(23 days)
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.
§ 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.