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The CO2 Laser Machine (Lume) is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.

The CO2 Laser Machine generate a 10,600nm wavelength, which is absorbed by water in the tissue.

The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).

It looks like the provided FDA 510(k) Clearance Letter for the Lume CO2 Laser Machine primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and adherence to general safety and performance standards for laser devices.

It does not contain information about a study that proves the device meets acceptance criteria related to a specific clinical performance metric (like accuracy for an AI device).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided document.

The document discusses:

• Indications for Use: The CO2 Laser Machine (Lume) is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.
• Technological Characteristics: This section compares the Lume's technical specifications (e.g., laser type, wavelength, power, spot size) to two predicate devices, arguing that differences do not negatively impact safety or effectiveness.
• Non-clinical Performance Tests: It lists compliance with various ISO and IEC standards related to electrical safety, electromagnetic compatibility, and laser safety.
• Biocompatibility: It mentions evaluation in accordance with ISO 10993 for cytotoxicity, skin sensitization, and irritation.

In summary, the provided text does not describe the kind of clinical or AI performance study you are asking about. It details how the device is considered substantially equivalent to existing laser devices, primarily through comparison of technical specifications and adherence to general safety standards.

If this were an AI/software device, the 510(k) submission would typically include a "Software Validation" section or a specific study demonstrating performance against a defined ground truth, with detailed acceptance criteria for metrics like sensitivity, specificity, or AUC. This document does not contain such details because it's for a physical CO2 laser machine.

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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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