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TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain.

EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for:

• · Relaxation of muscle spasm
• · Increasing local blood circulation and muscle re-education
• · Prevention or retardation of disuse atrophy
• · Prevention of venous thrombosis of the calf muscles immediately after surgery
• · Maintaining on increasing range of motion

MIC stands for Microcurrent Stimulation. Unipro MIC is used to provide sumptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.

IFT stands for Interferntial Stimulation. Unipro IFT is indicated for symptomatic relief of chronic intractable pain.

Unipro is a non-invasive, non-sterile, reusable medical device which is intended to be used in both the hospital and home healthcare environment. It is a microprocessor controlled, non-implantable, portable neuromuscular electrical stimulator which is powered by a built in Li-ion rechargeable battery.

Unipro is a multitherapy unit that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), MIC (Microcurrent Stimulation) and IFT (Interferential Therapy). The mode selection button on device will enable the user to switch between different modes (TENS, EMS II, EMS III, or massage). Each time the user changes the mode or program, the intensity level will revert to zero. This is a safety feature to alleviate any sudden feeling of a surge, as each program gives a different sensation.

Unipro Case L (large) features a white ABS case with a white silicone button pad and white power button. Power button is located on the right-hand side of the device. The hardware features a black perimeter border and black LCD display. Charging cable and lead inserts are located on the bottom of the device.

Unipro is supplied with self-adhesive electrodes which attach to the control unit via lead wires. A gentle electrical current is sent to underlying nerves and muscle groups via these electrodes applied on the skin to relieve pain. Placement of the electrode pads of the device depends on the selected device mode (TENS, EMS, IFT2, IFT4, MIC). For TENS, the easiest way is to apply the electrode pads around/near the source of the pain. For EMS, place two electrode pads over the bulk of the muscle, with one electrode over the muscle's motor point. For IFT2, electrodes should be placed either side of the area of pain and for IFT4, the pads need to apply in positions so that the signals from each channel cross over the point to be treated. Finally, for MIC, the electrode pads should be placed in such a way that a straight line between them passes through the problem area.

The TensCare Ltd Unipro (K232441) is a multi-therapy electrical stimulator combining TENS, EMS, MIC, and IFT functionalities. The submission claims substantial equivalence to the predicate device, Ultima NEO (K120054).

Here's a breakdown of the requested information based on the provided text:

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

The provided documentation does not explicitly list "acceptance criteria" for performance metrics in a pass/fail format. Instead, it compares the technical characteristics and indications for use of the Unipro to its predicate device, Ultima NEO, to demonstrate substantial equivalence. The "Comparison" column in the tables serves as a qualitative assessment of whether the Unipro's performance characteristics are similar enough to the predicate.

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

The submission indicates that "No clinical testing was considered necessary." Therefore, there is no sample size for a new test set or details on data provenance from a prospective or retrospective study involving the Unipro device. The equivalence claim is based on comparison to the predicate and literature review.

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 clinical testing was performed on the device to establish a new ground truth. The basis of the submission relies on the established safety and effectiveness of the predicate device and the modes of therapy.

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

Not applicable, as no clinical testing was performed that would require adjudication of a test set.

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 not an AI-assisted diagnostic or interpretative tool, and no MRMC study was conducted.

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

Not applicable. This device is a direct-use electrical stimulator, not an algorithm. Its performance is evaluated through bench testing against established standards and comparison to a predicate device.

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

The "ground truth" for the Unipro's substantial equivalence claim is based on the established safety and effectiveness of the legally marketed predicate device (Ultima NEO), and recognized international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10). Additionally, it mentions a formal review of published research and clinical evaluation on the use of TENS, EMS, IFT, and MC for pain relief and muscle training, which serves as a form of expert consensus and outcomes data from the broader scientific community.

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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For Mode 0, Ova+ is indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

For Modes 1, 2& 3 Ova+ is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

The Ova+ is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free period pain relief whilst maintaining a normal, active lifestyle.

The device is battery powered, single channel home using Transcutaneous Electrical Nerve Stimulation (TENS).

The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via these self-adhesive electrodes to superficial nerves.

The unit is intended for home use by the patient and is designed with simplicity and ease of use in mind. It has four preset treatment Modes. The level of electrical stimulation of Ova+ is easily controlled by the end user using manual, push-button controls.

