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Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) port wine birthmarks (532 nm) telangiectasias (532 nm) spider angioma (532 nm) cherry angioma (532 nm) spider nevi (532 nm) cafe-au-lait birthmarks (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles, nevus spilus (532 mm) nevus of ota (1064 nm)

The Helios III laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd–YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.

The provided text is a 510(k) summary for the Helios III Q-Switched Nd:YAG Laser System. It is an FDA submission seeking substantial equivalence to existing predicate devices, not a study proving the device meets specific acceptance criteria through clinical or AI-driven performance metrics.

The document primarily focuses on bench testing and comparison of technical specifications and intended uses with predicate devices to demonstrate substantial equivalence, rather than providing the kind of performance data you are asking for regarding AI/human reader studies.

Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) are not applicable (N/A) because this is not a submission for an AI/ML medical device or a clinical outcome study in the traditional sense you have described.

Here's a breakdown of the information that is available in the provided text:

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

The document doesn't provide explicit "acceptance criteria" in the format of pass/fail thresholds for clinical or AI performance. Instead, it presents a comparison of the Helios III's technical specifications and intended uses against two predicate devices recognized as legally marketed. The "performance" is demonstrated by showing that these specifications are comparable to or within acceptable ranges of the predicates.

Table 1: Approved Indication of Uses for Helios III Predicate Devices (Comparative)

Table 2: Performance Specification Comparison with Predicate Devices (Comparative)

Regarding the Study:

The document states:

• Performance Data: "Non-clinical testing of Helios III included visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench. Some of these tests include visual inspection, earthbond testing, software testing, transit testing, leakage current testing and measurements. Test reports have been submitted."
• This refers to bench testing for safety and functional performance as a laser device, not a comparative clinical study or AI performance evaluation.

Specific Answers to Your Questions (based on the provided text):

2. Sample sizes used for the test set and the data provenance: N/A. This document describes non-clinical bench testing of a laser device, not performance on a test set of medical images or patient data. Data provenance (country, retrospective/prospective) is also N/A for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment by experts is not described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. No adjudication process for a test set is mentioned.
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: N/A. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A. For the bench testing, "ground truth" would be the engineering specifications and safety standards met by the device.
8. The sample size for the training set: N/A. This device does not involve a training set as it is not an AI/ML product.
9. How the ground truth for the training set was established: N/A. Not an AI/ML product.

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The Lotus II Pulsed Er:YAG Laser System is a pulsed erbium doped yttrium-aluminum-garnet (Er:YAG) laser. It outputs laser light with a wavelength of 2940 nm, a wavelength very efficiently absorbed by the skin. It is intended for coagulation, vaporization, ablation and/or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and ophthalmology (skin around the eyes). This includes skin resurfacing and the treatment of wrinkles

The Lotus II Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

The Lotus II laser system is an Erbium:YAG laser with a wavelength of 2.94 um. Laser activation is by footswitch. Three basic elements of operations are as follows:

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

Here's the analysis of the provided text regarding the acceptance criteria and study for the Lotus II Pulsed Er:YAG Laser System:

Acceptance Criteria and Device Performance Study for Lotus II Pulsed Er:YAG Laser System (K083253)

1. Table of Acceptance Criteria and Reported Device Performance

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

No specific test set data, sample size, or data provenance (e.g., country of origin, retrospective/prospective) are provided in this 510(k) summary. The submission focuses on substantial equivalence.

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

Not applicable. No ground truth was established from an expert panel for this submission as a "performance data" study was not conducted. The determination was based on substantial equivalence to existing devices.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method was used for this submission.

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

No. There is no mention of an MRMC comparative effectiveness study in the provided document. The device's approval was based on substantial equivalence, not a clinical effectiveness study.

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

Not applicable. This device is a laser system, not an algorithm or AI-driven diagnostic tool. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

No direct ground truth was established through clinical data for the Lotus II Pulsed Er:YAG Laser System. The "ground truth" for its acceptance was the established safety and effectiveness of the predicate devices to which it claims substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, not an AI/ML algorithm that requires a training set.

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

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

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

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

Tattoo Removal

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

Treatment of Vascular Lesions:

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

Treatment of Pigmented Lesions:

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

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

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

2. A resonator then amplifies the beam.

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication method is described.

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

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

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

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

7. The Type of Ground Truth Used:

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

8. The Sample Size for the Training Set:

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

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

• Not applicable for the same reasons as above.

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