Search Results

The Q-Swithched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for for General Dermatology, Dermatologic and General Surgical Procedures as follows:

1064nm:

• Tattoo removal
  • dark ink: blue and black
• Treatment of Benign Pigmented Lesions
  • Nevus of ota

532nm:

• Tattoo removal
  • Light ink: red, sky blue and green.
• Treatment of benign vascular lesions
  • Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi.
• Treatment of benign pigmented lesions
  • Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

Nd:YAG laser is a type of solid laser that is stimulated through Yttrium Aluminum Garnet (YAG Crystal) doped with a very small amount of Neodymium (Nd). Nd:YAG laser can generate pulsed or continuous laser, emitting laser with specific wavelength (usually 532nm or 1064nm). The principle of Nd:YAG laser product is that electrons in atoms can absorb energy and change from a lower energy level to higher energy level, then these electrons fall back to the lower energy level, releasing energy in the form of photons. Compared with ordinary light source, laser is monochromatic, directional and brighter.

Q-Switched Nd:YAG Laser is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel.

Machine System
Q-Switched Nd:YAG Laser (hereinafter referred to as "Machine") consists of machine main body (including Laser Device, Transmission and Target Indicating Device, Laser Power Supply and Control System, Safety Protection System, Cooling System, Power Supply System, Control System), 7-Joint Laser Arm, Vari-Focusing Handpiece, Foot Switch, Laser Protective Glasses, Power Cable, Support Bar (A Group of Support Bar and 2 Support Clamps), Casters and Attached Machine Accessories, etc. As shown by Figure 1, the machine shell is ABS shell, its accessories are aluminum alloy parts.

The provided FDA 510(k) clearance letter and summary for the Q-Switched Nd:YAG Laser (SHE-LSP101-1) does not describe acceptance criteria, nor does it detail a study that proves the device meets specific performance criteria related to clinical outcomes or diagnostic accuracy.

The summary focuses on non-clinical tests to verify that the device meets safety and performance standards for laser equipment, and that its technological characteristics are similar to predicate devices. It explicitly states, "Clinical study is not applicable." This indicates that the regulatory pathway for this device did not require a study demonstrating its effectiveness or diagnostic performance against defined acceptance criteria in a clinical setting.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or cannot be extracted from the provided text.

Here's the information that can be derived from the document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Engineering Specifications)

Since no clinical acceptance criteria or performance against such criteria are explicitly stated in the document, the "performance" presented here relates to the engineering specifications and safety standards adherence.

Study Details (Non-Clinical)

1. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical tests (engineering and safety standards adherence), not a test set of data for clinical performance or AI evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established from experts for performance evaluation.

3. Adjudication method for the test set: Not applicable. No test set for clinical performance.

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: Not applicable. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests was adherence to established international safety and performance standards for medical electrical equipment and laser products (e.g., IEC, ISO standards) and verification of its stated engineering specifications (wavelength, energy, spot size). There is no clinical "ground truth" discussed.

7. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The "study" refers to a series of non-clinical tests conducted to verify that the Q-Switched Nd:YAG Laser (SHE-LSP101-1) met its design specifications and complied with relevant international safety and performance standards for medical devices and lasers. These tests confirmed parameters such as laser peak wavelength, spot size, laser pulse energy, and maximum fluence, finding them to be within the specified ranges. Additionally, the device demonstrated compliance with a comprehensive set of standards, including:

• Electrical Safety: IEC 60601-1 (general requirements for basic safety and essential performance).
• Electromagnetic Compatibility (EMC): IEC 60601-1-2 and IEC/TR 60601-4-2.
• Laser Specific Safety: IEC 60601-2-22 (for surgical, cosmetic, therapeutic, and diagnostic laser equipment) and IEC 60825-1 (safety of laser products).
• Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and delayed-type hypersensitivity), and ISO 10993-23 (irritation).

The conclusion of these non-clinical tests was that the device is substantially equivalent to its predicate devices based on these performance and validation studies. The document explicitly states that a "Clinical study is not applicable," indicating that clinical efficacy or diagnostic accuracy studies were not required for this 510(k) clearance.

Ask a specific question about this device

The Q-Switched Nd: Yag laser is indicated for the treatment of: benign cutaneous lessons, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and the removal of black or blue tattoos.

The Q-switched laser therapy device is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse. In laser handpiece, there is one optical cavity containing the Nd: YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.

The provided document is a 510(k) premarket notification letter from the FDA regarding a Q-Switched Nd:Yag laser device. This type of document establishes substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical data, especially not for AI/machine learning devices where such studies would be critical.

The document explicitly states:

• "No clinical study is included in this submission." (Page 9)
• The entire evaluation for substantial equivalence is based on "Non-Clinical Test Conclusion," showing compliance with various electrical safety, biocompatibility, and laser safety standards (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10), and Software Validation & Verification Test.

