(90 days)
The ProLite / Plasmalite MPX Pulsed Light System is indicated to permanently reduce unwanted hair.
The ProLite / Plasmalite MPX is intended to be used for the permanent reduction of unwanted hair.
The ProLite / PlasmaliteMPX 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
Below is an analysis of the provided text regarding the ProLite / Plasmalite MPX Pulsed Light System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (510(K) Summary for ProLite / Plasmalite MPX Pulsed Light System) focuses on demonstrating "substantial equivalence" to a predicate device rather than setting explicit, quantifiable "acceptance criteria" in the typical sense of a clinical trial's primary endpoint. The primary outcome discussed relates to the intended use of the device, which is "to permanently reduce unwanted hair."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Permanent reduction of unwanted hair (efficacy) | "The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal." |
| Safety Profile | "There was no scarring in any subject." |
| Equivalence to predicate device | The ProLite / Plasmalite MPX Pulsed Light System is considered "substantially equivalent to other existing pulsed light systems in commercial distribution for permanent hair reduction in Dermatology and Plastic Surgery." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of subjects in the clinical study. It generically states "Clinical studies were conducted" and "Observation in the clinical study were recorded prior to treatment and at 3-6 months after treatment."
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish a ground truth for the test set. The efficacy is described as being observed (e.g., reduction of hair, absence of scarring), but the method of assessment for this observation (e.g., expert clinical assessment, objective measurement) is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set results.
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 section is not applicable. The device is a pulsed light system for hair removal, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is a physical medical device (pulsed light system) and does not involve an algorithm working in a "standalone" capacity in the sense of AI performance. Its performance is directly tied to its physical application by a human operator.
7. The Type of Ground Truth Used
The "ground truth" for the efficacy of the hair removal system appears to be clinical observation/outcomes data. The document states:
- "Observation in the clinical study were recorded prior to treatment and at 3-6 months after treatment."
- "The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal."
- "There was no scarring in any subject."
This indicates that the effectiveness and safety were assessed directly from the patients' responses to the treatment.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical pulsed light system and does not involve a "training set" in the context of machine learning or AI algorithms. The "clinical studies" mentioned are for validation/testing, not for training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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.