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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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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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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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CO2 Laser System is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiaty, otolaryngology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The CO2 Laser System is a computer controlled radiofrequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The CO2 Laser System is comprised of multiple components, including the control unit and handpieces. Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.

The provided document is a 510(k) summary for a CO2 Laser System (Models: PureLase and VanLase). It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for testing or training, data provenance, expert ground truth establishment, or any kind of statistical study (like MRMC or standalone performance). It primarily lists the non-clinical tests performed to ensure the device meets design specifications and relevant safety/performance standards (e.g., IEC 60601 series, ISO 10993).

Therefore, I cannot provide the requested table and study details. The information about the study that proves the device meets the acceptance criteria is not present in this 510(k) summary. The document focuses on showing substantial equivalence based on technical specifications and adherence to safety/performance standards, not on clinical performance metrics typically associated with AI/software-as-a-medical-device (SaMD) clearances that often require clinical performance studies.

Here's what I can extract based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided. The document lists non-clinical tests (IEC standards, biocompatibility, software V&V, bench testing) but does not present specific quantitative acceptance criteria (e.g., accuracy > X%, sensitivity > Y%) or the results of such performance against a test set. This type of information is typically found in clearance documents for devices relying on diagnostic performance (like AI algorithms).

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

• Not provided. No information about a "test set" or "training set" of data (e.g., images, patient records) is mentioned. The tests conducted are primarily engineering and safety compliance tests, not clinical performance studies involving patient data.

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

• Not applicable/Not provided. Since there's no mention of a test set based on clinical data, there's no information about experts establishing ground truth for such data.

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

• Not applicable/Not provided.

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 provided. No MRMC study is mentioned. This device is a laser system, not an AI software intended to assist human readers in interpretation.

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

• Not applicable/Not provided. This is a hardware device, not a standalone algorithm.

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

• Not applicable/Not provided.

8. The sample size for the training set:

• Not provided.

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

• Not applicable/Not provided.

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Intended use The Dräger CO2 Mainstream Sensor for measuring the CO2 concentration in breathing gas (CO2 mainstream sensor).

Indications The CO2 mainstream sensor enables the diagnosis and monitoring of patients by measuring CO2. The use of the medical device is limited to one patient at a time.

The CO2 Mainstream Sensor is designed for continuous, non-invasive mainstream measurement of Carbon Dioxide. The sensor is able to monitor CO2 using an infrared absorption technique and measures end tidal CO2 and inspired CO2 and calculates the respiratory rate. The data are processed by a microcontroller and provided to the parent device via a serial interface.

The sensor is adapted to the breathing system by airway adapters (CO2 measuring cuvettes).

Here's a summary of the acceptance criteria and study information for the CO2 Mainstream Sensor, based on the provided FDA 510(k) premarket notification:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics of the CO2 Mainstream Sensor with corresponding reported values in a consolidated format. However, it mentions extensive testing against various standards, which imply certain performance criteria. The key performance-related mention is the "Measuring range," which has been slightly extended compared to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for specific performance tests or studies like clinical trials in terms of the number of patients or specific data points. The testing mentioned is primarily bench testing and in vitro evaluations against technical standards and requirements.

The data provenance is not specified beyond indicating "extensive testing" and "well-established methods." It's reasonable to infer these tests were conducted by the manufacturer (Drägerwerk AG & Co. KGaA) in Germany, given the submitter's location. The studies appear to be retrospective in nature, drawing from the predicate device's established performance and applying new testing to demonstrate equivalence or improvement.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for testing in the context you describe (e.g., radiologists for image interpretation). The testing conducted is primarily objective, technical verification and validation against pre-defined standards and specifications for a CO2 sensor. Therefore, the "ground truth" for the test set would be derived from:

• Reference gases with known concentrations for CO2 measurements.
• Calibrated instruments for temperature, humidity, pressure, and electrical measurements.
• Standardized test procedures and benchmarks for software, EMC, and safety.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned, as this type of human expert consensus is not typically applicable to the kind of technical and bench testing described for this device. Test results would be compared directly to the specified standards and requirements.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. The CO2 Mainstream Sensor is a measurement device where its output is directly read rather than interpreted by multiple human readers in a comparative setting.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the testing described appears to be primarily standalone performance testing, focusing on the algorithm (implicitly, the sensor's measurement principle and data processing) and hardware of the device itself. The "Discussion of Non-clinical Testing" section lists various technical evaluations, including software, electrical safety, EMC, and specific performance requirements from ISO 80601-2-55 for respiratory gas monitors. These are conducted on the device's inherent capabilities without human intervention for interpretation as part of the performance evaluation.

7. The Type of Ground Truth Used

The ground truth used for the technical testing would be:

• Reference Standards: Such as known concentrations of CO2 for accuracy testing, established environmental conditions (temperature, humidity, pressure), and defined electrical safety limits.
• Calibration Standards: High-precision instruments used to calibrate and verify the accuracy of the sensor's measurements.
• Compliance to Standards: The device's performance is measured against predefined thresholds and specifications outlined in the various IEC and ISO standards listed (e.g., ISO 80601-2-55 specific requirements for respiratory gas monitors).

