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The SMARTXIDE PRO is a medical device indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

SmartXide PRO is a 10.6um carbon dioxide laser (CO2 laser), which is highly absorbed by water. Since tissue is comprised mostly of water, this invisible wavelength is highly effective in the surgical treatment of soft tissues. Moreover, SmartXide PRO device can be equipped with a scanning unit, called HiScan DOT, which can be connected to the arm to provide high performance in specific fields. The scanning unit is intended for fractionated skin resurfacing or traditional skin resurfacing. The modifications to the device consist of a restyling of the device (chassis, cover plastic, dimensions, weight, plastic cover, CPU and GUI), a restyling of HiScan DOT unit. The intended use of the modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.

The provided text is a 510(k) summary for the SmartXide PRO device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a rigorous clinical study with novel performance metrics.

Therefore, the document does not contain the detailed information typically found in a clinical study report that directly addresses acceptance criteria and device performance in the way you've outlined. Specifically:

• There is no table of acceptance criteria and reported device performance. The "Performance Data" section only mentions electrical safety, EMC, and software validation, which are technical standards tests, not clinical performance metrics against specific acceptance criteria for efficacy or diagnostic accuracy.
• No sample size for a test set, data provenance, or details on ground truth establishment are provided because a clinical performance study (e.g., an MRMC study or standalone algorithm performance study) was not conducted or required for this type of submission (a Special 510(k) for device modifications where the intended use has not changed).
• Information on experts, adjudication methods, MRMC studies, or standalone performance is absent for the same reason.
• No training set size or ground truth establishment for a training set is mentioned, as this is related to AI/ML model development, which is not described nor a primary focus of this device's submission.

The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device based on identical (or nearly identical) indications for use and technological characteristics. The "Substantial equivalence discussion" table (part of section {5}) is the primary "proof" for this submission, showing feature-by-feature comparison to the predicate device.

Given the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study design as they relate to a clinical performance study. The document focuses on regulatory compliance through substantial equivalence, not on establishing a new performance claim for the device against pre-defined clinical acceptance criteria.

If the request implies that I should infer what such a study would look like for a hypothetical AI/ML device where the provided text is a template, that is outside the scope of merely extracting information from the given document.

In summary, the provided document does not contain the information required to answer your prompt because it is a 510(k) summary demonstrating substantial equivalence, not a report of a clinical performance study against specific acceptance criteria.

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Incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing.

The overall weight is approximately 62 kg and the sizes are 42 x 122 x 54cm (W x H x D) with folded articulated arm.

Electrical requirements: 100-230V ~ 50/60Hz, 1200VA (max).

This document is a 510(k) summary for a medical device called SMARTXIDE TETRA PRO, a CO2 laser surgical instrument. As such, it does not describe acceptance criteria and a study that proves the AI/ML device meets the acceptance criteria. The document explicitly states "Clinical Performance Data: None".

Instead, it focuses on demonstrating substantial equivalence to a predicate device (DEKA Smartxide family) through non-clinical performance data, primarily electrical safety, electromagnetic compatibility, and software validation.

To directly answer your request based on the provided text, the relevant information regarding acceptance criteria and device performance is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical testing of the device hardware and software, not a study involving patient data or test sets in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device is not relevant for the type of non-clinical testing described.

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 not an AI-assisted device for human readers.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device and testing. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the relevant electrical safety, EMC, and laser safety standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

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The DEKA SmartXide2 Trio CO2 laser is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

The DEKA Smartxide2 Trio 940nm diode laser is incision, excision, vaporization ablation and coagulation of soft tissues (open surgery), cutting, vaporization of soft tissues (endoscopic surgery) in medical specialties including: plastic surgery, dermatology, ENT, gynaecology, urology, general surgery, gastroenterology and dental procedures.

The DEKA SmartXide2 Trio 980mm diode laser is incision, excision, vaporization ablation and coagulation of soft tissues (open and endoscopic surgery) in medical specialties including plastic surgery, dermatology, ear, nose and throat and oral surgery (otolaryngology), gynaecology, neurosurgery, general and thoracic surgery, gastroenterology and dental procedures.

The DEKA SmartXide2 Trio is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source.

The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory (handpiece/scanner/micromanipulator) connected to its distal end, or through a hollow waveguide.

The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation.