The new device Ova+ uses the same technical principle and substantially equivalent stimulation parameters to the marketed device Livia (K183110) and/or reference predicate device Perfect EMS (K200694)

The Ova+ uses a rechargeable Li-Ion polymer battery and a custom TENS connecting lead with 2mm connecting pins.

The Ova+ is supplied with adhesive electrodes that are similar to those of the predicate devices.

The provided text is a U.S. FDA 510(k) summary for the TensCare Ova+ device, a transcutaneous electrical nerve stimulator (TENS). The document describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the TensCare Ova+ device is not a device that uses AI/ML or requires a complex study for its acceptance criteria. It is a TENS device that relies on established technology and regulatory pathways for electrical medical devices.

Therefore, many of the requested elements (e.g., acceptance criteria for AI performance, sample sizes for AI test/training sets, expert adjudication for ground truth, MRMC studies, standalone AI performance) are not applicable to this specific device submission.

The acceptance criteria for this device are based on its electrical performance, safety, and functional equivalence to legally marketed predicate TENS devices, as demonstrated through non-clinical bench testing and adherence to recognized consensus standards.

Here's an attempt to answer the relevant questions based on the provided document:

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

The document does not present explicit "acceptance criteria" in a table format with pass/fail results for each criterion. Instead, it compares the performance characteristics of the Ova+ device to its predicate devices to demonstrate substantial equivalence. The implication is that if the Ova+ device's performance characteristics are similar enough to the cleared predicate devices and meet relevant safety standards, it is considered acceptable.

Below is a summary of the comparative performance from the document (mostly from "Table 3: Comparison of output specifications" and "Table 2: Basic Unit Characteristics Comparison Table" but also other sections). The "Acceptance Criteria" here are implicitly "Substantially Equivalent to Predicate Device(s)" and "Compliance with relevant standards". The "Reported Device Performance" is the stated characteristic of the Ova+ device.

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Unicare is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Unicare is battery powered, single-channel, home-use electrical pelvic floor muscle stimulator. The device is supplied with a non-sterile, reusable (single-patient use) vaginal probe and self-adhesive electrodes which connect to the control unit by cable and plugs. The vaginal probe is inserted into the vagina. The optional self-adhesive electrodes is placed on patients' intact skin and is used for the treatment of only urge urinary incontinence in women. Electrical stimulation is delivered via the vaginal probe or the self-adhesive electrodes to the pelvic floor muscles. This electrical muscle stimulation works as a rehabilitation and training for pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women. The level of electrical stimulation of the Unicare can be controlled by the end user using manual push-button controls. This device is intended for over the counter (OTC) use.

The provided document does not contain information related to software-based medical devices that would involve acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set information as typically found for AI/ML-driven diagnostics.

The document is an FDA 510(k) clearance letter for a non-implanted electrical continence device called "Unicare." This device is a hardware product that provides electrical stimulation for pelvic floor muscles. The "Non-Clinical Testing" section lists various engineering and safety tests performed on the device (biocompatibility, electrical safety, electromagnetic compatibility, software verification/validation, battery life), but these are standard engineering tests for hardware and software aspects of a physical device, not performance studies for an AI/ML algorithm or diagnostic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for device performance in the context of AI/ML or diagnostic accuracy from this document. The information requested (e.g., sample size for test set, data provenance, expert adjudication, MRMC studies, ground truth types) is specific to studies evaluating the performance of diagnostic algorithms, particularly those involving image analysis or similar AI/ML applications, which is not applicable to the "Unicare" device described.

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TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS is intended for over-the-counter use.

The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.

The level of electrical stimulation is easily controlled by the end user using manual, pushbutton controls.

The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has six preset treatment programs and four manually adjustable programmes are available.

Accessories: 2 x 1.25m PVC Lead Wires (L-CPT) 50x50mm hydrogel electrode pads (E-CM5050)

Optional accessories: 50x100mm Large hydrogel electrode pads Pack of 4 (E-CM50100)

The provided text describes a 510(k) submission for the Perfect EMS device, asserting its substantial equivalence to a predicate device (HIVOX OTC Electrical Stimulator Model: EM49-2, K190347). The document focuses on demonstrating that the Perfect EMS meets safety and performance criteria by comparing it to the predicate and through compliance with recognized standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Perfect EMS device are implicitly defined by its substantial equivalence to the predicate device, EM49-2 (K190347), and adherence to a battery of safety and performance standards. The table above the horizontal line below summarizes the performance attributes of the Perfect EMS (Subject Device) and the predicate device, along with the comparison stating "Substantially equivalent" or "Identical."

