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Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Diamond Air+, Model: UI04A, UI04B, UI04C, UI04M, UI04G, UI04W 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 can 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 6038169.86mm (W x D x H). 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 Diamond Air+ is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

I am unable to provide information about the acceptance criteria and study that proves the device meets the acceptance criteria for the Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) based on the provided document.

The document primarily focuses on the FDA 510(k) clearance process, stating that the device is "substantially equivalent" to a legally marketed predicate device. While it mentions the device's intended use for hair removal and permanent reduction in hair regrowth, and touches upon parameters like wavelength and fluence, it does not contain a study that demonstrates the device's performance against specific acceptance criteria.

The "Conclusion" section within the document states: "The subject device 'Diamond Air+, Model: UI04A, UI04B, UI04C, UI04M, UI04G, UI04W' is substantial equivalent to the predicate device." This indicates that the clearance was based on demonstrating equivalence to an already cleared device, rather than providing a detailed study of the subject device's performance against pre-defined acceptance criteria.

Therefore, I cannot extract the information required for the table or the other requested points (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, type of ground truth, training set details) from this document.

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Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.

Diamond Air+ (Model: UI04A, UI04B, UI04C) is a light-based device for long-term hair removal intended to be sold over-the-counter directly to the end user. The subject device is identical to that cleared via K213558. 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 utilizes the IPL technology with 5 Levels of output energy. The size of the device is 6038169.86mm (W x D x H). It contains a Xenon Lamp and a skin contact sensor to detect appropriate skin application. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with not start treatment.

This document describes the Ulike Co., Ltd.'s Diamond Air+ (UI04A, UI04B, UI04C) device, a light-based device for long-term hair removal.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria in a quantitative manner (e.g., minimum percentage reduction in hair regrowth). Instead, it states the "Indications for Use" which defines the intended outcomes.

However, based on the Indications for Use as the implicit "acceptance criteria" through regulatory clearance, we can infer the following:

Important Note: The document explicitly states, "No new clinical performance data is reported in this submission." This means the device's performance against these indications is not newly supported by a specific study detailed within this submission. Instead, substantial equivalence to predicate devices (K213558 and K192432) is being claimed, and the performance is presumably supported by the predicate devices' data.

2. Sample size used for the test set and data provenance:

• The document states: "No new clinical performance data is reported in this submission."
• Therefore, there is no information provided on the sample size or data provenance (country of origin, retrospective/prospective) for a test set specifically for this device in this submission. The substantial equivalence relies on previously established data for predicate devices.

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

• Given that "No new clinical performance data is reported," there's no information on experts or ground truth establishment for a test set within this submission.

4. Adjudication method for the test set:

• Given that "No new clinical performance data is reported," there's no information on adjudication methods for a test set within this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• This device is a physical hair removal device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not conducted.

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

• This device is a physical hair removal device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not conducted.

7. The type of ground truth used:

• Since no new clinical performance data is reported, the type of ground truth used for this specific submission to demonstrate performance is not explicitly detailed. However, for hair removal efficacy studies, the ground truth would typically be objective measurements of hair count reduction over time, potentially assessed by qualified professionals (e.g., dermatologists or clinical researchers) or through photographic analysis. This ground truth would have been established for the predicate devices.

8. The sample size for the training set:

• This device is not an AI algorithm requiring a training set. Therefore, this question is not applicable.

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

• This device is not an AI algorithm requiring a training set. Therefore, this question is not applicable.

In summary:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting new clinical performance data for the Diamond Air+ device itself. The "acceptance criteria" are implied by the stated indications for use, and the device's ability to meet these is supported by the regulatory history and performance of the predicate devices. Human factors testing was conducted to support the Over-The-Counter (OTC) indication, but this is a usability/safety assessment, not a clinical efficacy study about hair reduction.

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The IPL Hair Removal Device (Model: U104A, U104C) 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 IPL Hair Removal Device 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.

IPL Hair Removal Device, Model: UI04A, UI04B, UI04C, 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 can 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 6038169.86mm (W x D x H). 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 text describes an IPL Hair Removal Device (K213558) and its substantial equivalence to predicate devices, but it does not include detailed information about an acceptance criteria table, device performance metrics, a study design (including sample sizes, ground truth establishment, or expert involvement), or comparative effectiveness studies (MRMC).

The document focuses on regulatory compliance, safety testing, and technological comparison to predicate devices rather than a performance study as typically understood for AI/algorithm-based devices.

Therefore, for most of your requested points, the information is not available in the provided text. I will provide what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The document lists "Specifications" for the device, which could be considered criteria, but it does not present a table of acceptance criteria with corresponding device performance results from a specific study.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document discusses "lab bench testing" for safety and performance (referencing standards like IEC 60601-1) and a comparison to predicate devices based on technological characteristics. It does not describe a clinical performance study with a test set of data or human subjects to measure efficacy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no such performance study is described.

4. Adjudication Method for the Test Set
Not applicable, as no such performance study is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described. The document focuses on the device's technical specifications and safety compliance, not a clinical trial comparing human performance with and without AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study is not described. This device is an IPL hair removal device, not an AI/software algorithm in the typical sense that would have "standalone performance" in data analysis. The "Software/Firmware/Microprocessor" is listed as "Yes" but no performance evaluation or study of this software is provided.

7. The Type of Ground Truth Used
Not applicable, as no performance study requiring a "ground truth" (like expert consensus, pathology, or outcomes data for diagnostic accuracy) is described. The device's "efficacy" is addressed by comparing its technological parameters (wavelength, fluence) to those of predicate devices, implying similar outcomes. The "Permanent hair reduction" definition mentions measurements at 6, 9, and 12 months, which are outcomes, but no study is detailed using these as ground truth.

8. The Sample Size for the Training Set
Not applicable, as no AI model training is described in the context of device performance, and no "training set" for such a purpose is mentioned.

9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI model training or associated training set ground truth is described.

Summary of available information related to performance/efficacy:

• Intended Use/Indications for Use: The IPL Hair Removal Device 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." It is also intended for "permanent reduction in unwanted hair."
• Definition of Permanent Hair Reduction: "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."
• Technological Comparison (indicating efficacy basis):
  • Relies on the same Intense Pulsed Light (IPL) technology as predicate devices.
  • Energy source: Xenon Arc Flashlamp (same as predicates).
  • Wavelength of emitted light (spectrum): 550-1200nm (same as predicates).
  • Fluence/flux: Delivers the same maximum energy (6 J/cm²) as predicate devices.
• Safety and Performance Evaluation: Evaluated by "lab bench testing" according to standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization).
• Conclusion: The subject device is deemed "substantially equivalent" to predicate devices, based on technological characteristics and the differences not raising new issues of safety or effectiveness.

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