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The Polaris Long Pulse and Q-Switched Ruby Laser is intended to remove blue/black tattoos and benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

The Polaris Long Pulse and Q-Switched Ruby Laser and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Energy is delivered using an articulated arm with interchangeable handpieces to adjust spot size. The wavelength is 694.3nm. The user activates laser by means of a footswitch.

The provided text describes a 510(k) summary for the Polaris Long Pulse and Q-Switched Ruby Laser, which is a medical device. For this type of device, the acceptance criteria and study designs are fundamentally different from those for AI/ML-based diagnostic devices. In the context of a 510(k) submission for a physical medical device, "acceptance criteria" typically refers to demonstrating substantial equivalence to a predicate device, based on technical specifications and intended use, rather than performance metrics like sensitivity, specificity, or F1 score derived from a clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are not reported as statistical performance metrics. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device, the LaseAway Long Pulse and Q-Switched Ruby Laser (K971193). The "reported device performance" is a comparison of technical specifications.

The conclusion states: "The Polaris Long Pulse and Q-Switched Ruby Laser is identical to the predicate device in terms of indications for use, technical specifications, operating performance features, general design." This statement acts as the "proof" that the device meets the implicit acceptance criteria for substantial equivalence to its predicate.

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

The provided document explicitly states:

• "Performance Data: None"
• "Results of Clinical Study: None"

Therefore, there was no test set or clinical data used in this 510(k) submission to demonstrate performance in the way one would for an AI/ML device. The basis for clearance was a comparison of technical specifications and intended use to a legally marketed predicate device.

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

Since no clinical study or performance data was used, no ground truth was established by experts for a test set. This type of device relies on established safety and efficacy of the predicate device.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring ground truth adjudication was used.

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

Not applicable. This device is a laser system, not an AI/ML diagnostic interpretation tool, and no MRMC study was conducted or required for this 510(k) submission.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (laser system), not an algorithm.

7. Type of Ground Truth Used

Not applicable, as no clinical performance data requiring ground truth was submitted or used. The "ground truth" for this 510(k) is effectively the established safety and effectiveness profile of the predicate device, demonstrated through the "substantial equivalence" framework.

8. Sample Size for the Training Set

Not applicable. No training set was used as this is not an AI/ML device.

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

Not applicable. No training set was used.

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The CO2 laser is indicated for coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

The Er: YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. There is an additional Er: YAG handpiece that attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.

The provided document is a 510(k) summary for the Cortex CO2 / Er:YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study for meeting explicit acceptance criteria in terms of device performance metrics like sensitivity, specificity, or improvement over human readers.

Here's an analysis based on your requested information:

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

Based on the provided text, no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding device performance results are reported for the Cortex CO2 / Er:YAG Laser System in the context of a clinical study. The submission instead relies on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technical specifications and intended use.

The "Performance Data" and "Results of Clinical Study" sections explicitly state "None." The "Technical Specifications Comparison" tables serve as the primary "performance" data, showing that the device's specifications are similar to the predicates.

The implied "acceptance criteria" is that these specifications are either identical or functionally equivalent to the predicate devices, leading to the conclusion: "The Cortex CO2 / Er:YAG Laser System is comparable to the predicate device in terms of indications for use, technical specifications, operating performance features, general design."

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 explicitly states "Performance Data: None" and "Results of Clinical Study: None." Therefore, there was no test set or associated data provenance (country of origin, retrospective/prospective). This submission relies on technical comparison, not clinical data from a test set.

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. No test set or clinical study was conducted, thus no expert-established ground truth was required for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set was used.

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 tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical laser system and does not involve AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical study or performance data requiring ground truth was presented. The "ground truth" for this 510(k) submission is the technical specifications and established safety/effectiveness of the predicate devices, against which the new device is compared.

8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. No training set exists for this type of device submission.

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The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

The Nd:YAG handpiece is indicated for:

• At the 1064nm wavelength dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.
• At the 532nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial telangiectasias, as, angiomas, and leg veins, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)

The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er:YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy is a wavelength of 2940nm. This handpiece can be removed and replaced with a q-switch Nd:YAG handpeice emitting wavelengths of 1064nm and 532nm laser energy can be added. The user activates the laser emission by means of a footswitch.

The provided text does not describe any acceptance criteria or a study that proves the device meets those criteria.

Instead, the document is a 510(k) Summary for a medical device (Triplex Er:YAG / Nd:YAG Laser System) seeking FDA clearance. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving efficacy against predetermined performance acceptance criteria through clinical studies.

The document explicitly states:

• "Results of Clinical Study: None" under the "Performance Data" section.
• The conclusion is that the device is "comparable to the predicate device in terms of indications for use, technical specifications, operating performance features, general design."

