(183 days)
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
The device detects the magnetic field generated by magnetic coils built directly into the endoscope or the probe inserted into the endoscope's instrument channel.
This device consists of the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) and a RECEIVER DISH (MAJ-1868). The RECEIVER DISH is connected to the UPD-Y0003 via a RECEIVER DISH CABLE (MAJ-1875 or MAJ-1927).
The ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) supplies "driving" signals to the source coils in 1) the endoscope or probe, 2) the Hand Coil and 3) the Reference Plate. The endoscope and probe have plural source coils. The Hand Coil has one source coil. The Reference Plate has plural source coils. The driving signals are sent to each source coil. The driving signal is delivered to the endoscope or probe through a UPD CABLE (MAJ-1881). The driving signal is delivered to the Hand Coil through an integrated cable and the Reference Plate through an integrated cable.
When the source coils receive the driving signal, a magnetic field is generated. The magnetic field is then detected by the sense coils built into the RECEIVER DISH. The signals detected by each sense coil are processed in the UPD-Y0003. The UPD-Y0003 calculates the spatial coordinates for the specific source coil. This calculation is repeated for every source coil built into the endoscope or probe. The UPD-Y0003 then creates the visual image of the endoscope on the monitor, by then putting the spatial coordinates of the multiple source coils in order (distal to proximal) and connects them.
Akin to the methodology described above, the same process takes place for the reference plate and hand coil. The spatial coordinates data obtained from the source coils in the reference plate are used to create the standard plane of endoscope's position. The source coil in the "hand coil" is used to create an independent reference point in the field of view, as displayed on the video monitor.
The provided text is a 510(k) summary for the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003. This document focuses on demonstrating substantial equivalence to a predicate device and outlines technical specifications and compliance with standards. It does not contain information about specific clinical trials, acceptance criteria with reported performance values, or detailed study methodologies that would typically be found in direct performance studies.
Therefore, many of the requested details cannot be extracted from this particular document.
Here's a breakdown of what can and cannot be found:
1. A table of acceptance criteria and the reported device performance
- Not Found: The document states that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." However, it does not provide the specific acceptance criteria or the reported performance values against these criteria for the device itself. The "Comparison of Specifications" table (Table 12-2) lists technical specifications, not performance acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Found: This document does not describe any specific test set or clinical study involving human patients. The testing primarily refers to "design verification tests" and "software validation activities" without specifying sample sizes or data 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)
- Not Found: As no specific test set involving medical image interpretation or diagnosis is described, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Found: No information on adjudication methods for a test set is provided.
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 Found: The device is an "ENDOSCOPE POSITION DETECTING UNIT," which detects and displays the shape of an endoscope. It is not an AI-assisted diagnostic tool that would typically involve human readers or comparative effectiveness studies of the kind described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially Applicable/Contextual: The device calculates and displays the endoscope's position. Its "performance" would likely be assessed by the accuracy of this display. The document mentions "Calculation method of the spatial coordinate of each source coil" as a modification. The "design verification tests" would assess this standalone performance, but the details (like specific metrics or results) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Found: Given the device's function (endoscope position detection), ground truth would likely refer to highly accurate physical measurements of endoscope position in controlled environments. However, the document does not specify how ground truth was established for its internal design verification tests.
8. The sample size for the training set
- Not Found: This device does not appear to be an AI/machine learning model that would require a "training set" in the conventional sense. The "modifications" were to the "mechanism to drive the source coils" and the "calculation method."
9. How the ground truth for the training set was established
- Not Applicable: No training set is mentioned.
§ 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.