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The eCO2 3D Laser System with fractional handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.

The eCO2 3D Laser System using the non-fractional handpieces (F100, F50, Zoom, and 500 micron tip) is also indicated for use in skin resurfacing and surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, and podiatry.

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
• Treatment of wrinkles, rhytids and furrows
• Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.

Dermatology, Plastic Surgery & General Surgery: Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.

Podiatry:
Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares.

The eCO2 3D Laser System consists of a self-contained console, with a 10.6μm wavelength delivered through an articulated arm. The emitted laser beam is then irradiated to the treatment area through a handpiece and a tip connected to the handpiece.

The eCO2 3D is used by a trained physician for procedures requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue.

The eCO2 3D Laser System utilizes an articulated arm to generate a laser beam with a wavelength of 10.6μm by applying patented chaos scanning technology. It radiates a micro-laser beam with an aiming beam of 520nm to the surgical area. Micro laser beams are radiated onto the treatment area, generating MAC (Micro Ablative Column), which improves the skin condition as it recovers. By changing the handpiece according to various application areas, the user can change the beam spot size to optimize the treatment effect. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip.

The system console is the heart of the eCO2 3D Laser System and contains the Touch LCD, handpieces, system control module, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD. There are 4 casters in the console base that can be used when moving the system.

This FDA 510(k) clearance letter pertains to the eCO2 3D Laser System, an ablative laser, not an AI/Software as a Medical Device (SaMD). Therefore, the typical acceptance criteria and study designs associated with AI/SaMDs (such as sensitivity, specificity, MRMC studies, ground truth establishment, etc.) are not applicable to this document.

The document describes the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence, as is standard for a 510(k) submission for a physical medical device. It explicitly states: "No clinical tests were performed for this submission." This means there is no data provided within this document regarding device performance against typical AI/SaMD acceptance criteria.

However, I can extract the information that is relevant to the device's clearance and structure it to address your request as best as possible within the limitations of the provided text.

Analysis of the Provided Document for Acceptance Criteria and Study Proof:

The eCO2 3D Laser System is a physical medical device (laser system) for dermatological and surgical procedures. The 510(k) clearance process for such a device primarily relies on demonstrating substantial equivalence to predicate devices through technical characteristics, safety standards compliance, and intended use alignment, rather than performance metrics on a 'test set' as would be seen for an AI diagnostic algorithm.

Therefore, many of the requested categories (related to AI performance metrics, test sets, ground truth, and human reader studies) are explicitly not present in this document because they are not relevant to the 510(k) clearance of this type of device.

Here's a breakdown based on the provided text, indicating where information is present and where it's not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are primarily related to safety, electrical performance, laser specifications, and functional equivalence to predicate devices. There are no performance metrics like sensitivity/specificity for a diagnostic AI.

Since this is not an AI/SaMD, the following sections are Not Applicable (N/A) based on the provided document:

2. Sample size used for the test set and the data provenance: N/A (No clinical test set described for performance evaluation; clearance based on substantial equivalence to predicate device specifications and non-clinical testing for safety/electrical performance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No external 'ground truth' establishment for diagnostic performance).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No adjudication required for this type of device clearance).
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: N/A (Not an AI-assisted device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI algorithm).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A (No diagnostic ground truth needed).
8. The sample size for the training set: N/A (No AI training set).
9. How the ground truth for the training set was established: N/A (No AI training set).

Conclusion from the Document:

The acceptance for the eCO2 3D Laser System is based on demonstrating substantial equivalence to its predicate device (Lutronic eCO2 Plus, K100610) and a reference device (SNJ Finexel, K213557). This demonstration relies on comparing technical specifications and compliance with relevant national and international safety and performance standards (as listed in 807.92(b)(1)). The document explicitly states: "No clinical tests were performed for this submission." Therefore, there is no performance study data in the context of diagnostic accuracy, human reader improvement, or algorithm-specific metrics available in this 510(k) clearance letter.

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1550nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

1927nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring the coagulation of soft tissue.

The Fiber laser Treatment systems (HS-232) is the desktop type, and (HS-233) is the mobile type. It consist of mainframe(touch-screen data input system, power supply control system and cooling system)，fiber treatment handpiece (laser output system ) and footswitch. The Fiber Laser Treatment System is an Erbium(1550nm) and Thulium(1927nm) fiber laser, producing a pulsed beam upon activation by a footswitch. The system is equipped with a 650nm aiming beam with less than 2mW, the beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.

