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The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.

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 regimen.

The EROSE-YA device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 430mm-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 systems 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.

The provided text describes a 510(k) premarket notification for an Intense Pulsed Light Treatment System. The core of this submission is to demonstrate "Substantial Equivalence" (SE) to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria in the sense of a clinical performance study for a novel AI device.

Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, and how ground truth was established for a novel AI device cannot be extracted from this document.

This document primarily focuses on engineering and safety comparisons between the proposed device and a predicate device.

However, I can extract the information that is present, which relates to non-clinical testing and the basis for the "Substantial Equivalence" claim.

Here's what can be gathered:

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

The document doesn't present "acceptance criteria" in the typical sense for an AI model's performance on a specific task (e.g., accuracy, sensitivity, specificity). Instead, it demonstrates equivalence to a predicate device across various technical specifications and safety standards. The "acceptance criteria" are implied by the predicate device's specifications and compliance with relevant IEC and ISO standards.

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

• Sample size: Not applicable. This submission relies on technical and safety testing rather than a clinical performance study with a "test set" of patients/data in the AI sense.
• Data provenance: Not applicable for a clinical test set. Non-clinical tests were conducted to verify design specifications and compliance with standards.

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 clinical "ground truth" establishment by experts is described for this type of submission.

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, an MRMC study was not done. The device is not an AI diagnostic or assistance tool for human readers.

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

• Not applicable. This is a physical, light-based treatment system, not an algorithm.

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

• For the non-clinical tests, the "ground truth" is adherence to established engineering and safety standards (e.g., IEC 60601-1, ISO 10993-5). For substantial equivalence, the "ground truth" is the specifications and safety profile of the predicate device.

8. The sample size for the training set:

• Not applicable. This device is not an AI model that undergoes training.

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

• Not applicable. This device is not an AI model.

In summary: The provided document is a 510(k) submission for a non-AI medical device (Intense Pulsed Light Treatment System). It does not present a clinical study or performance data as would be required for an AI-powered diagnostic or therapeutic device. Instead, it demonstrates substantial equivalence to an existing predicate device based on identical intended use, technological characteristics, and compliance with recognized electrical safety, EMC, and biocompatibility standards through non-clinical testing. The submission explicitly states: "No clinical study is included in this submission."

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The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, ablation, vaporization of soft tissue for general dermatology as follows: 532nm wavelength: * Removal of light ink (red. sky blue, green, purple, and orange) tattoo * Treatment of benign vascular lesions including, but not limited to: telangiectasias, * Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses ( Treatment of Post Inflammatory Hyper-Pigmentation 1064nm wavelength: * Removal dark ink (black, blue and brown) tattoo * Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma. * Removal or lightening of unwanted hair with or without adjuvant preparation * Skin resurfacing procedures for the treatment of acne scars and wrinkles

The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology.

The Nd: YAG Laser Therapy Systems includes five modules described as following: Control Panel, Main Control Module, Auxiliary Control Module, Laser, laser RF power supply and DC power supply module, Light arm module.

The provided text is a 510(k) summary for the "Nd: YAG Laser Therapy Systems Model: HM-YL900." This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a dedicated study with outcome measures.

The document discusses non-clinical testing performed to verify compliance with various safety and performance standards for medical electrical equipment and laser products. However, it explicitly states:

"No clinical study is performed to support substantial equivalence."

Therefore, I cannot provide detailed information about acceptance criteria and a study that proves the device meets them in the way typically associated with a clinical trial or performance study. The information below is derived from the non-clinical testing and the comparison tables within the document, rather than a standalone clinical study to establish performance metrics.

Here's an attempt to answer your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study with explicit performance acceptance criteria and results is mentioned, the "acceptance criteria" here refer to compliance with recognized standards and similarity to predicate devices' specifications during non-clinical testing. The "reported device performance" refers to the device's technical specifications and its demonstrated compliance with safety and electrical standards.

