(29 days)
The Mini me is an over-the counter device intended for the removal of unwanted hair. The Mini me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.
The Mini mē is a smaller version of its predicate device (K131649) and consists of a handheld unit that operates with an external power supply. Identical to its predicate device, the miniaturized version also delivers Intense Pulse Light (IPL) technology (output up to 4 J/cm²) to the treatment area for removing unwanted hair and also uses a skin contact sensor via low RF energy signal to establish skin contact prior to the emission of a pulse.
The provided text is a 510(k) summary for the Mini mē device. It states that the Mini mē is a smaller version of its predicate device (Mē System, K131649) and shares the same technological characteristics, including the use of Intense Pulse Light (IPL) technology (output up to 4 J/cm²), a skin contact sensor, and safety features.
The document does not contain a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert adjudication as typically found for new device efficacy claims. Instead, it relies on substantial equivalence to a predicate device.
Here's the breakdown of what the document does provide and why it doesn't fit the requested format for a study proving acceptance criteria:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document for the Mini mē regarding efficacy for hair removal. The document focuses on demonstrating that the Mini mē functions as intended based on non-clinical testing and that its performance is equivalent to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for efficacy. The document states "no new questions of efficacy are raised in the modified device" because it delivers energy within the same limits as the predicate device. | Not specified for efficacy. The document states that "in all instances, the Mini me device functioned as intended" for non-clinical tests (electrical safety, EMC, software, system V&V). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No clinical test set data is provided. The performance data section refers to non-clinical testing: electrical safety, electromagnetic compatibility, software verification and validation, and system verification and validation. No sample sizes for these tests are mentioned, nor is data provenance in the context of clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable as no clinical test set requiring expert ground truth establishment for efficacy is described. The document relies on engineering and system-level validation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as 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:
This information is not applicable. The device is an IPL hair removal system, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a user-operated IPL hair removal system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable for clinical efficacy evaluations of the Mini mē, as no such evaluations are detailed in the provided text. For the non-clinical tests, the "ground truth" would be the engineering specifications and regulatory standards the device was tested against.
8. The sample size for the training set:
This information is not applicable. The Mini mē is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
In summary: The provided document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. It highlights the technological characteristics and non-clinical performance testing (electrical safety, EMC, software, system V&V) to demonstrate that the Mini mē is as safe and effective as its predicate device (Mē System, K131649). It does not describe a clinical study with acceptance criteria, patient sample sizes, or expert adjudication for proving efficacy, as it leverages the prior clearance of the predicate device.
§ 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.