(96 days)
HEE HR Mini is an over-the-counter device intended for the removal of unwanted hair. The HEE HR Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
The HEE HR Mini devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The HR Mini devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the HR Mini devices is 3 cm². The device contains a lamp, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. If the HR Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the HR Mini will not trigger a pulse.
The device has an on/off button, skin color sensor, light exit window, flash button, led indicator, two intensity button, socket for battery charging.
The provided document does not contain detailed information about specific acceptance criteria related to a clinical study for the Hee Hr Mini device's effectiveness in hair removal or reduction. It primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons, safety, and regulatory compliance.
However, based on the Intended Use and the comparison table provided, we can infer the primary performance criteria the device is expected to meet, drawing parallels from its predicate devices which also claim "permanent reduction in hair regrowth."
Here's an analysis of the provided text in relation to your questions, noting where information is explicitly stated or can be inferred, and where it is not available.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for "permanent reduction in hair regrowth." However, the Intended Use for both the applicant device and its predicates defines this as:
"a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen."
The document states that the Hee Hr Mini passed all testing in support of the substantial equivalence determination, implying it met the expected performance for its intended use, which is aligned with the predicate devices. Since this is a 510(k) submission, the device is deemed "substantially equivalent" rather than proving superiority or achieving specific, novel clinical endpoints through a dedicated clinical trial for this submission.
| Acceptance Criteria (Inferred from Intended Use) | Reported Device Performance (Inferred) |
|---|---|
| Primary: Permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen. | The device passed all testing in support of the substantial equivalence determination, implying it is able to achieve the "permanent reduction in hair regrowth" as defined, similar to its predicate devices. No specific hair reduction percentage or count is provided. |
| Safety: Compliance with electrical safety, performance, and EMC standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 62471, and IEC 60601-1-2 for EMC). Biocompatibility (Cytotoxicity, Sensitization, Irritation). Software Verification and Validation (Moderate level of concern). | The device passed all specified safety and performance standards, biocompatibility testing, and software verification and validation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on a specific clinical test set for proving efficacy for this 510(k) submission. The performance data section focuses on "performance, software, electrical safety, EMC, biocompatibility and bench" testing, which are primarily technical and safety assessments, not an efficacy trial. It's common for 510(k) submissions to rely on substantial equivalence to predicate devices which have already established safety and efficacy, or on bench testing and limited human factor studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text, as a clinical efficacy study with explicit ground truth establishment is not detailed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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
This is not applicable to the Hee Hr Mini device, which is an aesthetic light-based hair removal device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance effect size is mentioned or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable as the device is a hardware-based hair removal system, not an algorithm, per se. Its performance is inherent to its physical operation. The "Software Verification and Validation Testing" section mentions software, but this relates to the device's internal control and safety features, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the lack of a detailed clinical efficacy study in this document, the type of ground truth used for efficacy (e.g., hair counts, photographic assessment by experts, patient self-assessment) for the Hee Hr Mini is not explicitly stated. For similar devices, ground truth for hair reduction efficacy is typically established through objective hair counts in a defined area, often by blinded assessors or using photographic analysis, over several months.
8. The sample size for the training set
The document does not mention a training set or provide details about any clinical trials or data used for training purposes, as this is not an AI/ML device in the context of typical "training sets."
9. How the ground truth for the training set was established
As described in point 8, the concept of a "training set" in the context of AI/ML is not applicable here.
§ 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.