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755mm:

Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I-VI) including tanned skin.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.

The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

Temporary increase of clear nail in patients with onychomycosis ( e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

Alexandrite Nd:YAG laser Models CPMT CANLASE , CPMT TORLASE contain two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat.

The provided document is a 510(k) premarket notification for a medical laser device, specifically the Alexandrite and Nd:YAG Laser models CANLASE and TORLASE. The FDA's letter states that the device is substantially equivalent to a legally marketed predicate device (GentleMax Pro Plus, K201111). The document primarily focuses on demonstrating this substantial equivalence through comparison of technological characteristics and performance data related to safety standards.

Regarding the specific requests for acceptance criteria and study details, it's important to note an inherent limitation of this type of regulatory document:

• This is a 510(k) summary, not a clinical study report. A 510(k) demonstrates substantial equivalence to a predicate device, often relying on existing knowledge of the predicate device's safety and effectiveness, and non-clinical performance testing of the new device. It generally does not include detailed clinical trials with specific acceptance criteria for efficacy in the way a PMA (Premarket Approval) submission would.
• The "performance data" section primarily addresses safety standards. The performance data explicitly mentioned are for biocompatibility, electrical safety, and electromagnetic compatibility (EMC), not clinical effectiveness for the stated indications.

Therefore, many of the requested details about acceptance criteria for clinical performance, sample sizes for test/training sets, expert involvement, and ground truth are not present in this document or are not applicable in the context of a 510(k) for this type of device.

However, I can extract the information that is available:

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

The document provides a comparison of technological characteristics and states that the device complies with certain safety standards. It does not list specific clinical acceptance criteria for efficacy (e.g., a specific percentage of hair reduction) for the subject device or its reported performance against such criteria. Instead, it relies on the substantial equivalence of its indications for use and technological characteristics to a predicate device already on the market.

Note on Efficacy Acceptance Criteria: The document does not state explicit quantitative clinical acceptance criteria (e.g., "70% hair reduction in 3 months") or report the device's performance against such criteria. The "indications for use" themselves serve as the qualitative efficacy claims, which are deemed substantially equivalent to the predicate device. For hair reduction, the definitions are provided (e.g., "long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime."). However, no specific clinical study data is presented to quantify this for the subject device.

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

• Sample size for test set: Not applicable for a clinical test set from this document. The "performance data" section refers to non-clinical (biocompatibility, electrical safety, EMC) testing, not clinical studies on human subjects.
• Data provenance: For the non-clinical tests, the data would originate from the manufacturer's testing facilities (Canadian Pioneer Medical Technology Corporation). No country of origin for clinical data is specified as no clinical data is presented.
• Retrospective or prospective: Not applicable as no clinical study data is presented.

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

• Not applicable as no clinical study data requiring ground truth establishment by experts is presented.

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

• Not applicable as no clinical study data requiring adjudication is presented.

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 device, not an AI-assisted diagnostic device, and no MRMC study or AI component is mentioned.

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

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

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

• Not applicable as no clinical study data requiring ground truth is presented. For the non-clinical tests, the "ground truth" is compliance with established international safety standards (e.g., IEC, ISO).

8. The sample size for the training set:

• Not applicable as no algorithm or training set for clinical performance is mentioned.

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

• Not applicable as no algorithm or training set is mentioned.

In summary: This 510(k) notification demonstrates substantial equivalence primarily through comparing the technical specifications and intended uses of the new device to a predicate device, and by showing compliance with relevant safety and performance standards through non-clinical testing. It does not contain the detailed clinical efficacy study data with specific acceptance criteria, expert involvement, or ground truth that would be found in a PMA submission or a full clinical trial report.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance data (biocompatibility, electrical safety, EMC) that demonstrates the device meets the specified safety and performance standards, and comparison of its technological characteristics and indications for use to a legally marketed predicate device to establish substantial equivalence.

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The device is intended for use in dermatologic and general surgical procedures.

The simultaneous triple wavelength handpiece is intended for use in dermatology procedures requiring coagulation. The indications for use for the Triple wavelength handpiece include: Benign vascular and vascular dependent lesions removal.

The indications for use for the handpiece of 1064nm include:

• -The Hair Removal is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
• Treatment of Pseudo folliculitis Barbae (PFB) -
• Use on all skin types (Fitzpatrick I-VI), including tanned skin. -

The indications for use for the handpiece of 808 nm include:

• -The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
• The treatment of benign vascular and pigmented lesions. -
• -Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The indications for use for the handpiece of 755 nm include:

• The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
• The treatment of benign vascular and pigmented lesions. -
• -Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Quadruple Laser System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit.

The Laser treatment device is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 808nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.

The proposed device includes power supply system, control system, control system, cooling system, laser system.

The 755nm, 808 nm, 1064nm handpieces with different treatment sizes are available for different models.

