(171 days)
The Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) and accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).
Surgical Handpieces
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with surgical handpieces are indicated for use for the particular indications as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- · laser skin resurfacing
- · laser derm-abrasion
- · laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.
OptiScan PRIME Scanner
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with OptiScan PRIME scanner are indicated for:
·Laser skin resurfacing (ablation and/or vaporization) of soft tissue
Youlaser PRIME and Youlaser PRIME MT with wavelength of 1550nm used in combination with OptiScan PRIME scanner, are indicated for:
· Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
Youlaser PRIME MT with wavelengths of 10600nm & 1550nm used in combination with OptiScan PRIME is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
The models of the Youlaser PRIME family are medical laser emitting at 10600nm (CO2 laser source), 1550nm, plus combined configurations.
The 1550nm laser source is a fiber laser, this wavelength lies in the invisible infrared part of the electromagnetic spectrum.
The CO2 laser source is an RF driven sealed gas tube emitting laser radiation both in continuous and pulsed mode in the invisible far-infrared part of the electromagnetic spectrum (10600nm).
The beam delivery system is an articulated arm with a handpiece or a scanner on its end.
The laser device is equipped with a display with a graphical user interface (GUI) for user-device interaction (e.g. laser parameters settings).
The scanner is also provided with a touchscreen display to select the scan pattern, shape, dimension,...etc. Laser emission is controlled via the external footswitch has an activation pedal which enables laser emission.
The provided text describes a 510(k) premarket notification for a laser surgical instrument. It details the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a human-in-the-loop or algorithm-only performance study as typically seen for AI/ML-based medical devices.
The "study" mentioned is an in vivo animal study (on minipigs) for the 1550nm fiber laser source to demonstrate safety and effectiveness, specifically regarding its ability to cause ablation and coagulation in tissue. This is a pre-clinical safety/performance study, not a clinical study assessing diagnostic or assistive performance against ground truth and acceptance criteria in the way an AI/ML device would be evaluated.
Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance is not present in the provided document.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance goals for a diagnostic algorithm. The document focuses on demonstrating substantial equivalence to predicate devices in terms of technical characteristics and intended use, and safety and effectiveness through non-clinical (animal) testing.
- Reported Device Performance:
- In vivo minipig study (for 1550nm fiber laser):
- Outcome: "Testing was performed safely on the test animals, and the histology results complied with the FDA requirements, from 0 to 14 days."
- "Re-epithelization was observed three days after radiation in all specimens."
- "Slight erythema was noted as the primary side effect in higher energy settings, but it was transient and resolved within days."
- "No cases of oedema were observed, and overall, the healing process was uncomplicated."
- "Histologic analysis performed with H&E staining at various time points (days 1, 4, and 14) revealed predictable levels of ablation and coagulation depending on the energy settings used, with the fiber laser causing predominantly coagulation while the CO2 laser focused on ablation."
- "By day 4, re-epithelization of the skin was already evident, and by day 14, the skin had fully healed."
- Conclusion: "The Youlaser PRIME device demonstrates predictable and controlled skin ablation and coagulation, ensuring patient safety and clinical efficacy." and "The findings confirm that the device is equivalent to other approved technologies, with precise control over energy output and microspot density to facilitate rapid healing and minimize side effects."
- In vivo minipig study (for 1550nm fiber laser):
2. Sample sized used for the test set and the data provenance
- Test Set (for the in vivo study): "Three animals were used in this study."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's an in vivo animal study, not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts: Not explicitly stated. The document mentions "histologic analysis performed with H&E staining," which implies expert pathological assessment, but the number and qualifications of the pathologists are not provided.
- Ground truth context: For this type of device, "ground truth" would be the observed biological effects (ablation, coagulation, healing) in the animal tissue, as assessed histologically.
4. Adjudication method for the test set
- Not applicable/Not mentioned, as this was an evaluation of physical effects on tissue, not a diagnostic decision process requiring adjudication.
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
- No. This type of study is for AI-assisted diagnostic devices. The Youlaser PRIME is a laser surgical instrument, and the evaluation presented is a non-clinical (animal) study of its physical effects, not a human-reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/algorithm-only device. The "study" refers to the laser's physical interaction with tissue.
7. The type of ground truth used
- For the in vivo animal study: Histology results (e.g., H&E staining at various time points) examining ablation, coagulation, and re-epithelialization in minipig skin tissue.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model.
Summary of Device and its Evaluation:
The Youlaser PRIME family devices are laser surgical instruments. The "study" mentioned in the document is an in vivo non-clinical study on minipigs designed to demonstrate the safety and effectiveness of the 1550nm fiber laser source by evaluating the biological response (ablation, coagulation, healing) in animal tissue. This type of evaluation is standard for surgical devices that interact directly with tissue, focusing on physical parameters and biological outcomes rather than diagnostic performance or human-AI interaction. The document's primary purpose is to establish substantial equivalence to legally marketed predicate devices, which is achieved by comparing technical specifications and demonstrating comparable safety and effectiveness through non-clinical testing.
§ 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.