The waveguide consists of a flexible silica capillary whose inside wall has been coated with a durable coating which is highly reflective at the intended wavelength of use.

The waveguides used with DEKA Smartxided Trio are manufactured by Laser Engineering and have been cleared by FDA with K112166.

The diode laser source can be provided in two alternative wavelengths: 940nm and 980mm.

The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces. The spot size is effectively the diameter of the fiber being connected to the system.

Emission parameters are selected on the front panel while laser emission is activated by a footswitch. The on-off switch and emergency switch are also located on the front panel of the svstem.

A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready.

Overall weight of the device is 100 kg, and the size is 240 cm x 59 cm x 56 cm (H x W x D). Electrical requirement is 100-120Vac 50/60Hz, 220-230Vac 50Hz, 16A.

The modification to the device is the addition of a hollow waveguide delivery system as an alternative to the articulated arm for the CO2 laser beam . It allows easier delivery of laser energy to the targeted tissue in some surgical procedures.

The intended use of the modified devices, as described in the labelling, has not changed as a result of the modification.

The provided document is a 510(k) summary for the DEKA Smartxide2 Trio, a medical laser system. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not necessarily to provide a detailed study proving the device meets specific acceptance criteria in the format requested.

Therefore, the information required for a comprehensive answer regarding acceptance criteria and a detailed study proving the device meets these criteria is largely not present in this type of FDA submission.

Here's an attempt to answer the questions based only on the provided text, highlighting what is available and what is missing:

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

The document does not provide a specific table of acceptance criteria linked to reported device performance metrics in the way one might expect from a detailed clinical or performance study. Instead, it focuses on demonstrating equivalence in features and specifications between the proposed device and the predicate device.

The Feature table on pages 4 and 5 implicitly shows the "performance" by comparing the specifications of the new device to the predicate. The "acceptance criteria" for this submission appear to be that the new device's specifications (including the new delivery system) are within an acceptable range or identical to the predicate, and that the "Intended Use" and "Principle of operation" remain the same.

The key change is the addition of a hollow waveguide delivery system for the CO2 laser. The "acceptance criteria" for this modification would be that its performance (e.g., CO2 laser output characteristics when using the waveguide) is safe and effective for the stated indications, and equivalent to the existing articulated arm delivery or the predicate device's capabilities.

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

This information is not provided. The document explicitly states "Clinical Performance Data: None" and describes "Non-Clinical Performance Data" as verification and validation activities. These are typically in-house engineering and bench tests, not studies with patient samples.

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. As "Clinical Performance Data: None" and the data being non-clinical verification/validation, there would be no ground truth established by medical experts in this context.

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

This information is not provided. Not applicable given the type of data presented.

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 provided. This device is a surgical laser system, not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant to this submission.

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

This information is not provided. As mentioned, this is not an AI algorithm. The performance evaluation focuses on the physical device's specifications.

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

For the "Non-Clinical Performance Data," the "ground truth" would be established by engineering specifications, technical standards, and internal test procedures. For example, a laser power meter would provide the "ground truth" for laser output power, or precise measurement tools for spot size. This is not derived from medical expert consensus or patient outcomes.

8. The sample size for the training set

This information is not provided. The device is a physical laser system, not an AI model, so there is no "training set."

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

This information is not provided. Not applicable as there is no training set.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The document broadly refers to "Non-Clinical Performance Data" as the study proving the device meets acceptance criteria. These activities included:

• Verification of CO2 laser output using the waveguide: This would involve testing the power, wavelength, beam stability, and other characteristics of the CO2 laser when delivered through the new waveguide. The acceptance criteria would be that these outputs meet predefined engineering specifications and are comparable to or within the established range of the predicate device's articulated arm delivery.
• Verification and validation of modified software: This ensures that any software changes related to the new waveguide or other aspects of the device operate correctly, safely, and as intended. Acceptance criteria would be based on software requirements and testing protocols.

The document explicitly states that "The test methods, acceptance criteria and test results are documented in the Design History File of Smartxide2 Trio," but these specific details are not included in this 510(k) summary. The overarching "proof" is that these non-clinical tests confirmed the modified device (including the new waveguide) performs equivalently and safely to the predicate device, allowing it to maintain the same indications for use.

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Incision, excision, ablation, vaporization of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The DEKA Smartxide Family of laser system are medical devices equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 30W/50W/60W. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The DEKA Smartxide Family laser is equipped with a Scanning Unit that allows to perform skin resurfacing treatments.

