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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.

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The Q Switched Nd: YAG Laser machine (QNHF-01) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, 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.

Q Switched Nd: YAG Laser machine (QNHF-01) is laser system which delivers laser at a wavelength 1064nm or 532nm. 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.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device: the Q Switched Nd:YAG Laser machine (QNHF-01). This type of document is a notification of intent to market and not a detailed study report providing acceptance criteria and performance data for an AI/ML-driven device, particularly not in the format requested.

Therefore, I cannot provide the requested information as the document does not contain details about:

• Acceptance criteria table and reported device performance for an AI/ML component.
• Sample sizes for test sets or their provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Details of multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

The document explicitly states: "No clinical study is included in this submission." This further confirms that it does not contain the kind of performance data usually required to demonstrate AI/ML device capabilities against pre-defined acceptance criteria.

The submission focuses on demonstrating substantial equivalence to a predicate device (K163123) based on technological similarities and non-clinical performance testing against recognized safety and performance standards (e.g., IEC 60601-1, ISO 10993 series for biocompatibility). This is typical for a traditional medical device, not an AI/ML device that requires complex evaluation of predictive accuracy or clinical utility improvements due to AI assistance.

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The PICOANDY is indicated for the following at the specified wavelength:

· 1064 mm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

· 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.

The PICOANDY is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The provided document lists information for a medical device called PICOANDY (Q-Switched Nd:YAG Laser), which is a laser surgical instrument. It includes a 510(k) summary for FDA clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a table format with specific target values for performance in the context of a clinical study or effectiveness evaluation. Instead, it details the technical specifications of the PICOANDY device and compares them against a predicate device (PICOHIGH), claiming "substantial equivalence."

However, we can infer performance specifications from the "Performance Testing" section and the comparison to the predicate device.

• Zoom 532nm: 10 ~ 200mJ ±10%
• Collimation Mode: 38 ~ 500mJ ±10%
• MLA (1064nm): 30 ~ 550mJ ±10%
• MLA (532nm): 10 ~ 200mJ ±10%
• 1064nm DOE: 30 ~ 550mJ ±10%
• 532nm DOE: 20 ~ 200mJ ±10% | Reported within these ranges. | Similar (Predicate range for handpiece output is only slightly different, including error range) |
  | Spot Size: | 2 to 10 mm (by 1mm step) | 1064nm mode: (2 to 10mm) step: 1mm, 532nm mode: (2 to 10mm) step: 1mm | Similar (Proposed device range included in predicate) |
  | Pulse Repetition Rate: | Max. 10Hz | 1064nm mode: 1-10Hz, 532nm mode: 1-10Hz | Same |
  | Laser Delivery Type: | Articulated Arm with Handpiece | Articulated Arm with Handpiece | Same |
  | Handpiece Types: | Zoom, Collimated, MLA, DOE | Zoom, Collimated, MLA, DOE | Same |
  | Patient Contact Material: | Aluminum Powder (Handpiece) | Aluminum Powder (Handpiece) | Same |

The "acceptance criteria" here are implicitly the specifications of the device and its demonstrated ability to perform within those specifications, and critically, to be "substantially equivalent" to a legally marketed predicate device.

Study Type and Details to Prove Acceptance:

The document states: "No clinical studies were considered necessary and performed." This indicates that the device's clearance was based on non-clinical data and comparison to a predicate device.

Therefore, the following information is not applicable or extractable from the provided document as no clinical or comparative effectiveness study was conducted:

• Sample size used for the test set and data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi Reader Multi Case (MRMC) comparative effectiveness study
• Effect size of human readers improving with AI vs. without AI assistance
• Standalone (algorithm only) performance study

Here's what was used to prove the device meets acceptance criteria (i.e., substantial equivalence):

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

• Not applicable / Not provided. No clinical test set. The evaluation relies on bench tests and comparison to a predicate device.

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

• Not applicable / Not provided. No ground truth established by experts for a clinical test set since no clinical studies were performed.

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

• Not applicable / Not provided. No clinical 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:

• No. An MRMC study was not done. This device 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 / Not provided. This device is a physical laser system, not a software algorithm for standalone performance. "Software Validation" refers to the internal software controlling the device, not a standalone diagnostic algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" implicitly refers to the engineering specifications and established safety and performance standards (e.g., IEC standards) and the characteristics of the predicate device. Compliance with these standards and demonstrating similar functionality to a predicate forms the basis of "truth" for substantial equivalence.

8. The sample size for the training set:

• Not applicable / Not provided. There is no "training set" in the context of an AI/ML algorithm for this device. The software validation mentioned is for the device's operational software, not for an AI model trained on data.

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

• Not applicable / Not provided. As there's no training set for an AI/ML algorithm described.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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