Search Results

The Q-MASTER Q-Switched Nd:YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology.

1064nm wavelength in Q-switched mode:

• Removal of dark ink (black, blue and brown) tattoos
• Treatment of nevus of Ota
• Treatment of common nevus
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064nm wavelength in non Q-switched mode:

• Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9 and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin
• Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not linited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece):

• Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
• Treatment of benign vascular lesions including, but not limited to:
• port wine birthmarks
• telangiectasias
• spider angioma
• cherry angioma
• spider nevus
• Treatment of benign pigmented lesions including, but not limited to:
• café-au-lait birthmarks
• solar lentigines
• senile lentigines
• Becker's nevus
• freckles
• common nevus
• nevus spilus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles

Not Found

This document is a 510(k) clearance letter for the Q-MASTER Q-Switched Nd:YAG Laser System. It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting specific performance metrics against pre-defined acceptance criteria in the format requested. The document lists the indications for use for the device, but it does not include a clinical study design, results, or acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study proving device performance based on the provided text.

Ask a specific question about this device

The Q10 Q-Switched Nd: YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology.

1064nm wavelength in Q-switched mode:

• Removal of dark ink (black, blue and brown) tattoos
• Treatment of nevus of Ota
• Treatment of common nevus
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064nm wavelength in non Q-switched mode:

• Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9, and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin
• Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece):

• Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
• Treatment of vascular lesions including, but not limited to:
• port wine birthmarks
• telangiectasias
• spider angioma
• cherry angioma
• spider nevus
• Treatment of pigmented lesions including, but not limited to:
• café-au-lait birthmarks
• solar lentigines
• senile lentigines
• Becker's nevus
• freckles
• common nevus
• nevus spilus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles

Not Found

This is a 510(k) premarket notification for a laser surgical instrument, and as such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for a novel AI or diagnostic device. Therefore, a direct response to your detailed questions regarding acceptance criteria and study design (as might be found for a new diagnostic algorithm) is not present in the provided document.

However, I can extract the relevant information from the document and explain why other requested details are not applicable here.

Here's a breakdown based on the provided text:

Pertaining to the Device:

• Trade/Device Name: Q-Switched Nd:YAG Laser System / IDS Model Q10 Q-Switched Nd: YAG Laser
• Regulation Number: 21 CFR 878.4810
• Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
• Regulatory Class: Class II
• Product Code: GEX

Analysis of your specific questions:

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

   • Not Applicable. This document is a 510(k) summary, which establishes substantial equivalence, not novel performance against specific acceptance criteria for a new diagnostic device. The device is a physical laser system, not an AI or diagnostic tool that would have performance metrics like sensitivity, specificity, or AUC against a ground truth. Its performance is inherent in its physical specifications and intended use, which are deemed equivalent to a predicate. The "Indications for Use" section outlines what the device is cleared to do, not its diagnostic performance.

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

   • Not Applicable. As this is a 510(k) for a physical laser device, it doesn't typically involve a "test set" in the context of evaluating an AI or diagnostic algorithm. Clinical data to support the indications may have been generated, but the specific details of a test set, its size, and provenance are not outlined in this 510(k) clearance letter. The FDA's review for substantial equivalence generally focuses on technological characteristics, safety, and effectiveness compared to a predicate, which might include relying on established literature or predicate device's safety record rather than a new clinical study with a "test set" for performance evaluation.

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):

   • Not Applicable. There is no "ground truth" establishment in the context of evaluating a diagnostic algorithm mentioned. The effectiveness of the laser for its stated indications (e.g., "removal of dark ink tattoos," "treatment of wrinkles") is generally supported by the predicate device's history and the understanding of laser-tissue interaction for these applications.

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

   • Not Applicable. No test set requiring expert adjudication is discussed in this document.

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 is a physical laser device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant here.

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

   • Not Applicable. This device is not an algorithm.

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

   • Not Applicable. As explained, the concept of "ground truth" as applied to evaluating a diagnostic algorithm doesn't apply to this type of device and submission. Efficacy is generally demonstrated by clinical observations and comparisons to predicate devices over time, rather than a single "ground truth" metric.

8. The sample size for the training set:

   • Not Applicable. Training sets are relevant for machine learning algorithms, which this device is not.

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

   • Not Applicable. This device does not have a training set or associated ground truth.

In summary, the provided document is a 510(k) clearance letter for a Q-Switched Nd:YAG Laser System, indicating that the FDA has determined it is substantially equivalent to legally marketed predicate devices. The nature of this submission (a physical device, not a diagnostic or AI product) means that the requested details regarding acceptance criteria, test/training sets, ground truth, and expert evaluations in the context of diagnostic performance are not applicable or provided within this type of regulatory document.

