(9 days)
The instrument has been designed to be used with Olympus endo-therapy accessories. The instrument is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.
The Single Use Guidewire consists of a Nickle Titanium alloy core wire with a gold coil and hydrophilic, PTFE and silicone coatings. The distal portion of the wire has been specially processed, which includes thinning, to increase the flexibility. This wire has been designed to be used with the Olympus Endo-therapy Accessories.
The provided document is a 510(k) summary for a medical device called "Single Use Guidewire." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, study details, and ground truth establishment is not present in this document.
However, I can extract the information related to the device's performance claims and how equivalence was established.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it states that the performance of the Single Use Guidewire is "substantially equivalent" to a predicate device based on bench testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | Substantially equivalent to the predicate device (LinearGuide, K021179) |
| Specific Performance Tests | Demonstrated through bench testing. (Details of specific tests and their outcomes are not provided in this summary.) |
| Manufacturing Controls | Include visual, functional, dimensional, and sterility tests. |
| Biocompatibility | Blood contacting materials were tested according to ISO-10993. Results demonstrate biocompatibility for externally communicating devices, tissue/bone/dentin communicating, limited contact (24 hrs). |
| Sterilization | Validated according to ANSI/AMMI/ISO 11135-1 to a SAL of 10⁻⁶. |
2. Sample size used for the test set and the data provenance
The document states that the equivalence was shown through "bench testing." It does not specify the sample size used for these tests, nor does it provide details about data provenance (e.g., country of origin, retrospective or prospective). Bench testing typically involves laboratory-controlled experiments rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document does not describe the establishment of a "ground truth" using experts. Bench testing typically relies on engineering specifications and physical measurements, not expert consensus on clinical cases.
4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication process for a test set, as this involves bench testing.
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 guidewire, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For bench testing, the "ground truth" would be the engineering specifications, physical measurements, and performance benchmarks derived from the predicate device or established industry standards for guidewires. This is not explicitly detailed but inferred from the nature of "bench testing."
8. The sample size for the training set
Not applicable. As a physical device demonstrably equivalent through bench testing, there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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.