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510(k) Data Aggregation
(261 days)
IPL Hair Removal Device 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.
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed twenty-three models with the same IPL technology for hair removal, which is model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL20, BHRL-21, BHRL-22. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch.
The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6±0.25cm² (Model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-07, BHRL-08, BHRL09, BHRL-10) and 2.7±0.25cm² (Model BHRL-05, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-06, BHRL-06B, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22) that is suitable for multiple hair removal areas, such as large areas (e.g. face, arms, legs) and small areas (e.g. armpits, bikini line).
The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function (except model: BHRL-06B), which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
The provided FDA 510(k) Clearance Letter concerns an IPL Hair Removal Device. It is clear from the document that this device is a physical product (Intense Pulsed Light device) designed for hair removal, not an AI/software-based medical device that would involve a test set for ground truth establishment, expert readers, or MRMC studies.
Therefore, the request to describe acceptance criteria and a study proving the device meets those criteria, focusing on aspects like AI performance, sample size for test sets (in the context of AI models), number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training/test sets, is not applicable to this device clearance.
The performance data provided in the 510(k) summary for this IPL Hair Removal Device focuses on:
- Biocompatibility Evaluation: Ensuring the materials are safe for body contact.
- Electrical Safety and EMC: Compliance with international safety and electromagnetic compatibility standards (IEC 60601 series).
- Eye Safety: Compliance with photobiological safety standards (IEC 62471).
- Software Verification and Validation: This refers to the embedded software controlling the device's hardware functions, not an AI algorithm performing diagnostic or therapeutic analysis based on data inputs. The documentation level of concern is "basic."
- Usability: Evaluation according to FDA guidance for human factors.
These are standard testing requirements for physical medical devices and do not involve the types of studies or acceptance criteria that would be relevant for an AI-powered diagnostic or therapeutic algorithm.
Therefore, I cannot populate the table or answer the specific questions related to AI device performance evaluation based on the provided document. The document describes a traditional hardware-based medical device clearance.
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(62 days)
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (PL), and it has been designed 3 models with the same IPL technology for hair removal, which is model JM-843, M-865, JM-638. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 530-1200m and 500-1200m. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores thermal relaxation time but sparing normal skin by limiting the thermal relaxation time for skin.
This document does not contain information about acceptance criteria for a device's performance in a clinical study for hair removal, nor does it describe a study proving the device meets such criteria.
The provided text is an FDA 510(k) summary for an IPL Hair Removal Device (models JM-843, JM-865, JM-638). This summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through:
- Comparison of technological characteristics: This involves comparing specifications like wavelength, energy density, spot size, pulse duration, and power supply.
- Performance data from bench testing: This includes biocompatibility, electrical safety, EMC, eye safety, software verification, and a "Verification Report of Times of Flash" (service life of the lamp tube).
The document does not include:
- Clinical acceptance criteria for hair removal efficacy (e.g., percentage of hair reduction after a certain period).
- Results from a clinical study on human subjects to evaluate hair removal performance.
- Details about a test set (sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods) for assessing hair removal efficacy.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance for hair removal.
- Details about a training set for an AI/algorithm related to hair removal efficacy.
The "Performance Data" section primarily addresses safety and technical performance aspects of the device, not its biological effectiveness in hair removal on humans. The conclusion states that "the subject device IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device," but this "effectiveness" is primarily inferred from the similarity of technological characteristics to predicate devices that are presumably already accepted for hair removal.
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The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and or facial hair.
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed three models with the same IPL technology for hair removal, which is model LS-T107 and LS-T108. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch.
The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.2cm2 of LS-T106 and LS-T108, 3.7cm2 of LS-T107 that is suitable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc.
The device contains a skin sensor to detect appropriate skin contact, if the light exti is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which will be activated throughout the whole har removal process to cool down the treatment area' s temperature and provide the user with a better using experience.
The provided text is a 510(k) Premarket Notification summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data from non-clinical testing. It does not present any clinical study data or acceptance criteria related to device efficacy for hair removal based on human trials.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to a clinical outcome (e.g., hair reduction percentage).
- Sample size and data provenance for a test set for clinical performance.
- Number of experts and their qualifications for establishing clinical ground truth.
