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As an NMES device, indications are for the following conditions:

• Retarding or preventing disuse atrophy
• Maintaining or increasing range of motion
• Re-educating muscles
• Relaxation of muscle spasms
• Increasing local blood circulation
• Prevention of venous thrombosis of the calf muscles immediately after surgery

As a TENS device, indications are for the following conditions:

• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Relief of pain associated with arthritis

As a Pulsed Current device, indications are for the following conditions:

• Reduction of edema (under negative electrode)
• Reduction of muscle spasm
• Influencing local blood circulation (under negative electrode)
• Retardation or prevention of disuse atrophy
• Facilitation of voluntary motor function
• Maintenance of increase of range of motion

As an FES device, the indications for the following condition:

• Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.

Not Found

The provided text is a 510(k) summary for the Empi Continuum device, a powered muscle stimulator. It details the device's indications for use, classification, and substantial equivalence to predicate devices, along with regulatory compliance information. However, it does not contain information about any specific study that proves the device meets acceptance criteria related to its performance characteristics.

The document focuses on regulatory compliance and substantial equivalence, which is a key aspect of the 510(k) process. Substantial equivalence generally means that the new device is as safe and effective as a legally marketed predicate device. This often involves demonstrating that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety and effectiveness.

Here's an breakdown of the requested information based on the provided text, and where the text is lacking:

Acceptance Criteria and Device Performance Study Information

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document does not describe a clinical test set or the use of human subjects to evaluate device performance against specific clinical outcomes. The compliance mentioned relates to recognized consensus standards for safety and EMC, which typically involve laboratory testing, not human subject testing in the context of efficacy claims for de novo devices. For 510(k) submissions based on substantial equivalence, clinical data might not always be required if technological characteristics are sufficiently similar to predicate devices.

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

• Not applicable/Not provided. No clinical test set requiring expert ground truth establishment is described in this document.

4. Adjudication method for the test set

• Not applicable/Not provided. No clinical test set is described.

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

• Not applicable/Not provided. This device is a muscle stimulator, not an imaging device or an AI-powered diagnostic tool, so an MRMC study and AI assistance are not relevant to its stated functionalities.

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

• Not applicable/Not provided. This device is not an algorithm or an AI product; it's a physical medical device. Performance would be assessed based on its electrical output characteristics and clinical outcomes when applied to a patient, not through standalone algorithm performance.

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

• Not applicable/Not provided for clinical claims. For the compliance declarations, the "ground truth" is defined by the technical specifications and test methodologies within the cited consensus standards (UL 60601-1, IEC 60601-1-2, IEC 60601-2-10). These standards themselves specify test conditions and acceptable ranges for various parameters (e.g., leakage current, electromagnetic emissions, output accuracy).

8. The sample size for the training set

• Not applicable/Not provided. As there is no AI/machine learning component described, there is no training set.

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

• Not applicable/Not provided. As there is no AI/machine learning component described, there is no training set or ground truth for it.

Summary of Device Acceptance:

The acceptance of the Empi Continuum device, as described in this 510(k) summary, is primarily based on demonstrating substantial equivalence to legally marketed predicate devices and conformity to recognized safety and electromagnetic compatibility consensus standards. The document states:

• "The Empi Continuum devices comply with the following FDA recognized Consensus Standards:" followed by a list of UL and IEC standards for medical electrical equipment safety and EMC. This compliance is the "study" demonstrating that the device meets safety and compatibility "acceptance criteria" as defined by these standards.
• The FDA's review resulted in a determination that the device is "substantially equivalent... to legally marketed predicate devices." This substantial equivalence finding implies that the device's intended use and technological characteristics (including performance) are considered safe and effective in comparison to the predicates, and therefore acceptable for marketing. No specific clinical performance studies showing efficacy against distinct acceptance criteria are detailed, which is common for devices cleared through the 510(k) pathway leveraging substantial equivalence to well-established predicate technologies.

