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510(k) Data Aggregation
(444 days)
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."
| Attribute | Acceptance Criteria (Implicitly from Predicate/Standards) | Reported Device Performance (Perfect EMS) | Comparison Conclusion |
|---|---|---|---|
| Product Code | NUH, NGX | NUH, NGX | Identical; Substantially equivalent |
| Regulation No. | 21 CFR 882.5890; 21 CFR 890.5850 | 21 CFR 882.5890; 21 CFR 890.5850 | Identical; Substantially equivalent |
| Indications for Use | Same as predicate (TENS: temporary pain relief for sore/aching muscles; EMS: stimulate healthy muscles for improved performance) | Same as predicate | Same indications for use; Substantially equivalent |
| Prescriptive or OTC | OTC | OTC | Identical; Substantially equivalent |
| Number of output modes | Within acceptable range compared to predicate (predicate had 70 modes) | 10 | Substantially equivalent |
| Number of output channels | 2 | 2 | Substantially equivalent |
| Timer (minutes) Range | Adjustable, comparable to predicate (predicate 5-100 mins) | Default 20 mins, Adjustable to 10, 20, 30, 45, 60, 90 minutes | Both are adjustable; Substantially Equivalent |
| Regulated Current or Regulated Voltage? | None | None | Substantially Equivalent. |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Identical control method |
| Automatic No-Load Trip? | Yes | Yes | Identical |
| Automatic Overload Trip? | Yes | Yes | Identical |
| Automatic Shut Off? | Yes | Yes | Identical |
| User Override Control? | Yes | Yes | Substantially Equivalent. |
| Indicator Display: On/Off status | Yes | Yes | Identical |
| Indicator Display: Low battery | Yes | Yes | Identical |
| Indicator Display: Voltage/Current level | Yes | Yes | Identical |
| Indicator Display: Time to cut-off | Yes | Yes | Identical |
| Frequency (Hz) | Within acceptable range compared to predicate (predicate 1-150Hz) | 1-120Hz | Substantially equivalent |
| Pulse Width (µs) | Within acceptable range compared to predicate (predicate 50-450µs) | 50-350µs | Substantially equivalent |
| Waveform | Bi-phasic | Bi-phasic | Identical |
| Shape | Rectangular | Rectangular | Identical |
| Maximum Output Voltage (V) | 50V@ 500Ω | 50V@ 500Ω | Substantially equivalent |
| Maximum Output Current (mA) | 100mA@ 500Ω | 100mA@ 500Ω | Substantially equivalent |
| Maximum Phase Charge (µC) | Within acceptable range compared to predicate (predicate 37.6µC@ 500Ω) | 20.5µC@ 500Ω | Substantially equivalent |
| Maximum Current Density, (mA/cm²) | Safe levels, compared to predicate (predicate 0.07426mA/cm²@ 500Ω) | 0.01013mA/cm²@ 500Ω (Area=25cm²) | Substantially equivalent |
| Maximum Power Density, (W/cm²) | Safe levels, less than 0.25 W/cm² (predicate 0.0066W/cm²@ 500Ω) | 0.00053W/cm²@ 500Ω (Area=25cm²) | Substantially equivalent |
| Power Source | Internal power supply (predicate used AAA batteries) | 2 Alkaline AA 1.5V Batteries | Both are internal power supply source: Substantially equivalent |
| Weight | Comparable to predicate (predicate 83g) | 75 g without batteries | Substantially Equivalent. |
| Dimensions (mm) [W x H x D] | Comparable to predicate (predicate 132 x 63 x 29.5 mm) | 120 x 60 x 31mm | Substantially Equivalent. |
| Housing Materials and Construction | Safe and effective (predicate ABS plastics) | Silicone, ABS plastics | Substantially Equivalent. |
| Electrode lead wires and patient cable | Yes (PVC) | Yes (PVC and nylon yarn) | Substantially equivalent |
| Compliance with Voluntary Standards | Yes | Yes (See section 1.3/VII for specific standards) | Substantially equivalent |
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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(170 days)
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.