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

The document does not specify a "test set" in the context of clinical data or patient outcomes. The performance evaluation is based on engineering and safety testing against recognized standards. Therefore, information regarding sample size and data provenance for a test set in the traditional sense (e.g., patient data) is not applicable here. The provenance for the device is the manufacturing facility in China (EasyMed Instruments Co Ltd).

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

This information is not applicable. The evaluation framework is based on compliance with established engineering and safety standards, and a comparison to a predicate device. There is no mention of human expert-established "ground truth" for the performance tests conducted on the device's technical specifications.

4. Adjudication method for the test set

This information is not applicable. As there is no clinical "test set" requiring human interpretation or decision-making, an adjudication method for such a set is not relevant.

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

An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic or decision-making systems. The Perfect EMS is an electrical stimulator for pain relief and muscle performance, not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not reported.

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

The Perfect EMS is a physical medical device, not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. Performance was assessed by measuring the device's electrical output and adherence to safety standards.

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

The "ground truth" in this context is the pre-defined acceptance criteria set by recognized safety and performance standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, IEC 62304, ISO 10993-1) and the technical specifications of the legally marketed predicate device (EM49-2 K190347). The device's performance was measured against these established quantitative parameters and qualitative design characteristics.

8. The sample size for the training set

This information is not applicable. The Perfect EMS is a hardware device; it does not explicitly mention any machine learning or AI components that would require a "training set" for an algorithm.

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

This information is not applicable for the same reason as point 8. There is no mention of a training set or AI algorithm in this context.

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Perfect PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

The Perfect PFE is a hand-held, home-use device designed to treat stress, urge and mixed urinary continence in women and maintain urinary continence in women. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe. The probe connects to the control unit by cable and plug and is inserted into the end user. The probe has a recommended usage duration of 6 months.

The device is battery powered, single channel, home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the 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, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.

The unit is intended for home use by the patient. It has four preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors.

Accessories: Lead Wire (L-CPT) Liberty Loop vaginal probe (X-VPL)

This document is a 510(k) Premarket Notification from TensCare Ltd. for their device, the "Perfect PFE," a non-implanted electrical continence device. The FDA determined the device to be substantially equivalent to legally marketed predicate devices.

The request asks for details on the acceptance criteria and the study proving the device meets these criteria. However, this document primarily focuses on demonstrating substantial equivalence to existing predicate devices (TensCare KegelFit and Yarlap), rather than presenting a performance study with acceptance criteria in the typical sense for a novel medical device. The 510(k) pathway for medical device clearance in the US does not generally require clinical trials to prove efficacy if substantial equivalence to a legally marketed predicate device can be demonstrated.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of submission. The "study" here is primarily a comparison against predicate devices and adherence to recognized safety standards.

Here's how the information maps to your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission based on substantial equivalence, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as the predicate device. This is primarily done through a comparison of technological characteristics, intended use, and adherence to relevant safety standards. The "performance" is shown by meeting these comparisons and standards.

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

• Sample Size for Test Set: Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices and compliance with recognized standards, not a specific clinical test set to evaluate performance metrics like sensitivity or specificity.
• Data Provenance: Not applicable in the context of a "test set" for performance evaluation. The data presented is primarily engineering specifications, comparison tables, and adherence to international safety standards.

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

• Number of Experts: Not applicable. "Ground truth" in the context of clinical performance data for a diagnostic/treatment device is not required for this type of 510(k) submission, as it's based on substantial equivalence rather than novel performance claims.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was performed.

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: Not applicable. This device is an electrical stimulator for home use, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies.

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

• Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm that operates in a standalone manner.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. Clinical "ground truth" (e.g., pathology, outcomes data) is not part of a substantial equivalence demonstration for a device of this type, which is cleared based on its similarity to existing cleared devices and adherence to safety standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use an AI algorithm that requires a training set.

