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The Clinicon SureLase CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, coagulation, or cauterization in specialties such as: general surgery, cosmetic surgery, dermatology, gynecology, head & neck surgery, neurosurgery, oral surgery, otorhinolaryngology, pediatric surgery, plastic & reconstructive surgery, podiatry, and urology.

The Clinicon SureLase laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 20 Watts Continuous Wave (CVV). Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece / tip assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.

The provided document describes the Clinicon SureLase CO2 Laser System, a medical device for various surgical procedures. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Instead, the document focuses on:

• Regulatory information: 510(k) summary, classification, product codes, predicate devices.
• Device description: Operating principles, technical specifications (power, pulse characteristics, physical dimensions).
• Intended use: The broad range of surgical specialties and procedures for which the laser is designed.
• Performance Testing (Regulatory Compliance): It states that performance was evaluated through "verification and validation tests per product requirements and specifications" and "inspections and tests derived from applicable regulations and safety standards" (e.g., 21 CFR 1040, IEC 60601 series, IEC 60825-1).

Crucially, Section 9 explicitly states: "Animal and Clinical Testing Device performance evaluation did not involve Animal of Clinical Testing." This means there was no clinical study conducted with human patients or animal models to assess the device's performance in terms of clinical outcomes, diagnostic accuracy, or comparison with human readers.

Therefore, I cannot provide the requested information in the format you specified because the document does not contain data related to:

1. Acceptance criteria and reported device performance (clinical/diagnostic): The document lists technical specifications (e.g., CW power 2-20 watts), which are internal performance requirements, but not external clinical acceptance criteria for effectiveness or safety in patient care.
2. Sample size, data provenance, number of experts, adjudication, MRMC studies, standalone performance, or type of ground truth for a test set. These are all concepts related to clinical or diagnostic performance studies, which were not performed.
3. Sample size or ground truth for a training set: Since no clinical studies were performed, there's no mention of training sets for an AI/algorithm-based device.

Based on the provided text, the Clinicon SureLase CO2 Laser System's approval was based on demonstrating substantial equivalence to predicate devices and compliance with relevant safety and performance standards for laser equipment, rather than a clinical effectiveness study with human subject data or an AI/algorithm performance study.

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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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The intended use of the Clinicon WaveGuide Platform is to deliver carbon dioxide laser energy from a CO2 laser source to a CO2 laser accessory, with minimal beam degradation. The waveguide platform can be used with various manufacturers' CO2 lasers and laser accessories, including Clinicon accessories. The specific indications are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached.

The Clinicon Interconnect enables Luxar accessories that are designed to be used with the standard Luxar cables to be connected with the Clinicon WaveGuide Platform.

The Clinicon WaveGuide Platform (K992472, SureGuide CO2 Laser Beam Delivery System now marketed as Clinicon WaveGuide Platform) is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover.

The WaveGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories.

The Clinicon Interconnect (Distal Adapter) is an accessory to the WaveGuide Platform that duplicates the termination end & laser beam characteristics of the Standard Luxar Fiber. This allows Luxar accessories to be attached to the WaveGuide Platform and used in the same manner.

The Clinicon WaveGuide Platform with Interconnect for Luxar Accessories (K014236) is an accessory for CO2 laser systems designed to deliver carbon dioxide laser energy from a CO2 laser source to a CO2 laser accessory with minimal beam degradation. The specific indications for use are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached.

The provided document does not contain a detailed study report with specific acceptance criteria and performance data in a format suitable for the requested table. This submission primarily focuses on establishing substantial equivalence to predicate devices (K992472 and K960475) based on technological characteristics and intended use.

However, based on the information provided, we can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria or provide detailed performance data from a dedicated study. The information below is inferred from the description of substantial equivalence and device characteristics.

2. Sample Size for the Test Set and Data Provenance

The document does not report on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The substantial equivalence claim is based on technological characteristics, intended use comparison to predicate devices, and likely internal engineering tests, rather than a clinical or performance study with a defined test set of patients or medical scenarios.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts or the establishment of ground truth in the context of a performance study for the K014236 device. This type of evaluation is not typically required for a device like a CO2 laser accessory where performance is primarily measured through engineering specifications and functional testing rather than interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Since no specific test set requiring expert interpretation is described, there is no mention of an adjudication method.

