(42 days)
The NovaGold Guidewire is intended for use in selective cannulation of the billary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic devices during endoscopic procedures.
The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
This document is a 510(k) summary for the NovaGold™ High Performance Guidewire. It describes a medical device and its intended use, and argues for its substantial equivalence to a predicate device. The information provided is for regulatory clearance and does not detail a clinical study proving performance against acceptance criteria in the way requested.
Therefore, many of the requested points cannot be directly answered from the provided text as it focuses on bench testing and comparative characteristics rather than a clinical study with human subjects, established ground truth, or expert review for diagnostic performance.
However, I can extract information related to the functional and safety testing as described:
1. Table of acceptance criteria and reported device performance:
The document states that "representative samples of the device underwent bench testing in accordance to applicable standards and guidances" to "verify that device design met functional and performance requirements." It then lists the types of tests performed. However, it does not explicitly state specific numerical acceptance criteria or the quantitative results (reported device performance) for each test. It only concludes that the data provided "an acceptable assurance of the safety and effectiveness" and demonstrated equivalence to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Fracture resistance | Met requirements (data provides acceptable assurance) |
| Flex resistance | Met requirements (data provides acceptable assurance) |
| Tensile strength | Met requirements (data provides acceptable assurance) |
| Torqueability | Met requirements (data provides acceptable assurance) |
| Torque Strength | Met requirements (data provides acceptable assurance) |
| Tip flexibility | Met requirements (data provides acceptable assurance) |
| Distal fatigue resistance | Met requirements (data provides acceptable assurance) |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified beyond "representative samples of the device."
- Data provenance: Bench testing results, no country of origin is mentioned for the bench tests. The tests are non-clinical, so the concept of "retrospective or prospective" doesn't directly apply in the same way it would to human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the tests performed were non-clinical bench tests on the device itself, not diagnostic performance evaluations requiring expert assessment of medical images or patient outcomes.
4. Adjudication method for the test set:
Not applicable, as this was non-clinical 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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a guidewire, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this device is a guidewire, not an algorithm, so this is not applicable.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" would be engineering specifications and established performance standards for guidewires, against which the device's physical and mechanical properties were measured. It is not expert consensus, pathology, or outcomes data, as those apply to clinical/diagnostic studies.
8. The sample size for the training set:
Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable, as this device does not involve a training set.
§ 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.