(120 days)
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.
§ 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.