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

No MRMC comparative effectiveness study was performed or reported. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance. This device is a surgical instrument accessory, not a diagnostic tool requiring human interpretation of output.

6. Standalone Performance Study

The document describes the device's technological characteristics and its intended function (delivering laser energy with minimal degradation and maintaining specific beam characteristics). While implicit in the design and engineering, the document does not present a formal "standalone" performance study report in the manner of a clinical trial for a diagnostic or therapeutic device. The "proof" is largely based on demonstrating that its technical specifications and functional output are equivalent to the predicate devices and meet its stated purpose.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic device validation (e.g., pathology, expert consensus) is not applicable to this submission. The validation evidence for this device would rely on engineering measurements (e.g., laser power output, beam divergence, fiber transmission efficiency, material compatibility, sterile barrier integrity) and functional testing to confirm it performs as intended and is equivalent to the predicate devices.

8. Sample Size for the Training Set

No training set is mentioned or applicable as this device is a physical CO2 laser accessory, not an AI/machine learning algorithm.

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

Not applicable as there is no training set for an AI/machine learning algorithm.

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The Clinicon UHP/disposable tip is/are indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-mino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, cauterization of soft tissue.

The Clinicon UHP/disposable tip indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

The Universal WaveGuide Handpiece comes in two designs, one that accepts 1.5 mm O.D. size fiber tips and one that accepts 2.5 mm O.D. size fiber tips. The 1.5 mm handpiece is used with the Free Beam and Flexible fiber tips. The 2.5 mm handpiece is used with the rigid fiber tips.

The collet component determines the O.D. size fibers that can be inserted into the handpiece. The nozzle and tip lock collet secures the fiber and prevents twisting of the fiber tip. The hand piece is attached to the Clinicon WaveGuide Platform by the FSMA connector at the distal end of the waveguide.

The Fiber Tips are made of the same proprietary waveguide fiber as the Clinicon WaveGuide Platform, described in the premarket notification, K992472, SUREGUIDE CO2 Laser Beam Delivery System.

The waveguide fiber is inserted into a straight or curved stainless steel sheath for the 2.5 mm O.D. rigid fiber tips or into a Teflon tube for the 1.5 mm O.D. flexible fiber tips.

The fiber tips, both rigid and flexible are of various lengths for use in various surgical procedures. The rigid fiber tips are also of various degrees of curvature and certain tips may have a contact probe tip cover made of Teflon.

The fiber tips are disposable, single-use devices, and both the rigid and flexible fiber tips have a section of colored polyethylene at the distal end of the fiber cable that acts as a depth gauge to assure the fiber is completely seated in the handpiece. The colored polyethylene also acts as a sterilizer indicator that will render the tips unusable if they are re-sterilized by distorting the polyethylene and preventing the fiber from being inserted into the handpiece.

The provided text describes a 510(k) premarket notification for the Clinicon Universal WaveGuide Handpiece and Fiber Tips. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML performance metrics, is not available in the provided text.

Here's an analysis of why the requested information cannot be found and what is present in the document:

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

• Not Available: The submission is for a medical device (CO2 Laser Powered Surgical Instrument), not an AI/ML diagnostic or predictive device. The FDA 510(k) process for such devices typically focuses on comparing the new device's technological characteristics, intended use, and safety/effectiveness to a legally marketed predicate device. This usually doesn't involve defining specific performance metrics (like sensitivity, specificity, AUC) and comparing them against pre-defined acceptance criteria in a quantitative table.

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/Not Available: Since no formal performance study with a test set (in the context of AI/ML) is described, these details are not present. The submission focuses on substantial equivalence through design and material comparison.

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 Available: This refers to the establishment of ground truth for a diagnostic or predictive algorithm. As this is a surgical instrument, such expert-driven ground truth establishment for a test set is irrelevant and not mentioned.

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

• Not Applicable/Not Available: Similar to the above, adjudication methods are used to resolve discrepancies in expert-labeled ground truth for diagnostic studies. This is not relevant to a surgical instrument.

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 Available: MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This device is a surgical tool, not an AI diagnostic tool.

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

• Not Applicable/Not Available: This refers to standalone AI algorithm performance. This device is a physical surgical instrument.

