(132 days)
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted 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.
Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. This product emits light pulses and is designed to be suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the treatment light pulses. The device includes a cooling function to cool the skin during the hair removal process to provide users with a more comfortable experience.
The provided text is a 510(k) summary for the Shenzhen Ulike Smart Electronics Co., Ltd. Ice Cooling IPL Hair Removal Device. It describes the device, its intended use, and its comparison to predicate devices, along with performance testing. However, it does not contain the specific details about clinical study results, acceptance criteria, or the methodology that would be required to answer all the questions in the prompt.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for performance metrics related to hair removal (e.g., specific percentages of hair reduction deemed acceptable). It only mentions 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" as part of the Indications for Use.
The document does not report specific quantitative performance data for the hair reduction effectiveness of the device. Instead, it refers to "Performance data supports that the device is safe and as effective as the predicate devices for its intended use" as a general statement for substantial equivalence.
Therefore, for the specific request of a table of acceptance criteria and reported device performance related to the primary indication of hair removal, the necessary information is not present in the provided text.
The document does list standards and tests for safety and general performance, which implies that the device met the requirements of these standards. For example:
| Acceptance Criteria (Implied by standard compliance) | Reported Device Performance (Implied by passing tests) |
|---|---|
| Biocompatibility standards (ISO 10993-5, -10, -23) are met. | Device passed biocompatibility testing. |
| Electrical safety standards (IEC 60601-1, -1-2, -1-11, -2-57, -2-83) are met. | Device passed electrical safety and EMC testing. |
| Light safety standard (IEC 62471) is met. | Device passed light safety testing. |
| Software requirements are met and hazards mitigated. | Software documentation submitted; system testing demonstrated specifications met and hazards mitigated. |
| Usability standard (IEC 60601-1-6) and FDA guidance for human factors are met. | Product usability evaluated and validated. |
Missing Information:
The following information is not available in the provided text:
- Sample size used for the test set and the data provenance: There is no mention of a clinical test set or the number of participants.
- Number of experts used to establish the ground truth for the test set and qualifications: This information would be relevant for clinical studies, which are not detailed here.
- Adjudication method for the test set: Not applicable as no clinical test set is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: This type of study is not mentioned. The device is a "home-use" device, so human-in-the-loop performance is not evaluated in the context of an MRMC study with AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device functions autonomously for hair removal, the performance described is purely device-centric rather than an "algorithm only" evaluation in the context of diagnostic AI.
- The type of ground truth used: As no clinical study results are detailed, no specific ground truth for hair removal efficacy is provided or referenced.
- The sample size for the training set: Not applicable as this document does not describe the development or evaluation of an AI/ML training set.
- How the ground truth for the training set was established: Not applicable.
Summary based on available info:
The document primarily focuses on establishing "substantial equivalence" to predicate devices through technical comparisons and compliance with relevant safety and performance standards (biocompatibility, electrical safety, light safety, software, usability). It asserts that performance data supports the device's safety and effectiveness, but it does not present the detailed clinical study design, results, or specific acceptance criteria for hair removal efficacy that would directly answer your questions about acceptance criteria and how a study proves it. For a medical device of this type, a clinical study would typically be conducted, and those results would contain the information you are requesting. This 510(k) summary only notes that such data was "provided in support of the substantial equivalence determination" but does not elaborate on the specific findings or methodology of that data.
§ 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.