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The ReGenesis EMS Chair is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both male and female patients.

The ReGenesis Chair is an electromagnetic muscle stimulation device. It is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both adult male and female patients. This is intended to be operated by trained professionals only.
The ReGenesis EMS Chair consists of the main unit (the chair) and a wired, color, touch screen, control Panel. The device consists of a control unit that internally houses a power supply, cooling system, user interface, and control system. The electromagnetic coil is contained in the chair applicator, which is fashioned as a seat for the patient. The subject device uses electromagnetic fields to stimulate the muscles of the pelvic floor.

This document is a 510(k) clearance letter for a medical device and does not contain the acceptance criteria or results of a study demonstrating the device meets those criteria. The primary purpose of a 510(k) summary is to establish substantial equivalence to a predicate device, not necessarily to detail comprehensive clinical performance or specific acceptance criteria.

The "Non-Clinical Testing" section mentions that "All pre-determined acceptance criteria were met," but it does not list what those criteria are nor does it provide a table of acceptance criteria versus reported performance.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the provided document:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in the document. The document mentions "All pre-determined acceptance criteria were met" for non-clinical and performance bench testing, but does not provide the criteria themselves.
• Reported Device Performance: Not explicitly stated in a quantitative manner against specific acceptance criteria. The document only confirms that the non-clinical tests were "successfully completed" and "All pre-determined acceptance criteria were met."

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

• Since no clinical study results are detailed, there is no information provided on the sample size for a clinical test set or its provenance. The testing mentioned is non-clinical bench testing.

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

• Not applicable based on the provided document. The document describes non-clinical bench testing, not a study involving human experts to establish ground truth for a test set.

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

• Not applicable based on the provided document. No clinical study with adjudicated ground truth establishment 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 versus without AI assistance:

• No, an MRMC comparative effectiveness study was not done or is not reported in this document. The device is an electromagnetic muscle stimulation device, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable in the context of an "algorithm." The ReGenesis EMS Chair is a physical device that delivers electromagnetic stimulation. The "Software Verification and Validation Testing" indicates software is involved, but "standalone" performance in the sense of an algorithm making a diagnosis or prediction is not relevant here. The device's primary function is a physical intervention.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" would be defined by engineering specifications and recognized standards (e.g., electrical safety limits, electromagnetic compatibility limits, mechanical durability expectations, temperature thresholds).

8. The sample size for the training set:

• Not applicable. The document describes a physical medical device. It does not mention any machine learning or AI components that would require a "training set" in the typical sense.

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

• Not applicable. As above, no training set for an AI algorithm is mentioned.

Summary of what is available from the document regarding acceptance criteria and study:

The document states that non-clinical testing was performed to demonstrate substantial equivalence to the predicate device. These tests included:

• Electrical Safety testing (per IEC 60601‐1: 2020)
• Electromagnetic Compatibility testing (per IEC 60601‐1-2: 2020)
• Nerve and muscle stimulator specific requirements (per IEC 60601-2-10:2016)
• Software Verification and Validation Testing (per FDA guidance)
• Performance bench data, including:
  • Service life verification test
  • Stimulation Coil Surface Temperature Rise Test

The document explicitly states: "All pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria for each of these tests and the reported quantitative performance are not detailed in this 510(k) summary. The sample size for these bench tests (e.g., how many units were tested for service life or temperature rise) is also not provided.

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STIM: Electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in adult women.
EMG: Relaxation muscle training and muscle re-education.
ETS: Treatment of stress, urge or mixed urinary incontinence by assessing EMG activity of the pelvic floor and strengthening pelvic floor muscles using electrical stimulation.
This device is intended to be used by adult women (aged above 22 years).

The NeuroTrac® MyoPlus Pro is a single-channel pelvic floor muscle stimulator (STIM) designed to assist patients with urinary incontinence to increase muscle control and overcome pelvic muscle dysfunction. It can also act as an electromyograph (EMG) and features an EMG-triggered stimulation (ETS) mode. The stimulation waveform is symmetrical, rectangular and biphasic. Stimulation is delivered using a vaginal probe. The vaginal probe included with the subject device was cleared under K122194. The subject device may either be operated directly by the prescribing physician, or by the patient as instructed by the physician.

I apologize, but the provided text from the FDA 510(k) Clearance Letter for the NeuroTrac® MyoPlus Pro (MYO120U) does not contain any information regarding the specific acceptance criteria for a study proving device performance, nor details about such a study itself.

