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HPM-6000UF 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 HPM-6000UF is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The electromagnetic field delivered in the muscular or neuronal tissue area is triggering the stimulation and tonisation.

The HPM-6000UF is equipped with a color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen, buttons and knob on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

The HPM-6000UF device and its predicates are comprised of a system console and applicator. The system consists of the electromagnetic field generators, computer, and the touch-screen control panel. Applicator Chair is designed for non-invasive therapy of urinal incontinence. The coil is located in the middle of the seat and air cooled. Running therapy is indicated by illuminated segments in armrests. For precise patient positioning prior to the therapy, the seat height can be electronically adjusted by a remote control.

This document, K181497, is a 510(k) summary for the HPM-6000UF device, a non-invasive electromagnetic stimulator for pelvic floor muscles, intended for the treatment of male and female urinary incontinence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The provided document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone clinical trial that defines and meets specific acceptance criteria for performance. The "clinical testing" mentioned is specifically to address temperature safety in males for an expanded indication, and not for efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) clearance process for this device (HPM-6000UF) is based on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance acceptance criteria (like sensitivity, specificity, accuracy for a diagnostic device) through a comparative study against a ground truth.

Therefore, a table of acceptance criteria and reported device performance in the context of clinical efficacy is not directly provided or the primary focus of this submission. The "performance" demonstrated for clearance is primarily about safety and equivalent technological characteristics and intended use compared to the predicates.

The closest thing to a "performance" metric related to a study is the thermal safety for male subjects:

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

• Test Set Sample Size: The document states: "In order to demonstrate safety of the HPM-6000UF in the treatment of males (specifically, thermal safety to the testes), a clinical study has been conducted." However, the sample size for this clinical study is NOT specified in the provided text.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a "clinical study conducted" for safety, it would typically be a prospective study.

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

• This information is not applicable in the traditional sense for this 510(k) submission. The clinical study mentioned was for thermal safety demonstration, not for establishing a ground truth for efficacy using expert consensus. The "ground truth" for safety would be measured physiological parameters (temperature).

4. Adjudication Method for the Test Set

• This information is not applicable as the clinical study described is for thermal safety, not for evaluating device performance against an adjudicated ground truth for efficacy.

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

• No, an MRMC comparative effectiveness study was not done according to the provided information. This type of study is more common for diagnostic imaging devices where human readers interpret images with and without AI assistance. The HPM-6000UF is a therapeutic device.

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

• This concept is not applicable to the HPM-6000UF. This device is a physical instrument for therapeutic use, not a diagnostic algorithm. Its "performance" is its ability to deliver the electromagnetic field and achieve neuromuscular stimulation for the stated indication. The closest "standalone" performance would be its technical specifications and safety profile, which are covered by non-clinical testing and the thermal safety study.

7. Type of Ground Truth Used

• The "ground truth" for the single clinical study mentioned was physiological measurement (scrotal surface temperature) to demonstrate thermal safety.
• For the overall substantial equivalence claim, the "ground truth" is effectively the performance and safety profile of the legally marketed predicate devices. The new device (HPM-6000UF) is asserted to be "identical in design" to its primary predicate (HPM-6000U) with the only difference being an expanded indication for use to include males, which prompted the specific thermal safety study.

8. Sample Size for the Training Set

• This device is not an AI/ML algorithm that requires a "training set" in the computational sense. The "HPM-6000UF is identical in design to the HPM-6000U predicate." The design and engineering would be based on established principles and the prior device's development, not a data-driven training set.

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

• Not applicable as there is no "training set" for an AI/ML algorithm in this context.

Summary of Device Performance and Equivalence Claim:

The HPM-6000UF's acceptance for market is based on its substantial equivalence to the HPM-6000U and InToneMV predicate devices. The key arguments for equivalence are:

• Identical Design to Primary Predicate: The HPM-6000UF is stated to be "identical in design to the HPM-6000U predicate."
• Expanded Indications Addressed: The only difference from the HPM-6000U is the expansion of the indication to include males.
• Clinical Study for Safety (Males): A specific clinical study was conducted only to address the safety concern of thermal effects on male testes when expanding the indication. This study concluded there was "no meaningful rise in scrotal surface temperature."
• Similar Principle of Action: While the HPM-6000UF uses a magnetic field and InToneMV uses direct current, both lead to "induction of electrical stimulus in the neuromuscular tissue resulting in the muscle contraction."
• No New Safety/Effectiveness Questions: The technological differences are asserted not to "raise any new types of safety or effectiveness questions."

In essence, the device's "performance" for regulatory purposes in this 510(k) is primarily its demonstrated safety for the expanded indication and its technological and intended use similarity to already cleared devices. It is not presenting novel efficacy data in a comparative trial setting against a clinical "ground truth."

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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.

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