Ask a specific question about this device

Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications:

1064 nm wavelength

• . Tattoo Removal (dark ink: blue and black)
• Dermal Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines, Nevi, . Melasma and Cafe-au-lait
• Removal or lightening of hair with or without adjuvant preparation. .
• . Skin Resurfacing for Acne Scars and Wrinkles
• Benign cutaneous lesions; including, but not limited to: striae and scars (excludes the 650nm . wavelength)
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)

532 nm Wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dyc Laser Handpiece)

• Tattoo removal (light ink: red, sky blue, green) .
• Vascular Iesions including but not limited to: port wine birthmarks, telangiectasias, spider . angioma, cherry angioma, spider nevi
• Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar . lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis
• Skin Resurfacing for Acne Scars and Wrinkles .
• Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes the 650nm . wavelength)
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)

The RevLite Q-Switched Nd: YAG Laser System consist of an electrically powered Console, in which laser energy produced within the system is delivered to the tissues by means of an articulated arm, Handpiece Adaptor and specially designed handpieces. The user ectivates laser emission by means of a footswitch.

The provided text is a 510(k) Summary for a medical laser system and does not contain information about a study comparing the device to acceptance criteria in the manner typically seen for AI/ML-based medical devices (e.g., performance metrics, expert reviews, ground truth establishment). Instead, this document focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested points regarding acceptance criteria, study design, and performance metrics (especially those related to AI/ML product evaluation) cannot be extracted from this specific document.

Here's what can be extracted based on the provided text, and where gaps exist:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The "acceptance criteria" in this context are not quantitative performance thresholds in the way one might expect for an AI/ML diagnostic. Instead, they are met by demonstrating that the proposed device has the same intended use, technological characteristics, and performance characteristics as legally marketed predicate devices, thereby establishing it is "as safe, as effective, and performs as well as the predicate devices."

The study that proves the device meets "acceptance criteria" is essentially the substantial equivalence comparison presented in the document itself, rather than a separate clinical trial or technical performance study with a defined test set.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a test set, sample size, or data provenance because it's a 510(k) submission based on substantial equivalence to predicate devices, not on a new clinical performance study with a test cohort. The "study" here is primarily a comparison of specifications and intended uses with existing approved devices.

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

Not applicable. No new test set or ground truth establishment relevant to an AI/ML context is mentioned.

4. Adjudication method for the test set

Not applicable. No test set or adjudication process is described.

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 is a laser system, not an AI-assisted diagnostic tool.

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

Not applicable. This is a laser system, not an AI-based algorithm.

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

Not applicable. The "ground truth" for this submission is established through the regulatory clearance of predicate devices, validating their safety and effectiveness for their stated intended uses and technological characteristics.

8. The sample size for the training set

Not applicable. This document does not describe an AI/ML device with a training set.

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

Not applicable. This document does not describe an AI/ML device with a training set.

Ask a specific question about this device

The Q-Switched Nd: YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Caf6-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles

The Q-Switched Nd: YAG Laser System is a new device for 510(k) submission and shares the same indications for use and safety compliance, similar design features and functional features with the predicate device.

The Q-Switched Nd:YAG Laser System (GlobalCure-SC6) delivers laser at two wavelengths of 1064nm and 532nm. The double wavelengths cause maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target. to minimize heat transfer to surrounding tissues.

The Q-Switched Nd:YAG Laser System covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Q-Switched Nd:YAG Laser System:

Based on the provided 510(k) summary, the device is a Q-Switched Nd:YAG Laser System. The submission is for a medical device and therefore the acceptance criteria are not clinical performance metrics but rather compliance with design specifications and regulatory standards.

Acceptance Criteria and Reported Device Performance

• IEC 60601-2-22:1995 (Medical Electrical Equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)
• IEC 60601-1:1988+A1:1991+A2:1995 (Medical Electrical Equipment - Part 1: General requirements for safety) | "Laboratory testing was conducted to validate and verify that the proposed device Q-Switched Nd: YAG Laser System (GlobalCure-SC6) met all design specifications and was substantially equivalent to the predicate device."
  The submission asserts that the device is designed, tested and will be manufactured in accordance with these standards, implying it meets them. |
  | Electromagnetic Compatibility (EMC) | - IEC60601-1-2:2001+A1:2004 (Medical Electrical Equipment - Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility -Requirements and tests) | "The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification." |
  | Regulatory Compliance | - European Medical Device Directive 93/42/EEC
• US Federal Performance Standards 21 CFR 1002.10 (including 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products)
• 21 CFR Part 820 (Quality System Regulation)
• ISO9001 and ISO13485 System Certification | The document explicitly states: "The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification." |
  | Substantial Equivalence | Demonstrating substantial equivalence to the predicate device (Spectra VRMII, K073436) in terms of indications for use, safety, design, and functional features. | "The Q-Switched Nd: YAG Laser System shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device, Spectra VRMII (O-Switched Nd:YAG) (K073436)."
  "In addition, a review of the predicate device demonstrates that the O-Switched Laser System is safe and effective as the predicate device as they share equivalent wavelengths, and are used to perform the same indicated surgical procedures. Therefore the proposed device is substantially equivalent (SE) to the predicate device." |

Study Information

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

   • The provided text does not mention any clinical test set involving human subjects or data. The testing discussed is non-clinical laboratory testing to verify design specifications and compliance with standards.
   • The "data provenance" mentioned is compliance with international standards (IEC) and national regulations (US FDA, EU MDD).

