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ZIDA Wearable Neuromodulation System is a neuromodulation system that is intended to treat patients with an overactive bladder (OAB) and associated symptoms of urinary frequency, and urge incontinence.

ZIDA Wearable Neuromodulation System (ZIDA System) is a home-use system that is a neuromodulation system designed to deliver non-invasive access to the sacral nerve plexus through transcutaneous electrical stimulation of the posterior tibial nerve. The method of treatment is referred to as Transcutaneous Tibial Nerve Stimulation (TTNS).

The ZIDA System is a combination of the battery powered ZIDA Control Unit and the ZIDA Embedded Garment (Sock or Tights).

The provided text describes a 510(k) summary for the ZIDA Wearable Neuromodulation System, demonstrating its substantial equivalence to a predicate device (Urgent PC Neuromodulation System). However, it does not explicitly detail "acceptance criteria" and "reported device performance" in a quantitative manner that would allow for a direct filling of a table as requested. The text focuses on clinical outcomes and safety rather than pre-defined performance metrics for the device itself against set criteria.

The clinical study described is a comparative effectiveness study against a sham control, not a direct comparison of the ZIDA device's performance against specific, pre-determined numerical acceptance criteria for its output or diagnostic capabilities. The study assesses the effectiveness of the device in treating OAB symptoms, which is a clinical outcome, not a device output performance metric.

Therefore, I cannot populate a table of acceptance criteria and reported device performance directly from the provided text in the way typically expected for a medical device's technical specifications or diagnostic accuracy.

However, I can extract and infer information related to the clinical study's success metrics and other requested points:

1. A table of (Inferred Clinical) Acceptance Criteria and Reported Device Performance

Based on the clinical study's primary endpoint for effectiveness:

Additional Performance Observations:

• Greater decrease in the number of urgent episodes from baseline to Week 12 compared to sham control.
• Greater decrease in the number of incontinence episodes from baseline to Week 12 compared to sham control.
• Greater decrease in the total number of voids per day from baseline to Week 12 compared to sham control.
• Improved quality of life compared to sham control. |
  | Safety: Device-related adverse events. | Reported Device-Related AEs: Two subjects reported a mild AE of pain in the foot during or immediately after treatment that resolved within half an hour of treatment cessation. These were considered expected mild AEs. Other reported AEs (urinary tract infection) were not considered related to study treatment. |

Note: The document details compliance with various electrical safety, usability, and biocompatibility standards (e.g., IEC 60601-1, ISO 10993-5, -10). These are implied "acceptance criteria" for the device's design and manufacturing, but the document does not provide specific numerical test results for these standards.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size:
  • First clinical investigation: 23 subjects (stopped early).
  • Second clinical investigation: 40 subjects.
  • Total for effectiveness and safety evaluation: 63 subjects (randomized 1:1 to treatment or sham).
• Data Provenance: United States, single center. The studies were described as "clinical investigations," implying a prospective nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The ground truth for the clinical study was based on patient-reported outcomes (urinary urgency, frequency, incontinence from bladder diaries) and Quality of Life questionnaires (OAB-q Short Form).
• The text does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy or image interpretation, as this device is a neuromodulation therapy system, not a diagnostic tool that requires expert interpretation for ground truth. Patient symptom diaries serve as the primary "ground truth" for effectiveness in this therapeutic context.

4. Adjudication method for the test set

• The text does not describe an adjudication method (like 2+1 or 3+1) for the clinical study data. The primary data collection seems to be via patient self-report (bladder diaries) and standardized questionnaires. Clinical investigators would have monitored and collected this data.

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, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic AI devices where human readers interpret medical images with or without AI assistance. The ZIDA Wearable Neuromodulation System is a therapeutic device, not an AI-powered diagnostic tool, so an MRMC study is not applicable.

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

• Not applicable. The ZIDA device is a therapeutic neuromodulation system, not an algorithm, so "standalone performance" in the context of AI is not relevant. The device's "standalone" performance is its therapeutic effect, which was assessed in the clinical trials against a sham control.

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

• Outcomes Data (Patient-reported): The ground truth for evaluating the device's effectiveness was based on patient-reported symptoms from bladder diaries (urinary urgency, urinary frequency, urge incontinence) and Quality of Life (QoL) scores.

8. The sample size for the training set

• The document does not mention a "training set" in the context of an AI/ML model for this device. This is a medical device, not an AI model, for which a training set would be defined. The clinical studies described are for validation of the device's safety and effectiveness, not for training a model.

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

• Not applicable, as there is no mention of a training set for an AI/ML model.

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