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510(k) Data Aggregation
(119 days)
Slendertone connect Abs
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Essential Performance (General): Compliance with IEC 60601-1: 2005/A1:2012 | Performance testing was conducted in accordance with IEC 60601-1: 2005/A1:2012. (Implicitly, the device met the requirements.) |
| Usability: Compliance with IEC 60601-1-6:2010 | Performance testing was conducted in accordance with IEC 60601-1-6:2010. (Implicitly, the device met the requirements.) |
| Electromagnetic Compatibility (EMC): Compliance with EN 60601-1-2:2007 | Performance testing was conducted in accordance with EN 60601-1-2:2007. (Implicitly, the device met the requirements.) |
| Safety of Nerve and Muscle Stimulators (Specific): Compliance with IEC 60601-2-10:2012 | Performance testing was conducted in accordance with IEC 60601-2-10:2012. (Implicitly, the device met the requirements.) |
| Home Healthcare Environment: Compliance with IEC 60601-1-11:2010 | Performance testing was conducted in accordance with IEC 60601-1-11:2010. (Implicitly, the device met the requirements.) |
| Biocompatibility (Cytotoxicity): Compliance with ISO 10993-5:2009 | Performance testing was conducted in accordance with ISO 10993-5:2009. (Implicitly, the device met the requirements.) |
| Biocompatibility (Irritation & Skin Sensitization): Compliance with ISO 10993-10:2010 | Performance testing was conducted in accordance with ISO 10993-10:2010. (Implicitly, the device met the requirements.) |
| Wireless Co-existence (Bluetooth/Wi-Fi): Device functions as specified in an environment with other ISM band equipment. | The performance of SLENDERTONE® Connect Abs for wireless co-existence was evaluated in an environment with equipment operating in the ISM band (Bluetooth, Wi-Fi, cellphones, cordless phones). The device met all specified requirements. |
| Bluetooth Module Safety: Compliance with EN 60950-1:2006+A11:2009 +A1:2010+A12:2011+A2:2013 (Safety of Technology Equipment) and FCC Rule Part 15.247:2012 (Radio Frequency Devices) | BLE module testing was conducted in accordance with EN 60950-1:2006+A11:2009 +A1:2010+A12:2011+A2:2013 and FCC Rule Part 15.247:2012. (Implicitly, the device met the requirements.) |
| Battery Safety: Compliance with IEC 62133:2012 (Secondary cells and batteries, safety requirements for portable sealed secondary cells and for batteries made from them, for use in portable applications). | Battery testing was conducted in accordance with IEC 62133:2012. (Implicitly, the device met the requirements.) |
| Substantial Equivalence (General): Same principles of operation, differences in technological characteristics do not raise new issues of safety or effectiveness. | "The SLENDERTONE® connect Abs, Type 570 has the same principles of operation as its predicate devices and any differences in technological characteristics do not raise new issues of safety or effectiveness." Comparison tables (Table I and II) detail similarities and differences with predicates. |
| Indications for Use: Differences in Indications for Use do not alter intended therapeutic use or affect safety/effectiveness. | "The Indications for Use statement is not identical to the predicate devices; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device." |
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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