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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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The Intense Pulsed Light System is intended for medical use in 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 document is a 510(k) premarket notification for an Intense Pulsed Light System. It details the device's indications for use, technological characteristics, and comparison to a predicate device. However, the document does not contain information on acceptance criteria for a study demonstrating device performance against specific metrics, nor does it describe a study involving human subjects or AI performance.

The "Performance Data" section of the document primarily addresses:

• Electrical safety and electromagnetic compatibility: Compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 62471, and IEC 60601-2-57.
• Software Verification and Validation Testing: Stating that V&V testing was conducted, and the software was considered "moderate" level of concern.
• Sterilization and Shelf-Life: Asserting the device is not sterile, is reusable, and has no restricted shelf-life.
• Biocompatibility: Reporting results of cytotoxicity, sensitization, and irritation tests on the handpiece sapphire tip, concluding compliance with ISO 10993-1.
• Bench testing: Verifying that the spatial variation of the light source equipment output over the treatment area does not deviate by more than ±20%, and fulfilling IEC 60601-2-57 requirements.

Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance (in the context of clinical or AI performance), sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone AI performance, type of ground truth, training set sample size, or how training ground truth was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and compliance with safety and bench testing standards, rather than proving efficacy or performance through clinical endpoint studies or AI-driven assessments.

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The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Shaser Skin Beauty Intense Pulsed Light System Family For Acne is an Over-The-Counter, Light-Based Acne Clearing Device. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger/AC cord. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. The Principle of Operation is both photochemical and photothermal. The Mechanism of Action is to stimulate oxygen production which attacks p.acne and to reduce inflammation due to acne.

The Shaser Skin Beauty Intense Pulsed Light System Family for Acne (K150282) is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., a specific reduction percentage in acne). Instead, the clinical performance data focuses on label comprehension and usability to ensure safe and appropriate use of the device by consumers in a home setting.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 84 study subjects were tested for label comprehension and usability.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "simulated home-use environment," implying a prospective study design for the usability and comprehension aspects.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not describe the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or disease diagnosis. The assessments were focused on consumer understanding and ability to use the device, rather than expert diagnostic accuracy. Therefore, information on the number and qualifications of experts for ground truth is not applicable in this context.

4. Adjudication Method (Test Set)

No adjudication method is described, as the studies conducted focused on label comprehension and usability by the subjects themselves, rather than expert assessment of an outcome requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The study focused on consumer (user) performance in understanding and operating the device, not on diagnostic accuracy or comparison of human readers with and without AI assistance for acne diagnosis.

6. Standalone Performance (Algorithm Only)

The device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to its physical operation and user interaction.

7. Type of Ground Truth Used (Test Set)

For the clinical performance data presented (label comprehension and usability), the "ground truth" was established by observing and evaluating the subjects' ability to understand the instructions and use the device correctly and safely. This is an assessment of human behavior and understanding in relation to the device, rather than a medical ground truth (e.g., pathology, clinical outcomes, expert consensus on disease state).

8. Sample Size for Training Set

The document describes a medical device study for 510(k) clearance, which typically involves demonstrating substantial equivalence to a predicate device and verifying safety and effectiveness through non-clinical and clinical performance testing. This is not a machine learning or AI algorithm submission that would have a distinct "training set." Therefore, information on the sample size for a training set is not applicable.

9. How Ground Truth for Training Set was Established

As there is no "training set" in the context of an AI algorithm, this question is not applicable.

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The Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to provide phototherapeutic light to the body. It is specifically intended for:
The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosecea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.

Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family devices are prescription home use, light-based skin care systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Action is to lighten or resolve lesions using light for preferentially heating. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

The provided text describes the Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family, a prescription home-use device for treating benign pigmented and vascular lesions. The document focuses on regulatory approval (510(k)) and demonstrates substantial equivalence to predicate devices.

However, the document does not contain the detailed information needed to construct a table of "acceptance criteria and reported device performance" as typically understood in a medical device study (e.g., sensitivity, specificity, accuracy, or specific clinical outcomes for lesion treatment). The acceptance criteria described are primarily related to label comprehension and safe usability in a simulated home-use environment, rather than the clinical efficacy of treating lesions.

Therefore, many of the requested fields cannot be filled directly from this document.

Here's an attempt to answer based on the available information:

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

2. Sample size used for the test set and the data provenance

• Label Comprehension Test Set Sample Size: 150 subjects
• Usability Test Set Sample Size: 123 subjects
• Data Provenance: The study was a "label comprehension and usability test of consumers" and was conducted in a "simulated home-use environment." The country of origin is not specified, but the submission is to the U.S. FDA. It would be considered a prospective study for regulatory purposes. The text explicitly mentions "Both test populations included low literacy subjects."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The ground truth for label comprehension and usability would typically be established by defining correct understanding and safe operation, likely assessed by trained observers or evaluators, but no details on their number or qualifications are given.

