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The US 450 Diode Laser Equipment is intended for 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.

US450 Diode Laser Equipment is a device which adopts the high-energy and continuous diode laser to realize the conversion of electricity, light and heat energy, and thus achieves disease treatment. Therefore, this is a laser therapeutic product that integrates laser technology, electronic technology, computer science and medical science.

Under the control of microprocessor, laser power supply can provide the adjustable constant current for the laser module, the high power laser diode in the laser module can transform the electric energy into the light, generate the continuous laser beam with a wavelength of 808mm. Semiconductor laser used for hair removal is mainly based on the principle of selective photothermal action, that is, a specific wavelength of laser can only be selectively absorbed by the target color base.

US450 Diode Laser Equipment consists of power supply system, microprocessor control system, operation display system, cooling system, treatment handle and safety alarm system.

This document is a 510(k) summary for the US 450 Diode Laser Equipment, a device intended for hair reduction. The content focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data from a specific clinical study for an AI/algorithm-based device.

Therefore, many of the requested elements for an AI/algorithm-based device (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or not available within this document. This submission primarily relies on non-clinical testing and comparison with a predicate device to establish safety and effectiveness.

Here’s an attempt to answer the questions based only on the provided text, indicating when information is not applicable or not present.

Device: US 450 Diode Laser Equipment
Intended Use: 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.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device (Diode Laser Hair Removal System, Model:M-DL100, K162659) and compliance with relevant safety and performance standards. The "performance" in this context refers to the device's technical specifications and safety profile, rather than a clinical success rate, as no clinical study was conducted for this submission.

Table of Acceptance Criteria and Reported Device "Performance" (Comparison to Predicate Device)

Study Details (Focusing on the Provided Document)

This document is a 510(k) summary, which inherently focuses on comparing a new device to a legally marketed predicate device to demonstrate substantial equivalence, rather than providing results from a detailed clinical trial or an AI/algorithm performance study.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. The submission explicitly states: "No clinical study is included in this submission." The evaluation relies entirely on non-clinical tests (electrical safety, EMC, biocompatibility, performance tests demonstrating compliance with standards) and comparison to a predicate device.

2. 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):

   • N/A. As no clinical study or test set with ground truth annotations was conducted or used in this 510(k) submission, this information is not applicable.

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

   • N/A. No clinical test set.

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:

   • N/A. This device is a laser hair removal system, not an AI-assisted diagnostic tool.

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

   • N/A. This applies to an AI/algorithm, which this device is not. The "performance test" mentioned for the device itself would be the closest analogue, confirming the laser system's physical output parameters (energy, frequency, etc.) meet specifications and ensure safety and effectiveness.

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

   • N/A. No ground truth in the context of clinical interpretation/diagnosis was established for this submission. The "ground truth" for the device's performance is adherence to established engineering standards (e.g., IEC 60601-1, ISO 10993) and the demonstrated technical specifications being within acceptable ranges or justified differences compared to a predicate device with known effectiveness.
   • For the intended use of "permanent hair reduction," the definition is provided: "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 new clinical data demonstrating this outcome with the proposed device is provided.

7. The sample size for the training set:

   • N/A. This is not an AI/algorithm-based device.

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

   • N/A. This is not an AI/algorithm-based device.

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The US 500 Intense Pulsed Light Equipment is indicated for use in surgical and aesthetic applications in permanent hair removal. Permanent hair removal 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 regimen.

The USS00 Intense Pulsed Light Equipment is a device that emits intense pulsed light in order to achieve hair reduction. The light source is a Xenon lamp that emits light which is filtered to include suitable wavelengths for hair reduction. The device is electrically powered, and main components include the console which includes electrical components and a touchscreen user interface, the IPL handpiece and cable, and a footswitch. The light pulses are emitted from the handpiece which is water cooled. The device is for prescription use only.

The provided text does not include acceptance criteria for standalone device performance, nor details of a study that proves the device meets such criteria. In fact, point 7 of the document explicitly states: "A clinical study was not considered to be needed for this 510(k)." This indicates that no clinical performance study was conducted to demonstrate the device's effectiveness through a direct comparison against predefined acceptance criteria for clinical outcomes.

The document focuses on non-clinical testing and a substantial equivalence comparison to a predicate device (K161286) based on technical characteristics and indications for use.

Therefore, the requested information cannot be extracted from the provided text.

Here's an explanation of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The document lists non-clinical tests (electrical safety, EMC, photobiological safety, biocompatibility) but does not state performance metrics or acceptance criteria for hair reduction effectiveness.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical study was performed.
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 was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical study was performed.
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 an Intense Pulsed Light (IPL) equipment, not an AI-powered diagnostic tool, and no clinical effectiveness study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone clinical performance study was done to assess its effectiveness in hair reduction against specific clinical metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study was performed.
8. The sample size for the training set: Not applicable, as no clinical study (and therefore no training set for a clinical algorithm) was performed.
9. How the ground truth for the training set was established: Not applicable, as no clinical study (and therefore no training set for a clinical algorithm) was performed.

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (K161286), primarily through:

• Non-clinical safety testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471, ISO 10993-5, ISO 10993-10).
• Comparison of technical specifications and indications for use.

The rationale for not needing a clinical study is implied by the concept of substantial equivalence, where the new device is sufficiently similar to a predicate device that has already demonstrated safety and effectiveness for similar indications.

