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BMR Face is intended for facial stimulation and is indicated for over the counter cosmetic use

BMR Face. Type 371/372* (* Type 372 is simply a black version of Type 371) is a twochannel, battery operated cosmetic device which is intended for use on the face. The device consists of a rechargeable electronic device which connects to an applicator. Each side paddle of the applicator contains a set of replaceable twin conductive gel pads which deliver electrical impulses to the face. The BMR Face device operates by applying Transcutaneous Electrical Nerve Stimulation (TENS) to the facial area. Low-level electrical impulses are sent from the stimulator unit via an applicator to gel pads that are positioned anterior to each ear and strategically over the cranial nerve #7 of the face, 3 programs are available to the user and these vary in treatment times from 10 to 20 minutes. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit and there is no capability for charging the unit whilst any treatment is ongoing. All internal connections of the unit are over molded to prevent moisture ingress.

The provided text describes a 510(k) submission for the "BMR Face, Type 371 & Type 372" device. It focuses on demonstrating substantial equivalence to a predicate device ("Rejuvenique® System") rather than presenting a study to prove the device meets specific acceptance criteria for performance in a clinical outcome.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of clinical effectiveness or performance as an AI/ML device.

Here's a breakdown of why this information isn't available in the provided text:

• Device Type: This is a physical, electrical stimulator, not an AI-powered diagnostic or therapeutic device. The submission is for a medical device seeking clearance based on substantial equivalence to a legally marketed predicate device.
• Focus of the Submission: The 510(k) submission primarily focuses on comparing the technological characteristics of the new device to the predicate device to demonstrate that it is as safe and effective. It highlights aspects like intended use, indications for use, anatomical site utilized, energy used, materials, biocompatibility, electrical safety, mechanical safety, and adherence to various electrical and safety standards.
• Absence of Clinical Performance Data: The document explicitly states: "Clinical Tests: No new clinical studies have been submitted as part of this Premarket Notification." This confirms that no studies were conducted to measure specific performance metrics (like sensitivity, specificity, accuracy, etc.) against acceptance criteria for a clinical outcome.
• "Acceptance Criteria" in this context: The "acceptance criteria" here refer to the regulatory requirements and standards the device must meet (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) to be deemed substantially equivalent and safe for marketing, not performance metrics related to a diagnostic or therapeutic outcome.

Based on the provided text, I cannot complete the requested tables and information because the document does not present a study proving the device meets performance-based acceptance criteria in the way typically expected for AI/ML devices or studies evaluating clinical effectiveness metrics.

The text only provides a summary of non-clinical tests demonstrating compliance with safety standards and a comparison of technological characteristics to a predicate device.

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