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• CO2 LASER Part:
  Fractional mode is indicated only for ablative skin resurfacing.

Non-fractional mode (Impulse mode) is indicated for incision, excision, 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 Machine uses a CO2 laser with the emission wavelength of 10600nm to emit focal spots through a high focus lens. The target is water in skin tissue. A certain amount of thermal stripping, more thermal coagulation and obvious thermal effect are produced at the part directly penetrated by the focal spot.

The Fractional CO2 Laser Machine has two operational modes, fractional mode and impulse mode.

• Fractional mode includes three modes: normal, random and midsplit;
• Impulse mode includes three modes: single, continuous and impulse.

The Fractional CO2 Laser Machine has 5 modules: Control display panel module, Main control power module, Light guide arm module, Fan cooling module, Laser module.

The provided FDA 510(k) clearance letter describes a "Fractional CO2 Laser Machine" (K250782) and its substantial equivalence to a predicate device, the "Ilooda Fraxis CO2 Laser" (K172096).

However, the document primarily focuses on demonstrating substantial equivalence through non-clinical performance and safety comparisons rather than detailing specific acceptance criteria for a study that proves the device meets those criteria, particularly in the context of device performance outcomes for intended use. The clearance is based on the device being as safe and effective as its predicate through these comparisons and compliance with relevant standards.

Therefore, many of the requested sections regarding the study that proves acceptance criteria (especially clinical study details, ground truth, expert involvement, and reader studies) cannot be extracted from this document as such studies are explicitly stated to be not included.

Here's an analysis of what can and cannot be extracted:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Compliance)

The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and compliance with recognized safety and performance standards. The "reported device performance" is presented through direct comparison with the predicate.

Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on the provided document)

As per Section 10, "No clinical study is included in this submission," and Section 9 "Non Clinical Test Conclusion," the device relies on non-clinical testing and substantial equivalence to a predicate. Therefore, the following sections cannot be fully addressed with the provided text for a clinical study proving acceptance criteria.

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

   • Test Set Sample Size: Not applicable (N/A) for clinical outcomes given no clinical study was performed. For non-clinical tests, specific sample sizes (e.g., number of units tested for electrical safety, number of samples for biocompatibility) are not detailed in this summary, but are typically defined by the referenced standards.
   • Data Provenance: N/A for clinical data. For non-clinical compliance testing, the provenance is from manufacturer-conducted tests or accredited labs demonstrating adherence to international standards (e.g., IEC, ISO).

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

   • N/A. No clinical study for which ground truth would be established by experts is described.

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

   • N/A. No clinical study with adjudicated outcomes is described.

4. 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:

   • N/A. Such a study would be relevant for devices involving image interpretation or AI assistance, which this laser device is not described as having.

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

   • N/A. This is not an AI/algorithm-driven diagnostic device.

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

   • N/A. For non-clinical tests, the "ground truth" is defined by the passing criteria of the referenced international standards (e.g., specific thresholds for electromagnetic compatibility, absence of cytotoxicity).

7. The sample size for the training set:

   • N/A. No algorithm or AI component requiring a training set is mentioned.

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

   • N/A. No algorithm or AI component requiring a training set is mentioned.

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The Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status.

Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration. The device is intended for use by qualified medical personnel within a hospital, ambulatory care, transport, or any other clinical environment.

The TG-980P and TG-980P1, collectively referred to as TG-980P/TG-980P1, are CO2 Sensor Kits used to measure the concentration of carbon dioxide (CO2 or CO2) during patient expiration. The TG-980P/TG-980P1 is intended for use by qualified medical personnel as an aid for determining patient ventilatory status within a hospital, ambulatory care, transport, or any other clinical environment.

The TG-980P/TG-980P1 CO2 Sensor Kit comprises three main components: a CO2 sensor, an interface connector, and a sensor cable. It utilizes the mainstream measurement method to sample gas directly from the patient's airway and non-dispersive infrared (NDIR) absorption technology to measure CO2 concentration during patient expiration. CO2 gas absorbs infrared light at specific wavelengths, and the amount absorbed is directly related to CO2 concentration. The CO2 sensor is equipped with a light source that generates infrared light. The light passes through an attached Nihon Kohden accessory (except the Thermal Airflow Sensor) through which the expired air flows and is converted by photodetectors to voltage, which is used to calculate CO2 concentration. The calculated digital data is then transmitted and displayed on a connected patient monitor or other device.

