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The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency.

The Vivally System is a wearable, non-invasive, bladder control therapy with a mobile application to treat patients with the conditions of urge urinary incontinence and urinary urgency, without the need for surgery, implants, drugs, or needle-electrodes. The Vivally System utilizes neuromodulation to deliver electrical signals to the tibial nerve. The tibial nerve is a mixed (motor and sensory) peripheral nerve that feeds into the sacral plexus which contains the nerves that innervate the detrusor muscle surrounding the urinary bladder. The Vivally System also includes an analog input that measures the electromyogram (EMG) signal from the patient's foot via three additional EMG electrodes embedded on the Garment. The system operates in a combination of closed-loop using EMG as the physiological feedback, as well as in open-loop when the feedback signal is unreliable or unreadable. The main components of the Vivally System include a rechargeable-controller (Stimulator) powered by a rechargeable lithium-ion battery, an ankle worn Garment designed to be used on the left or right ankle, Gel Cushions and charging accessories. The Vivally System also includes a mobile application on the patient's personal device and a HIPAAcompliant cloud database. The Vivally Mobile Application allows the patient to start and manage a therapy session and provides access to condition support tools such as an electronic bladder diary to record symptoms, fluid intake and other factors impacting their condition and a record of therapy compliance. The HIPAA-compliant Vivally Cloud Database collects patient therapy statistics, therapy compliance and symptom tracking over time and can be accessed by the patient and physician as a tool to monitor and manage treatment.

Here is a summary of the acceptance criteria and study information for the Vivally System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the clinical study in the form of numerical thresholds for responder rates or symptom reduction required for clearance. Instead, it describes what was reported from the study. The FDA's conclusion indicates that the study demonstrated clinically meaningful improvement in UUI and urinary urgency symptoms.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set):
  • Intent-to-Treat (ITT) population: 96 subjects
  • Evaluable population: 94 subjects
  • Per Protocol (PP) population: 73 subjects
  • 6-month follow-up: 47 subjects
  • 12-month follow-up: 39 subjects
• Data Provenance: Prospective, multi-center study conducted at nine centers within the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document describes a clinical study where subjects reported their symptoms using a 3-day bladder diary. There is no mention of external experts establishing the ground truth for the test set. The patients themselves provided the data on their symptoms (UUI, urges, voids) which served as the "ground truth" for assessing effectiveness, as measured by symptom reduction and responder rates against their baseline.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The symptom data was derived from patient-recorded 3-day bladder diaries.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study was a single-arm clinical trial evaluating the device in a cohort of patients, not comparing human readers' performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the effectiveness outcomes presented are for the device (Vivally System) as a standalone treatment used by the patient at home. While personalization of therapeutic range was set by a physician, and a mobile application and cloud database are part of the system for therapy management and patient/physician access, the effectiveness results are based on the device's direct therapeutic action. The study assessed the device's ability to reduce symptoms and improve QOL.

7. The Type of Ground Truth Used

The ground truth for effectiveness outcomes was based on patient-reported symptoms recorded in a 3-day bladder diary at baseline and various follow-up periods. Quality of Life (QOL) assessments were also patient-reported using validated questionnaires (OAB-q, I-QoL, IIQ-7, PGIC, and OHG).

8. The Sample Size for the Training Set

The document describes a clinical study for product evaluation, not an AI/algorithm development study with distinct "training" and "test" sets in the typical machine learning sense. Therefore, there is no specified "training set" sample size for an algorithm in this context. The clinical study enrolled 96 subjects who served as the study population for evaluating the device's effectiveness.

9. How the Ground Truth for the Training Set Was Established

As there is no distinct "training set" in the context of an AI algorithm, this question is not applicable based on the provided text. The clinical study evaluated the device's performance directly using patient-reported outcomes as the "ground truth."

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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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The NURO Neuromodulation System (Stimulator model NURO 100) is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

The NURO Neuromodulation System is designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The NURO Neuromodulation System is a combination of the Stimulator with permanently attached single insulated lead wire, and number of single-use accessories which are sold separately, including: the acupuncture needle (provided in a single-use sterile package), needle holder, and electrode pad. The Stimulator is a small and portable pulse generator, and should only be used in conjunction with the lead wire and the single-use items listed above. The system also includes a micro USB-to-USB cable, and a USB wall charger. The Stimulator device provides treatment functions by purchasing therapy credits from a commercial website. Therapy credits are downloaded to the device through the micro-USB connection to a computer with a USB port and internet access. The Stimulator stores a record of the therapy credits purchased and available. Each therapy cycle uses a single credit. A therapy credit is required to be available on the Stimulator device in order to begin a patient treatment session. These therapy credits may be purchased with 99 as the maximum purchase. The Stimulator does not store or transfer via the USB cable any patient data. The credit transfer function is strictly a financial transaction. No patient data is stored or transferred by the Stimulator. There is no impact on safety or efficacy with purchase of therapy credits.

The NURO Neuromodulation System is a medical device designed to treat Overactive Bladder (OAB) and its associated symptoms. The submission K132561 focuses on establishing substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria met by specific device performance metrics in a clinical context. Therefore, the information typically requested for a study proving device performance against acceptance criteria (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not directly applicable or available in this 510(k) summary.

The document describes nonclinical performance testing focusing on meeting recognized electrical safety and electromagnetic compatibility standards, indicating that the device meets these technical requirements to ensure safety and effectiveness comparable to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The submission focuses on non-clinical performance testing against safety and electrical standards, not on a clinical test set with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. No clinical ground truth was established as part of this submission. The ground truth refers to the compliance with established electrical and safety standards.

