(98 days)
The Silk'n Model H5003 is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
The Silk'n MODEL H5003 device is an over-the-counter home use EMS device intended for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. The Silk'n Model H5003 system is comprised of a treatment unit - "applicator", a belt for placing and holding the applicator and a cradle unit for charging of the applicator's battery. The device generates an electrical signal. which is required for muscle stimulation and is transferred to the muscles via the device electrodes.
The Silk'n MODEL H5003 device is easily operated by a single mode push-button, two operational buttons for selection of EMS level, and a set of light indicators informing the lay-user on the device current operation mode (i.e., EMS level treatment, standby or error), all are located on the applicator user interface board.
The Silk'n MODEL H5003 device is equipped with a safety proximity sensor, which initiates the signal only upon full contact between the electrodes and the skin, and disconnects the power in case of no contact during the device operation.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Silk'n MODEL H5003 device, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance letter and 510(k) summary for the Silk'n MODEL H5003 device primarily rely on demonstrating substantial equivalence to a predicate device, rather than defining novel clinical performance acceptance criteria with specific thresholds for a new clinical indication.
Instead, the "acceptance criteria" are implied by compliance with recognized standards and the demonstration that the device's technical specifications and intended use are similar to a legally marketed predicate device, without raising new questions of safety or effectiveness.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Subject Device) | Predicate Device (Body Control System "4M") Performance |
|---|---|---|
| Intended Use Equivalence: Improvement of muscle tone and firmness, strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not for injured/impaired muscles, therapy, or medical conditions/diseases. | The Silk'n Model H5003 is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas. Contraindicated use on injured or otherwise impaired muscles. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. | The Body Control System "4M" is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Contraindicated use on injured or otherwise impaired muscles. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. |
| Technological Equivalence (Key Parameters): | Output voltage: 30v±2.00v | (Data not available in the provided text for comparison, but implied to be similar enough for substantial equivalence) |
| Output current@500Ω: 60mA±4mA | 64 mA (Max output current @ 500 ohms) | (Data not available) |
| Pulse rate: 40Hz±10Hz | 40±10 Hz (Frequency) | (Data not available) |
| Pulse width: 400usec±50usec | 400±50 usec (Phase duration) | (Data not available) |
| Safety Standard Compliance: | AAMI/ANSI 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-11 | AAMI/ANSI 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-4 |
| Electrical Safety Features: Automatic shut-off, safety proximity sensor, system abnormalities check. | Equipped with a safety proximity sensor, which initiates the signal only upon full contact between the electrodes and the skin, and disconnects the power in case of no contact. Automatic shut-off. System abnormalities check (implied by "similar safety features" to predicate). | Incorporate similar safety features, including automatic shut off of the energy source at the end of predetermined treatment time period, system abnormalities check, and safety proximity sensor. |
| Biocompatibility of Skin-Contact Materials: | Conductive fabric electrodes (biocompatible with ISO 10993-5 and ISO 10993-10 requirements). | Adhesive electrodes with hydrophilic gel (implied to be biocompatible). |
| Lack of New Safety/Efficacy Concerns: | "The results of these tests demonstrated that all the device specifications meet the system requirements and do not raise new safety or effectiveness concerns." | Basis for substantial equivalence. |
| Output Waveform (Primary Difference Acknowledged): | Symmetrical biphasic, Rectangular shape | Monophasic, Rectangular shape |
| Power Supply: | 1 rechargeable Li-Ion battery, 3.7 V | 3 batteries, 1.5V |
| User Interface: | Push-button, two operational buttons for EMS level, light indicators (LEDs). | User interface (implied to be similar enough for substantial equivalence), LCD display. |
Summary of the Study Proving Acceptance Criteria:
The provided document describes a Non-Clinical (Bench) Performance Data study to demonstrate that the device performs as expected and meets design requirements. It is not a clinical study to establish new clinical efficacy or safety, but rather to show that the device performs technically as intended and is safe when used according to its design specifications. The primary study presented is for Substantial Equivalence to a predicate device.
Details of the Study:
2. Sample size used for the test set and the data provenance:
- Non-Clinical (Bench) Performance Data: The document does not specify a "sample size" in terms of patients or human subjects, as it was a bench test. It implies multiple units of the Silk'n MODEL H5003 device were tested.
- Data Provenance: The tests were conducted internally ("A set of performance tests were conducted... to demonstrate that the Silk'n MODEL H5003 device performs as expected..."). No country of origin for the data is explicitly stated for the bench tests, but the applicant and contact persons are based in Israel. The study is retrospective in the sense that the testing was performed on the completed device design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A): This type of information (experts, ground truth, qualifications) is relevant for studies involving human interpretation or subjective assessments, often in clinical or diagnostic contexts. For bench testing of an electrical device against technical specifications and safety standards, the "ground truth" is established by the specifications themselves and the relevant international standards (e.g., IEC 60601 series). Compliance is measured by instrumentation, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A: Adjudication methods are used in clinical trials or studies where there is subjective assessment or disagreement among multiple evaluators. For bench testing against objective technical standards, adjudication is not typically employed. The results are based on objective measurements by testing equipment.
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: No MRMC or clinical comparative effectiveness study involving human readers or AI assistance was performed or reported. The device is a "Powered Muscle Stimulator" and the evaluation focuses on its technical safety and performance compared to a predicate device, not on AI-assisted interpretation or diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: The device is a physical electromedical device; it does not feature an algorithm for diagnostic or interpretative purposes in the way an AI medical device would. Its performance is related to its electrical output and safety mechanisms, which were tested in a standalone (algorithm-only) sense, meaning the device itself was tested without human interaction during the measurement process, but this is not analogous to an AI algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance data, the "ground truth" was based on predefined technical specifications and international safety/performance standards (e.g., output voltage, current, pulse rate, pulse width measurements, and compliance with IEC 60601 series). These are objective, measurable parameters.
8. The sample size for the training set:
- N/A: The provided document does not mention a "training set." This term is typically used in the development of machine learning or AI models. The Silk'n MODEL H5003 device is an electrical stimulator, not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A: As there's no mention of a training set, the establishment of ground truth for such a set is not applicable.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).