(57 days)
The IPL Hair Removal Device OBT-02 Version 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 re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
IPL Hair Removal, Model: OBT-02, a small over-the-counter device, is a home-use device for the permanent reduction of hair growth based on 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. A personal Light-Based Hair Removal System. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 220g, and the size is 150 x 75 x 45mm (H"W"D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
The provided document is a 510(k) summary for the IPL Hair Removal, Model: OBT-02 device. It details the device's technical specifications and compares it to predicate devices to demonstrate substantial equivalence for safety and effectiveness. However, it does not contain the information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of clinical performance, user studies, or specific performance metrics for hair removal efficacy.
Here's a breakdown of what the document does and does not provide, based on your requested information:
1. A table of acceptance criteria and the reported device performance
- Does not fully provide this. The document lists safety and performance tests (electrical safety, EMC, biocompatibility, software V&V, bench performance for pulse duration, output energy, fluence, and wavelength deviation). It states "Bench performance testing conducted to demonstrate that the pulse duration, output energy, maximum fluence, and wavelength do not deviate in excess of the allotted 10% tolerance." This implies an acceptance criterion of "not deviating in excess of 10% tolerance" for these physical parameters, and the testing demonstrated that the device met this without providing specific numerical results.
- The document does NOT provide acceptance criteria or reported performance for the clinical efficacy aspects such as the percentage of hair reduction or the number of patients achieving permanent reduction. This information would typically be present in clinical study results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes bench testing and biocompatibility testing but does not mention any clinical test sets, their sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. Since no clinical test set for efficacy is described, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical test set is described.
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/Not provided. This is an IPL hair removal device, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. This device is a hardware-based IPL hair removal system, not an algorithm, so this concept does not apply.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not provided for clinical efficacy. For the bench performance tests, the "ground truth" would be established by the calibration of the measuring instruments. For biocompatibility, it's based on established standards (ISO 10993). However, for the primary indication of hair removal, no clinical ground truth data is presented.
8. The sample size for the training set
- Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, no training set is mentioned.
Summary of available "acceptance criteria" and "reported performance" from the document:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical safety according to AAMI/ANSI ES60601-1:2005(R) 2012, A1:2012, IEC 60601-1-11:2015, IEC 60601-2-57:2011 | "evaluated the safety... by lab bench testing... satisfied" |
| Electromagnetic compatibility according to IEC 60601-1-2:2014 | "evaluated the safety... by lab bench testing... satisfied" |
| Biocompatibility according to ISO 10993-5 and ISO 10993-10 (In-Vitro Cytotoxicity, Skin Sensitization, Skin Irritation) | "test reports for the following biocompatibility evaluation... satisfied" |
| Software verification and validation according to FDA Guidance "Guidance for PreMarket Submissions and for Software Contained in Medical Devices" | "Software verification and validation test according to the requirements... satisfied" |
| Pulse duration, output energy, maximum fluence, and wavelength do not deviate in excess of the allotted 10% tolerance | "Bench performance testing conducted to demonstrate that... do not deviate in excess of the allotted 10% tolerance" |
Study Details:
The document primarily describes non-clinical bench testing to demonstrate compliance with recognized electrical safety, EMC, biocompatibility, and software standards, as well as the stability of physical output parameters. It does not detail a clinical study to prove the efficacy of hair removal or reduction against specific acceptance criteria. The statement of "permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime" is an indication for use, not a performance criterion with associated study results given in this document. The equivalence relies on comparison of similar technological characteristics to predicate devices that have already demonstrated such efficacy.
§ 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.