Therefore, I cannot provide the requested information for an acceptance criteria table, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided FDA 510(k) summary for this laser device.

The questions you've posed (acceptance criteria, sample size, expert ground truth, MRMC, etc.) are highly relevant for the validation of AI/ML-based medical devices or devices with a diagnostic component whose performance is assessed against human interpretation or clinical outcomes. The device in this document is a physical laser for treatment, and its FDA clearance is based on demonstrating equivalence in its technical specifications and adherence to relevant safety standards, not on diagnostic accuracy or AI performance.

Ask a specific question about this device

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

The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:

1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red. Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064 nm) and frequency doubled KTP Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. It is composed of laser module, articulated arm, laser power supply, cooling system and display and control system.

The Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body.

The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.

The provided document is a 510(k) summary for the Beijing Sincoheren Science And Technology Development Co.'s Q-Switched Nd:YAG Laser Therapy Systems. It aims to demonstrate substantial equivalence to a predicate device, not to establish new safety or effectiveness. Therefore, the document discusses performance data in the context of equivalence rather than proving acceptance criteria for a novel device.

The document does not describe specific acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or accuracy) for a new clinical indication or a new type of device. Instead, it relies on demonstrating that the performance characteristics of the proposed device are comparable to or better than those of the predicate device, and that it complies with relevant safety standards.

Here's an analysis of the provided information based on your requested points, framed within the context of a 510(k) submission for substantial equivalence:

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

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly that the proposed device performs at least as well as, or is sufficiently similar to, the predicate device in terms of technical specifications and safety. The reported device performance is presented as a comparison table against the predicate device.

In addition to these direct comparisons, the submission outlines compliance with various safety and performance standards as "performance data" to support the substantial equivalence claim:

• Biocompatibility testing: Compliance with ISO 10993-1, including Cytotoxicity, Sensitization, and Irritation tests. (Implicit acceptance criteria: device materials must be biocompatible according to recognized standards for skin and subcutaneous tissue contact < 24 hours).
• Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). (Implicit acceptance criteria: device must meet electrical safety and EMC standards).
• Performance testing: Compliance with IEC 60825-1 (laser safety). (Implicit acceptance criteria: laser performance must meet safety standards).
• Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance for "moderate" level of concern software. (Implicit acceptance criteria: software must be verified and validated according to FDA guidance for its risk level).

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 "test set" in the context of clinical or image-based studies. The performance data presented are primarily technical specifications and compliance with international standards, not data from a clinical test set. Therefore, information on sample size and data provenance for a test set is not applicable to this submission as described.

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, as there is no clinical or image-based "test set" described with ground truth established by experts.

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

Not applicable, as there is no clinical or image-based "test set" requiring 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

Not applicable. This device is a laser therapy system, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or image interpretation.

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

Not applicable. This is a physical laser device, not an algorithm.

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

Not applicable. For this type of device and submission, the "ground truth" for demonstrating substantial equivalence lies in meeting established engineering standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993-1) and demonstrating comparable basic technical performance to a legally marketed predicate device for the same indications for use. There is no biological "ground truth" involved in the sense of clinical validation of a diagnostic or treatment outcome for this specific 510(k) submission.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable, as there is no training set.

In summary:

This 510(k) submission primarily relies on bench testing, compliance with recognized international standards (IEC, ISO), and a direct comparison of technical specifications to a predicate device to demonstrate substantial equivalence. It does not involve experimental clinical studies, human reader studies, or AI algorithm validation data that would typically require "test sets," "ground truth," or "training sets" as you've defined them. The "acceptance criteria" are effectively met by demonstrating that the device is technically comparable or improved (e.g., safer, more effective according to physical principles) for the same intended use as a legally marketed predicate device, and that it adheres to relevant safety and performance standards for medical lasers.

Ask a specific question about this device

1064 nm wavelength: Tattoo Removal (Dark Ink, Black & Blue ) Ota's nevus
532 nm wavelength: Tattoo Removal (Light Ink, Red, Sky Blue and Green) Treatment of Pigmented Lesions Solar Lentiginos Senile Lentiginos

The proposed device includes three models as YILIYA- 1064QCH, YILIYA- 1064QCL and Aeslight-1064QEH, the differences between three models described in the subsection 5 specification. The proposed device is the laser system with modularization and multi-wavelength, includes the waveform as 1064 nm and 532 nm. The proposed device consisted by control system, power supplier, cooling system, laser generator, articulated arm and foot switch.

The provided text is a 510(k) Summary for a Q-Switched ND: YAG Laser Device. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for a clinical study with acceptance criteria and performance reporting in the same way a new, high-risk device might be.

Therefore, many of the requested categories for a clinical study will not be explicitly present or applicable in this document. The submission focuses on bench tests and technological characteristics comparison to show equivalence.