Therefore, I cannot fill in the table or answer the specific questions about acceptance criteria and studies because the provided document indicates that no such study was performed or required for this type of FDA clearance. The clearance was based on technological characteristics and substantial equivalence, not performance against acceptance criteria derived from a clinical trial.

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The Er:YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coaqulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:
Hair Removal (650nm filter) Permanent hair reduction (650nm filter) Treatment of vascular lesions (510nm filter) Treatment of benign pigmented lesions (510 nm filter) Mild to Moderate inflammatory acne (450nm filter)

The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er: YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy produced within the device is delivered to the tissue in a wavelength of 2940nm. The Intense Pulsed Light wavelengths are 450nm - 1200nm The user activates laser and IPL emission by means of a footswitch.

The provided document is a 510(k) summary for the Apex Er:YAG / IPL System. This type of submission focuses on demonstrating substantial equivalence to pre-existing devices, rather than proving novel effectiveness through new clinical studies. As such, the document explicitly states there is no performance data and no results of a clinical study provided for the Apex Er:YAG / IPL System itself.

Therefore, the following information, typically found in a clinical study report for device acceptance, is not available in the provided document:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

However, based on the provided text, here's what can be stated about the acceptance criteria and the study that "proves" the device meets them within the context of a 510(k) submission:

1. Acceptance Criteria and Device Performance:

For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating substantial equivalence to legally marketed predicate devices. The "device performance" is shown through a comparison of technological characteristics and intended uses.

• Acceptance Criteria (Implicit for 510(k)): The device must be substantially equivalent to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. This means the new device should not raise new questions of safety or effectiveness.
• Reported Device Performance (as demonstrated for 510(k) equivalence): The document provides a comparison of the Apex Er:YAG / IPL System with its predicate devices.

2. Study that proves the device meets the acceptance criteria (Substantial Equivalence):

The "study" in this context is a comparison of technological characteristics and intended uses against legally marketed predicate devices, rather than a de novo clinical trial.

• Type of Study: Predicate device comparison for substantial equivalence.
• Data Provenance: The data is a comparison of technical specifications provided by the manufacturer against the specifications of the identified predicate devices. It is not derived from retrospective or prospective patient data from a specific country.
• Sample Size: Not applicable. This is not a study involving patient or image data. The comparison is feature-by-feature.

3. & 4. Experts and Adjudication:

• Number of Experts/Qualifications: Not applicable. The 510(k) process for this device did not involve expert review or adjudication of patient cases or images to establish a ground truth. The comparison relies on documented technical specifications.
• Adjudication Method: Not applicable.

5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done: No. The document explicitly states "Results of Clinical Study: None."

6. Standalone (Algorithm Only) Performance:

• Standalone Study Done: No. This device is a physical laser/IPL system, not an algorithm. The document explicitly states "Performance Data: None."

7. Type of Ground Truth:

• Ground Truth Used: Not applicable in the traditional sense of a clinical study. The "ground truth" for a 510(k) is the established performance and safety of the predicate devices. The new device is accepted if it is shown to have similar characteristics and intended uses that do not raise new questions of safety or effectiveness.

8. & 9. Training Set and Ground Truth for Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.
• How Ground Truth for Training Set was Established: Not applicable.

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The Cheveux Diode Laser System is indicated for: Hair Removal Permanent hair reduction Treatment of vascular lesions Treatment of benign pigmented lesions Treatment of Leg Veins Treatment for pseudofolliculitis barbae The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin

The Cheveux Diode Laser System delivers laser light with an 810 nm wavelength. The system consists of a console and a handpiece connected to the system by an umbilical. Energy output is initiated with trigger on the handpiece.

The Cheneux Diode Laser System's 510(k) summary does not contain the level of detail requested for acceptance criteria and study design. The document is a regulatory submission for substantial equivalence to a predicate device, not a detailed report of clinical performance.

Here's a breakdown of what can be extracted and what is explicitly missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given document. The 510(k) summary states, "The Cheveux Diode Laser System is substantially equivalent to other existing diode laser systems in commercial distribution for use in Dermatology and Plastic Surgery." This is a regulatory conclusion, not a presentation of performance data against specific acceptance criteria.

The document lists "Performance Data" but then only states "Results of Clinical Study: The Cheveux Diode Laser System is substantially equivalent to other existing diode laser systems in commercial distribution for use in Dermatology and Plastic Surgery." This confirms the lack of specific performance metrics or acceptance criteria.

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

This information is not provided in the document. No specific clinical trial details are given, therefore no sample size for a test set or data provenance (country, retrospective/prospective) can be determined.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. Since no specific clinical trial data or ground truth establishment is described, neither the number nor the qualifications of experts are mentioned.

4. Adjudication Method

This information is not provided in the document. No adjudication method is mentioned as there is no detailed description of a clinical study or ground truth establishment.

