(487 days)
This is a hand held device intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
The Baby Quasar consists of a collection of red and near infrared diodes [LEDs], packaged in a compact handheld device. The device has a head containing the led array, momentary switch, and indicator light.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Baby Quasar Infrared Lamp:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Treatment of periorbital wrinkles |
| Technological Characteristics | Utilizes red and infrared diodes (LEDs) to provide narrow bands of light energy. Power densities and wavelengths are "nearly identical" to predicate devices. |
| Safety | Functional performance testing (power levels), electrical safety testing, and Electromagnetic Compatibility Testing (EMC) completed. AC power supply is UL listed. No new safety issues raised. |
| Effectiveness | Performs as intended. "The performance achieved by these devices are the same" (as predicate devices). No new effectiveness issues raised. |
| Regulatory Classification | Similar use and technological characteristics to predicate devices; deemed "substantially equivalent" to predicate devices (New-U K072459) for treatment of periorbital wrinkles. |
Note: The document focuses on demonstrating substantial equivalence to a predicate device rather than setting specific quantitative acceptance criteria or reporting detailed clinical performance metrics like wrinkle reduction percentages or photographic evidence. The "reported device performance" is largely framed by its similarity to the predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not mention any clinical test set involving human subjects for evaluating the effectiveness of the Baby Quasar device. The testing described primarily covers functional performance, electrical safety, and EMC of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
As there's no mention of a clinical test set with human subjects, there's no information about experts used to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set using human subjects 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. This device is an infrared lamp for wrinkle reduction, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related metrics are relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
For the device's functional and safety testing, the ground truth would be based on established engineering and safety standards (e.g., power level specifications, electrical safety criteria, EMC standards).
For the intended effect (wrinkle reduction), the document states an equivalence to predicate devices, which would have historically demonstrated effectiveness. However, no specific clinical ground truth (e.g., expert consensus on wrinkle severity, photographic analysis) is described for the Baby Quasar itself in this submission.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product that utilizes a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned.
§ 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.