The document primarily focuses on:

• The FDA's determination of substantial equivalence of the NeuroTrac® MyoPlus Pro to predicate devices.
• Regulatory information such as classification, product codes, general controls, and compliance requirements.
• Device description: its functions (STIM, EMG, ETS), and technical specifications.
• Comparison of technological characteristics with predicate devices.
• A list of nonclinical testing performed (Electrical Safety, EMC, Software V&V, Cybersecurity).

While it states, "All pre-determined acceptance criteria were met" under the "SUMMARY OF NONCLINICAL TESTING" section, this refers to the engineering and software testing listed (e.g., meeting IEC standards for electrical safety, validating software functionality, managing cybersecurity risks). It does not refer to a clinical performance study evaluating the device's effectiveness in treating urinary incontinence or muscle re-education against specific clinical performance metrics.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance: This level of detail about clinical performance criteria and results is not present.
2. Sample size used for the test set and data provenance: No clinical test set details are provided.
3. Number of experts and their qualifications for ground truth: Not applicable as no clinical study for ground truth establishment is mentioned.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study details: No such study is mentioned.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm being evaluated in isolation.
7. Type of ground truth used: Not applicable for a clinical performance study. The "ground truth" implicitly for the engineering tests is compliance with specified standards.
8. Sample size for the training set: Not applicable as this document does not describe the development or validation of a machine learning model.
9. How ground truth for the training set was established: Not applicable.

To answer your request, clinical study reports with detailed performance results against pre-specified acceptance criteria would be necessary, which are not included in this 510(k) clearance letter. Manufacturers typically submit such reports as part of their 510(k) submission, but this public letter only summarizes the outcome and key points.

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The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Levina Pelvic Floor Muscle Stimulator is a non-implantable, home use device for the treatments of stress, urge, and mixed urine incontinence through the intravaginal probe's electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions, which help users to achieve pelvic floor muscle strengthening for maintaining urinary continence in women. The subject device includes a remote control, a stimulator pod and a vagina stimulation probe. Both the remote control and the stimulator pod are powered by an off-the-shelf 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control the stimulator pod. The stimulator pod has two output channels and will perform electrical stimulation according to the parameter settings sent by the remote control. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe.

The provided text is a 510(k) summary for the Levina Pelvic Floor Muscle Stimulator, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria based on clinical outcomes or diagnostic accuracy. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics (like sensitivity, specificity, human reader improvement with AI, etc.) is not present.

However, the document does contain information about "Non-Clinical Testing" with "pre-determined acceptance criteria" which were met. I will extract and organize the available information based on your request.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document states: "All pre-determined acceptance criteria were met." but does not provide specific numerical targets or the results from the non-clinical tests in a detailed table format. It lists the types of tests performed.

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

This document primarily discusses non-clinical engineering and software testing. It does not refer to "test sets" in the context of clinical data (e.g., patient cases) or population-based data. Therefore, this information is not applicable or available in this document.

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

This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set.

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

This information is not applicable as the document does not describe a clinical study involving adjudication of a 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:

This information is not applicable. The device is a "Pelvic Floor Muscle Stimulator," an electrical therapy device, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable as the device is a physical stimulator and not an algorithm-only diagnostic or AI solution. The "Software Verification and Validation Testing" refers to the embedded software in the device, not a standalone AI algorithm for interpretation.

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

For the non-clinical tests, the "ground truth" would be defined by the technical specifications and requirements outlined in the referenced international standards (e.g., ISO 10993, IEC 60601 series). For example, electrical safety "ground truth" would be the specified limits for leakage current or dielectric strength. There is no clinical "ground truth" discussed in this document.

8. The sample size for the training set:

This information is not applicable. The document describes a physical medical device and its non-clinical engineering and software testing, not a machine learning model that would require a "training set."

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

This information is not applicable for the same reasons as point 8.

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The device is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.