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

   • This information is not applicable as there is no clinical test set described in the provided document. The "ground truth" for this submission focuses on engineering specifications and regulatory compliance.

3. Adjudication method for the test set:

   • This information is not applicable as there is no clinical test set described.

4. 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 document describes a laser system, not an AI-assisted diagnostic device, and therefore this type of study is not relevant to this submission.

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

   • No, this is not applicable. The device is a physical laser system, not an algorithm. The "standalone performance" refers to the device's ability to meet its technical specifications and regulatory requirements.

6. The type of ground truth used:

   • For this 510(k) submission, the "ground truth" is defined by established engineering design specifications, international performance and safety standards (e.g., IEC standards), and national/regional medical device regulations (e.g., 21 CFR, MDD). The device's performance against these specifications and standards constitutes the "ground truth" for its safety and effectiveness determination via substantial equivalence.

7. The sample size for the training set:

   • This information is not applicable as there is no discussion of a training set for an algorithm. The device is a physical laser system.

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

   • This information is not applicable as there is no discussion of a training set for an algorithm.

Ask a specific question about this device

Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications:
1064 nm wavelength

• Tattoo Removal (dark ink: blue and black)
• Nevus of Ota
• Removal or lightening of hair with or without adjuvant preparation.
• Skin Resurfacing for Acne Scars and Wrinkles
• Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

532 nm wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dye Laser Handpiece)

• Tattoo removal (light ink: red, sky blue, green)
• Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
• Epidermal Pigmented lesions including but not limited to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
• Skin Resurfacing for Acne Scars and Wrinkles
• Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

The entire laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece (532 nm and 1064 nm) or optional Multilite Dye Laser Handpiece (650 nm and 585 nm). The user activates laser emission by means of a footswitch.

The RevLite Systems are designed to provide laser energy for use in a variety of dermatological procedures (see indications for use). The 532 nm and 1064 nm wavelengths and optional 650 nm and 585 nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect. The laser incorporates very narrow laser pulses (5-20 ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.

This 510(k) submission for the RevLite™ Q-Switched Nd:YAG Laser System is for a new indication for use and therefore does not include a study to prove acceptance criteria. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria.

The provided document describes the device, its intended use, and compares it to predicate devices. It states under "Nonclinical Performance Data" and "Clinical Performance Data" that "None" were requested or provided at the time of this submission. The FDA's letter (K083899) confirms that the device was deemed "substantially equivalent" for the stated indications based on comparison to predicate devices, not on new performance data demonstrating specific acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I describe study details like sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided document.

Summary of unavailable information based on the provided document:

• A table of acceptance criteria and the reported device performance: Not provided. The submission states "None" for clinical performance data.
• Sample sized used for the test set and the data provenance: Not applicable, as no new clinical study data was presented.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 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. This is a laser system, not an AI diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a laser system, not an algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Incision, excision, ablation, vaporization of soft tissue for general dermatology.

Removal or lightening of unwanted hair with or without adjuvant preparation.

Tattoo Removal

• dark ink: blue and black .
• light ink. red
• light ink: sky blue
• light ink: green

Treatment of Vascular Lesions:

• port wine birthmarks
• telangiectasias .
• spider angioma
• cherry angioma .
• spider nevi

Treatment of Pigmented Lesions:

• café-au-lait birthmarks .
• solar lentiginos .
• senile lentiginos .
• becker's nevi
• freckles
• nevus spilus
• nevus of ota

The Helios II® laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows:

1. A Nd:YAG crystal is used as a gain medium which produces a laser beam.

2. A resonator then amplifies the beam.

3. A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd:YAG crystal - a gain medium - and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit.

The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.

The provided text is a 510(k) summary for the Helios II® Q-Switched Nd:YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies are not available in the provided document.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding device performance metrics. Instead, it states that the device "share very similar / exactly same performance specification parameters" as its predicate devices, implying that the performance of the predicate devices implicitly sets the "acceptance criteria."

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

• Sample size for the test set: Not provided. The document does not describe a specific "test set" in the context of performance evaluation with discrete metrics.
• Data Provenance: Not applicable, as no specific performance study with a test set is described.

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

• Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. The document states "None" under "Performance Data" except for the conclusion about substantial equivalence. This type of study would involve human readers and AI performance.