Here's the information extracted and organized based on your request, with notes on what is not available in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This document does not present acceptance criteria and performance in the "acceptance criteria" vs. "reported performance" format typically found in clinical studies validating device effectiveness. Instead, it demonstrates Substantial Equivalence (SE) to a predicate device by comparing technical specifications and ensuring compliance with recognized standards.

The table below summarizes the key technical specifications compared to the predicate device to demonstrate SE. The implicit "acceptance criteria" here is that the proposed device's specifications are within an acceptable range or are equivalent to the predicate device, especially regarding safety and intended use.

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

• Sample Size: Not applicable. This submission relies on non-clinical bench tests and comparison of technical specifications rather than a clinical human subject test set. The "test set" would be the device itself undergoing various engineering and electrical tests.
• Data Provenance: The data comes from bench tests conducted by the manufacturer, Beijing Honkon Technologies Co., Ltd. (P.R.China). This is a prospective evaluation of the newly designed device's physical and electrical characteristics against established standards and the predicate device's specifications.

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

• Not applicable. Ground truth in the context of clinical expert consensus or diagnostic accuracy is not relevant here. The "ground truth" for non-clinical bench tests is defined by international safety and performance standards (e.g., IEC standards) and the specifications of the legally marketed predicate device.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication is a process for resolving discrepancies among expert readers in clinical studies. This document describes non-clinical bench testing.

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. This is not an AI-assisted diagnostic device, nor is it a multi-reader, multi-case study. It's a laser device for dermatological and aesthetic procedures.

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

• Not applicable. This device does not involve an algorithm working in standalone mode. Its performance is evaluated through its physical and electrical outputs.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The "ground truth" for this submission are the international safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and the established technical specifications and Intended Use of the predicate device (RevLite™ Q-Switched Nd: YAG Laser System, K063834). Compliance with these standards and equivalence to the predicate's technical characteristics serves as the basis for demonstrating safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of machine learning or clinical trials for this type of device submission.

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

• Not applicable L. As there is no training set, this question is not relevant.

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

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

The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores.

The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for:

• Removal of dark tattoos
• Treatment of pigmented lesions

The Lumenis Quantum series of IPL/Nd: YAG systems are intense pulsed-light (IPL) and Nd: Y AG laser devices. Each Quantum system is comprised of three main components:

• A system console (including software and control electronics, key-operated power control switch, power-on indicator, emergency shut-off knob and a remote interlock connector);
• A control and display panel;
• One or more delivery handpiece(s), the Treatment Heads.

The Q-switched Nd: Y AG Treatment Head for the Quantum series is a pulsed laser operating at a wavelength of 1064 nanometers. It is an upgrade that can be installed on any Quantum system.

The Q-switched Nd: YAG Laser Treatment Head is a hand held device comprised of the laser head and optics, trigger circuit, safety components and cooling circuit. The Qswitched Nd: YAG Laser Treatment Head is connected to the Quantum console via an umbilical cable and connector.

The provided text describes the Q-switched Nd:YAG Laser Treatment Head for the Lumenis Quantum series. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device "shares the same indications for use, same principle of operation, same wavelength, same or similar fluence range and spot sizes as the predicate devices." It also notes that a "Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use." However, specific quantitative acceptance criteria (e.g., a certain percentage of tattoo removal, reduction in lesion size) and their corresponding performance metrics are not explicitly stated in the provided document. The document relies on substantial equivalence to predicate devices rather than establishing new, specific performance criteria.

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

The document mentions "A Clinical Evaluation Report" but does not provide details about the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature).

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 given text.

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

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) study is not mentioned in the document. The device is a laser treatment head, not an AI-assisted diagnostic or interpretative tool, so an MRMC study related to human reader improvement with AI would not be applicable here.

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

The device is a laser treatment head, which is a physical instrument used for medical procedures, not a standalone software algorithm. Therefore, a "standalone algorithm-only" performance study is not applicable. The "standalone" performance would be its inherent treatment efficacy, which the clinical evaluation report broadly addressed.

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

The document refers to a "Clinical Evaluation Report" which demonstrated "safety and effectiveness." This implies that clinical outcomes data (e.g., visual assessment of tattoo removal, reduction in lesion pigmentation, adverse event rates) would have been used as the ground truth. However, the exact methods for defining and measuring this ground truth are not detailed.

8. The sample size for the training set

The document does not mention a training set. This is consistent with a medical device submission focused on substantial equivalence to existing predicate devices, where extensive de novo training data for an algorithm might not be required or relevant in the same way it would be for an AI-powered diagnostic tool. The "Clinical Evaluation Report" would likely involve a test or validation set of patients, not a separate training set as understood in machine learning.

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

As no training set is mentioned or implied, this information is not applicable.

Ask a specific question about this device