The 1550nm laser and 1927nm laser works independently and cannot work together, the output laser source can be selected according to different indication for use

The provided text is a 510(k) clearance letter and an accompanying 510(k) summary for the Fiber Laser Treatment Systems (HS-232, HS-233). This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving the device meets acceptance criteria is not present in this document. The FDA 510(k) process for this type of device (laser surgical instrument) typically relies heavily on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing (electrical safety, EMC, performance against standards) and functional comparisons, rather than requiring extensive clinical trials with specific performance endpoints.

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

What can be extracted:

• Device Name: Fiber Laser Treatment Systems (HS-232, HS-233)
• Intended Use/Indications for Use:
  • 1550nm: Intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
  • 1927nm: Intended for use in dermatological procedures requiring the coagulation of soft tissue.
• Non-Clinical Testing Performed: Electrical safety and electromagnetic compatibility based on several IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
• Clinical Testing: Not applicable, as stated in the document.

What cannot be extracted (as per your request, because the document doesn't contain a specific study demonstrating performance against acceptance criteria beyond general safety and equivalence):

1. A table of acceptance criteria and the reported device performance: No specific performance acceptance criteria (e.g., minimum percentage of fractional skin resurfacing achieved, specific coagulation depth) or reported performance results (e.g., test scores, sensitivity, specificity, accuracy) are provided. The "performance testing" mentioned refers to verifying design specifications and compliance with standards, not performance against clinical or perceptual criteria.
2. Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned as clinical testing was not applicable.
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 test with expert-established ground truth was reported.
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 laser surgical instrument, not an AI-powered diagnostic device with human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established for "performance" beyond compliance with engineering standards.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA document focuses on demonstrating that the Fiber Laser Treatment Systems are substantially equivalent to previously cleared predicate devices based on technological similarity, indications for use comparison, and compliance with general electrical safety and laser standards. It does not detail a study proving the device meets specific clinical performance acceptance criteria.

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The AVAVA™ Skin Treatment System is indicated for use in the treatment of acne scars, and dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The AVAVA™ Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.

The AVAVA™ Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.

The AVAVA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the AVAVA.

The AVAVA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.

The AVAVA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port.

The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.

The provided text is a 510(k) clearance letter and summary for the AVAVA™ Skin Treatment System, a laser device. It does not describe an AI/ML device or a study proving its performance against specific acceptance criteria for such a device.

The study described is a clinical study for the device's efficacy and safety in treating acne scars. It involves human subjects, photographs, and expert evaluators, but it is not an AI/ML performance study where an algorithm's output is being evaluated against ground truth.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI/ML device meets them, as the provided document does not contain this information.

To illustrate, if this were an AI/ML device performance study, the sections would be filled using information that is NOT present in the provided document:

Hypothetical Section (based on the prompt's requirements, NOT the provided text):

Hypothetical AI/ML Device Performance Study Description (Illustrative, NOT from provided text)

This section outlines what would be expected for an AI/ML device performance study, but the information is not available in the provided 510(k) summary for the AVAVA™ Skin Treatment System.

1. Acceptance Criteria Table and Reported Device Performance

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The MOSAIC 3D Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for fractional skin resurfacing procedures.

The MOSAIC 3D Laser System is a non-ablative fractional Er:Glass (Erbium Glass) laser with a wavelength of 1550 nm. It uses Er:Glass to emit a laser beam that is then emitted onto the treatment area via the handpiece connected to the optical fiber of the main body of the system. It is comprised of a main body, a handpiece connected to an optical fiber, a tip, a footswitch, and goggles for laser protection. The laser beam is emitted onto the area to be treated through the tips (roller tip, sapphire tip, comb tip, pill tip) connected to the handpiece.

When the beam contacts tissue the laser beam emits many separate microbeams and creates a microscopic treatment zone (MTZ). Thermal coagulation is then induced in the dermis using the principle of fractional photo thermolysis, sparing the normal skin tissue surrounding the MTZ area. When the laser beam is emitted onto skin tissue, the energy of the beam is absorbed by specific tissues or chromophores such as water and is then converted into thermal energy, causing thermal damage to produce a therapeutic effect.
The MOSAIC 3D Laser System is controlled via a LCD touchscreen guided user interface in the front of the device, which is used to easily configure optimal treatment parameters and check parameters set in the device in the current system mode.