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

• How Ground Truth Established: Not applicable.

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KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support. The KegelFit is intended for OTC sale.

The KegelFit is a hand-held, home-use device designed to treat female stress urinary incontinence. The device is supplied with a vaginal two electrode stimulation probe (Trainer). The trainer connects to the control unit by cable and plug and is inserted into the vagina by the end user. Electrical stimulation is delivered via stainless steel electrodes on the trainer 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, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The device is battery powered single channel home use neuromuscular stimulation. 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, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has two preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors.

The provided text does not contain specific acceptance criteria with numerical thresholds, nor does it detail a clinical study with a control group and effect sizes to prove that the Tenscare KegelFit device meets such criteria. Instead, the submission focuses on establishing substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics, intended use, and safety documentation.

Here's an breakdown of the information that can be extracted from the document, organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria with specific numerical targets (e.g., "sensitivity > 90%") for the device's clinical performance are not provided in this document. The document focuses on demonstrating substantial equivalence to predicate devices, rather than meeting novel performance criteria through new clinical endpoints.

Instead of formal "acceptance criteria," the document outlines areas of comparison to establish substantial equivalence. The "reported device performance" is framed in terms of its similarity to predicates and successful safety testing.

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

The "testing" mentioned is not a human clinical trial test set in the traditional sense, but rather a combination of:

• Customer Reviews Analysis:
  • Sample Size: 13,758 OTC sales of the predicate device "itouch Sure" through Amazon UK.
  • Data Provenance: Retrospective, derived from customer reviews in the UK (EU market at the time).
• Customer Questionnaires:
  • Sample Size: 21 responses received from 120 users of "itouch Sure" who purchased OTC through eBay UK.
  • Data Provenance: Prospective (questionnaires sent out), with data from UK (EU market).
• Labeling Comparison: Not a "test set" in terms of subject count, but a comparison of documents.
• Clinical Literature Evaluation: Not a specific test set, but a review of existing literature.

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

• Customer Reviews/Questionnaires: No medical experts established "ground truth" for the usability and self-diagnosis aspects derived from customer feedback. The "truth" in this context is the aggregated perception and experience of lay users.
• Labeling Comparison: The comparison was performed by the submission authors (Tenscare Ltd.). The qualifications of these individuals are not specified in the provided text.
• Clinical Literature Review: This implies an expert review, but the number and specific qualifications of the individuals who conducted this review are not stated.

4. Adjudication Method for the Test Set

• Customer Reviews/Questionnaires: There is no mention of a formal adjudication method by experts. The analysis involved reviewing customer feedback.
• Labeling Comparison: This was a direct comparison done by the submitter, not requiring an adjudication panel.
• Clinical Literature Review: No specific 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an electrical muscle stimulator, not an AI-powered diagnostic tool requiring human reader interpretation of images or other data. This type of study is not relevant to this device.

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

The Tenscare KegelFit is a physical medical device (muscle stimulator) intended for home use by patients, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable. The device's performance is inherently linked to its use by a human operator. Its "standalone" performance might refer to its functional specifications (e.g., electrical parameters) which were tested in electrical safety and EMC tests, but not in a "standalone algorithm" context.

7. The Type of Ground Truth Used

• For safety and effectiveness: The "ground truth" relies on:
  • Substantial equivalence to predicate devices: The established safety and effectiveness of the existing itouch Sure and Apex devices (which presumably had their own ground truth established in prior clearances).
  • Clinical literature evaluation: Existing medical literature on the efficacy of electrical stimulation for stress urinary incontinence.
• For usability and self-selection for OTC use: The "ground truth" was established by:
  • Customer feedback/reviews: Direct user experience and statements regarding ease of use and understanding of instructions and contraindications. This serves as a proxy for "ground truth" in the context of user comprehension for an OTC product.

8. The Sample Size for the Training Set

Not Applicable. The Tenscare KegelFit is not an AI/ML algorithm that requires a "training set" of data. It is a hardware medical device with pre-programmed settings.

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

Not Applicable. As there is no AI/ML algorithm or training set, this question does not apply.

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The itouch Sure is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women

The itouch Sure is a small lightweight battery powered single channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has four preset treatment programs, an adjustable treatment timer, a compliance monitor, and open circuit detectors.