The TG-980P/TG-980P1 CO2 Sensor Kit can be connected via the interface connector and used with Nihon Kohden devices for which the operator's manual specifies compatibility with the TG-980P/TG-980P1.

This FDA 510(k) clearance letter pertains to a hardware device (CO2 Sensor Kit) and not an AI/ML software. Therefore, many of the requested criteria regarding AI-specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC study) are not applicable.

However, I can extract the relevant acceptance criteria and details of the non-clinical performance studies conducted for the device.

Acceptance Criteria and Device Performance (Non-AI Device)

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

The document provides the performance specifications for the CO2 Sensor Kit, rather than explicit "acceptance criteria" in the typical sense of a target for a specific study. The reported device performance is compared to the predicate device's performance.

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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 CO2 Sampling lines are the single patient, disposable device intended for monitoring expired gases from the patient.
Environment of use – hospital, sub-acute, and pre-hospital settings.
Patient population – Patients requiring expired gas monitoring.

Barbaras Development Inc. CO2 Sampling lines are the accessories in breathing system and intended for sampling of exhaled gases for monitoring, typically end-tidal CO2.

The Barbaras Development Inc. CO2 sampling lines are used to connect between the patient's end of the breathing system and the distant analyzer, such as the capnograph monitor, along this tube, the patient's breath is continuously sampled. the gas sampling is exhaust only and there is no gas flow back to patient.

The Barbaras Development Inc. CO2 Sampling Lines are a disposable, single patient use that allow to sample of patients exhaled gases. It consists of flexible extruded plastic tubes with and standard connectors on each end. We will present several different configurations like have the filter or without filter in the middle which have been tested and compared to predicates.

The Barbaras Development Inc. CO2 Sampling Lines are offered in the following models: 0184 CO2 Sampling line, 0184T CO2 Sampling line, 0139 CO2 Sampling line, 0182 CO2 Sampling line.

Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling line are connected to the monitor via a standard luer fitting, whether it is a female or male fitting.

The provided FDA 510(k) clearance letter details the clearance of CO2 Sampling lines manufactured by Barbaras Development Inc. The clearance is based on substantial equivalence to a predicate device, Tylenol Medical Instruments Co., Ltd - K181981 - CO2 sampling line, and a reference device, ProMedic – Gas Sampling Lines – K023579.

It's important to note that this document is a 510(k) summary for a medical device that is an accessory (CO2 sampling lines) and not an AI/ML powered diagnostic or prognostic tool. Therefore, many of the requested elements, such as MRMC studies, effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, adjudication methods, and training set details, are not applicable to this type of device and are not present in the provided text. The evaluation focuses on physical characteristics, material compatibility, and basic performance parameters against established standards.

Here's the breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes "Non-Clinical Testing Summary" and "Performance testing" categories, indicating that these were the acceptance criteria for the device. The reported performance is generally stated as "performed equivalent to the predicate" and "All testing demonstrated that the subject devices are substantially equivalent to the predicate." No specific numerical results are provided in this summary.

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

CO2 Laser System is a laser beam generated by electrically excited carbon dioxide gas molecules, which has a very small divergence angle and high energy density. After focusing, it can reach a power of several kilowatts per square centimeter for vaporization. The unfocused original light beam irradiates the lesion tissue, which can cause coagulation of biological tissue. The CO2 laser penetrates the tissue deeper, and after irradiation, it can heat and treat the deep tissue.

This 510(k) clearance letter is for a CO2 Laser System (CO2 Laser SST-L23), a physical medical device, not an AI/ML-driven software device. The provided text outlines the substantial equivalence claims based on technical specifications and safety standards, rather than performance metrics from a clinical study involving AI. Therefore, most of the requested information regarding acceptance criteria for AI performance, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable to this device and its clearance process.

The clearance relies on demonstrating that the device is substantially equivalent to a predicate device (K200042) in terms of its intended use, design, performance characteristics (e.g., maximum power, wavelength), and safety standards.

Here's a breakdown of the relevant information provided in the document:

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

For a physical device like a CO2 Laser, acceptance criteria are typically compliance with industry standards, performance specifications matching or being equivalent to a predicate device, and safety. The reported device performance is presented as a direct comparison to the predicate.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is described as Non-Clinical Testing.

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

• Sample Size: Not applicable in the context of an AI/ML test set. The evaluation is based on engineering specifications and compliance with standards.
• Data Provenance: Not applicable for a non-AI hardware device that relies on engineering testing and comparison to predicate specifications.