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

• Not Applicable/Not Available: The concept of "ground truth" as used in AI/ML performance validation does not apply to this surgical device. The "truth" in this context would be aspects like material properties, laser energy delivery capabilities, and sterility, which are assessed through engineering tests and regulatory compliance rather than "ground truth" derived from expert consensus or pathology data.

8. The sample size for the training set:

• Not Applicable/Not Available: No training set, in the AI/ML sense, is involved.

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

• Not Applicable/Not Available: No training set or ground truth establishment for it is relevant here.

What the document does describe (relevant to substantial equivalence):

The document provides information comparing the new device to existing predicate devices, focusing on:

• Intended Use: The device is intended to deliver carbon dioxide laser energy for the incision, excision, vaporization, ablation, coagulation or cauterization of soft tissue, similar to the predicate devices.
• Technological Characteristics:
  • The Clinicon Universal WaveGuide Handpieces have the "same technological characteristics" as Luxar handpieces (K903079).
  • The Clinicon Fiber Tips have the "same technological characteristics" as the Clinicon Sureguide CO2 Laser Beam Delivery System (K992472).
• Design Features: Descriptions of two handpiece designs (1.5mm and 2.5mm O.D. fiber tips), collet component, nozzle and tip lock collet, FSMA connector. Description of fiber tips (rigid/flexible, various lengths, curvature, Teflon contact probe tip cover), disposable nature, colored polyethylene depth gauge and sterilizer indicator.

Conclusion:

This 510(k) submission is for a conventional surgical instrument and relies on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/performance profiles, rather than presenting a statistical performance study against explicit acceptance criteria in the manner requested for an AI/ML device.

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The SureGuide CO2 Laser Beam Delivery System is intended for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue.

Refer to the laser system Directions for Use manual for specific indications for Use.

The SureGuide CO2 Laser Beam Delivery System is indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, otorhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue.

The specific SureGuide CO2 Laser Beam Delivery System indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

The SureGuide CO2 Laser Beam Delivery System is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover.

The SureGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories.

The laser adapter design is derived from the Medical Optics laser system flexible cable assembly interface adapter and has a section designed to fit the Luxar LX-20 mast interface. Beam alignment and focus optics are built into the interface adapter to allow correction of inherent beam alignment variations between laser systems and provides optimization of laser beam coupling into the SureGuide.

The provided text describes the acceptance criteria and the study conducted for the SureGuide CO2 Laser Beam Delivery System.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the "test set." It mentions "testing and analysis of laser power loss and beam quality" and "evaluation of the SureGuide on various commercially available medical CO2 laser systems." This suggests a laboratory or engineering testing environment rather than a clinical study with patient data.

The data provenance is industrial/engineering testing of the device itself with various commercially available medical CO2 laser systems. It is not a retrospective or prospective clinical study with patient data.

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 a test set in the context of clinical interpretation or diagnosis. The "ground truth" here seems to be defined by established engineering parameters for laser power loss, beam quality, and energy transmission, likely set by internal company standards or industry benchmarks for CO2 laser systems.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human-reviewed test set or any adjudication method. The evaluation appears to be based on objective physical measurements and comparisons to predicate devices' performance characteristics.

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

No, an MRMC comparative effectiveness study was not done. This device is a component of a laser delivery system, not an AI or diagnostic tool that assists human readers.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Performance

Yes, the testing described appears to be a standalone performance evaluation of the device itself (the SureGuide CO2 Laser Beam Delivery System) without human intervention in its operation or interpretation of its output. The device's performance characteristics (power loss, beam quality, energy transmission) were measured directly.

7. Type of Ground Truth Used

The ground truth used is based on engineering and performance specifications for laser power loss, beam quality, and energy transmission, which are then compared to "criteria established" (presumably from industry standards or performance of predicate devices).

8. Sample Size for the Training Set

Not applicable. The document describes non-clinical performance testing of a physical device, not a machine learning model that would require a training set.

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

Not applicable, as there is no training set for this type of device.

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The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures. Refer to the laser system Directions for Use manual for specific indications for Use.

The Diamond LaserKnife ™ is an accessory hand piece for CO2 laser systems, that consists of a diamond cutting blade and handle coupled to a flexible fiber guide cable that conducts CO2 laser energy to the blade tip. The laser energy is emitted from the facets at the blade tip to the tissue when the laser is energized.

