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The SLENDERTONE® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

The SLENDERTONE® Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains twelve pre-installed programs.

The control unit is connected to the abdominal belt garment via three magnetic connectors. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on or off and to increase or decrease the stimulation intensity. The SLENDERTONE® Evolve Abs, Type 735 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

The SLENDERTONE® Evolve Abs, Type 735 is rated as IP22 for ingress protection. The user has no access to the wiring or connectors within the garment. For purposes of hygiene, the garment may be cleaned and instructions for garment care are included in the user manual.

The provided document is a 510(k) summary for the SLENDERTONE® Evolve Abs, Type 735, a powered muscle stimulator. It does not contain information about a clinical study or acceptance criteria based on human performance or AI performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SLENDERTONE® Corefit Abs8, Type 734) by comparing technological characteristics and citing compliance with safety standards.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies for this specific device based on the given text.

The document states:

• Indications for Use: Improvement of abdominal muscle tone, strengthening of abdominal muscles, and development of a firmer abdomen.
• Performance Data (Safety Standards): The device complies with several international safety standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, and IEC 62133 for batteries). These standards typically involve engineering and electrical safety tests, not clinical efficacy studies for the stated indications.
• Conclusion: The device is considered substantially equivalent to the predicate device, and any differences in technological characteristics do not raise new issues of safety or effectiveness.

To answer your request, a clinical study demonstrating the efficacy of this specific device for its indications would be required, which is not present in this 510(k) summary. The document explicitly states "Performance data has demonstrated that the SLENDERTONE® Evolve Abs, Type 735 is as safe and effective as the predicate device and is substantially equivalent," but this "performance data" refers to compliance with electrical and safety standards, not a clinical trial proving its effectiveness in improving muscle tone or firmness.

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The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.

The Innovo is indicated for prescription use only.

The Innovo is a single channel, rechargeable, non-implanted electrical stimulator that is intended for the treatment of stress urinary incontinence.

The Innovo is comprised of the following main components, along with accessories:

• Controller
• Body Garments (right and left)
• Gel Pads (8 surface electrodes)
• Battery Charger
• Lead Wire
• Neck Strap

The Controller generates the electrical stimulation patterns for coupling the stimulation signals to the body when sued with the Gel Pad electrodes and lead wire. The Body Garments, equipped with 8 surface electrodes, are worn by the patient and cover the buttocks, lateral pelvis, and upper thighs. The electrodes have a skin conductive adhesive hydrogel laver, a current dispersing layer, and a garment conductive adhesive hydrogel layer.

The four electrodes on the right side are combined into a single equivalent electrode (and similarly as are the electrodes on the left side). The electrical stimulation current is passed across the pelvic area (from the right side to the left site), thereby stimulating the pelvic floor muscles.

Innovo Device Acceptance Criteria and Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Innovo device are primarily derived from the "Summary of Clinical Information" and "Benefit-Risk Determination" sections, particularly an observed meaningful clinical improvement for the target condition.

2. Sample Sizes and Data Provenance

The primary clinical evidence supporting the Innovo device comes from two studies:

• Study 1 (Germany - Sham Controlled Trial):
  • Sample Size: N=50 women (N=24 in treatment arm, N=26 in control/sham arm completed 12 weeks of treatment). This study was "prematurely stopped."
  • Data Provenance: Germany, prospective, randomized, double-blinded, sham-controlled.
• Study 2 (USA - Randomized Non-Inferiority Study):
  • Sample Size: N=180 subjects (N=89 in Innovo group, N=91 in iTouch Sure group).
  • Data Provenance: USA (12 US sites), prospective, multicenter, randomized, non-inferiority clinical study.

3. Number of Experts and their Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the clinical studies. However, the patient population for both studies consists of "women clinically diagnosed with stress urinary incontinence." This implies that the diagnoses were made by qualified medical professionals (e.g., urologists, gynecologists, or primary care physicians with relevant expertise), who would have established the initial inclusion criteria and therefore the "ground truth" of the SUI diagnosis for enrollment.

For objective measures like the 1-hour and 24-hour pad weight tests, the "ground truth" is established by the quantifiable weight of leaked urine, measured according to standardized protocols rather than a subjective expert assessment of individual cases. Similarly, questionnaires like iQoL and MESA rely on patient self-assessment.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for determining the "ground truth" of the test set beyond the initial clinical diagnosis for enrollment and the objective measurements of the primary and secondary endpoints. For quantitative outcomes like pad weight tests, the measurement itself serves as the ground truth. For patient-reported outcomes (QOL questionnaires), the patient's response is the ground truth.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The studies described are clinical trials evaluating the device's effectiveness and safety directly on patients, not AI-assisted reader performance. Therefore, there is no mention of the effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The Innovo device is a physical transcutaneous electrical stimulator, not an AI algorithm. Its "performance" refers to its efficacy in treating SUI in patients, not a standalone algorithm's diagnostic or predictive accuracy. Therefore, a standalone (algorithm only) performance study was not conducted or applicable to this device. The software in the controller manages stimulation patterns but is not described as an AI algorithm.

