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ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence in adult women.

ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women.

The ApexMV device is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women for Over-the-Counter use. The ApexMV device is to be distributed as a kit that contains the following items:

• · 1 ApexMV device
• 1 4 pack of AA batteries
• · 1 2 oz. tube of InControl Medical Electrode Gel**
• 1 ApexMV IFU/ User Manual
• · 1 ApexMV Quick Reference Card
• 1 Screw driver
• 1 Travel Bag
• 1 Animation Video

The ApexMV device consists of a hand held control unit with bio-feedback and inflation pump attached to a customizable inflatable probe via flexible tubing. The customizable inflatable probe is inserted vaginally or rectally and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is also used to improve the ability of the muscles to hold a contraction for an extended period of time for the treatment of stress, urge, or mixed urinary and/or fecal incontinence in adult women. During a session, high and low frequency stimulation is delivered by the device. The higher frequency stimulation is delivered to specific muscles to encourage their contraction, strengthening the muscles and helping the end user recognize which muscles to activate during self-directed contractions. Lower frequency stimulation calms the detrusor muscle, decreasing symptoms of urgency. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.

This document describes the regulatory submission for the ApexMV device, which is a non-implantable muscle stimulator for treating urinary and/or fecal incontinence in adult women.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for performance metrics. Instead, the "acceptance criteria" are implied by the successful completion of various tests and the determination of substantial equivalence to previously cleared predicate devices. The reported "device performance" is primarily qualitative, stating that the device "successfully passed all of this testing" and is "safe and effective."

Below is a table summarizing the tests performed and the reported outcomes, which implicitly serve as the device meeting the acceptance criteria for regulatory clearance:

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

• Test Set Sample Size:
  • For the Human Factors Usability Study, the document states "the subject/end users were able to properly self-identify...". However, it does not specify the exact number of participants (sample size) in this study.
  • For other tests (Software, Electrical Safety, EMC), sample sizes are not applicable in the same way as clinical studies. These typically involve testing the device itself or its components against a set of standards.
  • For clinical literature evaluation, no specific sample size from a new study is mentioned; instead, it's a review of existing literature on predicate devices.
• Data Provenance:
  • Human Factors Usability Study: Prospective study, conducted specifically for the ApexMV device. The country of origin for the study is not explicitly stated, but the submitter is InControl Medical, LLC, located in Brookfield, WI, USA, suggesting the study was likely conducted in the US.
  • Clinical Literature Evaluation: Retrospective (review of existing literature). The origin of this data would be diverse, based on the studies reviewed.
  • Software, Electrical Safety, EMC, Biocompatibility: These are engineering and bench tests, not directly involving patient data. For biocompatibility, the data used was retrospective from previous predicate device submissions.

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

• Human Factors Usability Study: The document states that the study was "conducted with collaboration with a supervising physician." This indicates at least one physician was involved in supervising and possibly establishing the ground truth regarding patient self-identification and safe device use based on labeling. Specific qualifications (e.g., years of experience, specialty beyond "physician") are not detailed.
• Clinical Literature Evaluation: An "appraisal of each article was completed." This implies experts reviewed the literature, but the number or specific qualifications of these experts are not provided.
• Other tests: Ground truth establishment by experts as described for medical image analysis is not directly applicable to these engineering and bench tests. Compliance with standards is the "ground truth."

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

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the Human Factors Usability Study. The assessment seems to be based on whether participants "were able to properly self-identify" and "complete critical tasks successfully" with the guidance of the supervising physician. For the clinical literature review, an "appraisal" was done but no specific adjudication process is mentioned.

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 comparative effectiveness study was done. The ApexMV device is a muscle stimulator, not an AI software intended to assist human readers in interpreting medical images. The primary evaluation method was substantial equivalence to existing predicate devices and direct testing of the device's adherence to safety and performance standards, and user interaction.

