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510(k) Data Aggregation
Kam Yuen Plastic Products Ltd.
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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(247 days)
Kam Yuen Plastic Products Ltd
The Laser Hair Growth Comb (Model: A-803) is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
Laser Hair Growth Comb
The provided text is a 510(k) clearance letter from the FDA for a Laser Hair Growth Comb. It confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report or performance evaluation. This letter is a regulatory clearance document, not a scientific study report.
Therefore, I cannot provide the requested information from the provided text. The document only states the "Indications for Use" for the device, which are:
- To promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V.
- To promote hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal.
- Both genders with Fitzpatrick Skin Phototypes I-IV.
To answer your questions, I would need a different type of document, such as a clinical study report, a performance evaluation summary, or a Section 510(k) summary that includes details of the device's technical performance and the studies conducted to support its efficacy.
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(233 days)
Kam Yuen Plastic Products Ltd.
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.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Laser hair growth helmet Model: A-800) |
|---|---|
| Intended Use | The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with Ludwig-Savin Classifications I-II, and in males with Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV. (Matches predicates) |
| LLLT Device Type | LLLT |
| Prescription Type | OTC (Matches Predicate II & Reference Device; Predicate I is prescription use) |
| Wavelength | 650nm ± 10nm (Matches all predicates) |
| Laser radiation output | 5mW (Matches Predicate I & Reference Device; Predicate II is 4-5mW) |
| Fluence | 3.03 J/cm² (Comparable to predicates, which range from 1.2 J/cm² to 4.9642 J/cm²) |
| Amount of laser diodes | 180 (Falls within the range of predicates: 36-272) |
| Irradiation over the treatment area | 2.02 mW/cm² (Comparable to Predicate II's range: 2.0857-2.3639 mW/cm²) |
| Classification according to IEC60825-1 | Class 3R (Matches all predicates) |
| Treatment Time (Each Treatment) | 25 min (Comparable to predicates: 20-35 min/30 min) |
| Treatment Time (Total Treatment) | Every two days (Comparable to predicates: every day/every other day) |
| Appearance Design | Helmet cap (Matches predicates: Helmet) |
| Safety and Performance Feature Compliance | Complied with IEC 60601-1, IEC 60601-1-2, IEC 60825-1 |
| Biocompatibility Compliance | All patient contacting materials complied with ISO 10993-5, ISO 10993-10 |
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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(80 days)
Kam Yuen Plastic Products Ltd.
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.
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(184 days)
Kam Yuen Plastic Products Ltd
The Aimanfun Lumea Comfort (Model: A-2788) 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, Model: A-2788 is a light-based device for long-term hair removal. 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 size of the device is about 138.98247.3mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal 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 document is a 510(k) summary for the Aimanfun Lumea Comfort (Model: A-2788) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed primary study data for specific acceptance criteria.
Therefore, the document does not contain the specific acceptance criteria and detailed study results in the manner typically found in a clinical study report. Instead, it relies on comparisons to predicate devices and adherence to recognized standards to support safety and effectiveness.
However, based on the information provided, here's a breakdown of what can be extracted and what is missing:
Description of Device and Intended Use:
The Aimanfun Lumea Comfort (Model: A-2788) is a light-based device intended for patient removal of unwanted hair using selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also intended for permanent reduction in unwanted hair, defined as a long-term stable reduction in hair regrowth measured at 6, 9, and 12 months post-treatment regimen completion.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative table format for performance. Instead, it relies on demonstrating substantial equivalence to predicate devices and compliance with recognized standards. The "performance" is implicitly demonstrated through the comparison table and the conclusion of substantial equivalence.