The BTL-398 is a non-invasive therapeutic device that delivers magnetic pulses to stimulate the pelvic floor muscles for the treatment of urinary incontinence in adult population. The BTL-398 device is intended for professional use in healthcare facilities as a prescription use only. The BTL-398 consists of a main unit and a Chair Applicator. The main unit consists of the electromagnetic field generators, the microprocessor-driven control unit, and the touch-screen control panel. The Chair Applicator is designed for non-invasive treatment of urinary incontinence. The magnetic coil is in the center of the seat, and its position is user-adjustable during therapy. Ongoing therapy is indicated by illuminated segments. The Chair Applicator is designed for precise patient positioning, ensuring the most appropriate posture before and during therapy. Prior to High-Intensity Focused Electromagnetic (HIFEM) therapy, the seat height and coil position can be adjusted using an attached remote controller. The Dynamic HFEM Technology (DHT) feature ensures the coil is optimally positioned at the right location beneath the patient before starting therapy. At the start of therapy, air is circulated through the seat cushion with the Pressure Wave Technology (PWT) feature (intensity of the PWT function is set based on patient feedback). The PWT feature helps patients maintain the correct therapeutic position during therapy. Both the PWT and DHT features can be readjusted, and the PWT feature can be turned off, at any time during the session. The touch screen display guides the user step-by-step through the entire therapy procedure. During therapy, the screen displays information about the applied therapy, remaining therapy time, and main therapy parameters. Therapy is administered through clothing.

The provided text is a 510(k) Premarket Notification from the FDA for a device called "BTL-398". This document primarily focuses on demonstrating substantial equivalence to a predicate device (HPM-6000UF) for regulatory clearance. It does not include information about clinical studies with human participants, AI components, or detailed performance data against acceptance criteria for such clinical or AI-specific assessments.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment, particularly concerning AI or human-in-the-loop performance, cannot be extracted from this document. The document explicitly mentions "non-clinical testing" and "performance bench data," suggesting that equivalence was primarily established through engineering and electromagnetic performance tests, not clinical efficacy trials for the UI treatment itself.

However, I can extract information related to what was used for acceptance and testing:

Acceptance Criteria and Device Performance (Based on "Non-clinical Testing")

Study Details (as per available information):

1. A table of acceptance criteria and the reported device performance:
   (See table above) The document states, "All pre-determined acceptance criteria were met." However, it does not provide specific numerical targets or results for the bench performance tests (e.g., exact magnetic field strength measured vs. target range). It only confirms compliance with standards and successful completion of tests.

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of human subjects or AI test sets. The testing described is non-clinical bench testing of the device's electrical, mechanical, thermal, electromagnetic, and software functions.
   • Data Provenance: N/A for clinical data. The data is from internal bench testing (performance bench 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 for clinical outcomes or diagnoses is not mentioned as this was primarily non-clinical testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. No human reader or expert adjudication process for clinical data or AI output 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:
   No MRMC study was mentioned. The device is a non-invasive electromagnetic stimulator, not an imaging or diagnostic AI device that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable for an AI algorithm. The device, the BTL-398, is a physical medical device. Its software functions were verified and validated, but this does not imply an AI component in the typical sense of diagnostic or image analysis AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests, the "ground truth" was established based on engineering specifications and compliance with recognized standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance for software verification and validation. For magnetic field strength, coil surface temperature, and PWT features, the ground truth would be the expected performance range derived from design specifications.

8. The sample size for the training set:
   Not applicable. No machine learning training set is mentioned.

9. How the ground truth for the training set was established:
   Not applicable. No machine learning training set is mentioned.

Summary of what the document focuses on:

The entire document pertains to establishing substantial equivalence of the BTL-398 to a predicate device (HPM-6000UF) through non-clinical testing. The key differences noted between the subject device (BTL-398) and the predicate are the inclusion of a "PWT feature" (Pressure Wave Technology for patient positioning) and a "DHT Feature" (Dynamic HFEM Technology for coil adjustment). The non-clinical tests were conducted to ensure these new features and the overall device design do not raise new questions of safety or effectiveness.

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For Prescription and Home Use by prescription from a medical professional:
The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.

As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• increasing local blood circulation
• immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
• Muscle re-education

As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:

• Helps to relearn voluntary motor functions of the extremities.

TrainFES' Advanced intended population is anybody aged 22 or over.

Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.

Platform: TrainFES is a battery-powered, wireless device, accessible through software.

TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone.

TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.

The provided document describes the FDA 510(k) premarket notification for the "TrainFES Advanced" device, a neuromuscular electrical stimulator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (Stella BIO, K210002).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the device's performance in a quantitative manner (e.g., target accuracy, sensitivity, specificity). Instead, the substantial equivalence justification relies on demonstrating that the TrainFES Advanced device performs similarly to or meets the safety and effectiveness standards of the predicate device, K210002.