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The Empi Active Transcutaneous Nerve Stimulator Device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma-acute pain

The Empi Active Transcutaneous Nerve Stimulator is a battery powered single-function device intended to provide clinicians with a TENS Simple Modulated Pulse (SMP) therapy. This device is intended to be easy to use without the hassle of configuration. Simply turn the device on and increase or decrease the intensity. It is a single-function electrotherapy device with one mode of treatment that allows for Transcutaneous Electrical Nerve Stimulation (TENS).

The provided text describes a 510(k) summary for the "Empi Active Transcutaneous Nerve Stimulator." This document confirms that no clinical studies were required or performed to demonstrate the safety and efficacy of this device.

The submission asserts that the device is substantially equivalent to a predicate device (Empi SELECT Model 4600, K061650) because it has the same intended use, technological characteristics, and does not significantly influence clinical endpoints where prospective clinical studies would be necessary. Therefore, the device meets the criteria for exemption from clinical testing as per FDA guidance document 95-4158.

As no clinical study was conducted, the following information cannot be provided from the given document:

1. Table of acceptance criteria and reported device performance: No clinical performance data is presented.
2. Sample size used for the test set and the data provenance: No test set was used for clinical evaluation.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth was established from clinical data.
4. Adjudication method for the test set: Not applicable as no clinical test set.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not conducted, as this is a medical device, not an algorithm.
7. Type of ground truth used: Not applicable as no clinical ground truth was established.
8. Sample size for the training set: Not applicable as no clinical training set was used.
9. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Testing and Acceptance Criteria (as described in the document):

The Empi Active Transcutaneous Nerve Stimulator underwent non-clinical testing to demonstrate compliance with product specifications and user needs.

• UL 60601-01 Medical electrical equipment Part 1: General requirements for safety. 2003
• CAN/CSA C22.2 No.601.1-M90 with Amendment A2. 2005
• IEC60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety – Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004) |

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria was non-clinical verification and validation testing. This included:

• Electrical testing: To ensure electrical safety and performance within specified parameters.
• Mechanical testing: To assess the durability and physical integrity of the device.
• Software testing: To verify the functionality and reliability of the device's embedded software.
• Validation testing: To confirm the device meets user needs and marketing requirements.

The document explicitly states: "No prospective clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance in the target markets." The justification for this is that the device "does not differ from the predicate device in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence."

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The Hybresis system is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.

An iontophoresis device is a device that is intended to use electrical current to introduce ions of water-soluble salts or drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the magnitude of the electrical current applied, patch composition, duration of current flow, and numerous other factors.

The Empi Hybresis integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, one-application use and can only be used with Empi's Hybresis dose controller. The Hybresis dose controller provides control of the current and therefore dosage delivered.

The Hybresis dose controller is a small, battery-powered, microprocessor-controlled Iontophoresis device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.

This document is a 510(k) Summary for the Hybresis Iontophoresis Drug Delivery System. It is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results in the format requested.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, specifically in the context of device performance metrics like accuracy, sensitivity, or specificity, is not present in the provided text.

The document states:

• Non-clinical Testing: "Verification of the Hybresis includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Hybresis includes testing to show the device meets user needs according to marketing requirements." (Page 1)
• Clinical Testing: "No prospective clinical studies are required to demonstrate safety and efficacy of the in support of applications for regulatory approval/clearance in the target markets. The Hybresis does not differ from the predicate devices in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence." (Page 1)

This indicates that the device's acceptance criteria are related to its electrical and mechanical specifications and user needs, which were assessed through non-clinical verification and validation testing. However, the specific quantitative acceptance criteria and the detailed results of those tests are not provided in this summary.

Given the nature of the device (an iontophoresis drug delivery system) and the type of submission (510(k) for substantial equivalence, specifically a modification for naming and contraindications), the focus is on maintaining equivalence to a predicate device rather than proving novel clinical efficacy or diagnostic performance. Therefore, a clinical study as would be seen for an AI/CADe device with metrics like sensitivity/specificity is explicitly stated as not required.