- Adjudication method for a clinical test set.
- MRMC comparative effectiveness study results.
- Algorithm-only (standalone) performance.
- Type of ground truth used for clinical efficacy.
- Sample size and ground truth establishment for a training set.
The document primarily covers non-clinical performance data, which includes:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical):
The acceptance criteria for this device are implied by its conformance to various international standards for safety and biocompatibility, as well as the demonstration of similar technological characteristics to predicate devices. The "reported device performance" is framed as successfully meeting these standards and being comparable to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Testing) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device must not cause adverse biological reactions when in contact with the body. Conformance to ISO 10993-5, ISO 10993-10, and ISO 10993-23. | Passed: Testing conducted per ISO 10993-5 (In vitro cytotoxicity), ISO 10993-10 (Skin sensitization), and ISO 10993-23 (Skin irritation). (Section VIII.1) |
| Electrical Safety & EMC | Device must be electrically safe and comply with electromagnetic compatibility standards for medical electrical equipment, including home healthcare use. Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83. | Passed: Testing performed to and passed the following standards: ANSI AAMI ES60601-1 (Medical electrical equipment for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-1-11 (Home Healthcare Environment), and IEC 60601-2-83 (Basic safety and essential performance of home light therapy equipment). (Section VIII.2) |
| Eye Safety | Device emissions must meet photobiological safety standards. Conformance to IEC 62471. | Passed: Testing performed to IEC 62471 (Photobiological safety of lamps and lamp systems). (Section VIII.3) |
| Software V&V | Software must be verified and validated to meet requirements and mitigate hazards, consistent with a moderate level of concern. | Demonstrated: Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated all software requirement specifications are met and all software hazards mitigated to acceptable risk levels. (Section VIII.4) |
| Technological Equivalence | Key technical specifications (wavelength, energy density, spot size, pulse duration, light source, etc.) must be similar to legally marketed predicate devices, with any differences not raising new safety or effectiveness concerns. | The device's wavelength range (LS-T106: 610-1200nm, LS-T107: 560-1200nm, LS-T108: 470-1200nm) is considered similar to predicates (e.g., predicate device 550-1200nm, reference device 1 470-1200nm). Differences like the min wavelength of LS-T106 being identical to reference device 4's range are noted. (Note 2, Section VII) Energy density (LS-T106: 2.0-4.87J/cm², LS-T107: 2.16-5.18J/cm², LS-T108: 2.0-5.62J/cm²) and output energy are considered similar, accounting for a ±20% error, and falling within the range of predicate and reference devices. (Note 3, Section VII) Spot sizes (LS-T106: 3.2 cm², LS-T107: 3.7 cm², LS-T108: 3.2 cm²) are similar to reference devices (3.0-3.6cm²). (Note 4, Section VII) Pulse durations (LS-T106: 0.64-2.4ms, LS-T107: 7.2-10.8ms, LS-T108: 6.8-10.2ms) are within or overlap with the ranges of predicate and reference devices. (Note 5, Section VII) The differing number of output intensity levels (3 for subject vs. 5-9 for others) is deemed not to raise safety or effectiveness issues due to comparable wavelength, energy, and density, and compliance with relevant standards. (Note 6, Section VII) |
Regarding your specific questions related to clinical efficacy studies (which are NOT in this document):
- 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data for efficacy is provided.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth for efficacy is provided.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set or adjudication process is mentioned.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This document does not describe such a study.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device, but a physical hair removal device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no clinical efficacy study reported. For the non-clinical tests, the "ground truth" is defined by the specific requirements and passing criteria of the referenced international standards.
- 8. The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set of patient data.
- 9. How the ground truth for the training set was established: Not applicable.
In summary: The provided FDA 510(k) summary for the IPL Hair Removal Device focuses on demonstrating substantial equivalence through non-clinical performance data (biocompatibility, electrical safety, eye safety, software validation) and comparison of technological characteristics with legally marketed predicate devices. It does not include any data or studies related to its clinical efficacy in hair removal (e.g., percentage of hair reduction) on human subjects. For medical devices like this, approval based on substantial equivalence often relies on demonstrating that the new device has similar technology and performance/safety characteristics to products already on the market, rather than requiring new clinical efficacy trials if the intended use and technological principles are well-established.
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