4. Adjudication method for the test set

This information is not provided in the document. For label comprehension and usability tests, an adjudication method (like 2+1 or 3+1) is not typically used as it would for clinical diagnostic endpoints. Assessments are usually made based on objective criteria or observer ratings.

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, an MRMC comparative effectiveness study was NOT done. This device is an Intense Pulsed Light System for direct treatment, not an AI-assisted diagnostic tool for "human readers." The document describes a usability and label comprehension study for a direct treatment device, not a diagnostic aid.

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

• This question is not applicable as the device described is a direct treatment device (Intense Pulsed Light System), not an algorithm or AI system. Its performance inherently involves human interaction for operation as a home-use device. The "standalone" performance here refers to its physical operation and energy output, which was subject to "Bench testing for performance verification."

7. The type of ground truth used

• For the label comprehension test: "Ground truth" was established by pre-defined correct answers/interpretations of the Instructions For Use (IFU) and safety warnings.
• For the usability test: "Ground truth" was established by pre-defined safe and appropriate operational steps and procedures for using the device.

8. The sample size for the training set

• This information is not provided. The document describes a usability and label comprehension study, which are typically evaluation studies, not "training set" development for machine learning models. The device's underlying technology (Intense Pulsed Light) relies on established principles of photothermolysis, not a machine learning model that requires a training set.

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

• This information is not applicable as there is no "training set" in the context of this device and study. The device's operation is based on physical principles, not a machine learning model.

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The Shaser Skin Beauty Intense Pulsed Light System Family is an over-the-counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser Skin Beauty Intense Pulsed Light System Family is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Shaser Hair Skin Beauty Intense Pulsed Light System Family devices are Over-The-Counter, Light-Based Hair Removal Systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

This 510(k) summary describes a new version of an Intense Pulsed Light (IPL) system for hair removal, claiming substantial equivalence to previously cleared devices. It relies on the predicate devices' performance and does not present new acceptance criteria or device performance data for hair reduction efficacy. Instead, the study focuses on user comprehension and usability for safe operation.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria for hair reduction or phototherapeutic effect are provided in this submission for the new device. The submission references the predicate devices (Shaser V-MINI 2 and Shaser Lumena FH) as having "identical performance specifications" and "the same basic design and performance characteristics related to device safety and effectiveness."

The only "performance data" presented for the new device relates to user-friendliness:

2. Sample Size Used for the Test Set and Data Provenance

• Label Comprehension: 150 study subjects.
• Usability Test: 123 study subjects.
• Data Provenance: Not explicitly stated, but the context of an OTC home-use device and consumer testing suggests the data is likely prospective and collected within the United States. The inclusion of "low literacy subjects" is noted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of "experts" establishing ground truth in the traditional sense (e.g., medical experts diagnosing conditions). For a label comprehension and usability study, the "ground truth" is typically established by:

• The instructions for use (IFU): This document defines the correct understanding and safe usage of the device.
• Study facilitators/observers: These individuals (whose qualifications are not specified) would assess whether subjects understood the label correctly and used the device safely according to predetermined criteria derived from the IFU.

4. Adjudication Method for the Test Set

Not applicable. This was not a study requiring adjudication of medical outcomes or interpretations. The assessment was based on direct observation of user interaction and responses to questions about the instructions.

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 IPL hair removal system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical consumer-use device, not an algorithm. The "standalone performance" of the device itself (hair removal efficacy) is presumably based on the predicate devices, but no new standalone efficacy study was presented for this specific submission. The study described focuses on the human user's interaction with the device.

7. The Type of Ground Truth Used

• For label comprehension: The correct interpretation of the instructions for use (IFU) provided with the device.
• For usability: Safe and appropriate operation of the device according to the IFU, as observed by trained study personnel.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device that requires a training set. The clinical performance data described for this submission relates to human user comprehension and usability testing, not to training an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an algorithm.

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Treatment of mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

The Isolaz® 2 System delivers non-coherent 400-1200 nm and 550-1200 nm intense pulsed light via a delivery handpiece utilizing photopneumatic technology. The system consists of a main console and a treatment handpiece. The desired power and delivery time are set by the operator. The modifications made to the device were to reduce and simplify device settings.

The provided text describes a 510(k) summary for the Isolaz® 2 Intense Pulsed Light System, which is a medical device intended for the treatment of mild to moderate acne. However, the text does not contain specific acceptance criteria or a detailed study plan with performance data in the way you've outlined in your request.