The TensCare itouch Sure Pelvic Floor Exerciser (K103698) is a Class II device intended to provide electrical stimulation and neuromuscular re-education for the rehabilitation of weak pelvic floor muscles to treat stress, urge, and mixed urinary incontinence in women.

The submission does not include a separate study that establishes acceptance criteria and proves the device meets them in the way clinical performance studies with specific endpoints would. Instead, the FDA's "substantial equivalence" determination for this 510(k) submission is based on a technological comparison to predicate devices. This means the device is deemed safe and effective because its technological characteristics and intended use are similar to those of devices already legally marketed, and any differences do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" here are inherent to the regulatory process for substantial equivalence, focusing on whether the new device is as safe and effective as its predicates based on a comparison of their features and performance characteristics.

Here’s an interpretation of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not explicit numerical targets from a performance study but rather the demonstration that the TensCare itouch Sure's technical specifications and safety profile are comparable to the predicate devices.

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TENS stands for Transcutaneous Electrical Nerve Stimulation. The itouch TENS system is indicated for:

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

A portable TENS device for pain relief.
Features:

• Innovative design
• Large LCD display
• Dual output isolated channels
• 2 AA Alkaline Batteries
• Adjustable frequency, pulse width, and timing parameters
• 9 different modes
• Timer option
• Doctor lock/unlock facility
• Open circuit detectors
• Non-volatile

The provided 510(k) summary for the Tenscare TENS Model itouch (K082377) does not contain a study that proves the device meets specific acceptance criteria in the way typically found for novel diagnostic algorithms or devices.

Instead, this submission primarily focuses on demonstrating substantial equivalence to predicate devices (EasyMed TENS Unit TN-28C and Gemore GM300T) via technological comparison, labeling comparison, and compliance with recognized safety standards. For TENS devices, the primary "acceptance criteria" are related to safety, electrical output specifications, and efficacy established by existing, legally marketed devices.

Here's an breakdown based on the provided text, addressing your points where information exists:

1. Table of Acceptance Criteria and Reported Device Performance

As per the document, specific, quantifiable acceptance criteria (e.g., target accuracy, sensitivity, specificity) for a clinical study proving device efficacy are not presented for the Tenscare itouch. Instead, the "performance" is implicitly tied to compliance with standards and equivalence to predicate devices which are already accepted as safe and effective.

The closest to "acceptance criteria" are:

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

• No specific clinical test set is described. The submission relies on technological comparison and compliance with standards rather than a new clinical performance study with a dedicated test set of patient data.
• The reference to "itouch has been marketed in Europe" and "review of Customer Complaints, Returned Product and the results of Post Market Feedback" suggests retrospective data analysis from real-world usage in Europe. However, no sample sizes for this feedback are provided.

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

• This is not applicable as there is no described clinical study with a "test set" and associated "ground truth" derived by experts for performance evaluation.

4. Adjudication method for the test set

• This is not applicable as there is no described clinical study with a "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

• This is not applicable. The device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic tool, and therefore, an MRMC study involving human readers and AI assistance is outside its scope.

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

• This is not applicable. The Tenscare itouch is a medical device for pain relief, not an algorithm.

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

• For the European post-market review, the "ground truth" was implicitly the real-world performance as intended by the device's design and specified requirements, based on customer complaints, returned products, and feedback. This can be considered a form of "outcomes data" related to device function and patient satisfaction, rather than a diagnostic ground truth.
• For the submission to the FDA, the "ground truth" for demonstrating equivalence is the established safety and efficacy profile of the predicate devices and compliance with recognized electrical safety and performance standards.

8. The sample size for the training set

• This is not applicable. The device is not an AI algorithm that requires a "training set." Its design and development are based on established engineering principles for TENS devices and comparison to predicate devices.

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

• This is not applicable as there is no "training set" for an AI algorithm.

In summary:

The K082377 submission for the Tenscare TENS Model itouch demonstrates substantial equivalence to predicate devices through technical comparisons, adherence to safety standards, and general claims of satisfactory performance in the European market. It does not present a clinical study with specific acceptance criteria, test sets, or ground truth establishment in the manner typically seen for novel diagnostic or AI-driven medical devices. The primary "proof" relies on the device being technologically similar to and meeting the same safety standards as already cleared TENS devices.

