(96 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 a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
The XTJF-Q160VF1 duodenoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum. The XTJF-Q160VF1 duodenoscope is basically identical to the predicate device, Olympus XTJF Type 160AF Duodenovideoscope, in intended use, specifications, performance. The optical system of the XTJF-Q160VF1 is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.
The provided document is a 510(k) summary for the Olympus XTJF-Q160VF1 Duodenovideoscope. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI/software as a medical device (SaMD) would.
Therefore, many of the requested data points related to clinical study design, acceptance criteria, sample sizes for test/training sets, expert adjudication methods, and standalone performance for AI/SaMD are not applicable to this type of regulatory submission for a medical device that is a physical endoscope.
However, I can extract information regarding the device's characteristics and its comparison to a predicate device, which serves as the basis for its "acceptance" or clearance by the FDA in this context.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't define "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or accuracy) in the way one would for an AI/SaMD device. Instead, the "acceptance" for this 510(k) submission is based on demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The "reported device performance" is essentially a comparison of its specifications to the predicate device.
| Characteristic (Acceptance Criteria for Equivalence) | Subject Device XTJF-Q160VF1 (Reported Performance) | Predicate Device XTJF-160AF (Comparison Standard) |
|---|---|---|
| Intended Use | Endoscopy and endoscopic surgery within the duodenum | Endoscopy and endoscopic surgery within the duodenum |
| Field of View | 100° | 100° |
| Direction of View | Backward, Sideviewing 5° | Backward, Sideviewing 5° |
| Depth of Field | 5~60mm | 5~60mm |
| Optical System | Color (CCD-based) | Color |
| Outer Diameter of Distal End | φ13.2mm | φ13.2mm |
| Outer Diameter of Insertion Tube | φ11.3mm | φ11.6mm |
| Angulation (UP) | 120° | 120° |
| Angulation (DOWN) | 90° | 90° |
| Angulation (RIGHT) | 110° | 110° |
| Angulation (LEFT) | 90° | 90° |
| Working Length | 1240mm | 1240mm |
| Inner Diameter of Instrument Channel | φ4.2mm | φ4.2mm |
| Material | (Implied similar, slight difference mentioned but not detailed) | (Implied similar, slight difference mentioned but not detailed) |
The document explicitly states: "The XTJF-Q160VF1 duodenoscope is basically identical to the predicate device, Olympus XTJF Type 160AF Duodenovideoscope, in intended use, specifications, performance. ... The new endoscope is basically identical to each predicate device shown in Table 15-1 in intended use, and similar in specifications, performance and materials." This confirms that "acceptance" means matching or being substantially equivalent to the predicate device's established specifications and intended use.
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a 510(k) for a physical medical device (an endoscope), not a clinical study on a dataset. The "test set" in this context would be the device itself tested against its own engineering specifications, not a clinical data set. The FDA clearance is based on comparison to a predicate device and adherence to general controls, not a performance study on a specific patient population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the sense of expert annotation for a dataset, is not relevant to this type of device submission.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
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 device is a traditional endoscope; it does not involve AI or "human readers" in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- Not Applicable. "Ground truth" in the AI/SaMD sense is irrelevant. The "truth" for this submission is that its specifications and intended use are similar to a previously cleared device.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Study Proving Device Meets Acceptance Criteria:
The "study" that proves the device meets the acceptance criteria (substantial equivalence) is the 510(k) Premarket Notification itself, specifically the comparison of technological characteristics outlined in Section 6 of the provided document (Table 15-2).
- Methodology: The manufacturer (Olympus Medical Systems Corp.) compared the specifications of the subject device (XTJF-Q160VF1 Duodenovideoscope) with those of the predicate device (XTJF-160AF Duodenovideoscope, K024033).
- Conclusion: The submission concludes that "When compared to the predicate device, the XTJF-160AF 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." The FDA's letter (K080403) concurs, stating that the device is "substantially equivalent" to legally marketed predicate devices.
In summary, for a traditional medical device like an endoscope subject to a 510(k) pathway, "acceptance criteria" and "study" refer to demonstrating substantial equivalence to a predicate device by comparing its design, materials, and technological characteristics against established, cleared devices, rather than a clinical performance study with statistical metrics typical for AI/SaMD.
§ 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.