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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® 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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The SLENDERTONE® connect Abs 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 intended for over-the-counter use.

The SLENDERTONE® Connect Abs, Type 570 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 one pre-installed program called 'Essential Toning'.

The SLENDERTONE® Connect Abs incorporates a Bluegiga BLE113 Bluetooth module to enable wireless communication and can be paired with a Bluetooth enabled iOS smart device running a Slendertone Connect iOS App, available from the Apple App store. The App implements a virtual control panel on the screen of the smart device where on-screen buttons are provided to the user.

The control unit is connected to the abdominal belt garment via an 8-pin interface. 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. These controls remain active while the control unit is wirelessly paired with a smart device and can be used in the event of loss of Bluetooth connection. The SLENDERTONE® connect Abs contains light emitting diodes (LED) which indicate status relating to battery charge, stimulation and bluetooth activity. 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® Connect Abs, Type 570 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.

This document is a 510(k) premarket notification for a muscle stimulator device, the Slendertone® connect Abs, Type 570. The purpose of this notification is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in the typical format of quantitative performance targets (e.g., sensitivity, specificity, accuracy) for clinical outcomes. Instead, the acceptance criteria are implicitly defined by compliance with a set of international safety and performance standards for medical electrical equipment and the demonstration of "substantial equivalence" to predicate devices. The reported "performance" is the demonstration of compliance with these standards and the comparison of technological characteristics to predicate devices.

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

The document describes performance testing against engineering and electrical standards, not a clinical study involving human subjects to evaluate muscle performance outcomes. Therefore, there is no "test set" in the context of a clinical study, no data provenance (country of origin, retrospective/prospective), and no "sample size" of patients/cases used for a clinical evaluation. The sample size for the engineering tests would refer to the number of devices tested, which is not specified but is typically a small, representative sample for such regulatory submissions.

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

Since there is no clinical "test set" with ground truth requiring expert adjudication for diagnosis or outcome, this information is not applicable to this submission. The "ground truth" here is compliance with established international engineering and safety standards, determined by testing procedures.

4. Adjudication Method for the Test Set

As there is no clinical "test set" requiring human interpretation or agreement on a diagnosis or outcome, an adjudication method is not applicable.

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

An MRMC comparative effectiveness study was not performed as part of this submission. This type of study is typically used to evaluate the diagnostic accuracy or effectiveness of an AI system (often in image-based diagnostics) compared to human readers, with or without AI assistance. This device is a muscle stimulator, and the submission focuses on engineering, electrical, and biocompatibility safety and performance, and substantial equivalence to predicates, not diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of diagnostic accuracy or clinical outcomes for an algorithm was not performed. The device itself is an electrical muscle stimulator, and while it has a "smart device" app, the "performance data" provided relates to the physical and electrical safety and functionality of the device, not an AI algorithm's standalone clinical performance.

7. Type of Ground Truth Used

The "ground truth" used for this submission is established international and national engineering, electrical, safety, and biocompatibility standards. Compliance is demonstrated through physical testing, measurements, and comparison to predicate device specifications. There is no pathology, expert consensus on clinical outcomes, or patient outcomes data presented in this context for "ground truth."

8. Sample Size for the Training Set

This submission does not involve an AI algorithm that requires a "training set" of data in the typical sense (e.g., for machine learning). The software/firmware in the device controls the electrical stimulation, but it's likely based on predefined programs and parameters, not a learned model from a large dataset. Therefore, there is no training set sample size described.

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

As there is no "training set," the method for establishing its ground truth is not applicable. The "ground truth" for the device's functional logic (i.e., how it's programmed to stimulate muscles) would stem from scientific understanding of neuromuscular stimulation and established therapeutic protocols, not from a data-driven training process for an AI.

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