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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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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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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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MFG-05 is intended to provide entirely non-invasive electromagnetic stimulation of the 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 MFG-05 is a non-invasive therapeutic device produces a magnetic field that interacts with the tissues of the human body. By stimulation of the pelvic floor musculature, the MFG-05 helps to treat of male and female urinary incontinence. The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels. One applicator is available for therapy and is positioned centrally under the pelvic floor of the patient while the patient is wearing sport pants or any other pants without metallic parts. The device is for prescription use and used by a trained medical professional in a professional healthcare facility. The main body of MFG-05 is used to control the function of magnetic stimulation. It is operated with parameters such as frequency, time and intensity. These parameters can be controlled by the user on screen display and with the help of a rotary knob at the user control panel.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing described is primarily device performance testing (e.g., electromagnetic compatibility, electrical safety, magnetic field intensity measurement, tissue heating simulation), not clinical studies involving patient data.

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

This information is not applicable or provided in the context of this regulatory submission. The document focuses on technical performance and compliance with recognized standards rather than expert-derived ground truth from clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable or provided. The testing described is against technical specifications and standards, not a review of clinical cases requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device, MFG-05, is a therapeutic device for muscle stimulation, not an imaging or diagnostic device that typically involves human readers or AI assistance in interpretation. The document compares the device to a predicate based on technical characteristics and performance standards.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable to the MFG-05. The device is a physical therapeutic device, not an AI algorithm. Its performance is evaluated through physical and electrical testing.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing is based on:

• Compliance with established voluntary standards: These standards define acceptable limits and testing methodologies for medical devices.
• Engineering specifications and design requirements: The device's performance (e.g., magnetic field intensity, temperature rise) is compared against its own design specifications.
• Comparison to predicate device's established performance: The safety and effectiveness are established by demonstrating that the MFG-05 performs comparably or within acceptable deviations from the legally marketed predicate device (HPM-6000UF).

8. The Sample Size for the Training Set

This information is not applicable as the MFG-05 is a physical medical device, not a machine learning or AI model that requires a training set.

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

This information is not applicable for the same reason as above.

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Pelvic Floor Muscle Stimulator (Model name: MagBelle AF180) 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 Pelvic Floor Muscle Stimulator (model: MagBelle AF180) is a non-invasive therapeutic device which produces electromagnetic field that interacts with the tissues in the pelvic region of the human body. The electromagnetic field delivered in the muscular tissue area triggers the muscle stimulation. MagBelle AF180 consists of the main unit and the chair applicator. The MagBelle AF180 is equipped with a color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters can also be set using the touch screen, buttons and knob on the device. During the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The subject device should only be used under the continued supervision or licensed practitioner. The device supports 3 different function modes: Magnetic stimulation function, Kegel biofeedback training function and Triggering magnetic stimulation function of Magnetic stimulation function and Kegel biofeedback training function).

The provided text describes a 510(k) premarket notification for a "Pelvic Floor Muscle Stimulator" (MagBelle AF180). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through a comprehensive clinical study with extensive statistical analysis of acceptance criteria. Therefore, the details requested in the prompt, such as specific acceptance criteria and detailed study outcomes with statistical measures, are not fully elaborated in the provided document in the typical format of a standalone clinical trial report.

However, based on the information provided, here's a summary of the available details regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All pre-determined acceptance criteria were met" for non-clinical testing. For the clinical data, the acceptance criterion was implicitly that the subject device's pelvic floor muscle strength measurements were "comparable" to a reference device. Specific quantitative criteria and detailed performance metrics are not provided in this regulatory summary.

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

• Sample Size for Kegel Biofeedback functionality test: 100 urinary incontinence patients (male and female, age range: 22-70).
• Data Provenance: The study was conducted "in a hospital set-up," implying a prospective study. The country of origin of the data is not explicitly stated but is likely China, given the submitter's location.

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

• Number of Experts: At least one clinician was involved in manually testing pelvic floor muscle strength using the modified Oxford Grading Scale. The document doesn't specify the number of additional clinicians or their specific qualifications (e.g., years of experience, specialty beyond "clinician").

4. Adjudication Method for the Test Set

• The document implies a comparison method where the subject device's measurements were calibrated and compared against manual assessment by a clinician and a reference device. It does not describe a formal expert adjudication method like "2+1" or "3+1." The clinician's manual assessment appears to serve as a form of ground truth or benchmark activity.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed or described. This device is a therapeutic device, not an AI diagnostic algorithm that assists human readers.

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

• The device itself is a standalone therapeutic device with a "Kegel Biofeedback functionality." The study assessed the performance of this functionality in measuring pelvic floor muscle strength, comparing its output to manual assessment and a reference device. This qualifies as evaluating a standalone function of the device.

7. The Type of Ground Truth Used

• For the Kegel Biofeedback functionality, the ground truth was established by:
  • Expert Clinical Assessment: Manual testing of pelvic floor muscle strength by a clinician using the modified Oxford Grading Scale.
  • Comparison to a Reference Device: Measurements from the subject device were compared to those from the legally marketed reference device, K201014 (MyOnyx System).

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of the clinical data presented. The 100 patients were used for verification and calibration of the Kegel biofeedback mode, which might imply a form of internal "training" or adjustment during development, but it's not described as a distinct training set for an AI/algorithm in the traditional sense. The focus here is on device function verification.

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

• As a training set is not explicitly mentioned, the method for establishing its ground truth is also not described. However, for the verification of the Kegel biofeedback mode, the calibration and comparison process involved manual assessment by a clinician and comparison with a reference device.

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