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The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions:

1. Moderate inflammatory acne vulgaris;
2. Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
3. Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations;
4. Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.

Intense Pulsed light (IPL) System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. There are six optical filters that can be using in this system listed in table. With these special properties, the IPL System has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption.

The provided FDA 510(k) summary (K240482) for the Smedtrum Medical Technology Co., Ltd. Intense Pulsed Light System (ST-690) indicates that the device's acceptance criteria are based on bench testing for optical energy output and electrical safety, and its performance is demonstrated by compliance with relevant IEC standards.

Here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

• IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2020 (Electromagnetic disturbances)
• IEC 62471 First edition 2006-07 (Photobiological safety)
• IEC 60601-2-57 Edition 1.0 2011-01 (Particular requirements for non-laser light source equipment) |
  | Bench Testing (Optical Energy Output): Spatial variation of the LS equipment output over the treatment area shall not deviate from the average irradiance or radiant exposure by more than ±20%. | The product fulfills the requirements of IEC 60601-2-57 (which includes parameters for optical energy output and spatial variation). Specifically, the document states "The Intense Pulsed Light system... has been determined through engineering testing to verify optical energy output... The product fulfills the requirements of IEC 60601-2-57." |
  | Intended Use and Indications for Use: Equivalence to the predicate device. | The device has the same intended use and indications for use as the predicate device (K231394). |
  | Technological Characteristics and Operating Principles: Equivalence to the predicate device. | The device has the same technological characteristics, energy used, and operating principles as the predicate device (K231394), with minor differences in form factor (tabletop vs. standing, single handpiece vs. potentially more on predicate). |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a patient-based test set sample size or data provenance (country, retrospective/prospective). The performance data cited is based on engineering and bench testing to verify hardware and software functionality and safety, not clinical trial data with human subjects.

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 to this submission. The ground truth relies on engineering and safety standards compliance, not expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. There was no clinical test set requiring human 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

This is not applicable. The device is an Intense Pulsed Light System, a physical medical device for treatment, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical therapeutic system, not an algorithm. Performance assessment is based on physical and electrical output specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for this submission is compliance with established international engineering and electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 62471, IEC 60601-2-57) and verification of optical energy output specifications.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an algorithm or AI model for this type of medical device submission. The device is evaluated based on its physical and electrical performance against predefined engineering standards.

9. How the ground truth for the training set was established

This is not applicable as there is no training set. The "ground truth" for the device's performance relies on engineering measurements and adherence to specified performance ranges outlined in the electrical and optical standards.

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