(21 days)
The Olympus GF-UE160-AL5 Ultrasonic Endoscope is intended to be used for endoscopic ultrasonic inaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs. It is to be used with the Aloka SSD-5000 (K033311) Diagnostic Ultrasound system and various other video and light source accessories.
The Olympus GF-UE160-AL5 is an ultrasonic gastro video endoscope to be used with an Aloka diagnostic ultrasound system, video system center, light source, video monitor, endo-therapy accessories for endoscopic ultrasound imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.
The Olympus GF-UC140P-A15 is an electronic radial scan ultrasound endoscope providing a 360° view angle.
The provided document is a 510(k) summary for the Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. As such, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving their fulfillment.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics. Instead, it compares the technological characteristics of the subject device to its predicate devices to demonstrate substantial equivalence. The implication is that if the new device has similar characteristics, it will perform equivalently.
| Specification | Acceptance Criteria (Implied: Substantially Equivalent to Predicates) | Reported Device Performance (GF-UE160-AL5) | Predicate Device 1 (GF-UC140P-A1.5) Performance | Predicate Device 2 (GF-UM130) Performance |
|---|---|---|---|---|
| Field of View (Optical) | 100° (video) | 100° (video) | Same (100° video) | Same (100° video) |
| Direction of View | 55° forward-oblique | 55° forward-oblique | Same (55° forward-oblique) | Same (55° forward-oblique) |
| Depth of Field | 3~100mm | 3~100mm | Same (3~100mm) | Same (3~100mm) |
| Outer Diameter of Distal End | Similar to predicates | ⌀ 13.8mm | ⌀ 14.2mm | ⌀12.7mm |
| Outer Diameter of Insertion Tube | Similar to predicates | ⌀ 11.8mm | Same (⌀ 11.8mm) | ⌀ 10.5mm |
| Angulations (Up, Down, Left, Right) | 130° (Up), 90° (Down), 90° (Left), 90° (Right) | 130° (Up), 90° (Down), 90° (Left), 90° (Right) | Same | Same |
| Working Length | 1250mm | 1250mm | Same (1250mm) | Same (1250mm) |
| Instrument Channel | Similar to predicates | ⌀ 2.2mm | ⌀ 2.8mm | ⌀ 2.2mm |
| Contact Method | Balloon Method/De-Aerated Water Immersion Method | Balloon Method/De-Aerated Water Immersion Method | Same | Same |
The "acceptance criteria" here are implicitly that the new device's specifications are comparable to, or within acceptable variations of, the predicate devices, thereby ensuring equivalent safety and effectiveness.
2. Sample size used for the test set and the data provenance
The document describes a submission for substantial equivalence based on technological characteristics and intended use comparison. It does not refer to a clinical "test set" in the context of performance evaluation with patient data. Therefore, there is no information on:
- Sample size used for a test set.
- Data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no clinical test set for performance evaluation is described, there is no information on:
- Number of experts used to establish ground truth.
- Qualifications of those experts.
4. Adjudication method for the test set
Similarly, as there is no clinical test set for performance evaluation, there is no information on an adjudication method.
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
The device is an endoscope and ultrasound system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable as the device is not an algorithm for standalone performance. It is a medical imaging device used by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe a study involving "ground truth" as typically understood in performance validation of diagnostic accuracy (e.g., against pathology). The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
The document describes a comparison to predicate devices, not a machine learning model. Therefore, there is no information on a "training set" sample size.
9. How the ground truth for the training set was established
As there is no training set for a machine learning model, this question is not applicable.
Summary of the Study (as described in the 510(k) submission):
The "study" presented here is a comparison to predicate devices to demonstrate substantial equivalence, as required for a 510(k) submission to the FDA. It is not a clinical study designed to test novel performance claims against specific acceptance criteria.
- Purpose: To demonstrate that the Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System is substantially equivalent to legally marketed predicate devices, specifically the Olympus GF-UC140P-AL5 Endoscope (K011314) and the GF-UM130 Endoscope (K971660).
- Methodology: Direct comparison of technological characteristics (physical specifications, optical characteristics, angulations, etc.) and intended use between the subject device and the predicate devices.
- Conclusion: The submission concludes that "When the GF-UE 160-AL5 is compared to its predicates, the device does not incorporate any significant changes in intended use, method of operation, material or design that could affect the safety and effectiveness." The FDA concurred with this finding of substantial equivalence.
- Key Finding for Equivalence: The key "performance" demonstrated is that the device's technical specifications and intended use are similar enough to existing, cleared devices that it can be considered equally safe and effective without requiring new clinical performance data.
§ 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.