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

The ApexMV is a direct-to-consumer medical device used by the patient. Its "standalone performance" refers to its electrical stimulation characteristics and biofeedback capabilities operating as designed, independent of a clinician's direct real-time intervention for each session. The software and electrical safety tests can be considered evaluations of its standalone functional performance against specifications.

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

• For Human Factors Usability Study: The ground truth was established by the performance of the test subjects in self-identifying and successfully using the device, as assessed by a supervising physician and the study protocol. The "ground truth" for self-identification was based on the subjects' actual condition and their ability to determine it based on the provided labeling.
• For Electrical Safety, EMC, Software, Biocompatibility: The "ground truth" is adherence to established international and FDA-recognized standards and internal specifications. For biocompatibility, the ground truth was established from previous testing on identical materials in predicate devices.
• Clinical Literature Review: The ground truth here is the evidence for safety and efficacy of similar electrical stimulation technologies as established and published in existing clinical literature.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or AI models. This device is an electrical stimulator, not an AI/ML diagnostic or assistive tool, so a training set in that sense is not applicable. The device's design and features are based on the established technology of predicate devices and general engineering principles.

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

As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The "ground truth" for the device's design and performance claims is established through compliance with regulatory standards, engineering principles, and demonstration of substantial equivalence to already-cleared devices.

Ask a specific question about this device

ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

ApexM is a hand-held, home-use device designed to treat female urinary incontinence. The device includes an inflatable probe. The inflatable probe is inserted into the vagina and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, high and low frequency stimulation is delivered by the device. The higher frequency stimulation is delivered to specific muscles to encourage their contraction, strengthening the muscles and helping the end user recognize which muscles to activate during self-directed contractions. Lower frequency stimulation calms the detrusor muscle, decreasing symptoms of urgency. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.

This document, K150183 for the ApexM device, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study for the new device itself. The information provided is primarily a comparison between the new device (ApexM) and two predicate devices (InTone and Apex) to show that the ApexM is equally safe and effective.

Therefore, many of the requested elements for acceptance criteria and a study proving the device meets them cannot be directly extracted as if a new, standalone performance study was conducted for ApexM with specific quantitative acceptance criteria. Instead, the document relies on comparing features and prior testing of predicate devices.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations:

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

Since this is a substantial equivalence submission, explicit "acceptance criteria" for the new device's performance (e.g., "device must achieve X% sensitivity") are not stated in the provided text. The "reported device performance" is essentially that its features and technical specifications are substantially equivalent to the predicates, which have presumably met their own performance and safety requirements.

We can, however, extrapolate the implicit "acceptance criteria" as being "identical or substantially equivalent to the predicate device Apex (K141158) or InTone (K110179) without introducing new safety or effectiveness concerns." The "reported device performance" is that it meets this equivalence across various characteristics.

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

• For ApexM specifically: No new separate clinical or human factors study was conducted for ApexM. Its "test set" and provenance are based on the studies or evaluations of its predicate devices.
• For the predicate Apex (K141158): A human factors/usability study was conducted.
  • Sample size: Not explicitly stated but the study was designed for a "general population of women."
  • Data provenance: Not specified in terms of country of origin but was a prospective "human factors / usability study."
• For predicate InTone (K110179) and InToneMV (K131420): Biocompatibility testing was performed on InToneMV, and electrical safety and EMC testing for InTone and Apex. These are generally lab-based tests, not human subject studies with a "test set" in the sense of clinical performance endpoints.

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

• The document mentions "InControl Medical collaborated with the supervising physician to make further labeling enhancements" for the predicate Apex's human factors study.
• Number of experts: At least one "supervising physician" mentioned.
• Qualifications: "Supervising physician" implies medical expertise, but specific qualifications (e.g., years of experience, specialty) are not detailed.
• No other expert involvement for "ground truth" on test sets is mentioned for ApexM or its predicates in the context of device performance, as the studies are focused on usability, safety, and technical equivalence.