7. Type of Ground Truth Used

The ground truth used in the clinical studies was based on a combination of:

• Clinical Diagnosis: Women "clinically diagnosed with stress urinary incontinence" (for patient enrollment).
• Objective Outcome Measures:
  • Pad Weight Tests: 1-hour and 24-hour pad weight tests (quantifiable leakage in grams). This could be considered a form of "objective measurement" or "outcomes data" rather than expert consensus on retrospective images.
• Patient-Reported Outcome (PRO) Measures:
  • Incontinence Quality of Life Questionnaire (iQoL)
  • Medical Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire
  • Global Impression of Improvement (PGI-I)

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI algorithm or machine learning. The clinical studies (Study 1 and Study 2) served as the primary data for evaluating the device's performance, but these are "test sets" in the clinical trial sense, not an AI training set. Therefore, a sample size for a training set is not applicable here.

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

As noted above, there is no mention of a "training set" for an AI algorithm. If "training set" is instead interpreted as data used to inform the device's design or initial performance parameters, these would likely come from pre-clinical research, feasibility studies, and possibly literature reviews, but the specific methods for establishing ground truth for such development phases are not detailed in this regulatory summary. The "series of smaller feasibility studies conducted during the development of the device" hint at such activities, but specific ground truth establishment for these is not provided.

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The SLENDERTONE® CoreFit Abs 8, Type 734 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

The SLENDERTONE® CoreFit Abs 8, Type 734 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains ten pre-installed programs. The control unit is connected to the abdominal belt garment via three magnetic connectors. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on off and to increase or decrease the stimulation intensity. The SLENDERTONE® CoreFit Abs 8. Type 734 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

This document is a 510(k) premarket notification for a medical device called SLENDERTONE CoreFit Abs 8, Type 734. It's a review by the FDA to determine if the device is "substantially equivalent" to a legally marketed predicate device. This type of submission relies on comparisons to existing devices rather than extensive clinical studies to prove effectiveness.

Therefore, the provided document does not contain the kind of detailed information about acceptance criteria, efficacy studies, expert adjudication, or MRMC studies that you requested for an AI/ML-based medical device.

The study described here is primarily safety and performance testing against electrical and electromagnetic compatibility standards, and biocompatibility testing of materials. It does not involve a "study that proves the device meets the acceptance criteria" in the sense of demonstrating improvement in muscle tone or strength through a clinical trial with human subjects and outcome metrics.

Here's an explanation based on the provided document, addressing your points where possible, and highlighting what is not present:

Key Takeaway from the Document:
The SLENDERTONE CoreFit Abs 8, Type 734 is an electrical muscle stimulator. Its clearance is based on substantial equivalence to a predicate device (Slendertone System Ultra, Type 390, Model E70/X70), meaning its technological characteristics and intended use are similar enough not to raise new questions of safety or effectiveness. This is not a new technology being proven effective through a clinical trial, but rather a demonstration that a new product design is as safe and performs similarly to an already approved one.

Here's a breakdown of the requested information, with answers based on the document and explanations for what is not applicable or present:

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

   The document does not provide acceptance criteria and reported device performance in terms of clinical efficacy (e.g., specific metrics for "improvement of abdominal muscle tone" or "strengthening of abdominal muscles" that would be measured in human subjects).

   Instead, it discusses biocompatibility testing results and compliance with international safety and performance standards for electrical medical devices.

   Table for Biocompatibility Testing:

   Test	Result	Toxicological Conclusion
   Cytotoxicity Test: MTT Method MEM with 10% FBS Extract	Potential toxicity at extract concentration >=75%	No toxicological risk to users.
   Cytotoxicity Test: MTT Method MEM Extract	No potential cytotoxic potential	No toxicological risk to users.
   Skin sensitization: Buehler test in guinea pigs	Dermal scoring using the Magnusson and Kligman scoring system was graded as 0 (no visible change)	No toxicological risk to users.
   Skin irritation Test: Direct contact	No abnormal signs were observed during the study. The response of skin on test side did not exceed that on the control side.	No toxicological risk to users.

   Performance Testing (Compliance with Standards):
   The document states: "Performance testing was conducted in accordance with the following international standards for safety:" followed by a list of IEC 60601 series standards (e.g., IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11) and IEC 62133 for battery testing.
   The "acceptance criterion" here is compliance with these standards, which implies the device demonstrated it met the requirements (e.g., limits for leakage current, electromagnetic compatibility, usability, etc.). The specific numerical results of these tests (e.g., exact leakage current measurements) are not detailed in this summary.

