Search Results

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.

Ask a specific question about this device

The Miniphysionzier 2.0 and Electrodes are intended for use in the iontophoretic transdermal administration of ionized medications.

Not Found

The provided text is a 510(k) premarket notification approval letter for the Physionizer 2.0 and Electrodes, an iontophoresis device. It grants permission to market the device based on its substantial equivalence to a legally marketed predicate device.

However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, study details (like sample sizes, ground truth establishment, or expert qualifications), or multi-reader multi-case studies. These details are typically found in the 510(k) submission itself, not the approval letter.

Therefore, I cannot provide the requested table and study information based on the given text. The approval letter only confirms the device's classification and substantial equivalence to a predicate device, noting the intended use for iontophoretic transdermal administration of ionized medications.

To answer your questions, I would need access to the actual 510(k) submission document for K022950, which would detail the performance studies and acceptance criteria used to support the substantial equivalence claim.

Ask a specific question about this device