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

Not applicable. The human factors/usability study for Apex was not a clinical trial requiring adjudication of outcomes by multiple experts. It assessed self-diagnosis, self-limiting usage based on contraindications, and safe use based on instructions. The results were deemed "favorable."

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrical muscle stimulator, not an AI-assisted diagnostic tool or imaging device that would involve human "readers" or an MRMC study.

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

Not applicable. This device is a muscle stimulator used by a human user. Software verification and validation were performed for algorithms within the device (if any, as it's firmware controlled), but not a standalone "algorithm only" performance study in the AI sense. The "standalone performance" is covered by the electrical safety, EMC, and biocompatibility testing of the hardware components which demonstrated compliance with relevant standards.

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

• For the human factors/usability study on predicate Apex: The "ground truth" was whether users could successfully self-diagnose, self-limit usage, and use the device safely as intended based on their understanding of the labeling. This implicitly relies on the medical accuracy of the diagnostic criteria presented in the labeling, which would be based on established medical knowledge and expert input in the development of those materials.
• For the clinical literature evaluation: The "ground truth" was derived from "evidence of the safety and efficacy of electrical stimulation for the treatment of female urinary incontinence" from published scientific literature, which would be based on clinical outcomes data from those studies.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. The "training" for the device's technical specifications and safety parameters comes from engineering design, adherence to standards, and prior testing of predicate devices.

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

Not applicable, as this is not an AI/ML device with a training set. The "ground truth" for the underlying principles of electrical stimulation and device safety were established through decades of medical and engineering science, published literature, and regulatory standards.

Ask a specific question about this device

InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary incontinence.

The InTone device includes three parts: an Insertion Unit, a Control Unit, and a Software Application for clinicians.

• The Insertion Unit includes an inflation pump and an inflatable probe. The inflatable probe is inserted into the vagina and the inflation pump is used by the patient to manually inflate the probe, ensuring a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Biofeedback is monitored via a pressure sensor within the Insertion Unit which records changes in pressure related to volitional muscle contraction.
• The Control Unit includes user keys to initiate and control treatment sessions, and a visual biofeedback graph to encourage muscle re-training. The Control Unit is designed to record and store results of the electrical stimulation and biofeedback sessions for clinician review at follow-up visits.
• The Software Application is utilized by the clinician to program the Control Unit and display the results of electrical stimulation and biofeedback sessions. The Software Application allows the clinician to select and lock in the appropriate electrical stimulation level necessary to stimulate pelvic floor contraction.

This document is a 510(k) premarket notification for the InTone device, seeking a determination of substantial equivalence to previously marketed predicate devices (InTone K110179 and InToneMV K134020). The document asserts that the new InTone device is substantially equivalent based on similarities in intended use, technology, engineering, performance, user interface, and prior testing conducted on the predicate devices.

Here's an analysis of the acceptance criteria and study information provided, focusing on what is stated and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of "acceptance criteria" for the new InTone device in the sense of predefined thresholds for performance metrics. Instead, it presents a "Substantial Equivalence Comparison Table" (Table 7.3) that compares features and functions of the new InTone with its predicate devices (K110179 and K134020). The reported "performance" is implicitly demonstrated through this comparison, indicating that the new device operates similarly to or within the parameters of the predicate devices. When a feature is "Substantially equivalent" or "Identical," the impact on safety and performance is noted as "None," implying that the new device's performance is acceptable because it matches that of legally marketed devices.

Key performance-related comparisons include:

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

• No specific sample size for a "test set" for the new device is provided. The document states that "New software verification and validation, electrical safety, EMC, and biocompatibility testing did not need to be performed to demonstrate the equivalent safety and effectiveness of this new version of the InTone."
• Instead, the reliance is on testing performed on the predicate devices:
  • Predicate InToneMV (K134020) for: Software verification and validation, Electrical safety, and EMC testing.
  • Predicate InTone (K110179) for: Biocompatibility testing.
• Data Provenance: The document does not explicitly state the country of origin or whether the testing data for the predicate devices was retrospective or prospective. It only mentions that the testing was "conducted on the predicate InToneMV" and "for the predicate InTone."