In summary, based only on the provided text, the following information cannot be extracted:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance (as no clinical test set is described).
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (as no clinical ground truth assessment is detailed).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document does mention "electrical and mechanical tests" and "validation testing" but does not detail the criteria or results.

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The Empi Dupel Transport Smart Iontophoresis System can be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections.

The Empi Dupel Transport Iontophoresis System is a disposable, single-use iontophoresis device with a self-contained battery and electrical circuitry. The system includes a power module, delivery electrode, return electrode and lead wires. The Dupel Transport is capable of delivering both negatively and positively charged ionic solutions. The device uses a microprocessor to precisely control the delivery time of 3 hours. An LED is utilized to confirm the device is turned on and provides an indication of how much time is remaining in the treatment period.

Here's a summary of the acceptance criteria and the study information regarding the Empi Dupel Transport Iontophoresis System, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not applicable. No clinical studies were conducted that involved a "test set" in the context of evaluating a medical device's diagnostic or predictive performance on patient data. Non-clinical testing was performed on the device itself. The text explicitly states: "No prospective clinical studies are required to demonstrate safety and efficacy of the in support of applications for regulatory approval/clearance in the target markets."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical studies were conducted that involved human interpretation or a "ground truth" derived from expert consensus.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. 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 iontophoresis system, not an imaging or diagnostic AI system that would typically involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "non-clinical testing" which included "electrical and mechanical tests" and "validation testing...to show the device meets according to marketing requirements." These tests would be considered standalone for the device's functional performance, but not in the context of an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be defined by the device's product specifications and marketing requirements. For example, if a specification states the device must deliver a specific current for a specific duration, the measured current and duration from the device's operation would be compared against that specification.

7. The sample size for the training set: Not applicable. No training set was involved as this is not an AI/machine learning device. The non-clinical tests verified the device against engineering specifications and marketing requirements.

8. How the ground truth for the training set was established: Not applicable.

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The Empi® SELECT Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma acute pain.

The SELECT® is a portable, dual channel TENS device with ten pre-programmed operational modes. It is powered by 3 standard AAA alkaline or rechargeable batteries. All operational modes produce the Empi Bi-Sourced® waveform. The user selects a pre-programmed mode by either pressing a Quick Select button with the picture of a body part needing treatment or by using the Program buttons to select one of ten program options. The user is able to adjust the intensity up or down. The lock mode prevents inadvertent changes to the intensity or the program option. The SELECT® is intended for use in the clinic or in the home with a prescription. A belt clip allows the patient to wear the Empi SELECT® on a belt or pants waistband. The SELECT® battery icon on the LCD will flash when the batteries need replacement. Compliance data can be retrieved by the clinician including number of sessions, average session length, and average intensity.

This device, the Empi SELECT® TENS System, is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for pain relief. The provided documentation does not include specific acceptance criteria with quantifiable metrics for device performance in the traditional sense of a diagnostic or predictive medical device. Instead, the focus is on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not applicable/Not explicitly stated. The evaluation relies on non-clinical testing (electrical and mechanical tests, and validation for user needs), not a clinical 'test set' with patient data.
• Data provenance: Not applicable. The "tests" refer to engineering and functional verification/validation of the device hardware and software, not clinical data from patients.

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

• Not applicable. As this is non-clinical testing and validation, there is no "ground truth" derived from expert consensus on patient data. The "ground truth" for electrical and mechanical tests would be the device's technical specifications and industry standards. For user needs validation, it would be marketing requirements and presumably user feedback/testing, but no details are provided about this.

4. Adjudication method for the test set

• Not applicable. There is no clinical test set requiring adjudication.

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. This device is a TENS unit, not an AI-powered diagnostic or interpretive device. Therefore, a MRMC study involving human readers and AI assistance is not relevant or applicable.