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

   This document refers to engineering and biocompatibility testing, not human clinical trials or AI model validation data.

   • Biocompatibility: The tests used guinea pigs for skin sensitization and likely in-vitro cell cultures for cytotoxicity. The sample sizes for these biological tests are not specified in this summary.
   • Electrical Performance: These involve testing the device hardware against electrical and EMC standards. The "sample size" would typically be a few devices subjected to a series of tests in a lab.
   • Data Provenance: Not applicable in the context of clinical data. The tests were conducted to international standards, presumably in a controlled lab environment.

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)

   This is not applicable. The "ground truth" for this device's clearance is its compliance with recognized safety and performance standards and its technological similarity to a legally marketed predicate device. There is no "test set" in the context of clinical images or patient data that would require expert annotation to establish ground truth for an AI algorithm.

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

   Not applicable. There is no human reading or interpretation task that requires adjudication for this type of device clearance.

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

   No. This device is an electrical muscle stimulator, not an AI diagnostic tool that assists human readers. Therefore, an MRMC study is not relevant.

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

   Not applicable. This is not an AI algorithm. Its performance is inherent to its electrical stimulation characteristics and physical design, not software-based interpretation of data.

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

   The "ground truth" for this 510(k) clearance is:

   • Compliance with established electrical safety and performance standards (IEC 60601 series).
   • Acceptable biocompatibility test results.
   • Demonstrated equivalence of technological characteristics and indications for use to a legally marketed predicate device.
   • Failure of a device to meet specific criteria outlined in these standards (e.g., excessive leakage current, failure of an electrical test) would constitute a "non-compliance" or "failure" against this ground truth.

8. The sample size for the training set

   Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

   Not applicable. There is no training set for an AI/ML algorithm.

In summary, the provided document describes a 510(k) substantial equivalence submission for a powered muscle stimulator. This process focuses on demonstrating safety and performance equivalence to an existing device through engineering tests and biocompatibility analysis, rather than proving clinical efficacy of a novel technology or validating an AI algorithm with clinical data. Therefore, most of your specific questions related to AI/ML device validation are not applicable to this document.

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The SLENDERTONE® Connect Abs, Type 570 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

The SLENDERTONE® Connect Abs, Type 570 is a portable, neuromuscular, electrical stimulation system intended to deliver electrical stimulation to the abdominal muscles. The system includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable, pouch and instructions for use. One toning program is pre-installed in the unit. Wireless communication is enabled by a Bluegiga BLE113 Bluetooth module. The modified Slendertone Connect Abs device supports a range of mobile devices via both iOS and android mobile applications.

This document is a 510(k) premarket notification for a medical device, the SLENDERTONE® Connect Abs, Type 570. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.

Therefore, the information requested regarding a study for acceptance criteria (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth for training set) is not present in this document. This typically means such a study was not required or was deemed unnecessary for a 510(k) submission based on substantial equivalence.

However, the document does list various performance testing conducted in accordance with international safety standards. These tests are the "acceptance criteria" in the context of this submission, demonstrating the device's adherence to safety and essential performance requirements.

Here's the breakdown of what is available and what is not:

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

Regarding the study that proves the device meets the acceptance criteria, the following information is NOT available in the provided text:

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

• Not provided. The document states "Performance testing was conducted," but does not detail the methodology, sample sizes of devices or participants, or data provenance for these engineering and safety tests.

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 for this type of testing. The "acceptance criteria" here relate to engineering safety and performance standards for a powered muscle stimulator, not diagnostic accuracy requiring expert panel review or ground truth establishment in a clinical imaging or diagnostic context.

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

• Not applicable for this type of testing. Adjudication methods are typically used in clinical studies involving interpretation of results, which is not the nature of these engineering and safety compliance tests.

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

• Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This device is hardware with firmware/software, not an algorithm in the sense of a diagnostic AI. The "standalone" performance here refers to the device's electrical and mechanical safety compliance.

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

• Not applicable/Implicit. For engineering and safety standards, the "ground truth" is defined by the parameters and methodologies outlined in the referenced international standards (e.g., electrical safety limits, biocompatibility requirements, electromagnetic compatibility limits). Compliance is measured against these defined benchmarks.

8. The sample size for the training set:

• Not applicable. This device uses pre-programmed functionalities and does not indicate any machine learning or AI components that would require a "training set."

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

• Not applicable. As no training set is mentioned or implied.

In summary, this 510(k) submission successfully demonstrates substantial equivalence through a comparison of technological characteristics to a predicate device and via compliance with relevant safety and performance standards, rather than presenting a clinical study with subjective endpoints that would require the detailed information you requested.

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