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

• Not applicable as this is a physical laser device, not an AI system requiring ground truth from experts for diagnostic or similar performance. The "ground truth" here is compliance with engineering standards and performance specifications.

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

• Not applicable. This device is a surgical laser, not a diagnostic AI tool that would assist human readers.

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

• Not applicable. This is not an algorithm, but a physical device. Its performance is evaluated intrinsically against its specifications and safety standards.

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

• Not applicable in the context of AI. The "ground truth" for this device's performance relies on engineering measurements, material properties, electrical safety tests, laser safety tests, and biological compatibility tests, all benchmarked against established international standards (e.g., IEC, ISO). The comparison to the predicate device serves as the primary "ground truth" for substantial equivalence.

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/ML system.

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

• Not applicable.

Summary of the Evaluation and "Study":

The "study" proving the device meets acceptance criteria is a series of non-clinical tests (engineering tests) and a comparison study to a legally marketed predicate device (K200042).

• Non-Clinical Tests Conducted:
  • Electrical Safety: Compliance with IEC 60601-1 (Edition 3.2 2020-08)
  • Laser Safety: Compliance with IEC 60825-1:2014 and IEC 60601-2-22:2012
  • Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 (Edition 4.1 2020-09)
  • Biocompatibility (if applicable to contact parts): Compliance with ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), and ISO 10993-5 (in vitro cytotoxicity).
• Predicate Comparison: The performance and safety characteristics of the proposed device are directly compared feature-by-feature to the cleared predicate device. Differences (e.g., cooling system, dimensions, weight) are analyzed to ensure they do not negatively affect safety or effectiveness.

In conclusion, the clearance of the CO2 Laser System (CO2 Laser SST-L23) through K250183 is based on demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards for physical medical devices, not on data science criteria applicable to AI/ML systems.

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Single Use CO2 Laser Fiber is indicated for the ablation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.

Single Use CO2 laser fiber is a single use hollow fiber compatible to CO2 laser systems with the following specifications:

• equipped with F-SMA receptacle connector; ●
• equipped with a CO2 laser source, emitting radiation at 10.6 µm wavelength with pulsed and continuous wave (CW) emission mode;
• . able to produce a beam of maximum 300 µm diameter with maximum 30 mrad divergence at the fiber input plane;
• . with a maximum power of 40 W;
• equipped with an internal compressed air delivery system capable to generate a positive air flow ● inside the fiber tube;

The fiber structure is reported in Figure 1. It is composed of two layers: a capillary tube made of fused silica and a jacket made of ETFE. The cavity is covered by two films: the outer one is made of silver and the inner one is made of silver iodide. Silver, due to its high reflectivity, allows laser beam reflection and, thus, propagation inside the cavity. The addition of a silver iodide film from oxidation. A summary of fiber materials is reported in Table 2. Such materials represent patient contacting materials. D1, the lumen diameter, also corresponds to the laser beam diameter.

Optical fiber main components are shown in Figure 2. It is equipped with a SMA905 connector to be coupled to the laser system and a code plug that, for laser systems equipped with a code plug connector, allows the laser device to detect the fiber presence. A protective cap, to be removed before use, is placed on the fiber tip. Strain relief protects the fiber from mechanical stress at the connector side.

This kind of fiber needs to be connected to a laser system with an internal compressed air system. An air flow inside the fiber lumen is necessary to both cool the fiber and keep it free from debris.

This document describes the 510(k) summary for the Single Use CO2 Laser Fiber (HAF005001). It does not contain information about an AI/ML device or its acceptance criteria and study data. The document focuses on demonstrating substantial equivalence to a predicate laser fiber through technical specifications, indications for use, and non-clinical bench testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving an AI/ML device meets them, as the provided text pertains to a laser medical device, not an AI/ML product.

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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 Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) and accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

Surgical Handpieces
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with surgical handpieces are indicated for use for the particular indications as follows:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

• · laser skin resurfacing
• · laser derm-abrasion
• · laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.

OptiScan PRIME Scanner
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with OptiScan PRIME scanner are indicated for:
·Laser skin resurfacing (ablation and/or vaporization) of soft tissue

Youlaser PRIME and Youlaser PRIME MT with wavelength of 1550nm used in combination with OptiScan PRIME scanner, are indicated for:
· Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

Youlaser PRIME MT with wavelengths of 10600nm & 1550nm used in combination with OptiScan PRIME is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The models of the Youlaser PRIME family are medical laser emitting at 10600nm (CO2 laser source), 1550nm, plus combined configurations.