Medical device 510(k) submissions typically focus on demonstrating "substantial equivalence" to a predicate device. This often means showing that the new device has similar technological characteristics and is as safe and effective as a legally marketed device, rather than presenting a novel study against predefined quantitative performance criteria.

Therefore, many of the requested data points (e.g., specific acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) are not available in the provided document.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantitative metrics. The overall acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device in terms of safety and effectiveness.
• Reported Device Performance: The document states:
  • "Verification and validation data show that the device meets all product specifications."
  • "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."
  • No specific clinical outcome percentages (e.g., X% reduction in acne lesions) are provided in this summary.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies mentioned ("Laboratory and performance tests") were likely internal engineering and safety tests rather than patient-based clinical trials for performance efficacy in the way a pharmaceutical trial might be.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. The summary focuses on engineering and safety compliance rather than clinical validation against expert judgment of acne condition.

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

• Not applicable/Not specified.

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 mentioned. This device is not an AI diagnostic tool that requires human interpretation.

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

• Not applicable. This is a light-based therapy device, not a diagnostic algorithm. Performance would relate to its physical output and biological effect, not an algorithmic output requiring standalone evaluation.

7. The type of ground truth used:

• Not applicable in the conventional sense of diagnostic device ground truth. The "ground truth" for this device would be its ability to consistently produce the specified light parameters and its safety in use, rather than a clinical outcome measured against an external standard like pathology. The summary mentions compliance with safety standards (IEC 60601-1, 60601-1-4, 60601-1-2) and biocompatibility (ISO 10993-1).

8. The sample size for the training set:

• Not applicable. This device does not use machine learning algorithms that require a "training set."

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

• Not applicable.

Summary of Device Rationale from the Document:

The Isolaz® 2 Intense Pulsed Light System is seeking 510(k) clearance by demonstrating substantial equivalence to its predicate device, the Isolaz® Intense Pulsed Light System (K083730).

Key claims for substantial equivalence:

• Similar Design and Technology: Delivers non-coherent 400-1200 nm and 550-1200 nm intense pulsed light via photopneumatic technology, similar to the predicate.
• Similar Intended Use: Treatment of mild to moderate acne (pustular, comedonal, inflammatory) in all skin types (Fitzpatrick I-VI), identical to the predicate.
• Similar Technological Characteristics: Similar in design specification, output energy, and delivery system.
• Minor Modifications: Modifications to the system console and handpiece hardware and circuitry do "not significantly affect the safety or effectiveness of the device."
• Compliance with Standards: Evaluated and found compliant with IEC 60601-1 and 60601-1-4 for electrical safety, IEC 60601-1-2 for EMI/EMC, and ISO 10993-1 for biocompatibility of treatment tips.
• Performance Data (General Statement): "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."

In essence, the "acceptance criteria" here are that the new Isolaz 2 system has not introduced new safety or effectiveness concerns compared to its predicate and that its modifications are minor, as demonstrated by engineering and safety testing, which allows it to leverage the predicate's established safety and efficacy profile.

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The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne , treatment of benign pigmented lesions, hair removal, treatment of vascular lesions as following:

1. Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
2. Intense Pulsed Light energy wavelengths from 400nm-1200nm are indicated for the treatment of acne.
3. Intense Pulsed Light energy wavelengths from 750nm-1200nm are indicated for the treatment of benign pigmented lesions, hair removal, and treatment of vascular lesions.

The GSD Intense Pulsed Light System (GP666C4 and GP666C) is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 400nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

This appears to be a 510(k) summary for the GSD Intense Pulsed Light System, which is a device for various dermatological treatments. The document states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria, study design, or performance metrics that would allow me to fill out the requested table and answer the detailed questions about a study proving the device meets acceptance criteria.

The 510(k) summary primarily focuses on:

• Device Description: What the device is and how it generally works (selective photothermolysis).
• Standards Compliance: Listing IEC 60601-1 and IEC 60601-1-2 as standards the device is designed, tested, and manufactured in accordance with. These are general safety and EMC standards, not performance criteria for clinical effectiveness.
• Substantial Equivalence Determination: Stating that the device is substantially equivalent to predicate devices.
• Intended Use/Indications for Use: Listing the medical conditions the device is intended to treat and the associated wavelength ranges.

Therefore, I cannot provide the requested information because the input text does not contain a study report or data on device performance against specific acceptance criteria.

To answer your questions, I would need a section detailing:

• Specific clinical performance endpoints (e.g., clearance rate for acne, hair reduction percentage, lesion fading percentage).
• Quantitative acceptance criteria for these endpoints (e.g., "90% hair reduction after X treatments").
• Results from a clinical study demonstrating achievement of these criteria.
• Details about the study design, sample size, data provenance, ground truth establishment, etc.

