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

Fractional CO2 Laser Therapy System consists of a main unit, a light guide arm (including a treatment head), a foot switch, and protective goggles. The fractional CO2 laser penetrates directly into the dermis utilizing the thermal effect of laser, instantly vaporizes the tissue in the lesion area. Parameters such as the laser energy density required for the treatment are set by the user appropriately. The Fractional CO2 Laser Machine has two operational modes, fractional mode and normal mode.

Based on the provided text, the device in question is a "Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)". The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

Instead, the document is a 510(k) premarket notification for a medical device (a laser system) and focuses on demonstrating its substantial equivalence to a legally marketed predicate device through non-clinical testing. It explicitly states:

"No clinical study is included in this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any studies related to AI/algorithm performance. The document only discusses the physical and electrical characteristics of the laser device and its general safety and effectiveness in comparison to a predicate device, as required for a 510(k) submission.

The questions you've asked (sample size for test/training sets, data provenance, expert consensus, MRMC studies, standalone algorithm performance) are highly relevant to the evaluation of AI/ML-based medical devices. This document, however, describes a traditional medical device submission for a laser system which does not appear to involve AI/ML components for which such performance criteria would be established and studied.

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Fractional mode is indicated only for ablative skin resurfacing.

Non-fractional mode is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

The Fractional CO2 Laser Therapy System has two operational modes: fractional mode and non-fractional mode.

The Fractional CO2 Laser Therapy System has 6 modules: Control Display Panel Module, Main Control program Module, Articulated arm Module, Fan Cooling Module, Laser Module and Foot switch module.

The provided document describes a 510(k) premarket notification for a medical device, the Fractional CO2 Laser Therapy System (EXFU CO2). It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing.

Crucially, this document explicitly states: "No clinical study is included in this submission." This means that there is no clinical data presented in this FDA submission regarding human performance, specifically in terms of how human readers or users might improve with or without AI assistance, or any other performance metrics that would typically come from a clinical trial in a human population.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable to this specific submission, as it relies solely on non-clinical testing and comparison to an equivalent predicate device's established performance and safety based on its technical specifications and non-clinical standards conformance.

However, based on the information provided, I can address the relevant points:

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

For a 510(k) submission based on substantial equivalence using non-clinical testing, the "acceptance criteria" are typically the conformance to recognized performance standards and the demonstration that the technical specifications of the proposed device are equivalent to or better than the predicate device. The "reported device performance" is the result of these non-clinical tests.

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

This information is not applicable as no clinical test set or human data was used. The submission relies entirely on bench testing and comparison of specifications.

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)

This information is not applicable as no clinical test set or human data was used, and thus no expert ground truth or adjudication was required in the context of this 510(k) submission. Ground truth for non-clinical testing refers to established engineering specifications and standard requirements.

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

This information is not applicable as no clinical test set or human data was used, and thus no adjudication of human interpretations 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a laser therapy system and is not an AI-powered diagnostic or assistive device that would involve human readers.

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

This information is not applicable. The device is a physical laser therapy system, not a software algorithm or AI that performs standalone analysis.

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

The "ground truth" for this 510(k) submission is derived from:

• Established engineering specifications and design requirements: The device's technical parameters (e.g., laser power, wavelength, pulse duration) are designed to meet specific values.
• International and national performance standards: Conformance to standards like ISO 10993 (biocompatibility) and IEC 60601 (electrical safety, laser safety) serves as the "ground truth" for safety and essential performance. Test reports demonstrate adherence to these standards.
• Predicate device's specifications and performance: The predicate device (K172096) serves as the benchmark against which the proposed device's specifications are compared for substantial equivalence. The predicate device's clearance implies its specifications are safe and effective for the indicated uses.

8. The sample size for the training set

This information is not applicable as no training set (for machine learning or AI) was used in this submission.

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

This information is not applicable as no training set was used.

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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.

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