(322 days)
The N-DO Endoinjector Needles are intended to deliver a variety of legally marketed therapeutic and diagnostic agents into the urethra, prostate and vesical cavities with visualization via a cystoscope.
Not Found
This is a 510(k) premarket notification for a medical device (N-DO Endoinjector Needle). The provided document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. This type of FDA clearance does not typically involve a study with acceptance criteria and device performance in the way a clinical trial for a new drug or a more complex medical device would.
The information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance) is characteristic of a performance study for AI/CADe devices or those requiring more extensive clinical validation. For a 510(k) clearance based on substantial equivalence, especially for a device like an endoinjector needle, the "study" demonstrating equivalence is usually based on bench testing and comparison to existing predicate devices, rather than a clinical trial with human subjects and ground truth established by experts.
Therefore, most of the information you've asked for is not applicable to this specific FDA clearance document.
Here's a breakdown of why and what can be inferred:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable in the traditional sense. This document does not present acceptance criteria for a performance study. Instead, the "acceptance criteria" for 510(k) substantial equivalence revolve around demonstrating that the new device has "the same intended use and the same technological characteristics as the predicate device" or "has different technological characteristics from the predicate device and the information submitted demonstrates that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness than the predicate device."
- Reported Device Performance: The letter states the device "is substantially equivalent... to legally marketed predicate devices." This implies that its performance, through bench testing or other non-clinical data, was deemed comparable to existing, safe, and effective devices.
2. Sample size used for the test set and the data provenance:
- Not Applicable. There is no "test set" in the context of a clinical performance study described here. The evaluation for substantial equivalence would involve comparing the physical and functional characteristics of the N-DO Endoinjector Needle to predicate devices. This might involve testing a sample of the needles for various parameters (e.g., dimensions, material strength, fluid delivery rates), but these are engineering/bench tests, not clinical performance tests on a "test set" of patient data.
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 context of clinical performance, is not established for this type of 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set or adjudication process is mentioned.
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 an endoinjector needle, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. Ground truth from clinical data is not applicable to this type of device and submission. The "ground truth" for substantial equivalence would be the established safety and effectiveness profile of the predicate device (based on its prior clearance) and the demonstration that the new device meets similar engineering and functional standards.
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.
In summary: The provided FDA letter pertains to a 510(k) clearance for an endoinjector needle, which is a physical medical device. The "study" for such a clearance primarily involves demonstrating substantial equivalence to existing predicate devices through bench testing, materials characterization, and comparison of technological characteristics and intended use. The detailed clinical performance study criteria and data provenance requested in your prompt are not typically relevant or included in such a submission.
§ 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.