The provided FDA 510(k) summary (K180193) for the DEKA Smartxide family of laser systems (Smartxide Touch, Smartxide Punto) does not describe an AI/ML-based device.

Instead, this document pertains to a medical laser system used for various surgical and aesthetic procedures. The submission is a "Special 510(k)" for modifications to an existing device, primarily related to increased maximum output power and external system/scanner covers.

Therefore, the following requested information regarding acceptance criteria and studies for an AI/ML device cannot be extracted from this document, as it is not relevant to the described device.

Key points from the document indicating it's not an AI/ML device:

• Device Name & Type: DEKA Smartxide family (Smartxide Touch, Smartxide Punto) are described as medical laser systems with a Carbon Dioxide (CO2) laser source.
• Modifications: The modifications are explicitly stated as "different maximum available output power" and "different external system and scanner covers." These are hardware-related changes, not software or AI/ML algorithm changes.
• Non-Clinical Performance Data: The verification activities performed are "Verification of actual maximum laser output," "Verification of electric safety and EMC compliance," and "Verification of new covers design specifications." These are standard tests for electrical and mechanical medical devices, not for AI/ML performance.
• Clinical Performance Data: The document explicitly states "None," which further confirms no clinical studies were performed on AI/ML performance.

Because the device is not AI/ML-based, the questions about sample sizes, ground truth, experts, MRMC studies, standalone performance, and training sets are not applicable to this document.

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Incision, excision, ablation, vaporization of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The DEKA SMARTXIDE TOUCH is a medical device equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 40W. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The DEKA SMARTXIDE TOUCH laser is equipped with a Scanning Unit, HiScan DOT+, that allows to perform skin resurfacing treatments.

This document is an FDA 510(k) premarket notification for the DEKA SMARTXIDE TOUCH laser system. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets said criteria related to clinical performance.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• Clinical Performance Data: The document explicitly states "Clinical Performance Data: None" (page 4). This means no clinical study was presented to demonstrate the device's effectiveness in a clinical setting against specific acceptance criteria.
• Substantial Equivalence: The FDA's 510(k) pathway often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies for every device. For devices like lasers that perform well-understood physical actions (ablation, vaporization), non-clinical testing for safety and electrical performance is often sufficient if the device operates similarly to existing ones.

Therefore, most of your specific questions cannot be answered based on the provided text. I will provide what can be gleamed from the document related to "acceptance criteria" through non-clinical testing.

Acceptance Criteria and Study for DEKA SMARTXIDE TOUCH

Based on the provided FDA 510(k) summary, the device's acceptance criteria are primarily related to non-clinical performance data and conformance to established international standards for medical electrical equipment and laser safety. There is no clinical performance data or associated acceptance criteria presented in this document.

1. Table of Acceptance Criteria and Reported Device Performance

• Laser Type: CO2 (matches predicate)
• Wavelength: 10.6μm (matches predicate)
• Max Power: 40W (within range of predicate: 25W, 60W HP)
• Handpieces Spot Sizes: 0.2 mm, 0.4 mm (matches predicate)
• Pulse Duration: 0.02 to 70 ms (comparable to predicate: 0.2 to 80 ms)
• Pulse Rep Rate: 5 to 100 Hz (matches predicate)
• Scanner Spot size: 350μm (matches predicate)
• Scanner Focal length (EFL): 100mm (matches predicate)
  The document states: "The DEKA SMARTXIDE TOUCH has the same indications for use as the abovementioned predicate device, with same principle of operation and essentially the same performances." |

Note: The "reported device performance" for the standards conformance is an interpretation that the device met these standards, as non-conformance would likely prevent 510(k) clearance.

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

• Test set sample size: Not applicable for a clinical test set as no clinical performance data was provided. For non-clinical (engineering/safety) testing, the "sample size" typically refers to the device itself and its components, which are tested against relevant standards. The provenance for these tests would be internal laboratory testing by the manufacturer or accredited testing bodies.
• Data provenance: Not explicitly stated beyond "The DEKA SMARTXIDE TOUCH was tested for standards conformance...". This likely refers to in-house testing by the manufacturer or third-party labs contracted by the manufacturer.

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

• This information is not applicable as no clinical study with a "ground truth" established by human experts was conducted or referenced in this 510(k) summary.