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

This information is not provided in the document. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. The device is a laser system, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

This information is not applicable and not provided. The Cheveux Diode Laser System is a physical medical device (a laser system), not an algorithm or AI system for which "standalone performance" would be relevant in the way you've described.

7. Type of Ground Truth Used

This information is not provided in the document. There is no mention of any ground truth (expert consensus, pathology, outcomes data) being established for a clinical study related to this device.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a laser system, not a machine learning algorithm that requires a training set.

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

This information is not applicable and not provided. As above, this is a physical device, not an AI algorithm.

In summary, the provided 510(k) summary for the Cheveux Diode Laser System focuses on demonstrating substantial equivalence to a predicate device (LightSheer Diode Laser System K003614) based on its technological characteristics and intended use. It does not include the detailed performance data, acceptance criteria, or study design information typically found in a clinical trial report for new technology or AI diagnostics. The "Performance Data" section explicitly states the conclusion of substantial equivalence rather than presenting specific quantitative performance results against criteria.

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Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

The LS-40 CO2 Laser System is a microprocessor- controlled CO2 laser system using a sealed CO2 laser tube providing 40 watts maximum power. The system incorporates a CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The unit is activated for laser emission by a footswitch.

The provided text describes a 510(k) summary for the LS-40 CO2 Laser System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific performance metrics for acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in the provided document. The document primarily highlights the device's intended use and equivalence to a predicate device.

Here's an analysis based on the available information:

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

The document does not explicitly state acceptance criteria or report specific device performance metrics in the way one would expect for a diagnostic or AI-driven device. Clinical performance is not detailed, as the submission relies on substantial equivalence.

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

Not applicable. The document describes a laser system, not an AI or diagnostic device that would typically involve a "test set" in the context of clinical data. The performance evaluation is based on engineering and safety standards, and equivalence to a predicate device, not a data-driven test set.

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

Not applicable. Ground truth establishment with experts is not relevant for this type of device submission based on substantial equivalence to a predicate laser system.

4. Adjudication method for the test set

Not applicable. There is no test set or adjudication process 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 surgical 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 physical medical device, not an algorithm.

7. The type of ground truth used

Not applicable. Clinical ground truth (pathology, expert consensus, outcomes data) is typically used for diagnostic devices. For a surgical laser, ground truth would relate to its physical properties, safety, and functionality, which are assessed through engineering tests and comparison to a predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

Conclusion from the provided information:

The LS-40 CO2 Laser System gained 510(k) clearance based on its substantial equivalence to the previously cleared LS-25 Family of CO2 Laser Systems (K040563). The submission primarily focuses on the device's technical specifications and intended use, demonstrating that it functions similarly and for the same indications as a legally marketed predicate device. This approach generally does not require new clinical studies demonstrating performance against specific acceptance criteria with clinical data, but rather relies on non-clinical performance data (e.g., electrical safety, electromagnetic compatibility, laser safety standards) and comparison to the predicate.

The "Performance Data: Results of Clinical Study:" section in the 510(k) summary (Attachment V) is empty, strongly suggesting that a clinical study with detailed performance metrics was not performed or was not necessary for clearance under the substantial equivalence pathway.

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• At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions . and the removal or lightening of hair.
• At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)

The UltraLight II Nd: Y AG Laser System consists of a power supply unit with cooling, a footswitch and an umbilical cord that connects to the laser, which is located in the handpiece. In standard use, the handpiece is held against the treatment area dn the light pulse is delivered when the footswitch is depressed. Laser parameters and other system features are controlled from the display panel located on the front of the power supply unit.

The provided text describes the UltraLight II Nd:YAG Laser System, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria. The "Performance Data: Results of Clinical Study:" section explicitly states "None," indicating that no clinical study was performed or submitted to support this 510(k) submission.

Therefore, I cannot provide the requested information, and the following table and details will be left blank or indicated as "Not provided in the input."

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

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

• Sample Size: Not provided in the input (no test set mentioned).
• Data Provenance: Not provided in the input (no test set mentioned).

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

• Number of Experts: Not provided in the input (no test set mentioned).
• Qualifications of Experts: Not provided in the input (no test set mentioned).

4. Adjudication method for the test set:

• Adjudication Method: Not provided in the input (no test set mentioned).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No.
• Effect Size: Not applicable (no MRMC study mentioned, and the device is a laser system, not an AI assistance tool for human readers).

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

• Standalone Performance Study: No. The device is a laser system, not an algorithm.

7. The type of ground truth used:

• Type of Ground Truth: Not applicable (no performance study was conducted or presented in this document).

8. The sample size for the training set:

• Sample Size: Not applicable (no training set mentioned, as no performance study was conducted or presented).

