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Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is an over-the-counter use device for the reduction of hair growth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the Intense Pulsed Light (IPL) technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve hair removal results at a fraction of the energy level used in other light-based hair removal equipment.

The hand-held device package includes main unit, adaptor and user manual and it 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 provided text does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document is an FDA 510(k) summary for a hair removal device, focusing on demonstrating substantial equivalence to predicate devices rather than detailing specific performance studies with acceptance criteria, sample sizes, expert involvement, or ground truth methodologies.

The "Performance Testing" section states: "As the modification 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 (legally existing device) are suitable for use in the assessment of the subject devices except for usability study verification. In usability study, the testing result demonstrates that the intended users can understand the package labeling, correctly choose the device and use it for the indicated OTC use, based on reading the lableling materials."

This indicates that clinical performance data was not deemed necessary for this specific submission because the device's technical characteristics were not changed from the predicate device, only its intended use (from prescription to Over-The-Counter). The only new testing mentioned is a usability study to confirm layperson understanding of instructions for OTC use. However, details of this usability study (sample size, criteria, etc.) are not provided.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

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The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.

The Laser hair growth helmet (Model: A-800) is hands-free, portable, non-invasive, low-level laser device, which consists of red visible light diode lasers, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically suspend the work if it is removed from scalp, and the power blue light indicator flashes.

The medical device is the Laser hair growth helmet (Model: A-800), intended for the promotion of hair growth in females with Ludwig-Savin Classifications I-II and males with Norwood Hamilton Classifications IIa-V, both with Fitzpatrick Classification of Skin Phototypes I-IV.

1. A table of acceptance criteria and the reported device performance:

The provided document does not contain explicit "acceptance criteria" for clinical performance. Instead, it states that "Clinical performance is not deemed necessary" and focuses on demonstrating substantial equivalence to predicate devices through technical specifications and safety/performance bench testing. The device's performance is therefore reported in terms of its technical characteristics matching or being comparable to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No clinical test set was used for this submission. The submission explicitly states: "Clinical performance is not deemed necessary." The data provenance for the performance testing is from laboratory bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set was used and clinical performance was not deemed necessary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set was used.

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:

Not applicable. This device is a laser hair growth helmet, not an AI-assisted diagnostic or interpretative tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a physical device, not an algorithm, and the submission did not include standalone clinical performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

No clinical ground truth was established or used, as no clinical trials were conducted for this submission. The "ground truth" for demonstrating device compliance was based on adherence to recognized international standards for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility, as well as verification and validation for integral software.

8. The sample size for the training set:

Not applicable, as no machine learning algorithm or AI component requiring a training set was part of this device submission.

9. How the ground truth for the training set was established:

Not applicable, as no machine learning algorithm or AI component requiring a training set was part of this device submission.

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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:

1. 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.

2. 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.

3. Experts for Ground Truth & Qualifications: Not applicable, as no new human-expert-validated test set was created for this submission.

4. Adjudication Method: Not applicable.

5. 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.

6. Standalone Performance: Not applicable as a new study. The 'performance' is considered equivalent to the predicate device.

7. 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.

8. 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.

9. 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.

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