Implied Performance Parameters and Comparison to Predicates (from the "Comparison to Preadicate device and conclusion" table):
| Element of Comparison | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Aimanfun Lumea Comfort) | Remarks (Extracted from Notes) |
|---|---|---|---|
| Indications for Use | Similar to Predicate I, IV (Permanent hair reduction at 6, 9, 12 months intervals) | Permanent reduction in unwanted hair, measured at 6, 9, and 12 months after treatment regimen completion. | SE Note 1: Consistent with Predicate IV (K132170) for prescription use. |
| IFU Type | Prescription use (Predicate IV) or OTC (Predicates I, II, III) | Prescription use | SE Note 2: Intended for prescription use to mitigate misuse on inappropriate skin tones, consistent with K132170 (Predicate IV). |
| Regulation Number | 878.4810 (All Predicates) | 878.4810 | SE (Substantially Equivalent) |
| Classification Product Code | OHT or ONF (Predicates) | ONF | SE |
| Device Type | Intense Pulsed Light (All Predicates) | Intense Pulsed Light | SE |
| Power Source | AC Mains, external power supply, battery charger | An external power supply | SE |
| Light Source | Xenon Arc Flashlamp (All Predicates) | Xenon Arc Flashlamp | SE |
| Wavelength | Ranges from 400nm-1200nm (Predicates) | 475nm~1200nm | SE |
| Spot Size | Ranges from 2 cm² to 4.5 cm² (Predicates) | 3.0 cm² | SE |
| Max. Fluence (J/cm²) | Ranges from 3-10 J/cm² (Predicates) | 4.5 J/cm² | SE |
| Pulse Duration | Ranges from 2-13 milliseconds (Predicates) | 3 milliseconds | SE Note 3: Covered by Predicate I (2-10ms) range. Photothermolysis depends on pulse output energy. |
| Output Energy | Ranges from 6-22 J (Predicates) | 7-13.5 J | SE Note 4: Lowest level (7J) covered by Predicate III (6-13.5J). |
| Pulsing Control | Finger switch (All Predicates) | Finger switch | SE |
| Delivery Device | Direct Illumination to Tissue (All Predicates) | Direct Illumination to Tissue | SE |
| Software Control | Yes (All Predicates) | Yes | SE |
| Compliance with Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 60601-1-11, IEC 62471, ISO 10993-5, ISO 10993-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, ISO 10993-5, ISO 10993-10 | SE (All standards are met as per the test summary) |
2. Sample Size for the Test Set and Data Provenance:
The document does not report specific sample sizes for a clinical test set for demonstrating device performance. This 510(k) submission relies on bench testing, comparison to predicate devices, and adherence to performance standards. There is no mention of human subject testing data for the Aimanfun Lumea Comfort device itself within this summary.
Therefore, questions regarding data provenance (country of origin, retrospective/prospective) are not applicable from the given text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since there is no reported clinical test set data from human subjects for the Aimanfun Lumea Comfort in this document, there is no information on experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set:
As there is no reported clinical test set data from human subjects, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or reported in this document. This submission is for a medical device (hair removal system), not an AI-assisted diagnostic tool where such studies are common. Therefore, information on the effect size of human readers with vs. without AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The Aimanfun Lumea Comfort is a physical device (IPL hair removal system), not a software algorithm. Therefore, a standalone algorithm performance study is not applicable to this device. Its "performance" refers to its physical characteristics and effectiveness in hair removal, which is implicitly supported by its substantial equivalence to predicate devices and compliance with safety standards.
7. Type of Ground Truth Used:
For this mechanical/electrical device, the "ground truth" for its safety and claimed performance (hair reduction) is implicitly established through:
- Engineering specifications and measurements: Bench testing for electrical safety, EMC, output energy, wavelength, etc., as per recognized standards (IEC, ISO).
- Comparison to legally marketed predicate devices: The functionality and expected outcome (hair reduction) are benchmarked against devices previously cleared by the FDA, using their established indications for use and performance parameters as a basis for substantial equivalence.
- Adherence to recognized standards: Compliance with standards like ISO 10993 for biocompatibility (cytotoxicity, sensitization, irritation) ensures the materials are safe for patient contact, which acts as a form of "ground truth" for material safety.
There is no mention of pathology, outcomes data from a prospective study for this specific device, or expert consensus on clinical images in this 510(k) summary.
8. Sample Size for the Training Set:
This device does not involve a "training set" in the context of machine learning or AI algorithms. It's an Intense Pulsed Light (IPL) device. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set was Established:
Since there is no "training set" for this device (as it's not an AI/ML algorithm), this question is not applicable.
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