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

• Yes, in a sense. The "non-clinical testing" and "validation testing" described are standalone evaluations of the device's inherent safety and performance characteristics (electrical, mechanical, meeting specifications, user needs). There is no "algorithm" in the context of an AI device, but the device's own functional performance was tested independently.

7. The type of ground truth used

• For electrical and mechanical tests: Device specifications, engineering standards, and regulatory requirements (e.g., for safety).
• For validation testing (user needs): Marketing requirements and potentially user feedback/usability studies (though details are not provided).
• For substantial equivalence: The established safety and effectiveness profiles of the predicate devices.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The device's design and programming are based on established engineering principles and the intended physiological effects of TENS.

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

• Not applicable, as there is no training set. The "ground truth" for the device's functionality is its design specifications and compliance with relevant standards for TENS devices.

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Encompass.Net™ device is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Encompass.Net™ receives imaging studies over a network from Empiric Systems servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Encompass.Net™ is a fully web-based system that operates in a Microsoft Internet Explorer (Version 6.0 and above) environment. Encompass.Net™ is run in a Windows 2003 environment, using Microsoft's Internet Information Server functions. The core database is Microsoft SQL 2000.

Encompass. Net is intended to acquire medical images for storage, archiving, and routing to medical professionals. In addition, Encompass.Net allows medical professionals to retrieve medical images on demand using Internet communication protocols according to various user options and lossy and/or lossless compression techniques for subsequent review. A host of image process tools are available for the medical professional.

In addition to Encompass. Net, the fully integrated RIS/PACS device, there are also multiple stand-alone PACS models (subsets of Encompass Net) that will be marketed. Those configurations are: R1.Net, R2.Net, and R3.Net.

The provided text is a 510(k) summary for the Encompass.Net™ device, which is a Picture Archiving Communications System (PACS). It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain any information about specific acceptance criteria or a study proving the device meets them.

The document is primarily a regulatory submission to the FDA for market clearance, focusing on:

• Device Description: Encompass.Net™ is a fully web-based system for acquiring, storing, archiving, routing, and retrieving medical images (CT, MR, CR, DR, US, and other DICOM compliant systems) for viewing and diagnostic interpretation. It supports both lossless and lossy compression.
• Indications for Use: Viewing and diagnostic interpretation of images from various medical imaging systems, with specific caveats for mammographic images (lossy compressed mammograms and digitized film-screen images) which must not be reviewed for primary interpretation, and requiring FDA-approved monitors for mammography.
• Technological Characteristics: It's a software product that handles digital medical images and does not contact the patient or control life-sustaining devices.
• Predicate Device: Amicas Light Beam Workstation (K022970).
• Conclusion: The submission aims to demonstrate substantial equivalence to the predicate device.

Therefore, I cannot provide the requested information about acceptance criteria or a study with performance data because it is not present in the provided text. The document does not describe a clinical performance study using test sets, ground truth, or expert readers. It appears to be a review of technical and functional equivalency rather than clinical efficacy or accuracy.

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The Infinity Plus is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES) and interferential current stimulation (IFS).

As a NMES device, the Infinity Plus device is indicated for the following conditions:

• Retarding or preventing disuse atrophy .
• Maintaining or increasing range of motion .
• Re-educating muscles .
• Relaxation of muscle spasm .
• Increasing local blood circulation .
• Prevention of venous thrombosis of the calf muscles immediately after surgery

As an IFS device, the Infinity Plus is indicated for the following conditions:

• Symptomatic relief of acute pain .
• Symptomatic relief and management of chronic intractable pain .
• As an adjunctive treatment for post surgical and post traumatic acute pain .

