Search Results

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.

Ask a specific question about this device