(123 days)
The ReBorn device is an LED technology-based system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
The ReBorn system is a non-invasive, LED-based system intended for non-invasive lipolysis and indicated for non-invasive lipolysis of the abdomen and flanks. The Lightfective ReBorn System is a Light Emitting Diode (LED) system, generating optical energy at 1050mm. The ReBorn's cooling and electrical systems maintain safe and comfortable skin surface temperatures. The Lightfective ReBorn system delivers power of up to 49 Watts (per each applicator) in continuous wave (CW) mode. The device consists of hardware and software. These elements are integrated in the ReBorn console and applicator/handpiece. The ReBorn system is supplied as a console and 4 identical applicators. The device is portable and was specifically designed to be utilized in clinic environments. The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems: Power Supply, Main Controller unit (CPU), Water cooling system (Chiller), Touchscreen display monitor, System on Module (SOM) and proprietary software, Applicator docking panel (cradle), Four designated applicator connector ports.
The provided text details a 510(k) premarket notification for the ReBorn device, an LED-based system for non-invasive lipolysis. However, it does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.
The document primarily focuses on establishing substantial equivalence to a predicate device (Venus Bliss, K190743) based on shared indications for use, technological characteristics, and performance data from non-clinical (bench) testing. There is no mention of an AI/ML component, a test set for AI performance, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the provided text does not contain this information.
To directly answer your specific points based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Not applicable. The document does not describe acceptance criteria for an AI/ML device's performance, nor does it report performance metrics relevant to AI/ML. It focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and bench testing. Bench tests performed include:
- Temperature Control Test
- Cooling Capacity Test
- Applicator Power Performance Test
- Applicator Contact Sensor Test
- Lifetime Rationale
- Ex-vivo Animal Study
- Not applicable. The document does not describe acceptance criteria for an AI/ML device's performance, nor does it report performance metrics relevant to AI/ML. It focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and bench testing. Bench tests performed include:
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Sample sized used for the test set and the data provenance:
- Not applicable. There is no mention of a test set for AI/ML performance. The "ex-vivo animal study" is mentioned, but details on sample size or specific "data provenance" (e.g., country) are not provided beyond it being ex-vivo porcine abdominal skin and adipose tissue.
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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. No experts or ground truth establishment relevant to AI/ML performance is described.
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Adjudication method for the test set:
- Not applicable. No test set for AI/ML performance is described, so no adjudication method is mentioned.
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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. An MRMC study was not done, as this is not an AI/ML device for diagnostic assistance. The device is for non-invasive lipolysis.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This isn't an AI/ML algorithm-only device. The "software" mentioned refers to control software for the device's operation.
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The type of ground truth used:
- Not applicable. There is no AI/ML component for which ground truth would be established. The "ex-vivo animal study" used the thermal effect on tissue as a measure, compared to the predicate device.
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The sample size for the training set:
- Not applicable. There is no mention of an AI/ML training set.
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How the ground truth for the training set was established:
- Not applicable. There is no mention of an AI/ML training set or its ground truth establishment.
In summary, the provided document pertains to the regulatory clearance of a medical device (ReBorn) based on substantial equivalence to an existing predicate, not on a study demonstrating AI/ML performance against specific acceptance criteria.
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.