The Quadruple Laser System (Models: CPMT ARES, CPMT NEMESIS, CPMT NYX PLUS, CPMT GRACE PLUS) obtained 510(k) clearance (K222915) through demonstrating substantial equivalence to predicate devices (K211722 and K172193). The review was based on non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical performance data (biocompatibility, electrical safety, EMC, laser safety) rather than clinical study data involving patient samples. Therefore, the concept of a "test set" in the context of clinical images or patient data is not applicable here.

• Sample Size: Not applicable for non-clinical testing.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. It only states that the testing was performed. These tests are typically conducted in a laboratory setting.
• Retrospective/Prospective: Not applicable for non-clinical testing.

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

Not applicable. The non-clinical tests rely on established international standards (ISO, IEC) rather than expert consensus on ground truth for individual cases. The "ground truth" for these tests is defined by the technical specifications and criteria within the respective standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., of medical images). This document describes non-clinical engineering and safety tests, which do not involve such 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 MRMC comparative effectiveness study was done. This device is a laser system for dermatologic and general surgical procedures, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a hardware laser system, not a software algorithm.

7. The Type of Ground Truth Used

For biocompatibility, electrical safety, EMC, and laser safety, the "ground truth" is defined by the specific requirements and test methods outlined in the cited international standards (ISO 10993-1, IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2). Compliance with these standards indicates that the device is safe and performs as intended.

8. The Sample Size for the Training Set

Not applicable. This device is a physical laser system, not an AI model that requires a training set.

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

Not applicable. As this is not an AI device, there is no training set or associated ground truth establishment process for training.

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The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for :
· Benign vascular lesions and vascular dependent lesions removal

The Laser Treatment System consists of the main unit and its handpieces. The system uses laser as an active medium placed in an optical cavity to produce amplified beam at the applicators and the Simultaneous triple-wavelength of 755,808 and 1064 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The Laser Treatment System is designed to be used dermatology procedures requiring coagulation. The indications for use for the 3 simultaneously wavelength 755,808,1064 nm Laser Module is treatment of benign vascular and vascular dependent lesions.

The provided text describes a medical device, a Laser Treatment System, and its substantial equivalence to a predicate device for FDA clearance. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria from a clinical performance perspective.

The document focuses on:

• Regulatory Clearance (K211722): This is an FDA 510(k) clearance letter, which determines substantial equivalence to a legally marketed predicate device, not necessarily clinical efficacy.
• Device Description and Intended Use: The device is a "Laser Treatment System" for "Benign vascular lesions and vascular dependent lesions removal."
• Comparison to Predicate Device (K172193): The comparison table highlights technological characteristics like product code, regulation number, indications for use, laser classification, wavelength, frequency, pulse duration, and compliance with various safety and biocompatibility standards.
• Performance Data (Non-Clinical):
  • Biocompatibility Testing: Evaluated according to ISO 10993-1, covering Cytotoxicity, Irritation, and Sensitization. All acceptance criteria for these biocompatibility tests were met.
  • Electrical Safety and Electromagnetic Compatibility (EMC): Tested to comply with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2.

Therefore, I cannot provide the requested information regarding acceptance criteria for clinical performance and the study proving it, as this information is not present in the provided text.

If this were a clinical study, the requested information would typically look something like this (hypothetical example, as the data is missing):

Hypothetical Acceptance Criteria and Performance (Based on common laser efficacy studies, NOT from the provided text)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: (Information not available in text. If applicable, would be a number of patients or lesions.)
• Data Provenance: (Information not available in text. If applicable, would specify country/region and if it was prospective/retrospective.)

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: (Information not available in text.)
• Qualifications of Experts: (Information not available in text. If applicable, would specify specialties like "Dermatologists with 5+ years of experience in laser treatments".)

4. Adjudication Method

• Adjudication Method: (Information not available in text. In clinical studies, this could be "independent review by 2 dermatologists, with a third adjudicator in case of disagreement (2+1)".)

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

• MRMC Study Done? No, the provided document does not mention an MRMC comparative effectiveness study for human readers with or without AI assistance. The device is a laser system, not an AI diagnostic tool that assists human readers.

6. Standalone Performance

• Standalone Performance: Not applicable for a laser treatment system in the context of "algorithm only without human-in-the-loop performance." The device is a physical therapeutic tool operated by a clinician.

7. Type of Ground Truth Used

• Type of Ground Truth: (Information not available in text. For laser efficacy, this would typically involve clinical assessments (e.g., photographs, visual grading scales, objective measurements like chromameter readings for redness/pigmentation), patient-reported outcomes, and possibly histological examination in some cases.)

8. Sample Size for Training Set

• Training Set Sample Size: Not applicable. The provided document concerns a physical device, not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

• Ground Truth for Training Set: Not applicable, as it's not an AI algorithm requiring a training set.

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The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Laser Treatment System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam at the wavelength of 808 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit.

The Diode Laser Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 808nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.

The proposed device includes power supply system, delivery system, control system, cooling system, laser system.

The models object of this submission are Armo and Hera:

Hera has one handpiece connector.

Armo has two handpiece connectors.