Note: This table reflects technical specifications and compliance with safety standards, not therapeutic efficacy metrics which would typically be derived from a clinical performance study.

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

• Sample Size for Test Set: Not applicable. No clinical test set or human data was used for performance evaluation. The "test set" implies non-clinical tests on the device hardware and software.
• Data Provenance: Not applicable for a clinical test set. The data presented is from internal non-clinical testing performed by the manufacturer to demonstrate compliance with standards and equivalence to predicate devices, as well as publicly available information on the predicate devices. The country of origin for the device manufacturer is China.

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

Not applicable. There was no clinical test set requiring expert-established ground truth for evaluation of clinical outcomes. The "ground truth" here is compliance with engineering and safety standards, established through testing against those standards.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication 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. The device is a laser therapy system, not an AI-assisted diagnostic tool. No MRMC study was performed, and no AI component is described.

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

Yes, in a non-clinical context. The "standalone" performance here refers to the device's technical specifications and its ability to meet safety and electrical standards independently, as verified through non-clinical testing. This is purely device-centric performance, not a clinical "algorithm only" performance.

7. The type of ground truth used

For the technical and safety performance, the "ground truth" was compliance with established international consensus standards (e.g., IEC 60601-1, IEC 60825-1) and the technical specifications of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

Not applicable. As there is no training set for an AI model, there is no ground truth establishment process for it.

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The Photodynamic Therapy (PDT) Equipment use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The red light (630mm wavelength) indicated to treatment of superficial, benign vascular, and pigmented lesions.

The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The Photodynamic Therapy (PDT) Equipment HM-PDT 900 is a vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (630±15nm), in the blue light regions of the light spectrum (415±15nm) and infrared light region of light spectrum (835±15nm). Five sets of LEDs panels are available for the device.

This document describes a 510(k) premarket notification for a Photodynamic Therapy (PDT) Equipment. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, clinical study specifics, and expert involvement is not available in this document.

Here's a breakdown of the information that can be extracted and what is explicitly stated as not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with numerical performance goals and achieved results for clinical effectiveness. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards.

The "performance comparison" in Table 7-2 highlights similarities and differences between the proposed device and the predicate. The "acceptance criteria" here is effectively "substantially equivalent to the predicate device."

Analysis from document regarding "differences": "The proposed device has different panel number, diode number of each LED, LED number, and treatment area than predicate device, but the difference does not affect the output energy for treatment. Therefore, the slight difference is considered to have no effectiveness and safe."

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

• Sample Size: Not applicable. No clinical test set.
• Data Provenance: Not applicable. The submission relies on non-clinical bench testing and adherence to international standards.

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 or ground truth derived from expert consensus for clinical performance. The "ground truth" for non-clinical tests would be the established specifications and standards.

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

• Not applicable. No clinical test set.

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 light therapy equipment, not an AI diagnostic tool. No MRMC study was performed.

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

• Not applicable. This is not an algorithm-based device. The device's performance is measured by its output parameters (wavelength, power density, etc.) as confirmed by bench testing.

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

• For the non-clinical tests (bench testing): The "ground truth" would be the engineering specifications and established performance limits defined by international standards (e.g., IEC 60601 series, IEC 62471).

8. The sample size for the training set:

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

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

• Not applicable. No training set was used.

Summary from the document regarding studies:

• Clinical Test Conclusion: "No clinical study is included in this submission." (Page 5)
• Non-Clinical Test Conclusion: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
  • IEC 60601-1-2:2014 (EMC)
  • IEC 60601-1:2005/A1:2012 (Basic safety and essential performance)
  • IEC 60601-2-57:2011 (Non-laser light source equipment safety)
  • IEC 62471:2006 (Photobiological safety)
  • Software Verification and Validation Testing
  • Bench Testing (Energy density output accuracy, Wavelength accuracy)" (Page 5-6)

In essence, the acceptance criteria for this device's 510(k) clearance was its ability to demonstrate substantial equivalence to a previously cleared predicate device through non-clinical testing verifying its physical and electrical performance parameters, and by adhering to relevant safety and performance standards. No clinical efficacy or performance studies with human subjects were conducted or required for this submission.

