(107 days)
The Ahwon RPL, R2PL system intended use for in Surgical, Asthetic and Cosmetic Application in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV.
The Ahwon's RPL, R2P1 are IPL ( Intense pulsed light) system, using visible rays created by Xenon Lamp through Sapphire which are installed on Hand Piece, and composed Main Board, unit LCD monitor controlled by computer Hand pieces Cooling system. This device uses computer controlled Power supply and filter to generate light pulses of prescribed duration, intensity and spectral distribution. This device also equipped the Cooling systems to maintain both the Treatment head / Systems at appropriate and safe temperatures. The light pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the system. This system has two hand pieces and each hand piece has 2 wavelengths to choose from. at the end of the Hand Piece, there is a sapphire filter and light is emitted when the button is pressed.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Ahwon RPL/R2PL system.
Important Note: The provided document is a 510(k) summary, which is a premarket notification for a medical device. This type of document primarily focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than presenting detailed standalone clinical trial data for acceptance criteria. As such, the information you're requesting regarding detailed studies proving the device meets acceptance criteria (especially in the context of AI/algorithms, ground truth, and sample sizes for testing and training datasets) is largely absent from this summary. This is typical for a 510(k) for a physical device like an IPL system, as opposed to an AI/ML SaMD product.
Therefore, the table and answers below will reflect the information available in the provided text, which largely pertains to the device's intended use and equivalence to existing devices.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary for an Intense Pulsed Light (IPL) system (a hardware device, not an AI/ML algorithm), the "acceptance criteria" are not framed in terms of AI performance metrics (like sensitivity, specificity, AUC) but rather in terms of demonstrating substantial equivalence to predicate devices and meeting stated intended uses. The "performance" is described by its claimed therapeutic applications and wavelengths.
| Acceptance Criteria (Implied by Intended Use & Equivalence) | Reported Device Performance (as claimed) |
|---|---|
| General Functionality: Operation as an IPL system | Operates as an IPL (Intense Pulsed Light) system using visible rays from a Xenon Lamp through Sapphire, controlled by a computer, with hand pieces and a cooling system. Manufactures in accordance with IEC60601-1 and IEC60601-1-2. |
| Intended Use - Specific Conditions (RPL model): | Treats skin types I-IV for: |
- Melasma, Ephelides (560-1200nm)
- Port Wine Stains, Rosacea (590-1200nm)
- Melasma (640-1200nm)
- Hair Reduction/Removal, Vascular Lesions (695-1200nm) |
| Intended Use - Specific Conditions (R2PL model): | Treats skin types I-IV for: - Acne, Vulgaris (415-950nm)
- Melasma, Ephelides (560-950nm)
- Port Wine Stains, Rosacea (590-950nm)
- Melasma (640-1200nm)
- Hair Reduction/Removal, Vascular Lesions (695-1200nm) |
| Substantial Equivalence: | The device is claimed to be "substantially equivalent" to predicate devices (GSD IPL System K091664, StrataPulse IPL system K090837) "at design, function, intended to use, treatment profile and performing," and "in respect to intended use, function, Technology, Principal operation and Performance." The FDA concurred with this determination based on the provided information, noting it does "not raise any additional concerns regarding safety and Effectiveness." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a physical device like an IPL system, a 510(k) typically relies on performance data from the predicate device(s) and engineering/safety testing, rather than a clinical "test set" in the way an AI/ML device would. There's no mention of a specific clinical study with a defined test set here.
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 provided and is not applicable to this type of device and submission. "Ground truth" establishment by experts in the context of diagnostic interpretation or image analysis is not relevant for an IPL system validation as described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to this type of device and submission.
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 provided and is not applicable. MRMC studies are used for evaluating AI-assisted diagnostic devices, not for therapeutic IPL systems. There is no AI component described in the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable, as this device is an IPL system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated in the context of the device's performance, as the submission focuses on substantial equivalence rather than a clinical trial with ground truth. The "ground truth" for an IPL system's effectiveness might implicitly come from established dermatological outcomes for conditions treated by similar IPL technologies, but this document does not detail specific "ground truth" for this device's validation.
8. The sample size for the training set
This information is not provided and is not applicable, as there is no AI/ML algorithm described that would require a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no AI/ML algorithm described that would require a training set with established ground truth.
Summary of the Document's Approach:
The provided 510(k) summary for the Ahwon RPL/R2PL system is a regulatory filing for a physical medical device (Intense Pulsed Light system) by demonstrating substantial equivalence to already cleared predicate devices. It focuses on:
- Device Description: What the device is and how it works.
- Intended Use/Indications for Use: The medical conditions it's designed to treat.
- Predicate Devices: Identifying similar, legally marketed devices.
- Claim of Substantial Equivalence: Asserting that the new device is as safe and effective as the predicate devices without raising new safety or effectiveness concerns, based on similarities in design, function, technology, and intended use.
- Compliance with Standards: Listing relevant electrical safety and electromagnetic compatibility standards.
It does not detail specific clinical studies with test sets, training sets, ground truth establishment, or expert reviews in the way an AI/ML-driven software device would. The "acceptance criteria" for this submission are met by demonstrating that the device falls within the established performance and safety profiles of its predicates and complies with relevant engineering standards.
§ 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.