The provided text is a 510(k) summary for the MOSAIC 3D Laser System, a surgical laser. Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of numerical thresholds for accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implied through substantial equivalence to predicate devices and the demonstration of safety and effectiveness through non-clinical and clinical testing.

The primary "performance" being evaluated for this device is its ability to induce coagulation of soft tissue and perform fractional skin resurfacing.

Here’s a table summarizing relevant device characteristics and clinical findings that demonstrate its performance:

• IEC 60601-1: 2012, ed 3.1 (Basic Safety and Essential Performance)
• IEC 60601-1-2 Edition 4: 2014 (Electromagnetic Compatibility)
• IEC 60601-2-22: 2012-10 ed 3.1 (Particular Requirements for Laser Equipment)
• IEC 60825-1 Ed. 3.0 (2014) (Safety of Laser Products)
• ISO 10993-5:2009 (Cytotoxicity)
• ISO 10993-10:2021 (Skin sensitization)
• ISO 10993-23:2021 (Skin Irritation) |
  | Effectiveness - Coagulation of soft tissue | Histological evaluation showed signs of coagulation formation. (Clinical Study) |
  | Effectiveness - Tissue Healing Post-treatment | Histological evaluation showed healing within 4 days after treatment. (Clinical Study) |
  | Safety - Adverse Events / Side Effects | All patients experienced mild anticipated side effects (erythema and edema) which typically resolved by end of day. No adverse events were noted during the study duration. (Clinical Study) |
  | Substantial Equivalence to Predicate Device (MOSAIC HP K080932) | The MOSAIC 3D shares identical or similar technological characteristics (Laser Type: Er:Glass Fiber laser, Wavelength: 1550 nm, Pulse Energy/MTZ: 4 - 70 mJ, Laser beam spot size: 100um, Cooling Mechanism: Air cooling, Aiming Beam: 658nm

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The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.

The MIRIA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the MIRIA.

The MIRIA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.

The MIRIA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port.

The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.

This FDA 510(k) summary does not contain the detailed information necessary to answer all aspects of your question regarding acceptance criteria, study details, and specific performance metrics. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical trial report.

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

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

The document mentions "performance testing results" and that "the data show that the MIRIA Skin Treatment System performs in accordance with its specifications and requirements for both safety and effectiveness in similarity to the predicate device." However, specific numerical acceptance criteria or performance metrics are not provided.

The performance testing listed is:

• Software verification and validation
• Electrical Safety testing (per ANSI AAMI ES 60601-1:2005(R)2012 and A1:2012)
• EMC Testing (per IEC 60601-1-2: 2014-02)
• Histology study and computational simulations to evaluate lesion geometry
• Sample clinical data to confirm the shape of the CTZs (conical thermal zones) and demonstrate safety.

Without the specific criteria for "lesion geometry" or "safety" from these studies, a table cannot be fully constructed.

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 states: "Sample clinical data were provided to confirm the shape of the CTZs (conical thermal zones) and demonstrate safety."

• Sample size: Not specified. It only says "Sample clinical data."
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 provided. The document mentions a "Histology study" and "computational simulations" to evaluate lesion geometry, and "sample clinical data" for safety and CTZ shape. It does not elaborate on how ground truth was established for these or who was involved.

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

This information is 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

This is not applicable as the device is a laser skin treatment system, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

This is not applicable in the context of typical AI algorithm evaluation. The device is a physical laser system. While it is "software-controlled," the performance testing described relates to the physical and electrical safety and the biological effect of the laser, not a diagnostic algorithm.

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

Based on the performance testing mentioned:

• Histology study and computational simulations: This suggests histology (pathology) would be a key ground truth for "lesion geometry." Computational simulations provide a model, not empirical ground truth.
• Sample clinical data: This would typically rely on clinical observations/assessments for safety and the confirmation of CTZ shape.

8. The sample size for the training set

This is not provided. If there was any machine learning involved in the device's control software to optimize treatment parameters, the document does not elaborate on it or any specifics about training data. Given the device type, "training set" in the context of typical AI/ML is likely not directly applicable here.

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

This is not provided, and again, may not be applicable in the traditional AI/ML sense for this type of device.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through technical specifications, safety standards compliance, and general performance statements rather than detailed clinical study data with specific acceptance criteria, sample sizes, and ground truth methodologies, especially those relevant to AI device evaluations.

