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

The device emits CO2 laser at the wavelength of 10.6um, which is the spectral line in the far infrared range. The device is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

This FDA 510(k) summary describes a CO2 Laser System by Beijing Superlaser Technology Co., Ltd. and seeks to demonstrate its substantial equivalence to a predicate device (K192528).

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

The document doesn't explicitly state "acceptance criteria" as a separate section with specific thresholds. Instead, the substantial equivalence is based on a comparison to a predicate device, showing that the proposed device performs "the same" or "similarly" across various specifications and complies with relevant safety standards.

Here's a table based on the "Performance Comparison" and "Safety Comparison" sections, with "Reported Device Performance" being the specifications of the Proposed Device and "Acceptance Criteria" being implicitly met if it's "SAME" or "SIMILAR" to the Predicate Device, or complies with established standards.

The study (non-clinical testing) states that "The test results demonstrated that the proposed device complies with the following standards" for safety and that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." This implicitly means the device meets the acceptance criteria of conforming to the predicate device's performance characteristics and a set of recognized electrical, EMC, and laser safety standards.

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

• Sample size for the test set: Not applicable. The document describes non-clinical bench testing and software validation, not a study with a "test set" of patient data or images.
• Data provenance: Not applicable, as there isn't patient data/images involved in this type of submission. The tests are bench tests performed in a laboratory setting by the manufacturer. The company is based in Beijing, China.

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

Not applicable. This submission is for a CO2 Laser System that performs surgical functions, not an AI/imaging device requiring expert consensus for ground truth on diagnostic interpretations. The "ground truth" for this device would be its physical performance specifications and adherence to safety standards, verified through engineering tests.

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

Not applicable, as there is no "test set" in the context of clinical or image-based studies 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, an MRMC comparative effectiveness study was not done. The device is a physical CO2 laser system, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is not an AI algorithm. The device performance is assessed through its physical operation and compliance with engineering standards.

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

The "ground truth" for this device's performance and safety is established through:

• Engineering specifications and measurements: Comparing output power, wavelength, spot size, etc., against the predicate device's documented specifications.
• Compliance with recognized international standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2 for electrical, EMC, and laser safety.
• Bench Performance Tests: These would involve direct measurements of the device's output and function.
• Software Validation & Verification Test: Ensuring the control system software operates correctly according to its design specifications.

8. The sample size for the training set:

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

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

The subject device, CO2 Laser System (Model: GP900F) 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 absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.

This document describes the CO2 Laser System (Model: GP900F) and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), or a study designed to prove the device meets such criteria in terms of clinical effectiveness.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through comparisons of technological characteristics, safety standards, and non-clinical testing. This type of submission (510(k)) generally does not require clinical effectiveness studies in the same way a PMA (Premarket Approval) would.

Therefore, many of the requested details cannot be extracted from the provided text. I will answer the questions based on the information that is available.

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

Based on the provided text, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) and corresponding device performance metrics are not detailed. The acceptance criteria are implicit in the demonstration of substantial equivalence to predicate devices and compliance with safety and performance standards.

The "performance" described relates to adherence to safety standards and the ability to deliver set laser energy parameters within specifications, not clinical outcomes or diagnostic accuracy.

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

Not applicable/Not provided. This document details a 510(k) submission, which typically relies on non-clinical testing and comparison to predicate devices, rather than clinical studies with test sets in the context of diagnostic or treatment accuracy. The "test set" here refers to the units of the device itself and materials used for engineering and biocompatibility tests.

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)

Not applicable/Not provided. Ground truth, in the context of clinical outcomes or diagnostic accuracy, is not discussed. The "truth" for this submission is compliance with established device safety and performance standards and technological equivalence to predicate devices. Experts involved would be engineers, physicists, and toxicologists related to the conducted tests.

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

Not applicable/Not provided. This refers to methods for resolving discrepancies in clinical assessments, which is not relevant to this type of device submission presented here.

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/Not provided. This device is a CO2 Laser System, a surgical instrument. It is not an AI-assisted diagnostic or interpretation device that would typically involve human "readers" or MRMC studies.

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

Not applicable/Not provided. The CO2 Laser System is a surgical instrument operated by a human, not an algorithm.

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

The "ground truth" for this 510(k) submission is primarily established through:

• Compliance with recognized international standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, and FDA guidance for software.
• Bench performance testing: Demonstrating that the device physically delivers its intended laser energy parameters as specified.
• Comparison to predicate devices: Establishing that the technological characteristics and indications for use are substantially equivalent to devices already cleared by the FDA.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a "training set" in the context of machine learning or AI models, as this is a physical medical device. If "training set" refers to manufacturing processes or quality control, that information is not detailed here.

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

Not applicable/Not provided. As there is no "training set" for an AI or machine learning model, the establishment of ground truth in that context is not relevant.

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eBeam CO2 Laser System are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery ,gynecology,podiary,dental and otorhinolaryngology

Dermatology, Plastic Surgery and General Surgery procedures including but not limited to:

Laser skin resurfacing

Treatment of furrows and wrinkles

Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.

Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.

Blepharoplasty

Site preparation for hair transplants

Dental procedure including but not limited to -

Periodontal procedures such as - gingivectomy, removal of hyperplasias gingivoplasty (incision and excision);

Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign /malignant lesion ablation, operculectomy and homeostasis

Podiatry procedures including but not limited to -

Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.