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

• Ground Truth Establishment: Not applicable (no training set mentioned).

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The scanning handpiece is intended to be used as an accessory to the LS Family of CO2 Lasers to deliver the laser light to the targeted area for skin resurfacing in a fractionated manner.

The LS Family of CO2 lasers are microprocessor-controlled laser systems that incorporate a handpiece to deliver energy to the tissue in a scanned, fractionated pattern.

The provided document describes a 510(k) submission for the LS Family of CO2 Lasers with a Scanning Handpiece. The focus of this submission is to demonstrate substantial equivalence to a previously cleared device (LS Family of CO2 Lasers cleared under K040563), rather than to establish novel performance criteria through a standalone study.

Therefore, many of the requested categories related to acceptance criteria, specific device performance metrics, and a detailed study design with sample sizes, expert ground truth, and comparative effectiveness are not applicable or not explicitly detailed in this type of regulatory document.

However, based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device (LS Family of CO2 Lasers cleared under K040563). This means that the new device (with the additional scanning handpiece) should perform as safely and effectively as the predicate device for its intended use. Specific quantitative performance metrics for "acceptance" are not explicitly listed, as the general approach is comparison to an already approved device.
• Reported Device Performance: The document states "Histology was collected from a small sample of patients to determine the depth of penetration." This indicates that the performance evaluated was the ability of the device, specifically the scanning handpiece, to achieve a certain depth of penetration in tissue, which is relevant to skin resurfacing. However, the specific "reported device performance" values or ranges (e.g., average depth of penetration, variability) are not provided in this summary. Instead, the conclusion is that the device "is substantially equivalent."

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

• Sample Size: "a small sample of patients." The exact number is not specified.
• Data Provenance: The study involved human patients, implying
  • Country of Origin: Not specified but typically assumes the location of the submitting company or clinical sites.
  • Retrospective or Prospective: Not explicitly stated, but clinical studies for such submissions are typically prospective to evaluate new features.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified, but for histological analysis, it would typically be a pathologist.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. For histological analysis, typically an independent pathologist would review the samples.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or conducted. The study performed was to determine depth of penetration, not a comparative study with human readers.
• Effect Size of AI vs. Without AI Assistance: Not applicable, as this device is a laser system, not an AI-powered diagnostic tool, and there were no human reader studies.

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

• Standalone Performance: Not applicable. This device is a laser system, not an algorithm. The "performance data" mentioned refers to the physical effects of the laser on tissue, not an algorithm's output.

7. Type of Ground Truth Used:

• Ground Truth: Histology was used as the ground truth to determine the depth of penetration. This is a direct measurement from tissue analysis.

8. Sample Size for the Training Set:

• Sample Size: The document does not mention a training set in the context of a machine learning algorithm. The "small sample of patients" was used for performance data (histology).

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

• Ground Truth Establishment: Not applicable, as there is no mention of a training set for an algorithm. The histological ground truth for the performance study was established through laboratory analysis of patient tissue samples.

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The Apollo Mini-IPL System is indicated for use skin types I-IV according to the Fitzpatrick Scale for the following indications: Hair Removal (650nm filter), Permanent hair reduction (650nm filter), Treatment of vascular lesions (510nm filter), Treatment of benign pigmented lesions (510nm filter), Mild to Moderate inflammatory acne (450nm filter).

The Apollo Mini IPL System delivers pulsed light at wavelengths starting at 450-1200nm nanometers. The device consists of the cabinet, which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide.

The provided text is a 510(k) Summary for the Apollo Mini IPL System. This document outlines the device's intended use and claims substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.

The "Performance Data" and "Results of Clinical Study" sections explicitly state "None." This means that Sandstone Medical Technologies, LLC did not submit performance data or clinical study results with their 510(k) application to demonstrate the Apollo Mini IPL System met specific acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device's performance based on the input text.

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At the 1064 nm wavelength dark ink tattoo removal of pigmented lesions . and the removal or lightening of hair.
and the Femoval of ifgifteding of help of red ink tattoos, treatment of vascular hesions . including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)

The UltraLight II Nd:YAG Laser System consists of a power supply unit with cooling, a footswitch and an umbilical cord that connects to the laser, which is located in the bandpiece. In standard use, the handpiece is held against the treatment area dn)the light pulse is delivered when the footswitch is depressed. Laser parameters and other system features are controlled from the display panel located on the front of the power supply unit.

The provided text does NOT contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the UltraLight II Nd:YAG Laser System, indicating its equivalence to predicate devices and outlining its intended uses.

Specifically, the "Performance Data: Results of Clinical Study:" section explicitly states "None," meaning no clinical study was presented in this summary to demonstrate performance or meet acceptance criteria.

Therefore, I cannot populate the requested table and information as the necessary data is not present in the provided text.

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