The table below summarizes the comparison of key technical characteristics between the TrainFES Advanced and its predicate, Stella BIO, highlighting where "performance" is discussed in terms of meeting relevant standards or being considered equivalent. The reported "performance" for TrainFES Advanced is intrinsically linked to its compliance with these standards and the assertion that differences do not raise new safety or effectiveness concerns.

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Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Not Found

I apologize, but this document does not contain the information you requested regarding acceptance criteria and the comprehensive study details.

The document is an FDA 510(k) clearance letter for a "Pelvic Floor Stimulator (Intrelief PFE)." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Results of a standalone (algorithm-only) performance study.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• How ground truth for any training set was established.

This letter focuses on the regulatory clearance process rather than providing a detailed technical or clinical study report.

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Fotona StarFormer is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the seat of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current which causes muscle contraction in the entire pelvic floor area, increasing the strength and endurance of the pelvic floor. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and a chair.

This document describes the StarFormer device, a non-invasive electromagnetic stimulator for pelvic floor muscles, and its substantial equivalence to a predicate device (Neotonus Model 100 Muscle Stimulator System).

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for clinical efficacy and corresponding device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Neotonus Model 100 Muscle Stimulator System). The acceptance criteria were met for nonclinical testing.

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

The document does not describe a clinical study for the StarFormer device's efficacy, nor does it specify a test set for clinical performance. The clearance is based on substantial equivalence to a predicate device and non-clinical bench testing. Therefore, there is no sample size for a clinical test set or data provenance related to a clinical study.

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

Since no clinical study is described for the StarFormer device itself, there is no mention of experts used to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set

As there is no described clinical test set for the StarFormer device's efficacy, there is no adjudication method mentioned.

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

No MRMC comparative effectiveness study was mentioned or performed. The clearance is based on non-clinical testing and substantial equivalence to a predicate device, not on a clinical trial comparing human readers with and without AI assistance.

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

The StarFormer device provides electromagnetic stimulation; it is a therapeutic device, not an AI-based diagnostic tool or analysis algorithm meant to operate standalone in a diagnostic context. Therefore, a standalone algorithm-only performance study, as typically understood for AI/ML devices, was not performed or relevant. The device's performance relies on its physical output (magnetic fields) and its mechanism of action on the human body.

7. The Type of Ground Truth Used

For the non-clinical tests (electrical safety, EMC, software, cybersecurity), the ground truth is established by adherence to recognized international and FDA standards/guidances. For the magnetic field strength, the "ground truth" would be the measured output of the device itself compared to its design specifications.

There is no ground truth described for clinical efficacy for the StarFormer device, as no clinical study for its efficacy is presented. The substantial equivalence argument relies on the predicate device's proven efficacy for similar indications.

8. The Sample Size for the Training Set

The StarFormer device is described as a non-invasive therapeutic device that uses electromagnetic stimulation; it is not presented as an AI/ML-based diagnostic or predictive system that typically requires "training sets." Therefore, there is no mention of a training set or its sample size.

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

As there is no training set for an AI/ML component, this question is not applicable.

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The Konmed Incontinence Stimulation Electrode include Vaginal Probe KM-504, KM-505, KM-506, KM-507, KM-5013 & Rectal Probe KM-502. KM-5018 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Konmed Incontinence Stimulation Electrode" does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

This document is a standard FDA clearance letter, which primarily states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and other administrative requirements.

To answer your request, a document detailing the verification and validation (V&V) testing performed by the manufacturer, including specific acceptance criteria and study results, would be necessary. This information is typically found in the 510(k) submission itself, which is not fully provided here.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement, as that data is absent from the provided text.

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Levina Incontinence Stimulation Electrodes are intended to provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Levina Incontinence Stimulation Electrodes are used to treat incontinence when paired with compatible, FDA-cleared electrical stimulators. The probes are intended to provide electrical stimulation to pelvic musculature and for the purpose of rehabilitation of pelvic floor muscles and restoration of neuromuscular control during treatment. The probes come in different models and are available for both vaginal and rectal insertion. The probes are used directly by the patients for home care and are for single-patient, repeat-use. The device comes non-sterile and should be cleaned before and after each use with water and mild soap or neutral detergent.

The provided text describes the 510(k) summary for the Levina Incontinence Stimulation Electrodes. However, it does not describe studies involving AI, human readers, or image analysis for diagnostics. The device is a physical electrode used for electrical stimulation and EMG feedback in treating urinary incontinence.