4. Adjudication method for the test set

• Not applicable as no clinical study requiring adjudication was conducted or referenced.

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 or assistive tool for human readers. No MRMC study was performed.

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

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

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

• Not applicable for clinical performance. For non-clinical testing, the "ground truth" would be the specifications and requirements of the international standards (e.g., specific electrical safety limits, laser output parameters).

8. The sample size for the training set

• Not applicable as no clinical training set was used.

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

• Not applicable as no clinical training set was used.

In summary, the provided document focuses on demonstrating substantial equivalence to an existing lawfully marketed device through comparison of technical specifications and conformance to recognized safety and electrical standards. It explicitly states there is no clinical performance data. Therefore, the questions related to clinical trials, expert ground truth, and AI performance are not addressed by this FDA submission.

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The SmartXide UltraSpeed laser is incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic urgery, and urology for surgical and aesthetic applications.

Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to:

• · Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement)
• · Biopsies
• Frenectomy, Frenum release
• Gingivoplasty
• Papillectomy
• · Vestibuloplasty
• · Hyperplasia
• Operculectomy
• · Drainage (abscess)
• · Flap surgerv
• · Fibroma (nonmalignant tumor, mucosa, tongue)
• Epulis
• · Aphthous ulcers
• · Removal of soft tissue, cysts, and tumors

· Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long iunctional enithelium).

DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.

The provided text is a 510(k) summary for a medical device, the DEKA SmartXide UltraSpeed laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It's crucial to understand that a 510(k) submission primarily focuses on substantial equivalence to a predicate device, not necessarily extensive clinical performance studies or AI model validation. Therefore, the information requested in your prompt regarding acceptance criteria, training/test sets, expert ground truth, and AI performance metrics will likely not be present in this type of document because the device in question is a laser surgical instrument, not an AI-driven diagnostic or therapeutic device. No AI or machine learning components are mentioned for this device.

Based on the provided document, here's an attempt to address your points, highlighting where the information is not applicable or not provided:

The DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser device for incision, excision, ablation, vaporization, and coagulation of body soft tissues. The 510(k) submission establishes its substantial equivalence to a predicate device (DEKA Smart US 20D/UltraSpeed and Smart Clinic laser, K081181) based on similar indications for use, principle of operation, and performance characteristics.

Regarding Acceptance Criteria and Device Performance (as requested for an AI/diagnostic device):

Since this is a laser surgical instrument and not an AI/diagnostic device, the concept of "acceptance criteria" in the context of sensitivity, specificity, or similar performance metrics for an AI model is not applicable. The "device performance" instead refers to its physical specifications and its ability to perform its intended surgical functions safely and effectively.

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

For a laser surgical instrument, acceptance criteria are generally related to its technical specifications and compliance with safety standards rather than diagnostic performance metrics.

Study Proving Device Meets Acceptance Criteria:

The document states: "Tests results demonstrated compliance to related standards." This indicates that non-clinical performance tests were conducted according to the listed international standards (ISO 10993-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) to ensure the device operates safely and effectively as designed.

The following points are largely N/A (Not Applicable) or N/P (Not Provided) in this 510(k) summary for a laser surgical instrument, as they pertain to AI/diagnostic model validation:

2. Sample size used for the test set and the data provenance: N/A. No test set of patient data (images, etc.) is mentioned as this is not an AI diagnostic device. The "tests" mentioned are non-clinical engineering and safety compliance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No "ground truth" derived from expert review of patient data is relevant for this type of device.

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

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. This is a surgical laser, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. There is no algorithm mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. The "ground truth" for this device would be its adherence to established engineering, electrical, and laser safety standards, and its consistent output of specified laser parameters.

8. The sample size for the training set: N/A. No AI model or training set is mentioned.

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

In summary, this 510(k) document is for a medical laser, not an AI or diagnostic device. Therefore, the detailed questions about AI model validation, test/training sets, and expert ground truth are not relevant to the information presented in this regulatory submission. The "study" proving the device meets criteria consists of non-clinical, engineering, and safety compliance tests against recognized international standards.

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

DEKA SmartXide² is a laser with a wavelength of 10600 nm having a maximal power of 60 Watts. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end.

Laser activation is by footswitch. Overall weight of the laser is 95 Kg, and the size is 210 x 59 x 56 cm (H x W x D).