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The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.

The MIRIA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the MIRIA.

The MIRIA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.

The MIRIA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.

The provided text describes the MIRIA Skin Treatment System and its substantial equivalence to a predicate device. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. The document outlines performance testing conducted to verify certain aspects of the device, particularly regarding its expanded pulse energy range compared to the predicate.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

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

The document mentions several verification methods and implies that the device performs in accordance with its specifications and requirements. However, it does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each performance metric, nor does it present the reported device performance in a comparative table against those criteria.

Information from the document (Implied Performance):

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

• Sample Size: The document does not specify the sample size for any of the performance tests (e.g., healing study, energy delivery verification).
• Data Provenance: The document does not provide information on the country of origin of the data, nor does it state whether the studies were retrospective or prospective.

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)

The document does not mention the use of experts to establish ground truth for any of the tests, nor does it specify their number or qualifications. The healing study implies some form of assessment, but details are absent.

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

No information regarding adjudication methods for the test set is 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

The MIRIA Skin Treatment System is a laser device for dermatologic procedures; it is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving "human readers" or "AI assistance" would not be applicable to this type of medical device as described in this document.

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

This question is not applicable. The MIRIA Skin Treatment System is a physical device with software control, not an algorithm being tested for standalone performance in a diagnostic context. The document confirms it is a "software-controlled device" and that "software verification and validation" were performed.

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

The document implicitly refers to "healing post-treatment" as an outcome, and the "creation of conical microscopic treatment zones (CTZs)" as verifiable physical effects. However, it does not explicitly state the method used to establish the ground truth for these observations (e.g., whether CTZs were confirmed by histology/pathology or expert visual assessment).

8. The sample size for the training set

The document describes performance testing and verification, not a machine learning model that would require a separate "training set." Therefore, this information is not applicable in the context of this submission. Software verification and validation refer to testing the software's functionality and adherence to specifications, not training a predictive model.

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

As there is no mention of a machine learning training set, this question is not applicable.

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The Fiber Laser Treatment System is in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

The Fiber laser Treatment system (HS-230) is the desktop type. It consist of mainframe(touch-screen data input system, power supply control system and cooling system), fiber treatment handpiece (laser output system ) and footswitch. The Fiber Laser Treatment System is a Erbium fiber laser, producing a pulsed beam of near-infrared light (1550nm) upon activation by a footswitch. The beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.

The provided text describes a 510(k) premarket notification for a medical device called "Fiber Laser Treatment System" (K221770). This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for a novel AI device.

Based on the provided information, I can extract the following:

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

The document describes non-clinical testing for safety and performance against recognized electrical and laser safety standards. Acceptance is implied by compliance with these standards.

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

• The document explicitly states that non-clinical testing was performed. This typically involves laboratory testing of the device itself and its components, not studies on a "test set" of patient data in the way AI/software devices are evaluated.
• Therefore, there is no patient sample size mentioned, nor is there information on data provenance (country of origin, retrospective/prospective) because such data was not applicable to this type of regulatory submission.

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 medical device (fiber laser) and not an AI/software device requiring interpretation of medical images or data, there was no "ground truth" to be established by experts in this context. The "ground truth" for compliance testing is against the specified engineering and safety standards.

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

• Not applicable. Since there was no test set involving expert review for diagnostic accuracy or similar, no adjudication method was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC study was not done. This device is a laser treatment system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical laser device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the non-clinical testing was compliance with recognized international standards for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993-1).

8. The sample size for the training set:

• Not applicable. The device is a physical laser system, not an AI algorithm that requires a training set.

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

• Not applicable. As there is no training set mentioned or implied, this question does not apply.

In summary: The provided document is for a traditional medical device (laser system) and focuses on demonstrating substantial equivalence through comparison of technical specifications and compliance with non-clinical performance and safety standards, rather than clinical studies involving patient data or AI performance evaluation. Therefore, many of the questions related to AI device evaluation are not applicable.

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1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

1927 nm: The Multifrax 1927 mm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).

The Multifrax Laser System provides non-ablative fractional treatment using the 1550 nm and 1927 nm wavelengths. The mode of action is delivering a series of light pulses in a row as the handpiece tip is moved across the skin which leaves a pattern of microdots (Micro Thermal Zone (MTZ)) of irradiated skin.

