explicitly stated: "No clinical study was performed to demonstrate substantial equivalence." The device described is an endoscopic imaging system, not an AI-powered diagnostic tool. The imaging modes (NBI, RDI, TXI, BAI-MAC) are described as "adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging" and "are not intended to replace histopathological sampling as a means of diagnosis."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe the device as an standalone algorithm. The device is a video system center and bronchoscopes. The performance evaluation focuses on the technical characteristics and imaging capabilities of the hardware and integrated imaging modes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Performance testing - Bench", the ground truth would be established by controlled experimental conditions and measurements against known physical standards. For the "Performance testing - Animal," the ground truth likely involved direct visual assessment and possibly histopathological examination of tissues within the animal model, though this is not explicitly stated.
8. The sample size for the training set
This is not applicable as the device is a hardware endoscopic system, not a machine learning algorithm that requires a training set in the typical sense. The "training set" concept does not apply to this type of device submission.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.