(88 days)
The Plasmalite Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.
The Plasmalite Pulsed Light System delivers pulsed light at a wavelength beginning at a wavelength of 600 nm. The device consists of three interconnected sections: The cabinet which houses the internal cooling system, power supply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
The provided text describes the Plasmalite Pulsed Light System and its substantial equivalence to a predicate device, the ProLite Pulsed Light System. However, it explicitly states that no clinical studies were specifically conducted for the Plasmalite device. Instead, it relies on the clinical studies performed for its predicate, the ProLite.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth for the Plasmalite device cannot be provided directly from this document. The information below reflects what is available or inferred from the provided text, primarily referencing the predicate device's studies when mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the Plasmalite Pulsed Light System. It asserts substantial equivalence to the ProLite Pulsed Light System, which was previously cleared. The "performance data" section only states that the Plasmalite is technically the exact device as the ProLite.
| Acceptance Criteria | Reported Device Performance (based on predicate ProLite) |
|---|---|
| Not explicitly stated | Intended for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale (as per predicate's studies for which results were submitted in K013366). |
2. Sample size used for the test set and the data provenance
The document states: "No Clinical studies were specifically conducted using the Plasmalite. The Plasmalite is technically the exact device as the predicate device, the ProLite. Results from the clinical studies for the ProLite were submitted in 510(K) number 013366."
Therefore, the sample size and data provenance information refers to the studies conducted for the predicate device, ProLite, and this specific document does not provide those details.
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 document, as no specific clinical studies for the Plasmalite device are detailed, and the details of the predicate's studies (K013366) are not included here.
4. Adjudication method for the test set
This information is not available in the provided document, as no specific clinical studies for the Plasmalite device are detailed, and the details of the predicate's studies (K013366) are not included here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
This information is not available in the provided document. The device is a pulsed light system for hair removal, not an imaging or diagnostic device that would typically involve a multi-reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical device for hair removal, not an AI algorithm.
7. The type of ground truth used
For the predicate device (ProLite), the ground truth for hair removal studies would typically involve objective measurements of hair count reduction or clinical assessment of hair regrowth over a period. However, the specific type of ground truth used for the ProLite studies is not described in this 510(k) summary.
8. The sample size for the training set
This question is not applicable as the device is a medical device, not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
This question is not applicable as the device is a medical device, not an AI algorithm.
§ 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.