(106 days)
Indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The guidewires are designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.
The Jagtail™ High Performance Guidewire Extension attached to the extendable Jagwire™ 260 cm Guidewire is designed for use during endoscopic biliary procedures for non-rapid exchange catheter introduction and exchanges. The attachment of the Jagtail High Performance Guidewire Extension to the extendable Jagwire 260 cm guidewire creates an extended guidewire that can be used to exchange out a non-rapid exchange biliary catheter without removing the original guidewire from the associated duct. When the exchange is completed, the Jagtail High Performance Guidewire Extension can be detached and the original, extendable Jagwire 260 cm guidewire can be used in a conventional manner.
Jagwire™ High Performance Guidewire, and Jagwire™ High Performance Extendable Guidewire:
The Boston Scientific Jagwire™ High Performance Guidewire is constructed of a metal alloy core, which is encapsulated in a striped PTFE jacket with a 5 cm hydrophilic radiopaque distal tip. The striped jacket provides endoscopically visible movement markings.
Jagtail™ High Performance Guidewire Extension:
The Boston Scientific Jagtail™ High Performance Guidewire Extension is a 200 cm long guidewire extension constructed of a stainless steel core with a connector at the distal end. The shaft is coated with a PTFE sleeve. The Jagtail High Performance Guidewire Extension is exclusively compatible with the Jagwire High Performance Extendable Guidewire, 260 cm. The distal end of the Jagtail High Performance Guidewire Extension is inserted into the proximal end of the extendable Jagwire 260 cm guidewire with the use of the alignment tool. The alignment tool is then removed from the Jagtail High Performance Guidewire Extension.
The provided document is a 510(k) premarket notification for a medical device called "Jagwire™ High Performance Guidewire" and its extensions. It is not an AI/ML device, therefore, a lot of the metrics that you requested are not relevant here. However, I will extract and provide the relevant information.
The document discusses the regulatory approval for a guidewire, which is a physical medical device used in endoscopic biliary procedures. The "acceptance criteria" and "study" described in the document relate to the physical and biological performance of this guidewire, rather than an AI/ML algorithm's diagnostic or predictive capabilities.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Performance Characteristic | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Acceptable results |
| Sensitization | Acceptable results | |
| Intracutaneous Reactivity | Acceptable results | |
| Latex | Acceptable results | |
| USP Physiochemical testing | Acceptable results | |
| Physical Performance | Tip Adhesion Shear Strength | Meets Product Specifications |
| End Product Tip Tensile | Meets Product Specifications | |
| Tip Column Strength | Meets Product Specifications | |
| Dimensional Test for Tip Outer Diameter | Meets Product Specifications | |
| Tip Cantilever Strength | Meets Product Specifications | |
| Atraumatic Tip | Meets Product Specifications | |
| Appearance and Cleanliness | Meets Product Specifications |
2. Sample size used for the test set and the data provenance:
The document does not specify a "sample size" in the context of an algorithm's test set or data provenance (e.g., country of origin, retrospective/prospective) because this applies to a physical device, not a data-driven model.
- Sample Size for Testing: Not explicitly stated as "sample size" in the context of a dataset. Instead, it refers to multiple units of the physical device or its components tested.
- Data Provenance: Not applicable as it's not a data-driven study, but rather a performance evaluation of a manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML diagnostic studies, not for the physical performance testing of a medical guidewire. The performance was assessed against established engineering and biocompatibility standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are used in diagnostic studies to resolve discrepancies in expert opinions for ground truth establishment. For physical device testing, the results are typically quantitative measurements against predefined specifications.
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:
This is not an AI/ML device, so no MRMC comparative effectiveness study involving human readers or AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not an AI/ML device, so no standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by engineering specifications, material science standards (e.g., biocompatibility standards like ISO 10993-1), and mechanical performance metrics. The device is deemed acceptable if it meets these predefined physical and biological requirements.
8. The sample size for the training set:
This information is not applicable. The device is a physical product, not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for a physical medical 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.