Electrical requirement is 100-120 Vac 15A, 50-60 Hz, single phase

The provided document is a 510(k) summary for a medical device called the DEKA SmartXide2 Laser System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a new type of device. Therefore, the information needed to answer the prompt thoroughly is not present in this document.

Here's an assessment based on the available information:

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

This information is not explicitly provided. The 510(k) summary aims to demonstrate substantial equivalence to a predicate device, DEKA SmartXide² Laser System (K113504) and Cynosure CO2 Laser (K081424), rather than meeting specific performance acceptance criteria for a novel device. The comparison focuses on:

• Indications for Use: The SmartXide² laser has the same indications for use as the predicate devices.
• Principle of Operation: Same as predicate devices.
• Wavelength: Same as predicate devices (10600 nm).
• Pulse Energy Range: Same as predicate devices.

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 for Test Set: Not applicable in the context of human clinical trials for performance acceptance criteria. The document mentions an animal study.
• Data Provenance: The animal study was conducted on "sheep's skin," but details about the country of origin, retrospective or prospective nature are not provided.

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 does not describe the use of human experts in establishing ground truth for performance evaluation in the way a diagnostic AI device might.

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

This information is not provided and is not applicable to the type of safety and performance study described (animal study for thermal lesion assessment).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a laser surgical instrument, not a diagnostic AI device requiring human reader interpretation.

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

• Standalone Study: Not directly applicable. The device itself (the laser system) is essentially "standalone" in its operation once activated by a human user via footswitch. It's a therapeutic device, not an algorithm providing diagnostic output.

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

For the animal study:

• Ground Truth Type: The study aimed to show "comparative effects of Smartxide laser and Affinity lasers on thermal lesion depth and width as well as ablation depth and width." This implies direct measurement of physical parameters on the tissue. The specific method for establishing this "ground truth" (e.g., histological analysis, direct measurement with calipers) is not detailed.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This document does not describe a machine learning or AI algorithm that would require a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned for this device.

Summary of Device and Study (as per document):

The DEKA SmartXide2 Laser System is a surgical laser. The 510(k) submission seeks to demonstrate substantial equivalence to existing predicate devices (DEKA SmartXide² Laser System K113504 and Cynosure CO2 Laser K081424).

The provided document indicates:

• Nonclinical Performance Data: None mentioned beyond the animal study.
• Clinical Performance Data: None mentioned.
• Animal Study Data: An animal study on sheep's skin was conducted. This study's purpose was to demonstrate "comparative effects of Smartxide laser and Affinity lasers on thermal lesion depth and width as well as ablation depth and width." The results presumably showed comparable effects to establish equivalence, but the specific numerical results or acceptance criteria for these measurements are not detailed in this summary.

Conclusion stated: "The SmartXide 2 laser is a safe and effective device for the intended [use]." This general conclusion is based on the demonstration of substantial equivalence rather than meeting pre-defined acceptance criteria for a novel device performance.

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The DEKA SmartXide2 CO2 laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

The DEKA SmartXide2 940nm diode laser is indicated for incision, excision, vaporization ablation and coagulation of soft tissues (open surgery), cutting, vaporization, ablation and coagulation of soft tissues (endoscopic surgery) in medical specialties including: plastic surgery, dermatology, ENT, gynaecology, urology, general surgery, gastroenterology and dental procedures.

The DEKA SmartXide2 980nm diode laser is indicated for incision, excision, vaporization ablation and coagulation of soft tissues (open and endoscopic surgery) in medical specialties including plastic surgery, dermatology, ear, nose and throat and oral surgery (otolaryngology), gynaecology, urology, neurosurgery, general and thoracic surgery, gastroenterology and dental procedures.

The DEKA SmartXide" system is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source.

The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory connected to its distal end.

The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation.

An air flow is provided by an internal pump in order to avoid dust and particles deposition on the optics during laser operations.

The DEKA SmartXide2 CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator.

The scanning units move the beam on the tissue with controlled velocity and defined patterns to optimize the laser ablation.

The CO2 laser focalized on very little spots by the micromanipulator and moved by scanning systems is useful to fasten the surgical procedures and limit the thermal damage to the tissues surrounding the ablation.

The diode laser source can be provided in two alternative wavelengths: 940nm and 980nm.

The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces. The spot size is effectively the diameter of the fiber being connected to the system.

