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The Fuji Dynamics Incontinence Stimulation Electrodes are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

The Fuji Dynamics Incontinence Stimulation Electrode models Fuji-01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 are the light weight cylinder consisting of two or three independent conductive rings or plates that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and handle for comfort positioning in vaginal canal for incontinent treatment and easy in removing after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing and drying between uses.

Here's an analysis of the provided text regarding the Fuji Dynamics Incontinence Stimulation Electrode, focusing on acceptance criteria and study details:

This document is a 510(k) summary for a medical device submitted to the FDA. It does not contain a detailed study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or clinical outcomes.

Instead, this 510(k) outlines the device's substantial equivalence to predicate devices based on identical intended use, technological characteristics, and safety testing (biocompatibility). The FDA's 510(k) pathway determines if a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily that it meets specific, predefined performance thresholds through a clinical study.

Therefore, many of your requested points related to performance studies (like sample size for test sets, number of experts, MRMC studies, standalone performance, training set details) will not be present in this type of document because such studies were not required for this specific 510(k) submission.

Here's a breakdown of the information that is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document does not present a table of specific quantitative "acceptance criteria" for device performance (e.g., a specific accuracy or sensitivity). The "acceptance" for this 510(k) is based on demonstrating substantial equivalence to the predicate devices. The "reported device performance" is primarily about its physical and functional characteristics matching or being acceptably different from the predicates.

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As a TENS device, FD TENS 2090 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

As a EMS device. FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for:

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

FD TENS 2095 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

FD TENS 2090 can provide both TENS treatments and EMS treatments. During TENS treatments, the FD TENS 2090 generates electrical pulses and transmit it to the electrodes which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

During EMS treatments, FD TENS 2090 generates electrical pulses and transmit it to the electrodes attached to the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms. prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, reeducate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.

FD TENS 2095 can provide TENS treatment, During treatment, the FD TENS 2095 generates electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

This document is a 510(k) Premarket Notification from the FDA for medical devices named FD TENS 2090 and FD TENS 2095. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (FD TENS 2030 and FD EMS), rather than presenting a study to prove a device meets specific acceptance criteria for a novel AI or diagnostic function.

Therefore, many of the requested elements for an AI-focused study are not present in this document. However, I can extract the information relevant to the device's performance characteristics and how its equivalence was established.

No study proving the device meets specific acceptance criteria in the context of an AI or diagnostic function is described in this document. The document describes a "substantial equivalence" determination based on comparison to predicate devices, focusing on technical characteristics and intended use.

Here's a breakdown of the requested information based on the provided document. Many fields will indicate "Not applicable" or "Not provided" because the document is a 510(k) summary for a non-AI device.

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

Since this is a substantial equivalence submission for TENS/EMS devices and not an AI or diagnostic device, there are no "acceptance criteria" in the traditional sense of diagnostic metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating that the new device's technical specifications and intended use are substantially equivalent to the predicate devices.

The "device performance" in this context is its electrical parameters compared to the predicate devices.

Note: The subject device's electrical characteristics are sometimes numerically different from the predicate device but are deemed "substantially equivalent" for this type of device, implying they operate within acceptable and safe ranges for their intended therapeutic effect. The FDA clearance confirms this. For EMS's On/Off Time, the subject device has fixed times while the predicate has adjustable, which is a design difference but likely deemed acceptable for 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)

• Sample size for test set: Not applicable. This is not a study assessing diagnostic performance on a dataset but a technical comparison of device specifications to predicate devices.
• Data provenance: Not applicable for a diagnostic test set. The data presented are engineering specifications of the devices.

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)

• Number of experts: Not applicable. Ground truth for a diagnostic test set is not relevant for this type of submission.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. No test set for diagnostic 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

• MRMC study: No. This is not an AI-assisted diagnostic device.
• Effect size: Not applicable.

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

• Standalone performance: No. This is not an AI algorithm.

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

• Type of ground truth: Not applicable. The "ground truth" for this submission are the established technical specifications and performance characteristics of the legally marketed predicate devices, against which the new device's specifications are compared. The safety and effectiveness are established by meeting these engineering and performance standards, and through compliance with recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2).

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not an AI device that requires a training set.

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

• Ground truth for training set: Not applicable.

