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The Intense Pulsed Light Treatment System (Model: LK-PT) 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 LK-PT device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 560mm ~ 1200nm. Intense Pulsed Light(IPL) system 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 does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as typically seen for AI/ML-enabled devices.

Instead, this document is a 510(k) Premarket Notification from the U.S. FDA, indicating that the device, an Intense Pulsed Light Treatment System (Model: LK-PT), has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (Intense Pulsed Light Treatment System, Model: HM-IPL-B8, K192521).

The type of analysis performed here is a comparison to a predicate device to show substantial equivalence, not a performance study against predefined acceptance criteria for an AI/ML algorithm.

Here's why the requested information cannot be extracted and what the document does discuss:

• No AI/ML Component: The device described is an "Intense Pulsed Light Treatment System." The description focuses on its physical parameters (wavelength, energy density, pulse width, spot size, power) and its working principle (selective thermolysis). There is no mention of any AI or machine learning component in the device. Therefore, questions 1, 3, 4, 5, 6, and 7, which relate to AI/ML study design, ground truth, and reader studies, are not applicable.
• No Acceptance Criteria for Performance: The document doesn't define acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) because it's not demonstrating de novo performance; it's demonstrating equivalence to an already cleared device.
• No Specific Performance Study: Section 10 explicitly states: "No clinical study is included in this submission." This means there was no clinical performance study conducted to prove the device meets specific acceptance criteria.
• Basis for Equivalence: The determination of substantial equivalence (SE) is based on:
  • Same intended use: Permanent hair removal, reduction of benign pigmented lesions, and benign vascular lesions.
  • Similar technological characteristics: Both are Intense Pulsed Light (IPL) systems.
  • Non-clinical performance tests: These tests are for safety and essential performance (e.g., electrical safety, electromagnetic compatibility, photobiological safety, biocompatibility), not for clinical efficacy or diagnostic accuracy.
  • Comparison of technical parameters: Wavelength, energy density, pulse delay, pulse width, spot size, and max power are compared to the predicate, with minor differences deemed not to negatively affect safety and effectiveness.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, AI performance studies, sample sizes for AI, ground truth establishment, or expert adjudication, as this information is not present in the provided 510(k) document for this non-AI/ML device.

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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 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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