| Acceptance Criterion (Demonstrating Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison/testing) |
|---|---|
| Similar Intended Use & Indications for Use | Perfect PFE's indications are "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." This is either identical or substantially equivalent to predicates. |
| Similar Technological Characteristics | Perfect PFE's design, function (electrical muscle stimulation, single-channel, battery-powered, home-use), and stimulation parameters (frequency, pulse width, max voltage, max current, max phase charge) are similar or substantially equivalent to the predicate devices (KegelFit and Yarlap) as shown in Table 1, page 6. The differences in specific parameters (e.g., number of output modes, channels, specific frequencies within programs) are argued to not raise new safety/effectiveness concerns. |
| Compliance with Safety Standards | The device complies with relevant safety consensus standards: ANSI AAMI ES60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 60601-2-10 (nerve and muscle stimulators), ISO 14971 (risk management), IEC 60601-1-6 (usability - though further usability testing was not done due to similarity), IEC 62304 (software life cycle processes), and ISO 10993-1 (biocompatibility, confirmed by cytotoxicity, sensitization, and irritation tests). |
| No New Questions of Safety or Effectiveness | The submission asserts that the information presented and performance testing (standard compliance) demonstrate with reasonable assurance that the device is at least as safe and effective as a legally marketed device and does not raise different questions about safety or effectiveness. |
| Probe Substantial Equivalence and Safety | The vaginal probe (Liberty Loop) is "similar in size, materials, and electrode position" to the predicate probe (Liberty vaginal probe), and both are reusable for single-patient use. The difference in shape (oval loop vs. solid) does not impact substantial equivalence for treating incontinence. |
| Maximum Power Density | The maximum power density of Perfect PFE is less than 0.25 watts per square centimeter of electrode conductive surface area, which is within the safe range for reducing thermal burns, similar to the predicate devices. |
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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(224 days)
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.
| Feature/Function (Analogous to Acceptance Criteria) | Tenscare KegelFit Performance (Reported Device Performance) | Comparison to Predicate A (itouch Sure) | Comparison to Predicate C (Apex) |
|---|---|---|---|
| Intended Use | Non-implanted muscle stimulator for female stress urinary incontinence, applies stimulation to pelvic floor muscles to improve strength and support. | Substantially equivalent (after removing Urge and Mixed incontinence programs, and modifying label for OTC). | Identical |
| Indications for Use | Treats female stress urinary incontinence by applying stimulation to pelvic floor muscles. | Substantially equivalent (removed non-stress incontinence indications). | Identical |
| Primary Function | Delivery of electrical stimulation. | Identical | Identical |
| Safety - Software | "Moderate" level of concern. Passed V&V. | Identical | Identical |
| Safety - Electrical | Complies with IEC 60601-1 and IEC60601-1-11. EMC tested to EN60601-1-2:2007. | Identical (to itouch Sure, concerning 21 CFR 898 for cable/lead). | Substantially equivalent (Apex has no leads for comparison). |
| Safety - Biocompatibility | Vaginal electrode material (ABS, stainless steel) tested per ISO 10993-5:2009 and ISO 10993-10:2002. | Identical (same electrode as itouch Sure). | Substantially equivalent (different materials, but both cleared). |
| Labeling Clarity for OTC Use | Designed for self-diagnosis of SUI and identification of contraindications, and effective use based on instructions. | Substantially equivalent (operating instructions based on itouch Sure, revised for usability). | Substantially equivalent (based on Apex for self-diagnosis, contraindications, warnings). |
| Usability/Ease of Use (for OTC) | Instructions easy to follow/device easy to use without training. | Supported by customer reviews of itouch Sure. | Supported by customer reviews of itouch Sure. |
| Output Modes | Two (TRAIN / 50Hz Stress, 35Hz Tone). | Substantially Equivalent (Reduced from four in itouch Sure, matching altered Intended Use). | Substantially equivalent (increased from one in Apex). |
| Max Output Voltage (500Ω) | 45V | Identical | Substantially equivalent (Apex 34.2V, both deemed safe/effective). |
| Max Output Current (500Ω) | 90mA | Identical | Substantially equivalent (Apex 68.2mA, both deemed safe/effective). |
| Max Phase Charge (500Ω) | 18.6 μC | Identical | Substantially equivalent (Apex 13.6 μC; Apex is monophasic). |
| Max Current Density | 10.46 mA/cm2 | Identical | Substantially equivalent (Apex 11.6 mA/cm2; both deemed safe/effective). |
| Max Average Power Density (500Ω) | 5.84 mW/cm2 | Identical | Substantially equivalent (Apex 3.95 mW/cm2; no special requirement for home use). |
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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(183 days)
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.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported TensCare itouch Sure Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: Treatment of urinary incontinence | "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." (Same as predicates) |