Otorhinolaryngology (ENT) procedures including but not limited to -

Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.

Gynecology

Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.

This device is for prescription use only.

The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device.

eBeam CO2 Laser System is an intelligent sealed-off CO2 laser. eBeam CO2 Laser System delivers laser energy to the treatment site via a 7-joint spring-balanced articulated arm in which mirrors reflect the laser beam along the axis of arms to enter the output device- the specially designed handpiece.

eBeam CO2 Laser System can produce a laser beam with a wavelength of 10.6 m which is effective on all soft tissues, thus it can be used in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic(dermatology and plastic surgery), general surgery, gynecology, podiatry, dental and otorhinolaryngology.

eBeam CO2 Laser System consists of control system, user interface, power supply, laser emission and delivery system, cooling system, safety features and handpieces (including scanning handpiece and normal handpiece).

The provided text describes a 510(k) submission for the "eBeam CO2 Laser System." This submission focuses on demonstrating substantial equivalence to a predicate device and does not involve a study to prove the device meets specific performance acceptance criteria in the way a diagnostic AI/ML device would. Instead, the "acceptance criteria" are based on compliance with established safety standards and the device's functional similarity to the predicate.

Therefore, many of the requested categories (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment, training set size) are not applicable to this type of regulatory submission and device.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable. This device is a surgical laser system, not a diagnostic AI/ML system requiring a test set of data. The "testing" referred to in the document is non-clinical laboratory testing of the device's engineering specifications and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no "test set" or "ground truth" in the context of expert review of data for this type of device.

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 is not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's regulatory acceptance is its adherence to international safety standards and its functional equivalence to a legally marketed predicate device, confirmed through non-clinical laboratory testing.

8. The sample size for the training set
Not applicable. This device does not use an AI/ML training set.

9. How the ground truth for the training set was established
Not applicable.

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The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties:

• Cosmetic Surgery .
• Dermatology .
• General Surgery .
• Gynecology .
• Head & Neck Surgery .
• Neurosurgery .
• Oral Surgery .
• Orthopedic Surgery ●
• Otorhinolaryngology t
• Pediatric Surgery ●
• Plastic & Reconstructive Surgery t
• Podiatry
• Urology

The CO2 Laser System, Model C-LAS is an easily transported table top laser console made of mainly machined aluminum and optics for the transmission of reflection of CO2 laser wave lengths. It is a carbon dioxide laser which emits laser light at 10.6 micrometers and has a RF excited laser tube which produces an output power of about 30 watts. The laser is for used by physicians for cutting and coagulation at a wound during surgery. The physician uses the laser light on tissue via lenses and a focusing hand piece, or via a diamond scalpel which transmits the laser light onto the scalpel.

This document describes a 510(k) premarket notification for a CO2 laser system, Model C-LAS. The information provided heavily focuses on regulatory aspects and comparison to a predicate device, rather than detailed performance studies and acceptance criteria as would typically be seen for a new diagnostic AI device.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative output power ranges with tolerances) for the device's cutting and coagulation abilities. Instead, it relies on substantial equivalence to a predicate device.

The "Performance Characteristics" section in the General Product Information (page 2) refers to "Software Test Procedures and Test Report," but the details of these tests and their criteria are not included in the provided text.

Based on the information given, the primary "acceptance criterion" appears to be Substantial Equivalence to the predicate device K875338: CHRYS™ MODEL MED-MAX.

Here's a table based on the similarities highlighted for substantial equivalence, which serves as a de-facto "performance" comparison in this context:

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

The document does not describe a "test set" in the context of clinical data for performance evaluation. It describes technological similarities to a predicate device. The "Software Test Procedures and Test Report" are mentioned (page 2), but their details, including sample sizes or data provenance, are not provided. Given the nature of a CO2 laser surgical instrument, "data provenance" related to patient data would not typically be applicable in the same way as for an AI diagnostic device.

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)

Not applicable. This is a medical device (laser surgical instrument), not a diagnostic AI system requiring expert-established ground truth from clinical images or patient data. The "ground truth" for a laser system would be its physical output parameters meeting specifications.

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

Not applicable. No "test set" in the traditional sense of clinical data requiring expert adjudication is described.

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 is a standalone medical device (CO2 laser), not an AI system designed to assist human readers.

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

The device itself is a standalone laser surgical instrument. Its performance would be evaluated based on engineering specifications and safety, not an algorithm's diagnostic performance. The document indicates that "Software Test Procedures and Test Report" were performed (page 2), implying software testing for the embedded control system, but not clinical "standalone performance" in the AI sense.

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

For this type of device (a CO2 laser surgical instrument), the "ground truth" would be established through:

• Engineering specifications and measurements: Verifying output power, wavelength, mode, and other physical parameters meet design requirements.
• Performance testing: Demonstrating the device can perform its intended functions (cutting and coagulation on tissue models or in animal studies, though not explicitly detailed here).
• Safety testing: Ensuring compliance with electrical safety, laser safety standards, and electromagnetic compatibility.

The document refers to a "Certificate of Conformity" and "Safety Risk Analysis" (page 2), which would cover these aspects.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI system that requires a "training set" of data.

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

Not applicable.

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