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The LL TENS 160A and LL TENS 160B are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

LL TENS 160A and LL TENS 160B are handheld battery powered TENS devices for pain relief intended for over-the-counter use. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's (user's) skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

LL TENS 160A and LL TENS 160B has two output channels and four preset programs. The program mode is displayed on LCD. The user can adjust the output intensity by 14 steps.

LL TENS 160A and LL TENS 160B have same hardware, software and mechanical structure. The difference is that LL TENS 160A's LCD display is placed on the bottom of keys while LL TENS 160B's LCD display is on the top of keys.

Since the device is battery powered, there is no connection to AC mains supply.

This document is a 510(k) Summary for the LL TENS 160A and LL TENS 160B devices, which are Transcutaneous Electrical Nerve Stimulators (T.E.N.S.) intended for over-the-counter use. The purpose of the document is to demonstrate substantial equivalence to a legally marketed predicate device, "Pain Buddy" (K102051).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define "acceptance criteria" as pass/fail thresholds for clinical performance metrics in the way a diagnostic AI device might. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical characteristics and safety parameters against established standards.

The "acceptance criteria" implicitly revolve around ensuring the new device's electrical stimulation parameters, safety features, and usability are within acceptable limits as defined by relevant IEC standards and are comparable to or safer than the predicate device.

Note: The document focuses on demonstrating equivalency rather than specific performance metrics against pre-defined, numerical acceptance criteria for clinical efficacy, as this is a 510(k) for a TENS device, not an AI diagnostic. The electrical parameters are compared to the predicate, with the overarching "acceptance" being that any differences do not impact safety or effectiveness beyond what is accepted for similar devices.

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

For the usability study, the document states "A usability study has been performed," but it does not specify the sample size of participants in the test set.

• Data Provenance: Not explicitly stated, meaning no information on country of origin or if it was retrospective or prospective. Given the nature of a usability study, it would typically be prospective, involving human participants performing tasks with the device.

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

For the usability study, the document does not mention the number of experts used to establish ground truth (e.g., assessing correct usage or safety issues), nor does it specify their qualifications. Typically, usability studies would involve human factors engineers or independent evaluators, but this is not detailed here.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the usability study.

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. This document pertains to Transcutaneous Electrical Nerve Stimulators (TENS devices), which are physical medical devices for pain relief, not AI software or diagnostic imaging devices that would typically involve human readers (e.g., radiologists) or AI assistance. The concept of "AI vs. without AI assistance" is not applicable here.

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

No, a standalone (algorithm only) performance study was not done. This is not an AI device. The "device" in question is a hardware TENS unit. The document mentions "software uses same mechanism as Pain Buddy," but this refers to the embedded firmware controlling the TENS unit, not a standalone algorithm in the AI sense.

7. The type of ground truth used

For the usability study, the "ground truth" would be the observed ability of users to operate the device correctly and safely, likely assessed against predefined operational requirements and safety criteria. This would be qualitative and quantitative data gathered during the usability testing sessions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set." The device is a TENS unit.

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

Not applicable. As above, there is no training set for this type of device.

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FD2070 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of chronic post-surgical and post-traumatic acute pain.

As a Transcutanous Electrical Nerve Stimulator (TENS) unit, FD2070 generates patientical pulses and transmit it to the electrodes, which are attached in the skin to the underlying peripheral pulses would then pass his gold then pass through the unders skin to the underlying peripheral nerves no aid in the pass through the skin to the underlying peripheral nerves to aid in the blocking to the traveling to the brain.

Here's an analysis of the provided text regarding the acceptance criteria and study data for the FD2070 Mini TENS device:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the FD TENS 2070 (K111654) demonstrates substantial equivalence to its predicate device, FD TENS 2030 (K052813). The acceptance criteria are implicitly defined by the technical specifications of the predicate device, as the new device is seeking to prove it is "as safe and as effective" as the predicate. The study conducted to demonstrate this equivalence is primarily non-clinical testing, with a direct comparison of technical specifications and compliance with relevant safety and EMC standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the specifications of the predicate device (FD TENS 2030, K052813). The reported device performance is that of the FD2070 / Mini TENS (K111654).

