(28 days)
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.