The provided document is a 510(k) summary for the Diamond LaserKnife™, a laser scalpel, and does not contain a study that proves the device meets specific acceptance criteria in the manner of a clinical trial or performance study with detailed statistical outcomes.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Sapphire Laser Scalpel, K863086). The "Conclusions Drawn from Tests and Analysis" section indicates that the device's performance was evaluated through non-clinical tests.

Therefore, the following information is extracted from the provided text, and where specific details are not available, it is explicitly stated.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)

Study Details (Based on available information)

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

   • Sample Size: Not applicable. This was a non-clinical evaluation comparing laser energy fields, not a study involving patient data or typical "test sets" for diagnostic or clinical performance.
   • Data Provenance: Not applicable. The "study" involved analysis of laser energy fields from the device itself and comparison to characteristics of similar, previously cleared devices. It was not a retrospective or prospective study from a specific country of origin in terms of patient data.

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

   • Not applicable. Ground truth, in a clinical or diagnostic sense, was not established since this was a non-clinical device characteristic comparison. The "ground truth" here would be the established performance characteristics (fluence, tissue reaction) of existing, cleared laser scalpels.

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

   • None. This type of adjudication is not relevant for the non-clinical tests described.

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

   • No. This is a laser scalpel, a surgical instrument; MRMC studies apply to diagnostic imaging, especially with AI assistance to human readers.

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

   • Not applicable. This device is a manual surgical instrument, not an AI algorithm. Its performance is inherent in its physical and energy delivery characteristics, used by a human surgeon.

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

   • The "ground truth" for this substantial equivalence determination was the established and accepted performance characteristics of legally marketed predicate laser scalpels, specifically regarding laser energy emission (fluence) and its anticipated effects on tissue.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

   • Not applicable, as there is no training set for this device.

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For use in vaporization, incision and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry.

The Clinicon C4 CO2 laser is a sealed, liquid and convection cooled carbon dioxide surgical laser that is DC excited. The output of the laser is a concentrated beam of invisible infrared light at 10.6 micrometer wavelength. The laser has an output power range of 0-25 watts delivered to tissue.

The laser system is fitted with a surgical hand piece as a standard accessory, producing a collimated beam with a spot size of 200 microns.

The hand piece is manufactured from 304 surgical stainless steel.

The provided text is a 510(k) summary for the Clinicon C4 CO2 laser. It describes the device's characteristics and intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial results or performance testing reports for AI/software devices.

The 510(k) process for a device like a surgical laser primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies against pre-defined acceptance criteria for, for example, diagnostic or AI-driven devices.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample sizes for test and training sets, expert information, adjudication methods, or MRMC studies, as this information is not present in the provided document for this particular type of device submission.

The document discusses:

• Device Description: Sealed, liquid and convection cooled CO2 surgical laser, DC excited, 0-25 watts output power, 10.6 micrometer wavelength, 200 micron spot size.
• Intended Use: Vaporization, incision, and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry.
• Substantial Equivalence: Claimed to Sharplan 20C (K963229), JMED CHRYS (K913606), and Surgical Laser Specialties Ultra MD Laser (510k Number Unknown).

The 510(k) process demonstrates that the new device is "substantially equivalent" to a predicate device, meaning it is as safe and effective as the previously cleared device. This typically involves comparing technological characteristics, intended use, and performance data if relevant, but not necessarily a specific "acceptance criteria" study in the way you might see for an AI-powered diagnostic tool.

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Wavelength range 430-1064 Nanometer

In this wavelength range, SureScan is designed to assist in the partial or full coagulation or denaturization of a variety of benign epidermal vascular and pigmented lesions where precise dosimetry is required to minimize damage to adjacent or underlying tissue layers. SureScan use is restricted for adaptation to those lasers that have received FDA clearance for applications in cutaneous laser surgery for the treatment of benign superficial vascular and pigmented lesions such as port wine stains angiomas, telangiectasia, café-au-lait marks, age spots, lentigines, tattoos and similar conditions.

Wavelength range 1440-10640 Nanometer

In this wavelength range. SureScan is designed to assist in a variety of procedures that require the ablation of soft tissue, where precise removal is required to minimize damage to adjacent or underlying tissue layers. SureScan use is restricted for adaptation to those lasers that have received FDA clearance for soft tissue ablation, such as scars, keloids, warts, skin malformations and similar conditions.

