(46 days)
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 biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the biliary tract.
The XCHF-T160, is a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract. The XCHF-T160 is basically identical to the predicate device, Olympus CHF-B20 Choledochoscope, hereinafter referred to as CHF-B20 in intended use, specifications, performance.
The optical system of the XCHF-T160 is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.
The new endoscope is basically identical to each predicate device shown in Table 14-1 in intended use, and similar in specifications, performance and materials.
The provided text is a 510(k) summary for the VIDEOSCOPE XCHF-T160, which is primarily a medical device submission to the FDA. Such documents focus on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for a new, innovative device that would typically undergo a rigorous clinical trial.
Therefore, the document does NOT contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The submission is based on demonstrating that the VIDEOSCOPE XCHF-T160 is "basically identical" in intended use, specifications, and performance to the predicate device, Olympus CHF-B20 Choledochoscope. This approach typically relies on engineering and performance comparisons rather than new clinical effectiveness studies with explicit acceptance criteria for performance metrics.
Here's what can be extracted based on the provided text, and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance:
-
Not Available. The document does not specify quantitative acceptance criteria or reported device performance metrics in the format requested. Instead, it provides a comparison of specifications to predicate devices to demonstrate substantial equivalence.
Here's a table showing the comparison of technical specifications, which serves as the basis for demonstrating similarity to predicate devices rather than direct performance results against acceptance criteria:
Specifications Subject Device XCHF-T160 Predicate Device 1 CHF-B20 Predicate Device 2 GIF-Q160Z Field of View 90° 100° 140° Depth of Field 1-50mm 3-50mm WIDE : 8-100mmTELE : 1.5-3mm Direction of View Forward Forward Forward Type of CCD Chip Inter color CCD (37071) (Not specified)Inter color CCD (3704) Outer Diameter of Distal End φ 5.7mm φ 4.1mm φ 10.8mm Outer Diameter of Insertion Tube φ 5.5mm φ 4.5mm φ 10.9mm Angulation UP/DOWN U 160° D 100° R 100° L 100° U 160° D 100° U 210° D 90° R 100° L 100° Working Length 1330mm 1870mm 1030mm Inner Diameter of Instrument Channel φ 2.0mm φ 1.2mm φ 1.7mm φ 2.8mm The conclusion states: "When compared to the predicate device, the CHF-B20 does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that the device meets "acceptance criteria" by being substantially equivalent to prior approved devices, rather than through a new set of defined performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. The document does not describe any specific test set of data with a sample size or provenance for evaluating the device's clinical performance. The focus is on comparing physical and technical specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Available. No test set or ground truth establishment by experts is mentioned in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Available. No test set or adjudication method is 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 / Not Available. This device is a videoscope, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be relevant or expected for this submission. The document does not mention any such study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Available. This device is a videoscope, which is an instrument operated by a human. There is no "algorithm only" performance to evaluate in this context.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Available. No specific ground truth methodology is mentioned as there isn't a stated clinical study to evaluate a specific performance claim. The "ground truth" for this 510(k) essentially relies on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not Applicable / Not Available. This submission does not describe a machine learning or AI model that would require a training set.
9. How the ground truth for the training set was established:
- Not Applicable / Not Available. No training set is implied or discussed.
§ 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.