Emission parameters are selected on the front panel while laser emission is activated by a footswitch. The on-off switch and emergency switch are also located on the front panel of the system.

A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready.

Overall weight of the device is 95 kg, and the size is 210 cm x 59 cm x 56 cm (H x W x D).

Electrical requirement is 100-120Vac 50/60Hz, 220-230Vac 50Hz, 16A.

Analysis of Acceptance Criteria and Device Performance for DEKA SmartXide2 Laser System

Based on the provided 510(k) summary (K113504), the DEKA SmartXide2 laser system is a medical laser system intended for various surgical applications. The submission's primary focus is demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria established by the manufacturer and validated through a standalone study.

1. Table of Acceptance Criteria and Reported Device Performance

As the submission is for substantial equivalence, formal quantitative acceptance criteria are not explicitly stated in the document in the way they would be for a novel device proving its safety and efficacy de novo. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device performs "as well as, or better than" the predicate devices. The performance is assessed through non-clinical bench testing and historical literature data.

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

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in the context of a clinical trial. The testing involved "histological evaluations... on three different animal tissues." The number of samples or specimens within those animal tissues is not specified.
• Data Provenance: The data is non-clinical bench test data conducted on "three different animal tissues." It is retrospective in the sense that existing scientific literature was used to support claims. The country of origin for the animal tissue studies is not specified, but the submitter is based in Italy.

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

• The document does not mention the use of experts to establish a "ground truth" for the non-clinical histological evaluations in the manner it would be done for diagnostic imaging or a comparative clinical study. The histological evaluations likely involved standard laboratory protocols and analyses by trained histologists or pathologists, but no specific number or qualifications of "experts" for ground truth establishment are provided.

4. Adjudication Method for the Test Set

• Given the nature of the non-clinical bench testing (histological evaluations and literature review), there was no mention of an adjudication method like 2+1 or 3+1 typically used in clinical studies with human readers. The results of the histological assessments would be based on scientific measurement and interpretation protocols within a laboratory setting.

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

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Performance Data: None." The evaluation was based on non-clinical bench testing and literature review to demonstrate substantial equivalence, not a direct comparison of human reader performance with or without AI assistance.

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

• This question is not applicable to the DEKA SmartXide2 laser system. This device is a surgical laser system controlled by a human operator, not an AI algorithm. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

• For the non-clinical performance data, the "ground truth" was derived from histological evaluations of ablated animal tissues, measuring parameters like ablation depth and lateral thermal damage. This is a direct physical measurement/assessment rather than expert consensus, pathology report (though pathology methods are used), or outcomes data in humans.

8. The Sample Size for the Training Set

• Not applicable. The DEKA SmartXide2 is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

• Not applicable. As a physical medical device, there is no "training set" for which ground truth needs to be established.

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The SmartXide 50 HS/MS system with its delivery accessories is a medical device indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery and genitourinary surgery.

SmartXide 50 HS/MS is a surgical CO2 laser with 50W of maximum power in continuous mode. The laser system is produced and sold with an internal predisposition for scanning system (HiScan Surgical for SmartXide HS, MiniScan Plus for SmartXide MS). Laser activation is by footswitch. Overall weight of the laser is 43 kg, and the size is 160 cm x 48 cm x 55 cm (H x W x D). Electrical requirement is 115VAC, 6A, 50-60 Hz, single phase. The wavelength of this laser is 10.600nm. This wavelength is mostly absorbed by water and that makes this laser particularly suitable for soft tissue surgery. The CO2 laser radiation is delivered to the treatment area through the handpiece. The handpiece is attached to the distal end of the articulated arm, which is a permanently mounted laser delivery system of the system. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis however the arm is oriented. The field of action of the articulated arm covers a radius of approximately 80 cm, the transfer efficiency of power is greater than 85%. The loss of 15% is balanced by a suitable calibration of the internal power meter. An air flow is provided by an internal pump in order to avoid dust and particles deposition on the optics during laser operations. Emission parameters are selected on the front panel while emission activation is by the footswitch. The on-off switch and emergency switch are also located on the front panel of the system. A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready. The CO2 laser microsurgery is done with microspot micromanipulators and scanning systems. The CO2 laser focalized on very little spots (140-250um) and moved by scanning systems is useful to fasten the surgical procedures and limit the thermal damage to the tissues surrounding the ablation. In the SmartXide 50 HS/MS series, the electronic controller of the scanner has been integrated in the laser system with touch screen settings. The scanning systems move the beam on the tissue with controlled velocity and defined patterns to optimize the laser ablation. The high Power Density reached though little spots and typical of the cutting, are thus well controlled by the operator, and the tissue destruction happens in a very quick, delicate and precise way, reducing drastically the surgery time and limiting the lateral thermal damage and the negative phenomenon of carbonisation, with evident advantage for the patient and for the surgeon as well. Both scanning units can be used together with Deka micromanipulator EasySpot. Easyspot has a single ring nut rapid focalization system that allows to focalize the beam to the same focal length of the microscope and fix the position with a mechanical block. In this way the micromanipulator "remembers" the focus position, still allowing eventually the surgeon to defocus the beam from the same ring nut. Thanks to its joystick, it is possible to regulate the mechanical tension and the maximum work field in order to easily control and never "loose" the beam even inside small size faryngoscopes. On top of the joystick Easyspot can mount a remote control specially conceived to command top level scanning systems (HiScan Surgical). It allows the surgeon to have under direct control the more useful electronic scanning functions (rotation and dimension of the figures, scan off-scan on, centering) without moving his eyes from the microscope.