The Empi Infinity Plus Electrotherapy System is a battery-powered/line-powered, multifunction device intended to provide clinicians with the flexibility to prescribe multiple stimulation therapy regimens with the same device. The Infinity Plus offers the following features:

• Channel 1 to 4, which are multi-purpose outputs (IF and NMES) .
• High Voltage output dedicated to the High Volt stimulation. (This is named CH5 in the Software Requirements Specification and Software Design Specification. It is a separate channel that is simply the output for the high voltage stimulation).
• Channel 1, 2, 3 and 4 support stimulation with:
• IF: 2 independent IF channels using the channel pairs: Channel 1/2 and Channel 3/4
• PM, NMES, Russian: 4 independent PM channels
• Serial contractions: 4 dependent channels forming the movement pattern
• HV out is dedicated to High Volt stimulation
• All channel outputs are electrically separated from each other
• Each channel has a dedicated intensity control, with the exception of the HV out. The intensity control of HV is achieved by using the Channel 1 intensity control.
• Maximum stimulation of 100 mA for IF, PM, NMES, and Russian; 500 V for High Volt
• Timed therapy sessions .
• Continuous or cycled stimulation .
• Adjustable pulse rates
• Adjustable ON and OFF time controls .
• Balanced symmetrical biphasic and monophasic high volt waveforms .
• Forty-three programs: three conventional interferential, three premodulated interferential, seven High Volt, thirteen NMES, thirteen Russian and four Serial Contraction
• Lock option for clinician to control treatment regimens and stimulus intensity
• Pause function for patient to pause stimulation. During pause, the timer will not count down if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters with stimulus intensity of zero

The provided text describes a 510(k) summary for the Infinity Plus Electrotherapy System. It details the device's intended use, description, and basis for substantial equivalence to predicate devices. However, the document does not contain information regarding
acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in a clinical study report or a more detailed submission for proving device performance.

Therefore, I cannot provide a complete answer to your request. The information below is limited to what is explicitly stated or can be inferred from the provided 510(k) summary.

Here's what can be extracted based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state any quantitative acceptance criteria or provide specific reported device performance metrics like sensitivity, specificity, accuracy, or effect sizes for clinical outcomes. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, and function.

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

The 510(k) summary does not describe any specific clinical "test set" or clinical study with a defined sample size to prove performance. The submission relies on a comparison to predicate devices. Therefore, information on data provenance (country of origin, retrospective/prospective) is also not available for such a test set.

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

Since no specific clinical "test set" is described for proving performance, there is no information provided on experts establishing ground truth. This type of information would typically be found in a clinical trial report.

4. Adjudication Method for the Test Set

As no specific clinical "test set" is described, there is no information provided on adjudication methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission focuses on device features and equivalence rather than comparative clinical outcomes with human readers or AI assistance.

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

The Infinity Plus Electrotherapy System is a physical medical device for delivering electrical stimulation, not a software algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply to this device. Its performance is inherent in its ability to generate and deliver the intended electrical waveforms, which is typically confirmed through engineering verification and validation, not standalone clinical studies in the AI sense.

7. The Type of Ground Truth Used

Given that no specific studies are detailed to prove performance in the clinical sense, there is no mention of a type of ground truth used (e.g., expert consensus, pathology, outcomes data). The "ground truth" in this context for a 510(k) relating to a physical electrotherapy device would be the device's ability to produce the specified electrical output parameters accurately and safely, as measured by engineering tests.

8. The Sample Size for the Training Set

The provided document does not discuss any "training set." This term is typically associated with machine learning or artificial intelligence models, which the Infinity Plus Electrotherapy System is not.

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

As there is no "training set" mentioned, there is no information on how its ground truth was established.

Summary of what the K041920 document DOES provide:

• Basis for Substantial Equivalence: The primary method for clearance for the Infinity Plus Electrotherapy System is demonstrating substantial equivalence to previously cleared predicate devices (Empi 300 PV and Chattanooga Vectra Pro 4 and Pro 2 Models).
• Comparison of Features: The document lists features of the Infinity Plus (e.g., four channels, Russian waveform, specific current/voltage limits) and highlights how these are either present in the predicate Empi 300 PV or in the other predicate devices (Chattanooga Vectra Models).
• Indications for Use: The Infinity Plus shares the same indications for use as the predicate devices for NMES and IFS.
• Regulatory Conclusion: FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls.