Therefore, many of the requested points regarding acceptance criteria and study details for an AI-powered diagnostic device, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and effect sizes of AI assistance, are not applicable to this submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on:

1. Indications for Use: Identical.
2. Technological Characteristics: Similar, with minor differences in materials, electrode surface area, probe length, and diameter, which are deemed not to raise new questions of safety or effectiveness.
3. Non-clinical Performance Testing: Primarily focused on biocompatibility, reprocessing instructions, and electrical/mechanical integrity (e.g., visual inspection, size measurement, impedance testing, stability tests like cycling, bending, and tensile strength of lead wires).

Given this, I cannot provide a table of acceptance criteria and reported device performance in the context of an AI-driven diagnostic as requested. The "performance" for this device relates to its physical and functional integrity, not to diagnostic accuracy metrics like sensitivity, specificity, or AUC which would be relevant for an AI system. No ground truth establishmen or adjudication methods as they relate to diagnostic interpretation are present in the document.

Summary of what can be extracted from the document:

• Device Name: Levina Incontinence Stimulation Electrodes
• Intended Use: To provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
• Key Comparison Points for Substantial Equivalence:
  • Identical: Product Code, Regulation Number, Regulation Name, Regulatory Class, Indication for Use, Prescriptive or Over-The-Counter Use, Electrode Placement, Environment of Use, Target Population, Usage Conditions, Sterility.
  • Similar (with justification for equivalence): Materials (medical grade PC, Stainless Steel vs. ABS, Stainless Steel), Reprocessing-Cleaning.
  • Different (with justification for equivalence): Electrode Surface Area, Probe Length, Probe Diameter. These differences are described as being "within the normal range for other cleared devices of this device type."

Regarding "Acceptance Criteria" for this specific device:

The acceptance criteria here are implicitly met through the non-clinical testing demonstrating the device's physical and electrical safety and performance in line with recognized standards and similarity to the predicate. The "study" proving this involves the specific bench testing outlined:

1. A table of acceptance criteria and the reported device performance:

For this type of device (electrodes), the "acceptance criteria" are not reported as specific numerical cutoffs for diagnostic performance, but rather as successful completion of required testing for safety and functional integrity.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI diagnostic with a test set of data. The testing involves actual device units. The number of samples for each bench test is not specified in this summary, but typically involves a representative sample size per standard requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic interpretation is not relevant for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

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 (expert concensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic AI. The "ground truth" for this device is its adherence to physical specifications, material properties, and electrical integrity, verified by standard bench testing and material analyses.

8. The sample size for the training set: Not applicable. This is not an AI diagnostic device.

9. How the ground truth for the training set was established: Not applicable.

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Unicare is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Unicare is battery powered, single-channel, home-use electrical pelvic floor muscle stimulator. The device is supplied with a non-sterile, reusable (single-patient use) vaginal probe and self-adhesive electrodes which connect to the control unit by cable and plugs. The vaginal probe is inserted into the vagina. The optional self-adhesive electrodes is placed on patients' intact skin and is used for the treatment of only urge urinary incontinence in women. Electrical stimulation is delivered via the vaginal probe or the self-adhesive electrodes to the pelvic floor muscles. This electrical muscle stimulation works as a rehabilitation and training for pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women. The level of electrical stimulation of the Unicare can be controlled by the end user using manual push-button controls. This device is intended for over the counter (OTC) use.

The provided document does not contain information related to software-based medical devices that would involve acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set information as typically found for AI/ML-driven diagnostics.

The document is an FDA 510(k) clearance letter for a non-implanted electrical continence device called "Unicare." This device is a hardware product that provides electrical stimulation for pelvic floor muscles. The "Non-Clinical Testing" section lists various engineering and safety tests performed on the device (biocompatibility, electrical safety, electromagnetic compatibility, software verification/validation, battery life), but these are standard engineering tests for hardware and software aspects of a physical device, not performance studies for an AI/ML algorithm or diagnostic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for device performance in the context of AI/ML or diagnostic accuracy from this document. The information requested (e.g., sample size for test set, data provenance, expert adjudication, MRMC studies, ground truth types) is specific to studies evaluating the performance of diagnostic algorithms, particularly those involving image analysis or similar AI/ML applications, which is not applicable to the "Unicare" device described.

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