| Technological Equivalence (Key Parameters): | (See detailed comparison table in the "Technological Comparison" section of the 510(k) summary) |
| Frequency (Hz) | 10/20/35/50 (Comparable to predicates, e.g., K941911: 12.5/50; K81480: 2-100) |
| Pulse Width (uS) | 200/250/300 (Comparable to predicates, e.g., K941911: 300; K81480: 50-450) |
| Output Current/Voltage | 0-45V = 0-90mA over 500 Ohm; Constant current 160-500 Ω, Constant voltage 500-1500 Ω (Comparable to predicates, e.g., K941911: 0-60mA (100mA override); K81480: 0-90 mA nominal) |
| Waveform Type & Shape | Bi-phasic, Rectangular at positive (Substantially equivalent to Kegel 8; difference in negative phase not clinically significant) |
| Biocompatibility: Probe materials are safe for patient contact. | Materials (ABS, Stainless Steel) are the same as Kegel 8 probe. Biocompatibility tests (ISO 10993-5:2009 and -10:2002) showed no cytotoxicity, negligible vaginal irritation, no sensitization. |
| Safety: Compliance with relevant safety standards, controlled output energy, no new safety hazards. | Designed to comply with recognized consensus standards. Output energy controlled within safety/effectiveness ranges. Test results, Risk Analysis, FMEA show it is safe. Device controls output at constant voltage > 500 Ω and pseudo-constant current < 500 Ω, reliably making it safe. No significant complaints or adverse events reported during European market experience (since April 2009). EMC tested to EN60601-1-2:2007. |
| Labelling Equivalence: Consistent with predicate devices. | "The Labelling is substantially equivalent to that of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not discuss a clinical "test set" in the traditional sense of a performance study with patient data. The evaluation primarily relies on engineering tests, comparisons to existing devices, and a review of post-market experience in Europe.
- Sample Size: Not applicable in terms of a clinical test set. The "sample" is the device itself and its components.
- Data Provenance:
- Engineering Test Data: Originates from internal testing conducted by Tenscare Ltd. (United Kingdom) and EasyMed Instrument Ltd. (China) to verify physical and electrical specifications (e.g., frequency, pulse width, output current, EMC testing).
- Biocompatibility Data: Results from tests performed according to ISO 10993 standards. The location of the testing lab is not specified but is likely external or internal testing related to the manufacturing process.
- Post-Market Data: Retrospective review of customer complaints, returned products, and post-market feedback since April 2009 (European market).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a study that involved expert interpretation or ground truth establishment from clinical cases. The "ground truth" for substantial equivalence is primarily defined by the performance and safety profiles of the legally marketed predicate devices, as well as validated engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or data, which is not relevant for this electrical stimulator.
6. Standalone (Algorithm Only) Performance Study
No. This device is an electrical stimulator, not an algorithm, so a standalone performance study in that context is not applicable. Its performance is assessed through its physical outputs and safety characteristics.
7. Type of Ground Truth Used
The "ground truth" for this 510(k) submission is established by:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (EMPI Innova K941911 and Kegel 8 K81480).
- Engineering and Safety Standards: Compliance with recognized consensus standards like IEC 60601-1-2:2007 for EMC and ISO 10993-5:2009 and -10:2002 for biocompatibility.
- Manufacturing Specifications: The device reliably performs according to its documented technical specifications.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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(90 days)
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.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Technological Substantial Equivalence to Predicate Devices: | The electrical, EMC, and software technologies (CPU series, passive/active electrical components, PCB layout) are identical or virtually identical to the TensCare Ultima TENS (K020846) for TENS functions and TensCare XL-Y3 (K011543) for EMS functions. EMS functions are software-derived and virtually identical. |
| Output Characteristics Substantial Equivalence to Predicate Devices: | Bench testing demonstrates that the output characteristics of the TensCare Ultima NMS/EMS are substantially equivalent to those of the two predicate devices. |
| Safety of Combined Functions: | Bench Testing, VVT, and Risk Analysis (including FMEA) demonstrate that the device performs as intended with no harm to the user. It is not possible to use TENS and EMS functions simultaneously due to mechanical integrity. The device includes 'shrouded patient cable connectors' for safety. |
| Patient Control Restriction Option: | The device has a Doctor Important anti-Misuse feature: Lock facility, allowing the Treating Physician to pre-set programs, preventing patient control over device outputs. |
| Post-Market Performance (European Market - TENS form): | Over two years of data from the European market (for the TENS form) including customer complaints, returned products, and post-market feedback, demonstrated that the product performed as intended to its specified requirements. |
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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