This 510(k) summary is a regulatory document focused on demonstrating equivalence for market clearance, rather than a detailed report of a clinical performance study with defined acceptance criteria and results.

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The Infinity is a multi-function electrotherapy device with various treatment modes that allow for conventional interferential and premodulated interferential current stimulation (IFS) and is indicated for the following conditions:

• Symptomatic relief of acute pain .
• . Symptomatic relief and management of chronic intractable pain
• . Symptomatic treatment for post-surgical and post-trauma acute pain

The Infinity is a multifunction electrotherapy device with various treatment modes that allows for interferential current stimulation (IFS) and premodulated interferential current stimulation. It has the ability to provide two channels of conventional interferential and premodulated interferential stimulation. The Infinity offers the following features:

• . Channels 1 and 2, which are multi-purpose outputs (IF and PM IF)
• . Each channel has a dedicated intensity control
• . Maximum stimulation of 50 mA/500 V from each channel
• . Timed therapy sessions
• . Continuous stimulation
• . Adjustable pulse rates
• Balanced asymmetrical and symmetrical biphasic waveforms
• . Seven programs: three for conventional interferential, three for premodulated interferential and one for custom stimulation
• . Lock option for clinician to control treatment regimens and stimulus intensity
• . Pause function for patient to pause stimulation. During pause, the timer will not count down if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters but a stimulus intensity of zero

The provided text is a 510(k) Summary for the Infinity Electrotherapy System. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, the requested information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth establishment cannot be extracted from the provided text. The document does not describe any specific studies conducted to establish performance metrics for the Infinity Electrotherapy System against defined acceptance criteria.

The 510(k) submission process for this type of device (a Class II or unclassified device) generally relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This is often done by comparing design, materials, intended use, and performance characteristics to the predicate, rather than conducting new clinical trials with acceptance criteria.

Information that can be extracted related to the device and its regulatory status:

• Device Name: Infinity Electrotherapy System
• Intended Use/Indications for Use:
  • Symptomatic relief of acute pain.
  • Symptomatic relief and management of chronic intractable pain.
  • Symptomatic relief for post-surgical and post-trauma acute pain.
• Predicate Devices:
  • Empi 300 PV (K021100)
  • Ryan Telemedicine (K030254)
• Basis for Substantial Equivalence: The Infinity is described as an extension of the 300 PV and similar in design and functions, offering multiple treatment programs. Differences noted are that Infinity is a two-channel system (300 PV is four-channel) and Infinity is not indicated for NMES, FES, or TENS.
• Regulatory Decision: A substantial equivalence determination was made by the FDA on December 17, 2004, allowing the device to be marketed.

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The Empi Action Patch Iontophoresis System is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.

The Empi Action Patch Iontophoresis System is a disposable single-use iontophoresis device with a self-contained battery and electrical circuitry. A single adhesive patch unifies both the battery-powered iontophoresis device and the active and return electrodes. The Empi Action Patch is designed to deliver a calibrated and fixed dose of ionic solution (between 1 and 160 mAmp * min.) over a specified time. After delivery of the specified dose, an LED indicator light extinguishes indicating that that the Patch can be removed.

This 510(k) premarket notification for the Empi Action Patch Iontophoresis System does not contain the detailed study information regarding acceptance criteria and performance data that you've requested.

The document primarily focuses on establishing substantial equivalence to predicate devices. This means that instead of presenting new clinical performance studies against defined acceptance criteria, the manufacturer is demonstrating that their new device is as safe and effective as devices already on the market.

Therefore, for your specific request, I can only provide the following based on the provided text:

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

This document does not define specific quantitative "acceptance criteria" and "reported device performance" in the way one would expect from a clinical trial or performance study aiming to prove efficacy against a predefined standard. The evaluation of this device is based on its substantial equivalence to predicate devices, focusing on:

The following information cannot be provided from the given document, as it pertains to clinical performance studies, which are typically not required for 510(k) submissions based on substantial equivalence to predicate devices for this type of medical device.

