(80 days)
The Aimanfun Lumea Comfort (Model: A-2789, A-3588) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regimen.
Aimanfun Lumea Comfort is a light-based device for long-term hair removal, designed for home environment used. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment.
The device uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
The device is a home-use and hand-held device consists of main unit and adaptor, for the permanent reduction of hair growth based on Intense Pulsed Light (IPL).
This document (K212907) is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the "Aimanfun Lumea Comfort" hair removal device. It primarily discusses the substantial equivalence of the new models (A-2789, A-3588) to a previously cleared predicate device (A-2788).
Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance or algorithm performance.
Instead, it relies on the concept of substantial equivalence to a predicate device. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, and therefore does not require new comprehensive clinical trials or extensive performance testing if the modifications are not deemed to raise new questions of safety or effectiveness.
The document states:
- "As the modifications of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device are suitable for use in the assessment of the subject device. So this submission leverages performance and electrical testing provided in previous submissions." (Page 5, Section 8: Performance Testing)
- "Clinical performance is not deemed necessary." (Page 6, Section 10: Clinical performance)
Therefore, based on the provided text, I cannot extract the information required to answer your prompt because the submission itself did not include new clinical or algorithm performance studies for the modifications. The acceptance criteria and "device performance" in this context refer to the established safety and effectiveness of the predicate device and the demonstration that the new models do not introduce significant changes that would alter those characteristics.
To answer your prompt fully, a different type of document (e.g., a clinical study report or a detailed test report that would have been part of the original predicate device's 510(k) submission or a PMA application) would be needed.
However, I can extract what is stated regarding the basis of substantial equivalence:
Summary of what can be inferred from the document regarding the device's assessment:
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Acceptance Criteria and Reported Device Performance: Not explicitly stated as new criteria or new performance data for this submission's devices. The acceptance is based on substantial equivalence to the predicate device, implying the predicate met its own performance criteria. The document states the new devices are "very similar in design principle, intended use, functions, material and the applicable standards" to the predicate.
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Sample Size and Data Provenance:
- Test Set Sample Size: Not applicable/not provided for this submission in terms of new clinical/performance testing. The assessment leverages prior data from the predicate device.
- Data Provenance: Not explicitly stated for performance/clinical data, as it's not a new study. The manufacturer is Kam Yuen Plastic Products Ltd. based in China.
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Experts for Ground Truth & Qualifications: Not applicable, as no new human-expert-validated test set was created for this submission.
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Adjudication Method: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is an IPL hair removal device, not an AI diagnostic/imaging device that typically undergoes MRMC studies.
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Standalone Performance: Not applicable as a new study. The 'performance' is considered equivalent to the predicate device.
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Type of Ground Truth: Not applicable for this submission. For the predicate device, the "ground truth" for "permanent hair reduction" would likely have been clinical measurements of hair regrowth at 6, 9, and 12 months post-treatment.
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Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set in the typical sense. It's a physical device.
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How Ground Truth for Training Set was Established: Not applicable.
In essence, the document confirms that the new models of the Aimanfun Lumea Comfort are substantially equivalent to the previously cleared A-2788 model, and therefore, new clinical performance data was not deemed necessary for this 510(k) submission. The FDA allows this pathway when modifications do not raise new questions of safety or effectiveness.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.