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The CO2 Laser Equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

The subject device CO2 Laser Equipment is a carbon dioxide laser used in medical and aesthetic industry. The device emits laser energy at 10.6 um wavelength to induce human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. The CO2 Laser Equipment includes two models US800/US800N, the two models have same mechanism of action, structure, material, motherboard, software, principle and specification. The difference is appearance and size.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the CO2 Laser Equipment (K212611):

1. Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K192528) through performance and safety comparisons, rather than explicitly stating quantitative "acceptance criteria" for a novel device performance claim. The "acceptance criteria" are implied by the "Remark" column being "SAME" or "SE" (Substantially Equivalent) between the proposed and predicate devices.

For dimensions and weight, the proposed device differs but is deemed acceptable by complying with IEC 60601-1, indicating that this difference is not expected to adversely affect safety and effectiveness.

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

This document describes a premarket notification for a Class II medical device (CO2 Laser Equipment). The submission is based on demonstrating substantial equivalence to a previously cleared predicate device.

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no specific "test set" of patient data in the way one would conduct a clinical trial for a novel device performance claim. The key assessment is against technical specifications and safety standards.
• Data Provenance: Not applicable for a typical clinical test set. The data provenance relates to the technical specifications, design documents, and results of non-clinical bench testing. The predicate device's prior clearance provides the established safety and effectiveness benchmark. The manufacturer is Beijing Globalipl Development Co., Ltd. (China).

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

Not applicable. This submission relies on demonstrating adherence to recognized consensus standards and equivalence to a predicate device, not on expert consensus to establish a "ground truth" for a diagnostic or predictive performance.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is needed or included in this submission."

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

Not applicable. This device is a CO2 Laser Equipment, a physical surgical instrument, not an AI algorithm or software-only device. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate device (K192528), along with compliance to recognized international safety and performance standards for medical electrical equipment and laser products (e.g., AAMI ES60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2). The submission argues that since the proposed device is technologically similar and meets the same or comparable performance standards, it is as safe and effective as the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would have a "training set."

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

Not applicable. This is not an AI/machine learning device.

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The IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair reduction of benign pigmented lesions and benign vascular lesions, and (inclusive of the handpiece used to deliver diode laser energy) 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 proposed device, IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions, and (inclusive of the handpiece used to deliver diode laser energy)is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

IPL are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 480mm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

IPL are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.

Diode Laser machine is based on the principles of selective photothermolysis (SPTL): a combination of the appropriate laser wavelength, pulse duration, and fluence can obtain optimal effect on a targeted tissue with minimal effect on surrounding tissue.

Wavelengths of 808 nanometers (nm) are widely used in hair removal treatment, it is selectively absorbed by melanin in the hair shaft, damaging the follicular epithelium, and further causes hair loss, while the competing chromophores (oxyhemoglobin and water) absorb less energy at these wavelengths.

The user could power on the device and use the key switch to start the system, and then set the output parameter, when the setting is done, the user could use the handpiece to aim the area to be treated by 808 nm laser delivering , the laser emitting could be triggered by foot switch controlled by user.

Function module description: Control Panel, Main Control Module, Constant current board module, Temperature and humidity control system, Handpiece module.

This document is a 510(k) Summary for a medical device (IPL + Diode Laser Machine) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel AI/software medical device.

Therefore, most of the requested information for an AI/software medical device (like acceptance criteria for AI performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable to this document.

However, I can extract information related to the device's non-clinical performance and the demonstration of its safety and effectiveness relative to predicates.

Here's what can be extracted and what cannot be for this specific document:

Information that CANNOT be extracted from this document (due to the nature of the device and submission type):

• A table of acceptance criteria and the reported device performance (for AI/software performance metrics): This document does not describe acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC) or report those metrics. It focuses on the device's physical and functional specifications.
• Sample sized used for the test set and the data provenance: No test set in the context of AI/software performance is mentioned. The "tests" refer to compliance with electrical, laser, and biocompatibility standards.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established here.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI-assisted reading device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for AI performance ground truth.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information that CAN be extracted regarding the device's non-clinical performance and comparison to predicates:

1. A table of acceptance criteria and the reported device performance
(Note: These are non-clinical hardware/physical criteria, not AI performance metrics)

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

• Test Set Sample Size: Not applicable. The "tests" mentioned are for compliance with recognized electrical, laser, and biocompatibility standards (e.g., IEC 60601 series, ISO 10993 series). These tests are typically performed on the device itself and its components, not on a "test set" of patient data for AI performance evaluation.
• Data Provenance: Not applicable.

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

• Not applicable. This device is cleared based on substantial equivalence to existing devices, relying on non-clinical engineering and safety standards, not on AI performance requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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:

• No MRMC study was done (or required) as this is not an AI-assisted reading device. The document explicitly states: "No clinical study is included in this submission."

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

• Not applicable. This device is a physical IPL+Laser machine, not a standalone algorithm.

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

• For the purpose of this 510(k), the "ground truth" for demonstrating substantial equivalence is the existing predicate devices and compliance with recognized international standards for medical electrical equipment, laser products, and biocompatibility. There is no patient-data-driven ground truth in the context of AI performance for this submission.

8. The sample size for the training set:

• Not applicable. This device does not use an AI training set.

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

• Not applicable.

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