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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.

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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).

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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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