Search Results

LightStim for Acne / LightStim for Acne Mini, model: LS4A/LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm and 630nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "LightStim for Acne/ LightStim for Acne Mini" device. However, it does not provide the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria in the way requested (e.g., acceptance criteria for an AI/ML device, details about ground truth establishment by experts, MRMC studies, training set details).

This document is a regulatory submission for a light therapy device, not an AI/ML diagnostic or prognostic tool. Therefore, the "study" mentioned is a usability study, not a performance study comparing the device's output against a medical ground truth established by experts.

Based on the provided text, here's what can be extracted and what cannot:

What can be extracted:

Device Name: LightStim for Acne / LightStim for Acne Mini
Intended Use: Treatment of mild to moderate acne (Over-The-Counter use).
Type of "Study" mentioned: A usability study.
Sample size for the "study": 40 participants.
Purpose of the "study": To show that participants adequately decided whether or not to use the device for their level of acne, and comprehended risks, warnings, cautions, precautions, and proper use from the Instruction Manual.

What CANNOT be extracted (because the document does not contain this information, as it's not a study proving device performance against medical acceptance criteria in the AI/ML context):

A table of acceptance criteria and the reported device performance: The document mentions a usability study, not a performance study with quantitative clinical outcomes like sensitivity, specificity, accuracy, etc., for a diagnostic or AI/ML device. The "performance" described is user comprehension and appropriate self-selection for device use, not clinical efficacy or diagnostic accuracy.
Sample size used for the test set and the data provenance: A "test set" in the context of AI/ML performance is not described. The 40 participants were for a usability study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment by experts is not applicable to a usability study for a light therapy device.
Adjudication method for the test set: Not applicable.
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, as this is not an AI/ML diagnostic or assistance device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in the sense of a medical diagnosis or outcome is not mentioned for the usability study. The "ground truth" was whether users understood the instructions and self-assessed their acne appropriately.
The sample size for the training set: Not applicable, as this is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) clearance letter and summary for a light therapy device. It discusses a usability study to demonstrate that users can safely operate the device and understand its appropriate use based on the instructions. It does not contain information about acceptance criteria or performance studies relevant to AI/ML devices or diagnostic accuracy, which would typically involve expert-adjudicated ground truth, sensitivity/specificity metrics, or MRMC studies.

Ask a Question

Ask a specific question about this device

K Number

K131461

Device Name

LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI

Manufacturer

LED INTELLECTUAL PROPERTIES, LLC

Date Cleared

2014-01-06

(231 days)

Product Code

OLP

Regulation Number

878.4810

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K093963,K080591

Intended Use

LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.

Device Description

LightStim for Acne Mini, model: LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the LightStim for Acne Mini device, based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the LightStim for Acne Mini are primarily based on demonstrating substantial equivalence to existing predicate devices. This means the device needs to show similar performance characteristics, indications for use, and safety attributes as the predicates. The document doesn't explicitly state quantitative performance targets for effectiveness (e.g., "reduce acne by X%"), but rather focuses on aligning with the established parameters of comparable devices already on the market.

Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (based on predicate devices)	Reported LightStim for Acne Mini Performance
Intended Use	Mild to moderate acne. (Matches all predicates: Tanda Skincare, Quasar Blue Light Therapy System, Silk'n Blue)	Mild to moderate acne. (Stated in the Indications for Use / Intended Use section and the comparison table. This is a direct match, indicating criterion met.)
Indications for Use	Treatment of mild to moderate acne. (Explicit from predicates)	Treatment of mild to moderate acne. (Explicit in the Indications for Use / Intended Use section and comparison table. This is a direct match, indicating criterion met.)
Target Population	Women and men with mild to moderate acne. (Matches all predicates)	Women and men with mild to moderate acne. (Stated in the comparison table. This is a direct match, indicating criterion met.)
Output in mW	50mW/cm² (Matches all predicates)	50mW/cm². (Stated in the comparison table. This is a direct match, indicating criterion met.)
Treatment Time	3 to 4 minutes per area (Matches Quasar and Silk'n Blue predicates, Tanda is 3 minutes twice daily)	3 to 4 minutes per area. (Stated in the comparison table and Device Description. This aligns with two of the three predicates, with Tanda being slightly different but within a similar range for single treatment duration. This is considered met for substantial equivalence.)
Treatment Area (cm²)	In line with similar hand-held devices (Predicates range from 7 to 27 cm²)	15.5 cm². (Stated in the comparison table. This falls within the range of the predicate devices. This is considered met for substantial equivalence.)
Wavelengths (nm)	415 nm (Matches all predicates)	415 nm. (Stated in the comparison table and Device Description. This is a direct match, indicating criterion met.)
Where Used	Home use (Matches all predicates)	Home. (Stated in the comparison table. This is a direct match, indicating criterion met.)
Design	Hand-held device (Matches all predicates)	Hand-held device. (Stated in the comparison table. This is a direct match, indicating criterion met.)
Materials	Rigid ABS or similar (Predicates use Rigid ABS or Stainless Steel)	Rigid ABS. (Stated in the comparison table. This matches two of the three predicate devices, indicating criterion met.)
Electromagnetic Compatibility	IEC 60601-1-2 compliant (Matches all predicates)	IEC 60601-1-2. (Stated in the comparison table. This is a direct match, indicating criterion met.)
Basic Safety and Essential Performance	IEC 60601-1 compliant (Matches all predicates)	IEC 60601-1. (Stated in the comparison table. This is a direct match, indicating criterion met.)
Radiation Safety	Addressed by recognized standards (Predicates "Unknown," but the subject device identifies its standard, suggesting adherence to modern safety practices)	IEC 62471/IEC 62471-2. (Stated in the comparison table. While predicates are "Unknown," the subject device explicitly states compliance with a relevant standard, suggesting it meets safety expectations in this regard, and likely exceeds the "unknown" status of predicates by providing a specific standard.) This is considered met for substantial equivalence.
Usability/User Comprehension	Users adequately decide whether to use the device and comprehend risks, warnings, cautions, precautions, and proper use.	"results showed that the participants adequately decided whether or not to use the device for their level of acne, and showed that users comprehended risks, warnings, cautions, precautions, and proper use of the device, from the Instruction Manual." (Stated in the Performance Data section. This directly confirms meeting the criterion for usability.)

Study Details for LightStim for Acne Mini:

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 40 participants.
- Data Provenance: The document does not explicitly state the country of origin. It appears to be a prospective study, as participants used the device and their comprehension and decision-making were evaluated as part of the study.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The study described is a usability study, not a clinical efficacy study requiring expert assessment of medical outcomes. Therefore, there is no mention of experts establishing a "ground truth" for acne severity or improvement. The "ground truth" for this study was user comprehension and appropriate device selection, which was assessed through observation and potentially questionnaires.
Adjudication Method for the Test Set:
- Not applicable. The study was a usability study focused on user comprehension, not on medical diagnoses or outcomes requiring adjudication by multiple experts.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This study focuses on usability and safety, not on comparing diagnostic accuracy or clinical effectiveness with or without AI assistance. The device is not an AI-powered diagnostic tool.
Standalone Performance Study:
- Yes, a standalone usability study was conducted. The described "Performance Data" section details a study where 40 participants used the device and were assessed on their "adequacy" in deciding to use the device and their "comprehension" of the instruction manual. This evaluates the device's human-interaction performance without comparison to other devices in terms of usability effectiveness.
Type of Ground Truth Used:
- For the usability study, the "ground truth" was user comprehension and appropriate decision-making regarding device use, as evaluated through the study protocol. This is observational/feedback-based, not medical pathology or outcomes data.
Sample Size for the Training Set:
- Not applicable. This device is a light therapy device, not an algorithm or AI model that requires a training set.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.

Ask a Question

Ask a specific question about this device

Page 1 of 1