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

• This information is not provided in the document. The document relies on engineering and biological testing and a clinical literature review for validation, not on expert-established ground truth from a test set in the conventional sense of a clinical study assessing diagnostic performance.

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

• This information is not applicable/not provided. The document describes technical testing (software V&V, electrical safety, EMC, biocompatibility) and a literature review, not a clinical study involving adjudication of results.

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 comparative effectiveness study was done as described. The device is for electrical stimulation and biofeedback therapy for urinary incontinence, not an AI-assisted diagnostic tool that would involve human readers.

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

• Not applicable in the context of diagnostic algorithms. The InTone device is a therapeutic device (electrical stimulator and biofeedback) with software, not a standalone diagnostic algorithm. The software verification and validation were performed on the predicate device's software, which was considered "moderate" level of concern.

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

• The concept of "ground truth" as typically used in diagnostic algorithm validation is not directly applicable to this submission. The validation relies on:
  • Compliance with recognized standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-1.
  • Software verification and validation: Against specifications and requirements.
  • Biocompatibility testing: Chemical/biological safety evaluation.
  • Clinical Literature Review: Documented evidence of safety and efficacy of electrical stimulation for female urinary incontinence in published articles and a MAUDE search for adverse events. This implicitly serves as "outcomes data" at a high level, validating the therapy type rather than specific device performance metrics against a gold standard for a new study.

8. The sample size for the training set:

• Not applicable/Not provided. The InTone device is not an AI/machine learning model that requires a training set in this context. Its function is based on established electrical stimulation and biofeedback principles.

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

• Not applicable/Not provided for the same reason as in point 8.

Ask a specific question about this device

Apex is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support.

Apex is a hand-held, home-use device designed to treat female stress urinary incontinence. The device includes an inflatable probe. The inflatable probe is inserted into the vagina and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.

The provided text describes the 510(k) premarket notification for the Apex device, a non-implanted muscle stimulator for treating female stress urinary incontinence. The acceptance criteria and the study proving the device meets these criteria are primarily focused on demonstrating substantial equivalence to a predicate device (InTone K110179) and ensuring safety for over-the-counter use.

Here's a breakdown of the requested information based on the provided document:

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

The document does not present explicit "acceptance criteria" in a quantitative performance table (e.g., Sensitivity X%, Specificity Y%). Instead, it focuses on demonstrating substantial equivalence to a predicate device and confirming safety and intended performance through various tests for its over-the-counter use.

The "Acceptance Criteria" implicitly stem from comparability to the predicate and compliance with relevant standards and usability requirements for an OTC device. "Reported Device Performance" is presented in terms of compliance with these standards and successful completion of the studies.

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

• Human Factors / Usability Study (Test Set): The document mentions that a human factors/usability study was "conducted to assess the safety of the Apex device for over-the-counter use." However, it does not specify the sample size used for this study.
• Data Provenance: The document does not explicitly state the country of origin for the human factors/usability study or whether it was retrospective or prospective. Given the FDA submission, it implicitly refers to a study conducted to support the US market. The nature of a usability study suggests it would be prospective (new data collected on actual users).
• Clinical Literature Evaluation: This involved evaluating existing literature, so it's a retrospective review of published studies. No specific sample size for a "test set" applies here as it's a review, not primary data collection.

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

• Human Factors / Usability Study: The document states that "InControl Medical collaborated with the supervising physician from the Human Factors and Usability Testing" for labeling enhancements and validation of contraindication understanding. This implies at least one supervising physician served as an expert. Their specific qualifications (e.g., years of experience, specialty) are not detailed beyond "supervising physician."
• Clinical Literature Evaluation: This involved an "appraisal of each article," which would typically be done by qualified individuals, but the document does not specify the number of experts or their qualifications for this appraisal.