2. Sample Size and Data Provenance

• Sample Size for the test set: Not applicable – this is a non-clinical, technical comparison of device specifications and compliance testing, not a clinical study involving patients or a test set of data in the traditional sense. The "test set" consists of the physical device being tested against engineering and safety standards.
• Data Provenance: The technical specifications and test results are generated from the manufacturing and testing activities of Fuji Dynamics Ltd. in Hong Kong. The data are from the prospective design, manufacturing, and electrical testing of the FD2070 device.

3. Number of Experts and Qualifications for Ground Truth

• Number of experts: Not applicable. Ground truth for device specifications and standard compliance is established via objective physical measurements and adherence to recognized international standards (e.g., EN60601-1). This does not involve expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the test set

• Adjudication method: Not applicable. The "test set" involves physical measurements and compliance verification against standards, not subjective interpretation requiring adjudication.

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

• MRMC study: No. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, a MRMC study is not relevant for this 510(k) submission.

6. Standalone (Algorithm Only) Performance

• Standalone performance: Not applicable. The device is a physical electronic medical device (TENS unit), not a software algorithm or AI model that would have a "standalone" or "human-in-the-loop" performance. Its performance is its physical output characteristics.

7. Type of Ground Truth Used

• Type of ground truth: Objective Technical Specifications and International Standards. The key ground truths are:
  • The published technical specifications of the predicate device (FD TENS 2030).
  • The requirements of EN60601-1 Safety requirement and EN60601-1-2 EMC requirements.
  • The principles of FDA software guidance for software verification.
  • The concept of electrical safety which dictates limits on parameters like net charge, current density, and power density to prevent tissue damage.

8. Sample Size for the Training Set

• Sample size for training set: Not applicable. This is not an AI/ML device where a "training set" in the machine learning sense would be used. The device design is based on established engineering principles and the predicate device's design.

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

• How ground truth for training set was established: Not applicable. As there is no training set for a machine learning model, this question is not relevant. The "ground truth" for the device's design and functionality is derived from engineering principles, safety standards, and the performance characteristics of previously cleared predicate devices.

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The FD2050 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

The FD2050 is a handheld battery powered TENS device. which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

FD2050 has two output channels and five preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 20 steps.

The provided text describes a 510(k) premarket notification for the FD2050 (Slide TENS) device, comparing it to a predicate device (SMART TENS). This document primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a study designed to establish acceptance criteria for a novel device's performance in a clinical setting.

Therefore, many of the requested categories for a study proving device performance (such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for the training set) are not applicable or not available in this type of regulatory submission. This document confirms the device's technical specifications and safety compliance.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the predicate device's specifications and compliance with relevant safety and EMC standards. The "reported device performance" is a comparison of the FD2050's output specifications against those of the predicate device.

Note on Differences: While many parameters are similar, some show differences (e.g., Max Frequency, Max Current Density, Max Power Density, and specific modulation programs). The submission argues these differences do not raise new questions of safety or effectiveness, as the overall electrical stimulus characteristics remain within generally accepted ranges for TENS devices.

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

• Not applicable. This submission is a 510(k) for a TENS device, which typically relies on demonstrating substantial equivalence to a predicate device through engineering similarity, performance testing (bench testing), and compliance with recognized standards. It does not involve human subject testing to establish efficacy or safety from a "test set" of patients or data in the way a diagnostic AI device would.
• The data provenance mentioned (e.g., country of origin, retrospective/prospective) is not relevant in this context.

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. No clinical ground truth from human experts was established for this type of device. The ground truth for performance is the technical specifications and safety standards.

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

• Not applicable. No clinical adjudication was performed as part of this submission.

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 is a hardware medical device (TENS) and does not involve AI or human "readers" (e.g., radiologists, pathologists). Therefore, MRMC studies are not relevant.

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

• Not applicable. This device is a TENS unit. While it contains software, its "performance" is its ability to generate specific electrical pulses, not to perform an algorithmic diagnosis or interpretation. Its functionality is inherently "standalone" in generating the electrical output once parameters are set by the user, but this term is not used in the context of standalone AI performance.

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

• The "ground truth" for this device's acceptance is its compliance with recognized electrical safety and EMC standards (EN60601-1, EN60601-1-2) and its technical electrical output specifications which are compared to a legally marketed predicate device. Additionally, biocompatibility testing was performed on the material (ABS) to ensure safety.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set of data.

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

• Not applicable. No training set was used.

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