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For the TENS function: TENS is used for the relief and management of symptomatic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post traumatic acute pain.
For the EMS function: The Ultima NMS/EMS is indicated for: Relaxation of muscle spasm. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Prevention of venous thrombosis of the calf. muscles immediately after surgery. Maintaining or increasing range of motion.

For the TENS function: A portable TENS device for pain relief.
For the EMS function: A portable EMS device for the re-education of muscles.
The Ultima NMS/EMS (the "New Device") brings together TENS and Powered Muscle Stimulator functions from two previously cleared for market devices; namely the Ultima TENS (K020846) for the TENS functions and the TensCare XL-Y3 (K011543) for the Powered Muscle Stimulator functions.
The electrical. EMC and software technologies used in the Ultima NMS/EMS (the 'New Device'), are identical to the Ultima TENS (the Predicate device - (K020846), in that the same CPU series is utilised (the difference being that the variant used has increased memory capacity).
In addition, the "New Device" uses the same passive and active electrical components and PCB layout, as the Predicate devices.
The Powered Muscle Stimulator functions are derived from software programmed into the CPU device and are based on and virtually identical to the Predicate device.
The TensCare Ultima NMS/EMS has a Doctor Important anti-Misuse feature: Lock facility, which means that at the Treating Physician's discretion, the patient has no control over the devices outputs; the Programs are pre-set by the Treating Physician.
The use of 'shrouded patient cable connectors' to comply with FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables" is utilised to further ensure no hazards exist.

Acceptance Criteria and Device Performance for TensCare Ultima NMS/EMS

This document summarizes the acceptance criteria and supporting study information for the TensCare Ultima NMS/EMS device based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not contain explicit, quantitative acceptance criteria for the TensCare Ultima NMS/EMS device in the form of a table. Instead, it relies on demonstrating substantial equivalence to predicate devices and performance in the European market.

The primary "acceptance criteria" appear to be:

• Substantial Equivalence: The electrical, EMC, and software technologies, as well as the passive and active electrical components and PCB layout, are identical or virtually identical to the predicate devices.
• Safety and Effectiveness: Bench testing, VVT (Verification, Validation, and Testing), and Risk Analysis (including FMEA) demonstrate that the device performs as intended with no harm to the user. Also, the device prevents simultaneous use of TENS and EMS functions.
• Post-Market Performance (EU): Review of customer complaints, returned products, and post-market feedback from over two years in the European market (in its TENS form) demonstrates performance as intended.

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

• Sample Size: Not applicable in the context of an AI/algorithm-based device as this device is a physical medical stimulator. The "testing" primarily involved bench testing, VVT, risk analysis, and post-market surveillance.
• Data Provenance:
  • Bench Testing, VVT, Risk Analysis: Likely internal company data.
  • Post-Market Feedback: European Market data from the TENS form of the product over two years.

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

Not applicable. The product is a physical device, and its safety and effectiveness were assessed through engineering comparisons, bench testing, and review of existing market performance, rather than through expert-driven ground truth establishment for an AI algorithm.

4. Adjudication Method for the Test Set:

Not applicable. This is not an AI/algorithm-based device requiring an adjudication process for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. The text explicitly states: "Clinical Testing was not necessary as no new or innovative aspects have been introduced." This indicates that the device's performance was not evaluated in a clinical trial comparing it against human performance or AI assistance.

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

Not applicable. This device is a physical medical stimulator, not an algorithm.

7. The Type of Ground Truth Used:

For the TensCare Ultima NMS/EMS, the "ground truth" for its safety and effectiveness was established through:

• Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the two predicate devices (TensCare Ultima TENS (K020846) and TensCare XL-Y3 (K011543)). The new device's equivalence to these legally marketed devices forms the basis of its clearance.
• Bench Test Results: Objective measurements of electrical output characteristics.
• VVT (Verification, Validation, and Testing): Standard engineering validation processes.
• Risk Analysis (FMEA): Identification and mitigation of potential hazards.
• Post-Market Surveillance Data: Real-world performance data (customer complaints, returned products) from the European market for the TENS functions.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI model that requires a training set.

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

Not applicable. As noted above, this device does not involve a "training set" for an AI algorithm.

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