4. Adjudication method for the test set

• For the Human Factors / Usability Study, the document mentions "collaboration with the supervising physician" for validating understanding of contraindications and refining labeling. This suggests an expert review/adjudication process for the usability and labeling aspects, but a formal (e.g., 2+1, 3+1) adjudication method is not explicitly 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 comparative effectiveness study was done. The Apex device is an electrical muscle stimulator, not an AI-assisted diagnostic device that would typically involve human readers interpreting images. The study focuses on the device's direct performance, safety for OTC use, and equivalence to a predicate device.

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

• Again, this question is more relevant to AI/diagnostic algorithms. For the Apex device, the "standalone" performance relates to its electrical stimulation characteristics, which were tested for compliance with electrical safety and EMC standards. The electrical stimulation parameters and safety features (e.g., self-limiting output, auto shut-off) represent the device's "standalone" functional performance, which were verified through the "Electrical Safety and Electromagnetic Compatibility Testing" and presented in the equivalence table.

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

• Human Factors / Usability Study: The "ground truth" for this study was the correct understanding and safe application of the device by the end-user based on the provided instructions and labeling, as verified by the supervising physician. It's effectively a form of user performance/behavioral data assessed against safety and usability benchmarks.
• Clinical Literature Evaluation: The ground truth for efficacy and safety was established by the peer-reviewed scientific literature on electrical stimulation for stress urinary incontinence. This relies on the outcomes data and conclusions from those published studies.
• Engineering/Electrical Testing: The ground truth was defined by international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) which the device demonstrated compliance with.

8. The sample size for the training set

• The document does not mention a traditional "training set" as would be used for machine learning. The studies described are for verification and validation of a hardware device and its usability, not for training a model.

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

• As there's no mention of a traditional machine learning "training set," this question is not applicable in the context of this device's submission.

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InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence.

The InToneMV device includes three parts: an insertion unit, control unit, and a software application for clinicians. Each of these parts are summarized below:

• The insertion unit includes (1) an inflation bulb, (2) the customizable inflatable probe, and (3) the flexible tubing connecting the inflation bulb and the inflatable probe. The inflatable probe is inserted into the vagina or rectum and manually inflated by the patient to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Biofeedback is monitored via a pressure sensor within the insertion unit which records changes in pressure related to volitional muscle contraction.
• The control unit includes user keys to initiate and control treatment sessions, and a visual biofeedback graph to provide muscle re-training. The control unit is designed to record and store results of the electrical stimulation and biofeedback sessions for clinician review at follow-up visits.
• The software application is utilized by the clinician to program the control unit and display the results of electrical stimulation and biofeedback sessions.

The provided text describes the InToneMV device, an electrical stimulator for incontinence, and its 510(k) submission to the FDA. However, it does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (InTone K110179 and evadri Bladder Control Systems K050483) through a comparison of features, functions, and safety aspects. The "Testing Summary" section broadly states that "InToneMV successfully passed all testing" and "Clinical evaluations for InToneMV have been completed to support the device as safe and effective according to the intended use," but no specific performance acceptance criteria or results from these evaluations are provided.

Therefore, many of the requested details about acceptance criteria and study design are not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

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

• Sample Size for Test Set: Not specified. The document only mentions "Clinical evaluations... have been completed" without providing details on the number of participants.
• Data Provenance (Country of Origin): Not specified.
• Retrospective or Prospective: Not specified.

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

• This information is not provided. The term "ground truth" and details about expert review are not mentioned in the context of performance evaluation.

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

• This information is not provided.

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. The device (InToneMV) is an electrical stimulator and biofeedback device for incontinence, not an imaging or diagnostic AI device that would typically involve "human readers" or "AI assistance" in the sense of image interpretation. The study mentioned is a "clinical evaluation" which is likely a clinical trial to assess safety and effectiveness of the therapeutic device.