SureScan adapts to laser systems with wavelengths in the visible spectrum from 430nm to 700nm ( blue, green, yellow and red ) and to lasers in the invisible spectrum from 755nm to 2940nm to deliver precise amounts of energy to tissue.

SureScan comes equipped with multiple treatment patterns in multiple sizes. SureScan is programmable to enable adjustment of scan speed across tissue to ensure uniform laser absorption or ablation which significantly reduces thermal damage and thus the potential for post operative scarring.

SureScan also has an adjustable spot overlap density and scanner dwell time feature which allows the surgeon to select individual treatment parameters most suitable for various tissue types and lesions.

SureScan employs a microprocessor controlled, mirror system for scanning the laser beam. SureScan juxtaposes laser beam spots with precisely controlled timing and predetermined amounts of space in between or with spatial overlap of these spots. Depending on the type of laser used and its wavelength, highly controlled tissue coagulation or ablation is achieved with minimal thermal injury.

SureScan's operation is controlled via an existing laser foot switch, to eliminate any adjustment of the internal electronics or workings of the laser. To ensure precise transmission of the laser beam through the SureScan device and subsequent safe delivery of laser energy to tissue, a user controlled adjustment feature allows for realignment of the laser beam due to a misaligned fiber or other delivery system as it is directed through the SureScan hand piece.

As a result, the operator is always assured of optimum beam quality without 'clipping', as the laser beam exits the SureScan hand piece.

Different sized squares, rectangles, triangles, hexagons, parallelograms and lines may be selected and are outlined by the laser systems pilot laser. These various patterns are then automatically covered by the therapeutic laser and coagulate, denaturize or ablate tissue in a single scan cycle. This results in a more predictable and controlled tissue effect to optimize treatment results.

The provided document (K964831) is a 510(k) summary for the SureScan device, a laser accessory. It describes the device, its indications for use, and a technical description. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a premarket notification for substantial equivalence, not a clinical study report or a validation study. It focuses on demonstrating that the SureScan device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information in the table or the subsequent points because the document does not contain details about:

1. Acceptance criteria and reported device performance: This document doesn't define specific performance metrics or acceptance criteria for the SureScan device's operation, nor does it report any testing results against such criteria.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details for a test set.
3. Training set sample size or ground truth establishment for a training set.

The document primarily focuses on:

• Device Description: Explaining what the SureScan does (adapts to laser systems for precise energy delivery, offers various treatment patterns, adjustable scan speed, spot overlap, and dwell time).
• Intended Use/Indications: Specifying the wavelengths supported and the types of benign epidermal vascular and pigmented lesions or soft tissue ablation procedures it assists with.
• Substantial Equivalence: Listing predicate devices to which it claims equivalence.

Without a clinical or technical performance study, the requested information cannot be extracted from this document.

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SureScan may be used for a variety of soft tissue ablation procedures where precise removal is required to minimize damage to adjacent or underlying tissue layers.

SureScan converts any CO2 laser, pulsed or CW, into a sophisticated aesthetic surgery laser system for performing a wide variety of laser procedures. It comes equipped with six different patterns in 26 different sizes. It automatically adjusts the scan speed to ensure uniform laser ablation which eliminates charring and thermal damage. The collimated beam ensures constant power density and tissue removal at any working distance. The SureScan has an adjustable spot overlap density for more precision and control. The Scan outline and size are clearly displayed on the tissue, allowing precise placement of the laser energy and subsequent scan shapes.

This 510(k) submission for the SureScan Laser Accessory describes a device that "converts any CO2 laser, pulsed or CW, into a sophisticated aesthetic surgery laser system for performing a wide variety of laser procedures." The document focuses on the device's technological characteristics and intended use, rather than a clinical study with acceptance criteria and performance metrics.

Therefore, the provided text does not contain the information required to populate a table of acceptance criteria and reported device performance, nor details about a study proving the device meets acceptance criteria.

The document, being a 510(k) summary from 1996, primarily focuses on demonstrating substantial equivalence to predicate devices (Lasersonics Parascan and Coherent Computerized Pattern Generator) based on technological characteristics and intended use, rather than a detailed performance study with defined acceptance criteria typically seen in more recent submissions involving novel AI or diagnostic devices.

The information you are requesting about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment would generally be found in a clinical or performance study section, which is not present in this 510(k) summary.

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