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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 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 surgical lasers are indicated for incision, and coagulation of body soft tissue. It's typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology and general surgery.

Smart CO₂ is a CO₂ laser, having a sealed CO₂ gas tube as the lasing medium. It is a laser with a wavelength of 10.6 μm. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.

The provided text is a 510(k) summary for the Smart CO2 laser. It explicitly states:

• "Nonclinical Performance Data: none"
• "Clinical Performance Data: none"

Therefore, based on the provided document, no studies were conducted to prove the device meets acceptance criteria, as there are no reported nonclinical or clinical performance data. The device's substantial equivalence determination was based on comparison to a predicate device (PhotoAppeal laser) with the same principle of operation, wavelength, and essentially the same power range and indications for use.

Consequently, none of the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) can be extracted from this document, as no such performance data or studies are mentioned.

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