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

• This question is not applicable in the context of this device. The InToneMV is a medical device for treatment, not an algorithm for diagnosis that would have standalone performance. Its function inherently involves patient interaction (insertion, self-inflation, muscle contraction) and clinician programming.

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

• Not explicitly stated. Given the nature of the device for treating incontinence, "outcomes data" (e.g., reduction in incontinence episodes, improved quality of life, strength of pelvic floor muscles) would be the most likely form of ground truth for its efficacy in a clinical evaluation. However, the document does not specify how "ground truth" was established or what specific metrics were used.

8. The sample size for the training set

• This is not applicable as the device is a physical medical device, not an AI/machine learning algorithm requiring a "training set" in the computational sense.

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

• This is not applicable for the same reason as above (not an AI/machine learning algorithm).

Ask a specific question about this device

The InToneMV device is a non-implanted electrical stimulator indicated for use in the treatment of female urinary incontinence. It applies electrical stimulation to the pelvic floor musculature and surrounding structures. It is intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: strengthening of pelvic floor muscles and inhibition of the detrusor muscle through reflexive mechanisms. The biofeedback feature can be used for muscle re-education purposes.

The InToneMV device includes three parts: an insertion unit, a hand-held control unit, and a PCbased software application.

• The insertion unit includes (1) an inflation bulb, (2) the inflatable probe, and (3) the flexible tubing connecting the inflation bulb and the probe. The inflatable probe is inserted into the vagina and manually inflated by the patient to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the probe to induce a contraction of the pelvic floor muscles.
• The external hand-held control unit includes user keys to initiate and control treatment sessions. The control unit is designed to record and store results of the electrical stimulation and patient generated pelvic floor exercises.
• The PC-based software application is utilized by the clinician to program the hand-held control unit, store and display the results of electrical stimulation and patient generated pelvic floor exercises. The application allows the clinician to select and lock in the appropriate amount of electrical stimulation necessary to stimulate pelvic floor contraction.

The provided document is a 510(k) summary for a medical device called InToneMV. This document describes the device, its intended use, and its substantial equivalence to a predicate device (InTone K110179).

However, the document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance or effectiveness metrics. Instead, it focuses on demonstrating substantial equivalence through modifications to an existing device and safety testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or clinical outcome measures) or reported device performance against such criteria. The submission is a Special 510(k), which typically involves modifications to an existing device where the original performance characteristics are assumed to be maintained if the modifications don't impact safety or effectiveness.

The document states: "The data collected and documented throughout this submission provides objective evidence that InToneMV performs as well as or better than the predicate device for the treatment of female urinary incontinence." This is a general claim of performance equivalence rather than a report against specific acceptance criteria for the InToneMV itself.

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

The document does not describe a clinical test set or sample size for evaluating the InToneMV's performance. It explicitly states: "Clinical performance of InToneMV is further detailed in Section 14." and "There have been no modifications to the clinical performance." However, Section 14 is not included in the provided snippets. Given that this is a Special 510(k) for device modifications, it's highly probable that new clinical data was not collected specifically for InToneMV's clinical performance because its clinical performance is considered identical to the predicate.

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

Not applicable, as no new clinical test set or ground truth establishment is described for the InToneMV device's clinical performance.

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

Not applicable, as no new clinical test set or ground truth establishment is described for the InToneMV device's clinical performance.

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. The InToneMV is a medical device (pelvic floor muscle stimulator), not an AI-assisted diagnostic tool.

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

Not applicable. The InToneMV is a medical device, not an algorithm. Its performance relies on the device's electrical stimulation and biofeedback capabilities for the patient, potentially overseen by a clinician.

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

Not applicable, as no new clinical test set or ground truth establishment is described for the InToneMV device's clinical performance. The submission relies on the predicate device's established effectiveness.

8. The sample size for the training set

Not applicable. The InToneMV is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable.