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The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. 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 regimen.

The HM-IPL-B8 device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 430mm-1200mm. 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 systems 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.

The provided text is a 510(k) summary for the "Intense Pulsed Light Treatment System" (Model: HM-IPL-B8) and details its substantial equivalence to a predicate device (Intense Pulsed Light (IPL) Systems, K122995).

Based on the document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with specified thresholds. Instead, it demonstrates "Substantial Equivalence (SE)" to a predicate device by comparing various specifications and performance parameters. The "acceptance criteria" can be inferred as being "substantially equivalent" to the predicate device for each listed characteristic.

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

The document explicitly states: "7. Clinical Test Conclusion: No clinical study is included in this submission."
Therefore, there is no test set, sample size, or data provenance related to clinical performance. The evaluation for substantial equivalence is based on non-clinical engineering tests and comparison of specifications to a previously cleared predicate device.

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

Since no clinical study was conducted, there are no experts involved in establishing ground truth for a clinical test set. The approval is based on non-clinical engineering and biological safety evaluations.

4. Adjudication Method for the Test Set

As there was no clinical study or test set involving expert assessments, no adjudication method was used.

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

No, an MRMC comparative effectiveness study was not done, as no clinical study was performed.

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

This device is an Intense Pulsed Light Treatment System, which is a physical device used for treatment, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance study is not applicable. The performance is related to its physical parameters and biological effects.

7. The Type of Ground Truth Used

For the non-clinical tests conducted (e.g., electrical safety, EMC, biocompatibility), the "ground truth" would be the established standards and regulations (e.g., IEC 60601-1, ISO 10993-5, ISO 10993-10). The device's performance was compared against these standards to demonstrate compliance. For the comparison to the predicate, the "ground truth" is the specifications and intended use of the legally marketed predicate device.

8. The Sample Size for the Training Set

There is no training set as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set.

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

The CO2 Laser Therapy System is a carbon dioxide laser used in medical and aesthetic industry. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and and then achieve the indications. The proposed device is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.

It appears there might be a misunderstanding regarding your request. The provided document is an FDA 510(k) summary for a CO2 Laser Therapy System, which is a medical device for surgical applications. This document does NOT contain information about an AI/ML-based device or a study involving acceptance criteria for such a device, human readers, ground truth establishment, or training sets.

My analysis of the provided text reveals that the medical device in question is a CO2 Laser Therapy System. This is a physical, hardware-based medical equipment used for tissue vaporization and coagulation. The FDA submission focuses on demonstrating its substantial equivalence to a predicate device, primarily through non-clinical testing against established safety and performance standards for laser equipment.

Therefore, I cannot fulfill your request for information about:

• Acceptance criteria and reported device performance for an AI/ML device: The document describes a physical laser device, not an algorithm.
• Sample size and data provenance for a test set (related to AI/ML): There is no mention of an AI/ML test set. The "test results" refer to engineering and safety tests on the hardware.
• Number of experts and qualifications for ground truth (related to AI/ML): No ground truth establishment for an AI/ML model is discussed.
• Adjudication method (related to AI/ML): Not applicable to this type of device submission.
• Multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance: No AI component is mentioned.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (pathology, outcomes data, etc. for AI/ML): Not applicable.
• Sample size for the training set (for AI/ML): Not applicable.
• How ground truth for the training set was established (for AI/ML): Not applicable.

The document explicitly states in Section 9: "No clinical study is included in this submission." and Section 8, "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

The "acceptance criteria" discussed in this document are primarily related to compliance with international electrical, EMC, and laser safety standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2) which are applied to the physical device. The "performance" refers to the device's physical specifications (e.g., maximum power, wavelength, work mode) and demonstrating they are equivalent to the predicate device.

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