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

• Not applicable. This device is a laser system, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance data section doesn't detail any standalone performance tests for the laser beyond the claim of substantial equivalence.

7. The Type of Ground Truth Used:

• Not applicable. No ground truth is described in the context of a performance study. The approval is based on substantial equivalence to predicate devices, which implies that the predicate devices' established safety and effectiveness serve as the "ground truth" for demonstrating equivalence.

8. The Sample Size for the Training Set:

• Not applicable. This device is a laser system, not an AI algorithm or a device requiring a "training set" in the typical sense of machine learning.

9. How the Ground Truth for the Training Set was Established:

• Not applicable for the same reasons as above.

Ask a specific question about this device

The RevLite O-switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications

1064 nm wavelength:

Tattoo Removal: Dark Ink: (Black & Blue)

Nevus of Ota

Removal or lightening of unwanted hair with or without adjuvant preparation.

Skin resurfacing procedures for the treatment of acne scars and wrinkles

532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece):

Tattoo Removal: Light Ink (Red, Sky Blue, Green)

Treatment of Vascular Lesions including, but not limited to:

• . Prot wine birthmarks
• Telangiectasias .
• Spider angioma .
• Cherry angioma .
• Spider nevi .

Treatment of Pigmented Lesions including, but not limited to:

• Café-au-lait bithmarks .
• Solar lentiginos .
• Senile lentiginos .
• Becker's nevi .
• Freckles .
• Nevus spilus .

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

The RevLite System with LCD Panel laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece or optional Multilite Dye Laser Handpieces. The user activates laser emission by means of a footswitch. The RevLite System incorporates 2 very narrow laser applications designed to apply more energy over a larger spot size at the same fluence level, enabling the physician to treat a larger area more rapidly.

The provided K063834 RevLite Q-Switched Laser System did not include any clinical performance data or studies. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: none".

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer any of the subsequent questions related to a study, as no such study is described in this document.

The FDA's decision was based on a comparison to an equivalent device (RevLite C6 Q-Switched Nd: YAG Laser System - K063112) in terms of indications for use, technical specifications, operating performance features, and general design features, rather than on new performance data for this specific submission.

Ask a specific question about this device

The Affinity QS laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal, and the incision, excision, ablation, vaporization of soft tissue for general dermatology.

The Affinity QS Q-Switched Nd:YAG Laser is a Q-Switched, frequency doubled laser system. It provides both 1064nm and 532nm wavelengths. Laser emission activation is by foot switch. Overall weight of the laser is 180 lbs., and the size is 25" x 15" x 78" (LxWxH). Electrical requirement is 230 VAC, 20A, 50-60 Hz, single phase.

The provided text is a 510(k) summary for the Cynosure Affinity QS Q-Switched Nd:YAG Laser system. Based on this document, the following information can be extracted regarding acceptance criteria and the study (or lack thereof) proving the device meets them:

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

Based on the provided K050382 510(k) summary, specific acceptance criteria and detailed device performance metrics are not present. The submission primarily relies on demonstrating substantial equivalence to a predicate device.

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

The 510(k) summary explicitly states under "Nonclinical Performance Data" and "Clinical Performance Data" that there is "none". This indicates that no specific test set was used for performance evaluation of this device as part of this submission, nor is there any data provenance.

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)

Since there was no "Clinical Performance Data" or "Nonclinical Performance Data" provided for this specific device in this 510(k) submission, there is no information on experts used to establish ground truth.

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

As no performance data was submitted, there is no adjudication method described for a test set.

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

The document does not mention any MRMC comparative effectiveness study, nor does it pertain to AI assistance. This device is a laser system, not an AI diagnostic tool.

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

This question is not applicable as the device is a laser system, not an algorithm. Therefore, no standalone performance study was done in the context of an algorithm.

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

Since no performance data was submitted for this device, there is no mention of the type of ground truth used.

8. The sample size for the training set

Given that no performance data was submitted and the device is a physical laser system (not an AI algorithm), there is no training set sample size mentioned.

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

As there is no training set for this type of device and submission, there is no information on how ground truth for a training set was established.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The 510(k) summary explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none."

Instead of performance studies, this 510(k) submission primarily relies on demonstrating substantial equivalence to an already legally marketed predicate device, the Medlite C6 Q-Switched Nd:YAG Laser system. The document states:

"The Affinity QS laser system has identical indication for use, the same principle of operation, and essentially the same wavelength range and pulse energy range as the predicate device."

Therefore, the "study" proving the device meets the acceptance criteria (implicitly, that it is safe and effective for its intended uses) is the legal and regulatory argument of substantial equivalence, rather than new performance data generated specifically for the Affinity QS laser. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and have determined the actived [sic] device is substantially equivalent... for the indications for use stated... to legally marketed predicate devices."

Ask a specific question about this device

Ask a specific question about this device