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The CO2 Laser Therapy Systems is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.

CO2 Laser Therapy Systems is monochromatic light with strong penetration and precise focusing; When a continuous laser beam with a certain energy irradiates biological tissue, the instantaneous high temperature causes photo induced solidification and photo induced vaporization to irradiated tissue.iradiates biological tissue, the instantane causes photo induced solidification and photo induced vaporization to irradiaed tissue. With modulation pulse mode of CO2 laser, treatment effect can be achieved by control of laser emission frequency. After chosing laser Power, despite the frequency of laser emission, the laser is continuously output at a fixed Interval Time of 1 ms. Changes in frect interval time.

This document is a 510(k) premarket notification for a CO2 Laser Therapy System (SHE-LSP003-1). It does not describe an AI/ML powered medical device, therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies for an AI device is not available in the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices (K161925 and K241670) based on technological characteristics and performance standards for laser therapy systems, not AI performance. It explicitly states, "No clinical study is included in this submission."

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The CO2 Laser Therapy System is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.

The CO2 Laser Therapy Systems 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).

I'm sorry, but the provided text describes a medical device called "CO2 Laser Therapy System" and its FDA 510(k) clearance application. It details the device's indications for use, technological characteristics, and comparison to predicate devices, along with non-clinical testing performed to meet electrical safety and electromagnetic compatibility standards.

However, the document explicitly states in section "VIII Clinical Testing" that "It is not applicable." This means that no clinical studies, which would typically involve testing the device's performance against defined acceptance criteria on a test set with ground truth, were conducted or included in this submission for the purpose of demonstrating substantial equivalence.

Therefore, I cannot provide the information requested regarding acceptance criteria, device performance, sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment, as this type of information is not present in the provided text. The FDA clearance was based on substantial equivalence to predicate devices and non-clinical performance testing.

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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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The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and skin resurfacing.

The CO2 Diode Laser Therapy Systems mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin is the main target of the CO2 fractional laser, after absorbed the energy of the laser, the water will release heat, then be evaporated and gasified immediately, the cutaneous lesion will be eliminated instantly. By setting up the suitable energy and other parameters on skin tissue based on its specific thermal relaxation time, the healthy tissue can be prevented from being harmed.

This document describes the premarket notification (510(k)) for the CO2 Laser Therapy Systems (K162398). The submission focuses on demonstrating substantial equivalence to a predicate device (CO2 Laser Therapy Machine, K161925) rather than providing a study where the device meets specific performance acceptance criteria from a clinical trial.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted because such a study is not part of this 510(k) summary. Instead, the document provides non-clinical performance data (biocompatibility, electrical safety, EMC, and software verification/validation) to support safety and effectiveness and substantial equivalence.

Here's a breakdown of the information that can be extracted, and where the requested information is not available:

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

This document does not present a table of specific acceptance criteria (e.g., specific clinical performance metrics like sensitivity, specificity, accuracy, or a reduction in wrinkles of a certain percentage) that the device was evaluated against in a clinical study. Instead, the performance data provided are non-clinical performance tests demonstrating compliance with recognized standards.

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

Not applicable. No clinical test set or patient data (retrospective or prospective) was used for this 510(k) submission. The performance testing described is non-clinical (biocompatibility, electrical safety, EMC, software).

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 requiring expert-established ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This device is a CO2 laser therapy system, not an AI diagnostic or assistance tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

Not applicable. This device is a CO2 laser therapy system, not an AI algorithm.

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

Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used or required for this 510(k) submission as no clinical studies were performed. The "ground truth" for the non-clinical tests was compliance with the specified international standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. This is a physical medical device (CO2 laser).

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

Not applicable. As noted above, this is not an AI/machine learning device.

Summary of what the document does provide regarding device performance:

The document focuses on demonstrating that the CO2 Laser Therapy Systems is substantially equivalent to a predicate device (K161925) and meets all applicable non-clinical safety standards. This is the primary method for demonstrating safety and effectiveness in a 510(k) submission when clinical studies are not deemed necessary by the FDA.

• Comparison of Technological Characteristics: A detailed table compares the proposed device with the predicate device across various specifications (Output power, Work mode, Laser medium/energy source, CO2 laser wavelength, Aiming Beam wavelength and power, Spot Size, Dot Quantity, Pulse Energy, Pulse Length, Cooling, Patient contact sites, Control System, Laser Operation, Power input). The conclusion is that differences do not raise new questions of safety and effectiveness.
• Non-Clinical Performance Data:
  • Biocompatibility: The device components that contact the patient were tested and found to be biocompatible according to recognized standards (ISO 10993-1).
  • Electrical Safety & EMC: The device complies with IEC 60601-1 and IEC 60601-1-2 standards, ensuring electrical safety and electromagnetic compatibility.
  • General Performance Testing: The device was tested according to IEC 60825-1, a standard for the safety of laser products.
  • Software Verification and Validation: Software testing was conducted, and it was deemed a "moderate" level of concern, with documentation provided as per FDA guidance.
• No Clinical Studies: The submission explicitly states, "The subject of this premarket submission, CO2 Laser Therapy Systems, does not require clinical studies to support substantial equivalence." This is why there is no information on clinical acceptance criteria or studies.

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