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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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