Since this information is absent, I must state that a direct response with the requested table and study details is not possible based on the provided text.

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The Angelite Family of Intense Pulsed Light Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow:

1. Intense Pulse Light Energy Wavelengths from 400 950 nm are indicated for the treatment of inflammatory acne.
2. Intense Pulse Light Energy Wavelengths from 560 1200 nm are indicated for the treatment of benign pigmented (epidermal and coetaneous) lesions including warts, scars and striae. For the treatment of benign (cutaneous) vascular lesions includes port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melagenna, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations.
3. Intense Pulse Light Energy Wavelengths from 700 1200 nm are indicated for the treatment of unwanted hair (i.e., hair removal).

Angelite Family of Intense Pulsed Light Systems

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Angelite Family of Intense Pulsed Light Systems," indicating its substantial equivalence to a legally marketed predicate device.

The document includes:

• The device name and regulatory information.
• Indications for Use.
• Basic FDA contact and regulatory compliance information.

It does not contain:

• Specific acceptance criteria for the device's performance.
• Details of any study (like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results) that would demonstrate the device meets acceptance criteria.

The information provided confirms that the device is cleared for market based on substantial equivalence, but it does not elaborate on the specific performance metrics or studies used to establish that equivalence beyond listing the indications for use.

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The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.

530 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles) * Benign cutaneous lesions including warts, scars, and striae

560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae

585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae

640 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-IV for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction

690 - 1400 nm wavelength is indicated for Fitzpatrick skin types IV and V for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction

The NannoLight Intense Pulsed Light System is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD) which displays the settings of power, pulse width, and pulse count which are manually adjusted by a touch screen display panel, a handpiece which contains the light source connected to the console by a power cord, and an on/off footswitch. The NannoLight Intense Pulsed Light System is not battery operated, but is controlled and operated with the aid of computer software.

The NannoLight Intense Pulsed Light System (K082033) 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

Instead of presenting performance data, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices (Sciton Profile BBL System (K032460) and Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems (K020839)) for its clearance. This means that the device's safety and effectiveness are supported by its similarity in design, intended use, and operational principles to already approved devices, rather than a novel study demonstrating its specific performance against defined metrics.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment, as this information is not present in the provided text.

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The MED flash II Intense Pulsed Light System is indicated for use in:

• Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction
• Treatment of inflammatory acne (acne vulgaris)
• Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait
• Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins
• The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.

The MED flash II Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. The system is based on a quick power discharge of capacitors in a Xenon lamp, mounted on a handpiece. This generates a rapid and Intense Pulsed Light.
The Med flash II system contains five principal components:

• Charge system of the capacitors .
• Electronic control system .
• Control panel .
• Handpiece with exchangeable lamp box ●
• Handpiece cooling system .

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the MED flash II Intense Pulsed Light System:

1. Table of Acceptance Criteria and Reported Device Performance

• Treatment of inflammatory acne (acne vulgaris)
• Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait
• Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins
• Integrated cooling handpiece intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications. | The device is deemed acceptable for these indications based on its substantial equivalence to predicate devices that have similar indications and technological characteristics. |
  | Technical Specifications (Implicit Acceptance for Equivalence) | - Emitting light radiation in the range from 590 nm to 1200 nm.
• Based on quick power discharge of capacitors in a Xenon lamp.
• Handpiece with exchangeable lamp box.
• Handpiece cooling system. | These technical specifications are presented in the device description, implying that they align with or are sufficiently similar to the predicate devices to support substantial equivalence. |

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states "None presented" under the "Performance Data" section. This indicates that no specific test set data, sample size, or information on data provenance (country of origin, retrospective/prospective) was provided or required for this 510(k) submission. The approval was based on demonstrating substantial equivalence to predicate devices, not on new clinical performance data from a specific test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. Since no specific performance data or test set was presented, there was no ground truth to be established by experts in the context of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. As no test set data was presented, no adjudication method was mentioned or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "None presented" for performance data. There is no mention of an MRMC study, or any comparative effectiveness study with or without AI assistance. This type of study would typically be part of a robust performance data section, which is absent here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/No. This device is an Intense Pulsed Light System, a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance without human interaction is not relevant to its type. The 510(k) summary does not mention any software or AI components that would require such a study.

7. The Type of Ground Truth Used

No specific ground truth type was used or reported in the context of a new performance study. The basis for clearance is substantial equivalence to predicate devices. This implies that the safety and effectiveness of the device are inferred from the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. As the approval is based on substantial equivalence to existing predicate devices and no new performance study data was presented, there are no references to a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. Since no training set was mentioned in this 510(k) summary, there is no information on how a ground truth for a training set would have been established.

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