8. The Sample Size for the Training Set

This device appears to be based on an established measurement principle (infrared absorption), and the submission focuses on demonstrating substantial equivalence through non-clinical testing rather than development of a novel algorithm that would require a "training set" in the machine learning sense. Therefore, there is no mention of a training set sample size as it's not applicable to the development verification of this type of device.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" mentioned in the context of machine learning, this question is not applicable to the information provided. The principles the device operates on are well-understood physics, and the validation relies on meeting established technical specifications and standards rather than learning from a dataset.

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

CO2 Laser System is a carbon dioxide surgical laser device intended for prescription use and is comprised mainly of three components: console, articulated arm and footswitch. CO2 Laser System contains a radio-frequency excited CO2 laser tube which generates laser sources at nominal wavelength of 10,600 nm. As CO2 laser radiation is invisible; therefore, a low-power, visible aiming laser source (650 mm) is required to position the treatment laser beam. The output of laser beam is delivered through articulated arm to a fractional handpiece or normal handpiece. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The physician activates laser emission by means of a footswitch. The fractional handpiece is suited mainly for general surgical application.

This document is a 510(k) premarket notification for a CO2 Laser System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on clinical performance metrics. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.

The "performance data" section primarily discusses non-clinical testing related to electrical safety, electromagnetic compatibility, laser safety standards, and software verification and validation. It does not provide clinical performance data or acceptance criteria in terms of accuracy, sensitivity, specificity, or similar metrics typically associated with AI/diagnostic device studies.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission describes non-clinical engineering and software testing of a physical laser device, not a study involving human subjects or data sets for performance evaluation of an AI or diagnostic algorithm.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth based on expert review of clinical data is mentioned. The "ground truth" here is compliance with engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudicated test set in the context of clinical or AI performance. The device's compliance is based on direct measurement and verification against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not describe any MRMC comparative effectiveness study, as it's for a surgical laser device and not an AI or diagnostic tool where reader performance is typically evaluated.

6. If a Standalone Performance Study was done

Yes, in a sense, a standalone engineering performance assessment was done. The device's electrical safety, laser safety, electromagnetic compatibility, and software were independently tested against specified standards. However, this is not a "standalone (i.e., algorithm only without human-in-the-loop performance)" in the context of AI or diagnostic algorithms.

7. The Type of Ground Truth Used

The "ground truth" in this context is adherence to established international and national engineering standards for medical electrical equipment, laser safety, and electromagnetic compatibility. For software, the ground truth is adherence to FDA's guidance for software verification and validation. There is no clinical "ground truth" (e.g., pathology, outcomes data) mentioned in this regulatory submission.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set was Established

Not applicable.

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The CO2 Laser Equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

The subject device CO2 Laser Equipment is a carbon dioxide laser used in medical and aesthetic industry. The device emits laser energy at 10.6 um wavelength to induce human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. The CO2 Laser Equipment includes two models US800/US800N, the two models have same mechanism of action, structure, material, motherboard, software, principle and specification. The difference is appearance and size.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the CO2 Laser Equipment (K212611):

1. Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K192528) through performance and safety comparisons, rather than explicitly stating quantitative "acceptance criteria" for a novel device performance claim. The "acceptance criteria" are implied by the "Remark" column being "SAME" or "SE" (Substantially Equivalent) between the proposed and predicate devices.

For dimensions and weight, the proposed device differs but is deemed acceptable by complying with IEC 60601-1, indicating that this difference is not expected to adversely affect safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a premarket notification for a Class II medical device (CO2 Laser Equipment). The submission is based on demonstrating substantial equivalence to a previously cleared predicate device.

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no specific "test set" of patient data in the way one would conduct a clinical trial for a novel device performance claim. The key assessment is against technical specifications and safety standards.
• Data Provenance: Not applicable for a typical clinical test set. The data provenance relates to the technical specifications, design documents, and results of non-clinical bench testing. The predicate device's prior clearance provides the established safety and effectiveness benchmark. The manufacturer is Beijing Globalipl Development Co., Ltd. (China).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This submission relies on demonstrating adherence to recognized consensus standards and equivalence to a predicate device, not on expert consensus to establish a "ground truth" for a diagnostic or predictive performance.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is needed or included in this submission."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a CO2 Laser Equipment, a physical surgical instrument, not an AI algorithm or software-only device. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate device (K192528), along with compliance to recognized international safety and performance standards for medical electrical equipment and laser products (e.g., AAMI ES60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2). The submission argues that since the proposed device is technologically similar and meets the same or comparable performance standards, it is as safe and effective as the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device.

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

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

The CO2 laser machine has two modes, continuous mode and multi-pulse mode. It utilizes CO2 laser to vaporize and heat tissue.