Multifrax Laser System is a dual-wavelength diode laser system comprising two laser sources emitting at 1550 and 1927 nm and generating fine pulses of energy.

• Multifrax is a non-ablative and non-invasive fractional laser device.
• Multifrax is a light portable laser combining a small laser unit and 2 long lasting rechargeable batteries equipped with a belt clip.
• Multifrax offers optimized technical characteristics: adjustable treatment width, adjustable distance between laser pulses, distal tip with integrated high-performance movement and skin contact tracking sensors, and color touch screen display.

The provided text describes the "Multifrax Laser System" and demonstrates its substantial equivalence to a predicate device, the "Fraxel Dual 1550/1927 nm Laser System," through non-clinical performance testing. However, it does not include any studies involving human subjects or AI algorithms. Therefore, I cannot provide information on acceptance criteria and device performance based on a study, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.

The document focuses on non-clinical testing to demonstrate safety and performance against established standards, not on clinical efficacy or comparative effectiveness with or without AI.

Here's a breakdown of what is available in the document regarding performance:

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

The document lists various non-clinical performance standards and states that the "Multifrax Laser System was found to meet the requirements." It doesn't provide specific quantitative acceptance criteria or detailed numerical performance metrics for each standard within the text. Instead, it refers to compliance with the standards themselves.

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

This information is not provided in the document as the testing described is non-clinical (i.e., not performed on human subjects).

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 the document describes non-clinical testing against engineering and safety standards, not clinical ground truth establishment.

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

This information is not applicable as the document describes non-clinical testing.

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

This information is not applicable as the document does not describe any clinical studies, MRMC studies, or AI components.

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

This information is not applicable as the device is a laser system, not an algorithm, and the document describes non-clinical performance evaluation.

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

This information is not applicable as the document describes non-clinical testing against engineering and safety standards, not clinical ground truth.

8. The sample size for the training set

This information is not applicable as the device is a laser system, not an AI algorithm requiring a training set.

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

This information is not applicable as the device is a laser system, not an AI algorithm.

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The SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The SR-1 Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.

The SR-1 Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.

The SR-1 Skin Treatment System is a 1550nm-based laser system intended to generate thermal zones of damage in skin. The system includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the optics, scanner, laser aperture, and contact cooling interface.

The SR-1 Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components.

The provided text describes the 510(k) summary for the SR-1 Skin Treatment System, comparing it to predicate devices. However, it does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics in a table, sample size for test set with data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance).

Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and safety and efficacy studies rather than outlining specific performance metrics for acceptance.

Here's an attempt to structure the information based on the request, extracting what is available and noting what is missing:

Acceptance Criteria and Study for SR-1 Skin Treatment System

The provided 510(k) summary does not detail specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria in the format requested. Instead, the submission relies on demonstrating substantial equivalence to predicate devices, which involves:

1. Technological Characteristics Comparison: Showing the SR-1 has similar operating principles, laser source, output power, etc., to predicate devices.
2. Safety and Performance Testing: Compliance with international standards for electrical safety, EMC, usability, biocompatibility, and laser safety.
3. In-vivo Human Study: A histological assessment comparing the thermal damage zones and healing rates to a predicate.

Therefore, a table of "acceptance criteria" as performance metrics isn't explicitly provided, as the criteria for clearance are primarily based on substantial equivalence and safety/functionality compliance with established standards.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for clinical performance (e.g., a specific percentage of improvement in skin resurfacing) are not detailed in this document, such a table cannot be constructed from the provided text. The document states that the histological data "show that the SR-1 Skin Treatment System performs in accordance with its specifications and requirements," implying that its performance (specifically in terms of thermal damage zones and healing rate) was found comparable to the predicate.

2. Sample Size for Test Set and Data Provenance

• Sample Size for In Vivo Study: 14 healthy subjects.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied to be a prospective in vivo human study based on the description "A 14 day in vivo human study assessing safety, healing and MTZ morphology was performed..."

3. Number of Experts and Qualifications for Ground Truth for Test Set

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified, other than "histological analysis" was performed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done?: No. The device is a laser treatment system, not an imaging interpretation device where human reader performance would be compared with and without AI assistance. The study described is an in vivo histological assessment.
• Effect size of human readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done?: Not directly applicable in the terms of an "algorithm only" performance for diagnosis. The device is a physical laser treatment system with software control. Software verification and validation were performed according to IEC 62304 and FDA guidance, indicating that the software's functionality was tested.

