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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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HPM-6000U 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.

The HPM-6000U 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-6000U 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 step-by-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 provided document is a 510(k) Premarket Notification for the HPM-6000U device, which is an electromagnetic stimulator for treating urinary incontinence in women. The document explicitly states that the substantial equivalence determination for the HPM-6000U is NOT based on clinical testing. Instead, its safety and efficacy were demonstrated by comparing its technical characteristics with a predicate device, the Neotonus Model 1000 Muscle Stimulator System (K973096).

Therefore, there is no study described in this document that proves the device meets specific acceptance criteria related to its clinical performance (e.g., sensitivity, specificity, accuracy) using a test set against a ground truth.

However, the document does contain information about non-clinical testing for compliance with safety standards and a comparison table of technical specifications between the HPM-6000U and the predicate device, which serves as the basis for its substantial equivalence claim.

Given the information provided in the document:

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

Since no clinical efficacy study with specific performance acceptance criteria is detailed, the "acceptance criteria" here relate to technical specifications and safety standards compliance.

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

• Not applicable. No clinical test set data is provided as clinical testing was not performed for substantial equivalence. The comparison is based on the technical specifications of the device and its predicate.

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

• Not applicable. No clinical test set or ground truth established by experts is described.

4. Adjudication method 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. This device is a therapeutic device, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

• Not applicable. The device is a physical therapeutic device, not an algorithm. Its performance is based on its physical/electromagnetic output, not an algorithm's classification or detection capabilities.

7. The type of ground truth used:

• Not applicable. For the substantial equivalence, the "ground truth" is implied to be the established safety and effectiveness of the legally marketed predicate device, as demonstrated through its technical specifications and intended use.

8. The sample size for the training set:

• Not applicable. No training set for an algorithm is mentioned as this is a physical medical device.

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

• Not applicable.

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The HPM-6000 device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The HPM-6000 device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

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

The HPM-6000 is a non-invasive therapeutic device produces electromagnetic field that interacts with the tissues of the human body, while mainly affected structures are muscular, collagenous, and neuronal tissue. The electromagnetic field is delivered in the subdermal, muscular or collagenous tissue area triggering the stimulation and relaxation. The subject device does not use electroconductive media.

The HPM-6000 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 step-by-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 provided text is a 510(k) Summary for the HPM-6000 device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device (Neotonus MS-101 Magnetic Muscle Stimulator System) rather than providing detailed acceptance criteria and a study proving those criteria are met for the HPM-6000 itself.

Specifically, the document states:
"The substantial equivalence determination for the HPM-6000 is not based on clinical testing. The device safety and efficacy was demonstrated by performance data and comparison of technical characteristics between the HPM-6000 and the predicate device."

Therefore, most of the requested information cannot be extracted directly from this document, as it describes a comparison study, not a study specifically designed to prove acceptance criteria for the HPM-6000 as a standalone device.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state acceptance criteria for the HPM-6000's performance in a standalone study. Instead, it compares the HPM-6000's characteristics to a predicate device to establish substantial equivalence.

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

The document explicitly states: "The substantial equivalence determination for the HPM-6000 is not based on clinical testing."
Therefore, there is no human test set described in this document. The "test" here refers to non-clinical testing and comparison of technical characteristics.

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 human test set or clinical study to establish "ground truth" for diagnostic performance was conducted. The ground truth for device safety and performance is based on engineering testing and comparison to established standards and predicate devices.

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

Not applicable, as no human test set with expert adjudication was conducted.

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 HPM-6000 is a physical medical device (muscle stimulator), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

A true "standalone" clinical performance study for the HPM-6000, as an algorithm, was not done. The document states "The substantial equivalence determination for the HPM-6000 is not based on clinical testing." Instead, the device's technical specifications and non-clinical performance (e.g., electrical safety, electromagnetic compatibility, usability, biological evaluation) were evaluated as a standalone product relative to established standards and then compared to a predicate device.

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

For the non-clinical testing performed, the "ground truth" would be engineering specifications, adherence to international standards (e.g., ISO, IEC), and measurements of physical parameters. For the substantial equivalence claim, the ground truth is the performance and characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device that requires a training set.

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

Not applicable, as this is not an AI/machine learning device that requires a training set.

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