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
  • Not provided. This document does not describe a test set or associated data provenance from a performance study.
• 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/provided. No test set or ground truth establishment by experts is described.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
  • Not applicable/provided. No test set or adjudication method is described.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
  • Not applicable/provided. This device is an iontophoresis system, not an AI-assisted diagnostic tool. An MRMC study is irrelevant in this context.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
  • Not applicable/provided. This is not an algorithm-based device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • Not applicable/provided. No clinical studies requiring ground truth are described. The "ground truth" for 510(k) equivalence is generally the established safety and efficacy of the predicate devices.
• 8. The sample size for the training set
  • Not applicable/provided. No training set for an algorithm is relevant to this device submission.
• 9. How the ground truth for the training set was established
  • Not applicable/provided. No training set for an algorithm is relevant to this device submission.

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The 300 PV is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve stimulation (TENS), interferential current stimulation (IFS) and functional electrical stimulation (FES).

As a NMES device, the 300 PV is indicated for the following conditions:

• Retarding or preventing disuse atrophy .
• . Maintaining or increasing range of motion
• Re-educating muscles .
• Relaxation of muscle spasm .
• Increasing local blood circulation .
• Prevention of venous thrombosis of the calf muscles immediately after . surgery

As a TENS device, the 300 PV is indicated for the following conditions:

• Symptomatic relief and management of chronic, intractable pain .
• Adjunctive treatment for post-surgical and post-trauma acute pain .

As an IFS device, the 300 PV is indicated for the following conditions:

• Symptomatic relief of acute pain .
• Symptomatic relief and management of chronic pain .

As a FES device, the 300 PV is indicated for the following condition:

• Stimulation of the muscles in the leg and ankle of partially paralyzed . patients to provide flexion of the foot and thus improve the patient's gait.

The Empi 300 PV Complete Electrotherapy System (300 PV) is a battery-powered, multifunction device intended to provide clinicians with the flexibility to prescribe multiple stimulation therapy regimens with the same device. The 300 PV offers the following features:

• . Two independent stimulation channels (CH1 and CH2), each of which can provide NMES, TENS, IF, or FES therapy. HV therapy can be accomplished using CH1.
• Two independent intensity controls corresponding to each of the stimulation ● channels with a maximum stimulation of 100 mA from each channel.
• Timed therapy sessions
• Continuous or cycled stimulation
• . Adjustable pulse rates
• . Adjustable ON and OFF time controls
• . Balanced asymmetrical and symmetrical biphasic waveforms
• Thirteen preprogrammed regimens: five for NMES; one for TENS; one for ● IF; two for HV and four that can be customized by the clinician (two NMES and two HV).
• Lock option for clinician to control treatment regimens and stimulus intensity .
• Pause button for patient to pause stimulation. During pause, the timer will ● not countdown if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters but a stimulus intensity of zero.
• . Optional external hand or foot switch used to control the device output during when used as an FES device for gait training

The provided text is a 510(k) summary for the "300 PV Complete Electrotherapy System." It details the device's indications for use and states its basis for substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria.

510(k) summaries primarily focus on demonstrating substantial equivalence to legally marketed predicate devices, often by comparing design, materials, indications for use, and performance characteristics. They typically do not include detailed performance studies with acceptance criteria in the way a PMA (Pre-Market Approval) or a de novo submission might.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not applicable as a specific performance study dataset is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an electrotherapy device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is an electrotherapy device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document discusses the basis for substantial equivalence by comparing the 300 PV to predicate devices like the Empi Focus, JACE Tristim, and RS Medical RS-4M+. It highlights improvements over the Empi Focus (simplified user interface, addition of interferential and high voltage regimens) and notes that specific features (high voltage galvanic stimulation, interferential current stimulation) are available on other predicate devices. This comparison serves as the "proof" for substantial equivalence rather than a new performance study against defined acceptance criteria.

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