The 808 nm handpieces with different spot sizes (3 spot sizes : 12×12mm,12×20mm,15×27m) are available for both models.

The provided text describes a 510(k) premarket notification for a laser treatment system (Model: Hera, Armo) intended for hair removal and permanent hair reduction. It focuses heavily on comparing the technological characteristics of the new device to a predicate device (Laser Treatment System, Model: NYX and Grace, K210033) and outlines various performance data, primarily in the areas of biocompatibility, electrical safety, electromagnetic compatibility (EMC), and software verification and validation.

Crucially, the document explicitly states that "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device." However, it does NOT contain any information about clinical performance studies or studies proving the device meets specific acceptance criteria related to its intended use (hair removal/reduction).

Therefore, I cannot provide the requested information regarding acceptance criteria for device performance based on the specific prompt's requirements, as those details are absent from the provided text. The document refers to "non-clinical testing" and does not detail any studies that would involve human subjects, expert review, ground truth establishment, or statistical analysis typical of device performance efficacy studies.

Thus, I can only state what is not present in the given text:

Based on the provided text, the following information regarding acceptance criteria and performance study details is NOT available:

1. A table of acceptance criteria and the reported device performance: The document lists technical specifications but no performance metrics for hair removal/reduction or acceptance criteria for those metrics.
2. Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set ground truth is discussed.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical laser treatment device.
7. The type of ground truth used: Not applicable, as no clinical performance data or ground truth related to hair reduction efficacy is presented.
8. The sample size for the training set: Not applicable, as no machine learning model or training set is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device primarily through technical characteristics and non-clinical safety testing. The "Performance data" section (Section VII) details:

• Biocompatibility testing: Evaluated according to ISO 10993-1, meeting acceptance criteria for Cytotoxicity, Irritation, and Sensitization.
• Electrical safety and electromagnetic compatibility (EMC): Tested to comply with ANSI/AAMI ES60601-1, IEC 60601-1-2.
• Bench Testing: Tested to comply with IEC 60601-2-22 and IEC 60825-1 (laser safety).
• Software Verification and Validation Testing: Conducted and documented as recommended by FDA guidance.

These are all safety and engineering standards compliance rather than performance efficacy data for the device's intended clinical use. The "Conclusion" explicitly states: "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device." This implies that clinical performance efficacy was not required for this 510(k) clearance, likely due to the substantial equivalence claim based on the predicate device's established performance profile.

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The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Laser Treatment System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam at the wavelength of 808 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The diode laser operates in a pulsed mode with a fixed pulse width and fixed pulse duration of the pulse train for each mode. The number of pulses can be adjusted within the preset range.

The Laser Treatment System includes two (2) models, NYX and Grace, the differences between them are the external shape and the numbers of the handpiece connectors, NYX is the desktop type with one handpiece connector, and Grace is vertical stand type with two handpiece connectors.

This FDA 510(k) summary describes a Laser Treatment System (Models: NYX and Grace) intended for hair removal and permanent hair reduction. The document focuses on demonstrating substantial equivalence to a predicate device (Diode Laser Treatment System, K182924) through non-clinical performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly present a table of "acceptance criteria" for clinical effectiveness in the context of hair removal/permanent hair reduction and corresponding "reported device performance." Instead, the acceptance criteria are largely implied by compliance with recognized standards for safety and the demonstration of equivalent technological characteristics to the predicate device.

The closest we get to performance criteria are the "Indications for Use":

• "The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin."
• "Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime."

However, the provided text does not contain data or study results demonstrating that the device meets this specific performance definition (i.e., measured hair reduction at 6, 9, and 12 months). The summary only describes non-clinical performance testing for safety and software.

Table summarizing implied acceptance criteria (primarily safety and technical equivalence) and their reported fulfillment:

Important Note: This 510(k) primarily demonstrates substantial equivalence to a predicate device, meaning it is as safe and effective as a device already on the market. It is not a de novo submission that requires extensive clinical trials to prove efficacy for the first time. The efficacy of laser hair removal devices is generally well-established in the medical literature, and clearance often relies on demonstrating that a new device operates similarly and safely.

The subsequent questions relate to clinical studies and ground truth establishment, which are not explicitly detailed in this 510(k) summary for the subject device. The document primarily focuses on non-clinical testing for safety and technical characteristics to demonstrate substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data for efficacy is provided for the subject device in this document, as the submission relies on substantial equivalence. The testing mentioned (biocompatibility, electrical safety, EMC, software) are non-clinical, controlled tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set for efficacy requiring expert ground truth is described for the subject device.

4. Adjudication method for the test set: Not applicable. (See #3)

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 treatment system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (See #5)

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical efficacy data for the subject device. For the non-clinical tests, the "ground truth" is defined by the standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601 series for safety) and the device's design specifications for energy output and software functionality.

8. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm that requires a training set. The "software verification and validation" refers to traditional software engineering testing.

9. How the ground truth for the training set was established: Not applicable. (See #8)

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