During the treatment, the water in skin tissues absorbs laser energy and then vaporizes.

Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through a LCD touch-screen.

The provided text does not describe acceptance criteria for a medical device's performance, nor does it detail a study proving its performance against such criteria.

Instead, this document is a 510(k) summary for a CO2 Laser Machine, Model: BW-203B, seeking market clearance from the FDA. The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as the predicate and does not raise different questions of safety and effectiveness.

The document focuses on comparing the proposed device to a predicate device (K200042) in terms of general characteristics, performance specifications, and safety standards.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from the given text.

However, I can extract information related to the comparison with the predicate device and the non-clinical tests performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the traditional sense of performance metrics that the device's output is measured against. Instead, it compares the proposed device's specifications and compliance with safety standards against a predicate device. The "Remark" column indicates if the characteristic is "SAME" or "SIMILAR."

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

The document explicitly states: "No clinical study is included in this submission." This implies there was no "test set" in the context of clinical performance evaluation. The evaluation for substantial equivalence was based on non-clinical tests (bench testing, standards compliance) and comparison to the predicate device's specifications.

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

Not applicable, as no clinical study or test set requiring expert ground truth was conducted.

4. Adjudication method for the test set:

Not applicable, as no clinical study or test set was conducted.

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 Machine for surgical use, not an AI-assisted diagnostic or imaging device that would typically involve human readers.

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

Not applicable. This device is hardware for surgical procedures, not an algorithm.

7. The type of ground truth used:

Not applicable. The "ground truth", in this context, is the compliance with established electrical, laser, and biocompatibility safety standards (IEC, ISO) and the functional specifications demonstrated through non-clinical testing.

8. The sample size for the training set:

Not applicable, as no AI/algorithm training was performed or reported.

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

Not applicable, as no AI/algorithm training was performed or reported.

Summary of what the document does provide:

The document focuses on demonstrating substantial equivalence to a predicate device (K200042) through:

• Comparison of technical specifications: Maximum power, work mode, wavelength, beam delivery, control system, cooling system, etc.
• Compliance with recognized standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10.
• Non-clinical testing: This involved verifying that the proposed device met design specifications and complied with the listed safety standards. It also mentions "Software Validation & Verification Test."
• Conclusion: Based on the comparison and non-clinical tests, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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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 CO2mbi LED SCB is a combination of an LED light source, intended to provide illumination, and an insufflation/ irrigation pump, intended to insufflate CO2 or air as a distention media in the gastronitestional tract or water irrigation for lens cleaning when used in conjunction with flexible endoscopes for GI endoscopic procedures.

CO2mbi LED SCB is a portable and compact all-in-one LED Light source and insufflation unit that includes a touchscreen control display, an insufflation pump and internal LED light source, intended to be connected to a compatible GI Videoendoscope and CCU for illumination and insufflation purposes. It is also equipped with a water bottle and lid with tube to provide irrigation for lens cleaning.

The provided text describes a medical device, the CO2mbiLED SCB, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of clinical performance. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical data.

Therefore, many of the requested details cannot be extracted from this document, as the document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence."

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not present a formal table of acceptance criteria for clinical performance because it did not conduct a clinical study. Instead, it refers to:

• Compliance with FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, IEC 62471).
• Software Verification and Validation Testing guided by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" with a "Level of concern: Moderate."
• Additional bench testing "to ensure the device met its design specifications."

The reported device performance, in terms of its functions, is stated as having:

• Different flow rates and flow rate settings compared to predicates.
• Slightly different operating pressures and pressure to activate the pressure relief valve (CO2) compared to predicates.

The summary then concludes that these differences "do not raise different questions of safety and effectiveness because the intended use, operating principles, technological characteristics, and features are significantly similar, if not identical. Both systems also comply with identical standards and safety testing, where applicable. Substantial equivalence on the effectiveness of the subject device is supported by the comparison of the flow rate, flow rate settings operating pressure and pressure to activate pressure relief valve (Table F) and bench testing to show that the subject device function as intended (Section 21 – Performance Testing)."

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 available because no clinical test set was used for a substantial equivalence determination in this document. The evaluation was based on non-clinical bench testing and comparison to predicate devices.

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

This information is not available because no clinical test set requiring expert-established ground truth was part of this submission for substantial equivalence.

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

This information is not available because no clinical test set requiring adjudication was part of this submission.

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

An MRMC comparative effectiveness study was not done. The device is an endoscope accessory (light source and insufflation/irrigation pump), not an AI-powered diagnostic tool for human reader improvement.

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

This question is not applicable as the device is not an algorithm, but a hardware device (light source and pump).

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

For the non-clinical performance, the "ground truth" was established by design specifications for the device, and compliance with recognized consensus standards.

8. The sample size for the training set

This information is not available as the device is not an AI/machine learning algorithm that requires a training set. The evaluation was based on non-clinical bench testing.

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

This information is not available as the device is not an AI/machine learning algorithm requiring a training set with established ground truth.

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