(64 days)
The Iluminage Skin Smoothing Laser is indicated for use in the treatment of periorbital and perioral wrinkles.
The Iluminage Skin Smoothing Laser is a battery powered, home use (OTC) diode laser. The device emits continuous wave diode laser energy for a specified period of time to a fixed area of skin. This energy triggers the body's natural response to generate new collagen, which helps tighten the skin which reduces wrinkles.
The device is composed of a handpiece for delivery of laser energy, base unit for charging and storage when not in use, an A.C. charging adapter, Instructions for Use, USB data cable and carrying pouch. The handpiece contains a 1440nm laser diode light source, internal energy power source and control electronics with embedded software. The device has been modified to add user convenience features.
The provided document is a 510(k) summary for the Iluminage Skin Smoothing Laser. It focuses on demonstrating substantial equivalence to a predicate device, the Cynosure Iluminage Diode Laser (K111454), rather than providing detailed acceptance criteria and a study to prove they are met in the manner typically seen for new algorithm-based medical devices.
The modifications to the device primarily involve user convenience features and do not change the indications for use or the core technological characteristics (wavelength, fluence, spot size, repetition rate). Therefore, the "acceptance criteria" and "study" described are focused on verifying that these modifications function correctly and do not negatively impact the device's performance, which is assumed to be equivalent to the predicate.
Here's the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance for the Iluminage Skin Smoothing Laser as a new, standalone device to treat wrinkles. Instead, it demonstrates through testing that modifications to the device were correctly implemented and that the device performs the same as the predicate device. The "acceptance criteria" can be inferred from the nature of the modifications and the non-clinical tests performed.
| Acceptance Criterion (Inferred from non-clinical tests) | Reported Device Performance |
|---|---|
| Correct Implementation of Revised Arming Sequence | The testing confirmed that the revised arming sequence was correctly implemented and the laser would function when followed. |
| Ability to Change Treatment Levels | The testing confirmed that treatment levels could be changed. |
| Functionality of Indicators (Skin Contact, Battery Status, Treatment Count, High Temp) | The testing confirmed that indicators such as skin contact, battery status, treatment count, and high-temperature limits would function. |
| Data Acquisition Functionality | The testing confirmed that data acquisition could be performed (a new feature for the modified device). |
| Overall Performance Equivalence to Predicate Device | "Testing confirmed that the performance of the Iluminage Skin Smoothing Laser meets the product system requirements, which is based on the predicate device. Therefore, the modification resulted in a device that performs the same as the predicate device." The technological characteristics (Wavelength, Fluence, Spot Size, Rep. Rate) are identical to the predicate device, suggesting equivalent fundamental performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical software verification testing. This typically involves internal hardware/software testing and verification by the manufacturer, not a clinical "test set" with patient data in the sense of an algorithm.
- Sample Size: Not specified in terms of patient data. The "test set" refers to verification procedures performed on the device itself.
- Data Provenance: Not applicable in the context of patient data. This was internal device verification.
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 the evaluation was not based on expert-established ground truth for patient data or an algorithm's output. It was a device functionality and performance verification against its own design specifications and equivalence to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the evaluation was a device functionality and performance verification, not a clinical study involving human readers or interpretation of results that would require adjudication.
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
No MRMC study was done. This device is a direct-to-consumer laser for wrinkle reduction; it does not involve human readers' interpretation of images or AI assistance. The study described is a non-clinical verification of device modifications.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This is a physical laser device, not an algorithm. The "software verification" was for the embedded control software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was the expected functional behavior and performance defined by the device's design specifications and its equivalence to the predicate device. For example, the "ground truth" for the arming sequence test was that the laser should function when the proper sequence is followed.
8. The sample size for the training set
Not Applicable. This is a hardware device with embedded control software, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
Not Applicable. As mentioned above, there is no "training set."
§ 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.