Summary of what the document does describe regarding validation:

• Bench Testing: "Bench testing of InToneMV is further detailed in Section 13." This would relate to the physical and electrical safety and performance of the modified device components (e.g., smaller probe, flexible cord).
• Electrical Safety Tests: "IEC60601 electrical safety tests were performed on the modifications. Results identified InToneMV as electrically safe."
• Software: "The software in InToneMV is identical to the predicate device, InTone (K110179). There have been no modifications to the existing, validated software."
• Materials: "The patient contact materials used in InToneMV are identical to the predicate device, InTone. There have been no modifications to the materials."
• Design Controls and Risk Management: Modifications were completed according to internal procedures, and risks were evaluated per ISO 14971, with an acceptable risk/benefit analysis.

The core argument for the InToneMV's performance and safety is its substantial equivalence to the predicate device (InTone K110179) and the fact that modifications only apply to the insertion unit, which were validated through non-clinical testing (bench and electrical safety) and adherence to design controls. The clinical performance and effectiveness are considered to be unchanged from the predicate device.

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The InControl InTone device is a non-implanted electrical stimulator indicated for use in the treatment of female urinary incontinence. It applies electrical stimulation to the pelvic floor musculature and surrounding structures. It is intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: strengthening of pelvic floor muscles, inhibition of the detrusor muscle through reflexive mechanisms. The biofeedback feature can be used for muscle re-education purposes.

The device includes three parts; an insertion probe and a hand-held control unit. The insertion The device includes three parts, an inoortion provides more adaptable fit for intra-vaginal use. The probe includes stainless steel electrodes to deliver electro-stimulation. The hand-held control probe includes stainless steel clours and displays the results of electro-stimulation and patient and ulsplay device records, storos, and alspiary one to select and lock in the correct amount generated pervic noor excressor from to the contraction. It also stores data on contraction of current necessary to stimulate pervice noor ochination to select and lock in the correct amount of current necessary to stimulate pelvic floor contraction.

The provided document is a 510(k) summary for the InControl InTone device, a non-implantable electrical stimulator for treating female urinary incontinence. The claims are for "substantial equivalence" of the InControl InTone device to predicate devices on the market and do not detail any clinical studies. Therefore, this document does not contain information to answer the bulk of your questions regarding acceptance criteria, study sizes, ground truth establishment, or clinical performance metrics.

However, based on the provided tables comparing the InControl InTone device to its predicate devices (Otto Bock STIWELL med4, MyoTrac Infiniti, and Hollister evadri), we can infer the acceptance criteria were based on demonstrating equivalence in intended use, technology, engineering, and performance specifications.

Here's the information that can be extracted from the provided text:

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

The acceptance criteria are not explicitly stated with numeric thresholds or targets for device performance. Instead, the "Comparison" column indicates whether the InControl InTone's features are "Identical," "Equivalent," or "Within range" compared to predicate devices. The "Reported Device Performance" for the InControl InTone is simply its listed specifications.

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

This information is not present in the provided 510(k) summary. The document describes a substantial equivalence submission based on technical features and intended use comparison to predicate devices, not clinical studies with test sets.

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

This information is not present in the provided 510(k) summary. No test sets or ground truth establishment by experts are mentioned.

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

This information is not present in the provided 510(k) summary. No test sets or adjudication methods are mentioned.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned in the provided document. The device is a direct patient treatment device, not an AI diagnostic tool that assists human readers.

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

This is not applicable as the InControl InTone is an electrical stimulator device, not an AI algorithm. Its performance is related to its physical and electrical specifications, which were assessed through "EMC, electrical, mechanical, safety (operator and patient), temperature/humidity, and software testing."

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

This information is not present in the provided 510(k) summary for any clinical performance. The "ground truth" for the device's technical performance seems to be established through engineering compliance testing against applicable standards (e.g. EMC, electrical, mechanical safety).

8. The sample size for the training set

This information is not present in the provided 510(k) summary. No training sets are mentioned.

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

This information is not present in the provided 510(k) summary. No training sets or ground truth establishment for them are mentioned.

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