This submission describes a CO2 laser system (Smartxide 50 HS/MS) for soft tissue surgery. The key aspect of this 510(k) is that no acceptance criteria or studies proving performance were conducted or are required for this type of device.

Here's why:

• Predicate Device Equivalence: The safety and effectiveness of the Smartxide 50 HS/MS are established by demonstrating substantial equivalence to previously cleared predicate devices: Lumenis Acupulse30 ST/40 ST (K082809), DEKA Smart CO2 (K072159), and Lumenis UltraPulse Surgitouch (K030147).
• "Nonclinical Performance Data: None" & "Clinical Performance Data: None": The document explicitly states that no nonclinical or clinical performance data was provided or deemed necessary for this 510(k) submission. This is common for devices that are "substantially equivalent" to existing, cleared devices and do not introduce new technology or indications that would necessitate new performance testing.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone studies, and training set information is not applicable to this 510(k) submission.

Summary of Device and Regulatory Context (based on the provided text):

1. Acceptance Criteria & Reported Device Performance: Not applicable. Performance is established through substantial equivalence to predicate devices, not by meeting specific acceptance criteria or through a new performance study.

2. Sample Size & Data Provenance (for test set): Not applicable, as no dedicated performance study using a test set was conducted for this submission.

3. Number of Experts & Qualifications (for ground truth): Not applicable, as no new ground truth determination was required for a performance study.

4. Adjudication Method (for test set): Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. No such study was performed or required.

6. Standalone (Algorithm Only) Performance Study: Not applicable. This is a physical medical device (CO2 laser), not an algorithm.

7. Type of Ground Truth Used: Not applicable. Safety and effectiveness are based on the known performance and predicate devices.

8. Sample Size for Training Set: Not applicable, as no machine learning algorithm was developed or tested for this device.

9. How Ground Truth for Training Set was Established: Not applicable.

Conclusion from the 510(k) Summary:
"The Smartxide 50 HS, Smartxide 50 MS lasers with delivery accessories are safe and effective devices for incision, excision, ablation, vaporization and coagulation of body soft tissue, including intraoral tissue." This conclusion is based on substantial equivalence to predicate devices.

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The smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The Smart CO2 lasers (SmartXide, Smart US20D) are CO2 laser, having a sealed CO2 gas tube as the lasing medium. These are lasers with a wavelength of 10.6 um. Laser activation is by a footswitch. Overall weight of the laser is 30 kg, and the size is 120 cm x 48 cm x 55 cm (H x W x D). Electrical requirement is 115VAC, 15A, 50-60 Hz, single phase.

This 510(k) summary for the Smart CO2 (SmartXide, Smart US20D) Laser with DOT scanner does not contain information about acceptance criteria or a study proving the device meets them.

Instead, the submission states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

The basis for clearance is substantial equivalence to a predicate device (Lumenis UltraPulse Encore). The document argues that the Smart CO2 lasers are substantially equivalent because:

"They are both CO2 lasers with a scanning unit as an accessory, for the identical indications for use."

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because they are not present in the provided text.

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