(172 days)
The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.
Galvanic Spa, Model: SKB-1405 is a non-invasive facial toning device intended for facial stimulation. It produces micro-current discharged through the dual probes that are designed for optimal contact with faces of all shapes and sizes.Micro-current is an aesthetic modality providing electric current in millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles by supplying 0-390 μΑ.
Galvanic Spa, Model: SKB-1405 is not for use on injured or otherwise impaired skin or muscles, and in any therapy for the treatment, or prevention of any disease. This device is not for use near any devices with Electromagnetic Interference (EMI). This device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper.
The provided text is a 510(k) summary for the "Galvanic Spa, Model: SKB-1405" device. It focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study or performance study with a test set, ground truth, or expert readers in the context of AI/machine learning.
Therefore, most of the information requested in your prompt (acceptance criteria, details of a study using a test set, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set information) is not present in this type of regulatory submission for this particular device.
This document primarily addresses:
- Device Description and Intended Use: The Galvanic Spa is a non-invasive facial toning device intended for facial stimulation for over-the-counter cosmetic use.
- Comparison to a Predicate Device: The core of the submission is to show substantial equivalence to the NūFACE® Plus device (K103472).
- Bench Testing and Compliance with Standards: The document mentions various bench tests conducted to ensure safety and performance, such as electrical safety tests (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility tests (IEC 60601-1-2), software verification and validation, and waveform tests.
- Biocompatibility Testing: Details are provided for cytotoxicity, skin sensitization, and skin irritation tests for patient-contacting materials (electrodes made of stainless steel).
The prompt's questions are designed for a situation where a new AI/ML-driven medical device is being evaluated for its diagnostic or prognostic performance against a ground truth, often involving human readers. This document describes a physical electrical stimulation device that does not perform such functions, and as such, the type of "study" described in the prompt is not applicable here.
Here's a breakdown of why the requested information is largely absent or not applicable:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (as would be understood for an AI/ML device): Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for this device are demonstrated by compliance with general safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2), biocompatibility standards (ISO 10993-5, ISO 10993-10), and substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety.
- Reported Device Performance: The performance is reported in terms of physical characteristics (e.g., maximum output current, voltage, pulse duration, frequency), and compliance with the aforementioned safety and biocompatibility standards. There are no performance metrics related to diagnostic accuracy or AI/ML output.
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Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI/ML evaluation. The safety and performance are evaluated through bench testing (measuring electrical characteristics, checking biocompatibility, etc.) and comparison to a known safe and effective predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts in the sense of image interpretation or clinical diagnosis for this device type.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is not an AI-assisted diagnostic device requiring human reader comparison studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrical stimulator, not an algorithm. Its "standalone" performance is its electrical output and safety, which is evaluated through bench testing.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device is compliance with engineering specifications, safety standards, and observed physical/electrical properties of the device, attested through various lab tests.
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The sample size for the training set: Not applicable. This device does not use machine learning, so there is no training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (Transcutaneous Electrical Nerve Stimulator for Pain Relief, specifically for cosmetic facial stimulation) seeking 510(k) clearance by demonstrating substantial equivalence. It is not an AI/ML device, and therefore the framework of questions you've posed is not suitable for describing its "acceptance criteria" and "study" in the way you intend for AI/ML products.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).