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The Fuji Dynamics Incontinence Stimulation Electrodes are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

The Fuji Dynamics Incontinence Stimulation Electrode models Fuji-01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 are the light weight cylinder consisting of two or three independent conductive rings or plates that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and handle for comfort positioning in vaginal canal for incontinent treatment and easy in removing after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing and drying between uses.

Here's an analysis of the provided text regarding the Fuji Dynamics Incontinence Stimulation Electrode, focusing on acceptance criteria and study details:

This document is a 510(k) summary for a medical device submitted to the FDA. It does not contain a detailed study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or clinical outcomes.

Instead, this 510(k) outlines the device's substantial equivalence to predicate devices based on identical intended use, technological characteristics, and safety testing (biocompatibility). The FDA's 510(k) pathway determines if a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily that it meets specific, predefined performance thresholds through a clinical study.

Therefore, many of your requested points related to performance studies (like sample size for test sets, number of experts, MRMC studies, standalone performance, training set details) will not be present in this type of document because such studies were not required for this specific 510(k) submission.

Here's a breakdown of the information that is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document does not present a table of specific quantitative "acceptance criteria" for device performance (e.g., a specific accuracy or sensitivity). The "acceptance" for this 510(k) is based on demonstrating substantial equivalence to the predicate devices. The "reported device performance" is primarily about its physical and functional characteristics matching or being acceptably different from the predicates.

The overall "acceptance criteria" here is that the differences in features (electrode orientation, connector, dimensions) between the subject device and the predicate devices do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No clinical performance test set was used for this 510(k) submission. The assessment was a comparison to existing predicate devices and non-clinical biocompatibility testing. The data provenance for the biocompatibility test (ISO 10993) is a recognized international standard, but specific country of origin for the test itself is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. There was no clinical test set requiring expert ground truth establishment for performance evaluation in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set.

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 electrode for electrical stimulation/EMG biofeedback, not an AI-powered diagnostic device, and no MRMC study was conducted or required for this 510(k).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is an electrode, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the biocompatibility test: The "ground truth" is adherence to ISO 10993 standards and obtaining results within acceptable limits for biological safety.
• For substantial equivalence: The "ground truth" is the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-driven device requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. No training set was used.

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