7. Type of Ground Truth Used

• Ground Truth Type: "Histological analysis" was used to determine the zones of thermal damage and healing rate in the in vivo human study.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is a laser treatment system, not an AI model that requires a training set in the conventional sense (e.g., for image classification or diagnosis). Its software underwent "verification and validation testing."

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

• Ground Truth Establishment: Not applicable, as there is no "training set" in the context of an AI model being trained for diagnostic or predictive tasks. The software "ground truth" (i.e., its correct functionality) would be established through software requirements, design specifications, and subsequent verification and validation testing.

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The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) includes three main parts, Main Console, Connector and Scan Handpiece.

The main console is used for system control, such as control of user interface, power on/off and other functions, and also used as holder for other components.

The Connector is used to connect with accessories or power supplier, such as foot switch, pipeline holder, cold air device etc.

The Scan Handpiece is used to provide laser emission and graphic scanning functions. It provides three scan heads (AccuTip, EffiTip, GrowTip) for treatment areas.

This document is a 510(k) Summary for a medical device called "Medical Non-Ablative Fractional Laser Systems (Model: WFB-01)" by Wingderm Electro-Optics Ltd. It states that no clinical tests were conducted. Therefore, there is no information available in the provided text regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies that would typically be associated with a clinical study.

The submission is based on substantial equivalence to a predicate device (Lumenis, Ltd.'s M22 And Resurfx Systems, K170060) through non-clinical testing.

Here's a breakdown of the information that is available, specifically highlighting the absence of clinical study data:

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

Since no clinical study was performed, there's no table of clinical acceptance criteria or reported clinical device performance based on human subjects. The table provided (Table 2 Performance Comparison) focuses on technical specifications and shows the proposed device's specifications are "SAME" or "Analysis" (meaning there's a difference but it's deemed not to affect safety/effectiveness) compared to the predicate device.

| ITEM | Proposed Device | Predicate Device
K170060 | Remark |
|------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------|
| Wavelengths | 1550 nm | 1565 nm | SAME |
| Fluence | Up to 70 mJ per Micro-beam | Up to 70 mJ per Micro-beam | SAME |
| Laser Power | 15 W | 15 W | SAME |
| Dot Density
(Dot/cm²) | 500 | Up to 500 | SAME |
| Laser Beam
Diameter | 110 um | 110 um | SAME |
| Inter-beam
spacing | 0.4 mm - 1.0 mm | 0.4 mm - 1.0 mm | SAME |
| Beam diameter
variability | Fixed | Fixed | SAME |
| Pulse Duration | 10 ms | 10 ms | SAME |
| Type of laser | Er:Glass | Er:Glass | SAME |
| Tip treatment
Area | AccuTip: 10mmX10mm,
EffiTip: 20mmX20mm
GrowTip: 10mmX20mm | 18mm SapphireCool Tip
18mm Precision Tip | Analysis |
| Scanning shapes | Rectangle, Hexagon, Ellipse, Triangle,
Circle | Line, square, rectangle, circle, donut,
hexagon, vertical line, and vertical rectangle | Analysis |

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

Not applicable, as no clinical study was conducted.

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, as no clinical study was conducted with a test set requiring expert ground truth.

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

Not applicable, as no clinical study 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. The device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was mentioned.

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

Not applicable. The device is a laser system, not an algorithm.

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

Not applicable, as no clinical study was conducted. The "ground truth" for demonstrating substantial equivalence relied on non-clinical engineering and performance testing against recognized standards and comparison to a predicate device's specifications.

8. The sample size for the training set

Not applicable, as no clinical study was conducted or AI algorithm trained.

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

Not applicable, as no clinical study was conducted or AI algorithm trained.

Summary based on the provided document:

The device, "Medical Non-Ablative Fractional Laser Systems (Model: WFB-01)," obtained 510(k) clearance by demonstrating substantial equivalence to a predicate device based on non-clinical testing. This included adherence to international standards for medical electrical equipment safety, electromagnetic compatibility, laser safety, and biocompatibility, as well as performance testing for energy output accuracy. No clinical studies were performed, and therefore, no clinical performance data, patient sample sizes, expert-established ground truth, or MRMC studies are discussed in this document.

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