4. Adjudication Method for the Test Set:
Not applicable. No clinical adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was conducted or reported. This submission establishes substantial equivalence based on technological characteristics and non-clinical performance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Not applicable. This device is a neuromodulation system for physical treatment and does not involve an algorithm with "standalone" performance in the context of diagnostic or interpretive AI. Its "performance" refers to its electrical output and safety characteristics.

7. Type of Ground Truth Used:
The "ground truth" for the non-clinical performance testing was the established requirements and specifications within the referenced IEC and cleaning validation standards.

8. Sample Size for the Training Set:
Not applicable. This submission does not involve a training set for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. There was no training set for an AI/ML algorithm.

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The Urgent PC Neuromodulation System is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.

The provided text does not contain a study that proves the device meets specific acceptance criteria in the manner requested. The document is a 510(k) premarket notification for the Urgent® PC Neuromodulation System. It highlights that the "new device" is substantially equivalent to a previously cleared predicate device (K071822). The primary difference noted is a change in the wording of the indications statement to incorporate "Overactive Bladder (OAB)" terminology, which is described as an "update in wording rather than a change in the device patient population."

Therefore, the submission relies on the established performance and safety of the predicate device, rather than presenting new clinical study data with specific acceptance criteria and detailed performance metrics for the updated device itself.

Based on the provided information, I cannot complete the requested tables and details as the document does not include a new study with explicit acceptance criteria and corresponding performance data for the device.

Here's an explanation of why the requested information cannot be extracted:

• No explicit acceptance criteria or measured performance: The document states that the "Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use," but it does not provide any specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or clinical efficacy rates) or reported performance values against those criteria.
• No new study details: The submission is a 510(k) for substantial equivalence, not a new clinical trial reporting primary endpoints and statistical analysis. It does not describe a study involving test sets, ground truth establishment, expert adjudication, or MRMC studies.

In summary, the provided document is a regulatory submission asserting substantial equivalence to a predicate device, and thus does not contain the detailed study information (acceptance criteria, sample sizes, ground truth methodology, etc.) that would typically be found in a clinical study report.

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The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.

The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.

The provided document is a 510(k) Pre-market Notification for the Urgent® PC Neuromodulation System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with specific acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) application.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission states that the new device and the predicate device are "technologically the same" and that the new device "allows for the successful performance of the product's intended use," implying that its performance is equivalent to the predicate, but no specific performance metrics or acceptance criteria are given.
2. Sample size used for the test set and the data provenance: Not applicable, as no new clinical study data is presented for this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary from the document:

The Urgent® PC Neuromodulation System (K071822) is being cleared as substantially equivalent to a previously cleared device (Urgent® PC Neuromodulation System, K061333). The basis for this equivalence is that:

• Both devices have the same intended use: to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.
• They are technologically the same: percutaneous tibial nerve stimulator devices with lead sets, intended to deliver retrograde access to the sacral nerve.
• Both have the same principles of action.
• The only difference is in the Instructions for Use.

The submission concludes that the new device allows for the successful performance of its intended use based on its substantial equivalence to the predicate, implying that the predicate's performance history and regulatory clearance serve as the "proof" for the new device.

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The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.

The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.

The provided text is a 510(k) summary for the Uroplasty, Inc. Urgent® PC Neuromodulation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance metrics. Therefore, many of the requested details about a study proving device performance against acceptance criteria are not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or provide a table of performance metrics for the Urgent® PC Neuromodulation System itself. The submission is a Special 510(k), which typically relies on comparisons to changes made in a previously cleared device. The key acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device.

The "Performance" section explicitly states: "The Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use." This is a qualitative statement, not a quantified performance metric.

2. Sample Size Used for the Test Set and Data Provenance:

No test set or associated sample size is mentioned. This submission is a Special 510(k) for a modification to an already cleared device, not a new clinical study. The submission focuses on technological equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. No test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set:

Not applicable. No test set is described.

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 a neuromodulation system, not an AI-powered diagnostic device, and no MRMC study is mentioned.

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

Not applicable. This device is a neuromodulation system, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No ground truth is established as there is no new clinical trial described. The "ground truth" for the 510(k) revolves around demonstrating the device's technological and safety equivalence to its predicate.

8. The Sample Size for the Training Set:

Not applicable. This device is a neuromodulation system, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set is described.

Summary of what the document does communicate:

• Device: Urgent® PC Neuromodulation System, used for percutaneous tibial nerve stimulation (PTNS) to treat urinary urgency, frequency, and urge incontinence.
• Regulatory Pathway: Special 510(k) (K061333).
• Predicate Device: Urgent® PC Neuromodulation System (K052025).
• Key Argument for Equivalence: The new and predicate devices are "technologically the same" with similar intended uses and principles of action. Any differences are stated not to raise concerns about safety or effectiveness.
• Conclusion: The device is substantially equivalent to the previously cleared predicate.

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The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.

The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.

The provided text is a 510(k) premarket notification summary and the FDA's clearance letter for the Uroplasty, Inc. Urgent® PC Neuromodulation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a new product.

Therefore, the document does NOT contain information on:

• A table of acceptance criteria and reported device performance based on a new study.
• Sample sizes used for a test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.).
• Sample size for a training set.
• How ground truth for a training set was established.

Explanation Based on Provided Text:

The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (UroSurge® Percutaneous SANS™ Device, K992069). This means the focus is on showing that the new device has the same intended use, technological characteristics, and principles of operation, and that any differences do not raise new questions of safety or effectiveness.

The "Performance" section within the 510(k) summary states: "The Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use." This is a declarative statement of perceived performance, not a report of a specific study with defined acceptance criteria and quantitative results.

The FDA's decision letter confirms this approach, stating "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

In summary, there is no detailed study described in this document that would provide the requested information regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement for a performance study. The device's "performance" is implicitly accepted because it is deemed substantially equivalent to a device already cleared by the FDA.

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