Search Results

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.

Ask a specific question about this device