The 1550nm laser source is a fiber laser, this wavelength lies in the invisible infrared part of the electromagnetic spectrum.

The CO2 laser source is an RF driven sealed gas tube emitting laser radiation both in continuous and pulsed mode in the invisible far-infrared part of the electromagnetic spectrum (10600nm).

The beam delivery system is an articulated arm with a handpiece or a scanner on its end.

The laser device is equipped with a display with a graphical user interface (GUI) for user-device interaction (e.g. laser parameters settings).

The scanner is also provided with a touchscreen display to select the scan pattern, shape, dimension,...etc. Laser emission is controlled via the external footswitch has an activation pedal which enables laser emission.

The provided text describes a 510(k) premarket notification for a laser surgical instrument. It details the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a human-in-the-loop or algorithm-only performance study as typically seen for AI/ML-based medical devices.

The "study" mentioned is an in vivo animal study (on minipigs) for the 1550nm fiber laser source to demonstrate safety and effectiveness, specifically regarding its ability to cause ablation and coagulation in tissue. This is a pre-clinical safety/performance study, not a clinical study assessing diagnostic or assistive performance against ground truth and acceptance criteria in the way an AI/ML device would be evaluated.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance is not present in the provided document.

Here's what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance goals for a diagnostic algorithm. The document focuses on demonstrating substantial equivalence to predicate devices in terms of technical characteristics and intended use, and safety and effectiveness through non-clinical (animal) testing.
• Reported Device Performance:
  • In vivo minipig study (for 1550nm fiber laser):
    • Outcome: "Testing was performed safely on the test animals, and the histology results complied with the FDA requirements, from 0 to 14 days."
    • "Re-epithelization was observed three days after radiation in all specimens."
    • "Slight erythema was noted as the primary side effect in higher energy settings, but it was transient and resolved within days."
    • "No cases of oedema were observed, and overall, the healing process was uncomplicated."
    • "Histologic analysis performed with H&E staining at various time points (days 1, 4, and 14) revealed predictable levels of ablation and coagulation depending on the energy settings used, with the fiber laser causing predominantly coagulation while the CO2 laser focused on ablation."
    • "By day 4, re-epithelization of the skin was already evident, and by day 14, the skin had fully healed."
  • Conclusion: "The Youlaser PRIME device demonstrates predictable and controlled skin ablation and coagulation, ensuring patient safety and clinical efficacy." and "The findings confirm that the device is equivalent to other approved technologies, with precise control over energy output and microspot density to facilitate rapid healing and minimize side effects."

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

• Test Set (for the in vivo study): "Three animals were used in this study."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's an in vivo animal study, not human clinical data.

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

• Experts: Not explicitly stated. The document mentions "histologic analysis performed with H&E staining," which implies expert pathological assessment, but the number and qualifications of the pathologists are not provided.
• Ground truth context: For this type of device, "ground truth" would be the observed biological effects (ablation, coagulation, healing) in the animal tissue, as assessed histologically.

4. Adjudication method for the test set

• Not applicable/Not mentioned, as this was an evaluation of physical effects on tissue, not a diagnostic decision process requiring adjudication.

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. This type of study is for AI-assisted diagnostic devices. The Youlaser PRIME is a laser surgical instrument, and the evaluation presented is a non-clinical (animal) study of its physical effects, not a human-reader study.

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

• No. This is not an AI/algorithm-only device. The "study" refers to the laser's physical interaction with tissue.

7. The type of ground truth used

• For the in vivo animal study: Histology results (e.g., H&E staining at various time points) examining ablation, coagulation, and re-epithelialization in minipig skin tissue.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. No training set for an AI/ML model.

Summary of Device and its Evaluation:

The Youlaser PRIME family devices are laser surgical instruments. The "study" mentioned in the document is an in vivo non-clinical study on minipigs designed to demonstrate the safety and effectiveness of the 1550nm fiber laser source by evaluating the biological response (ablation, coagulation, healing) in animal tissue. This type of evaluation is standard for surgical devices that interact directly with tissue, focusing on physical parameters and biological outcomes rather than diagnostic performance or human-AI interaction. The document's primary purpose is to establish substantial equivalence to legally marketed predicate devices, which is achieved by comparing technical specifications and demonstrating comparable safety and effectiveness through non-clinical testing.

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