(185 days)
The LucentLite Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology:
1064 nm:
- To effect stable long-term, or permanent* hair reduction through selective targeting of melanin in hair follicles.
- For the removal of unwanted hair.
- For coagulation and hemostasis of vascular lesions.
- For Incision/excision of soft body tissues in dermatology.
- For soft tissue general surgery applications: skin incision; tissue dissection; excision of external turnors and lesions; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation.
- Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after treatment regimen.
1320 nm:
- For the treatment of periorbital and perioral wrinkles.
The LucentLite Laser is comprised of the following main components:
- Console (including laser, electronics, cooling system, and software);
- Control panel;
- Permanently attached fiberoptic-coupled handpiece;
- Skin cooling device;
- Foot pedal;
- Remote interlock connector.
The provided text is a 510(k) summary for the LucentLite Laser, a medical device. This document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed clinical study results with acceptance criteria and specific performance metrics for the LucentLite device itself.
Therefore, many of the requested details about acceptance criteria, study methodologies, sample sizes, and ground truth establishment cannot be found in this document. The 510(k) process for this type of device typically relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as a legally marketed predicate device, rather than requiring extensive de novo clinical trials with predefined acceptance criteria.
Here's the information that can be extracted or inferred based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided 510(k) summary, specific acceptance criteria and detailed device performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative measurements for efficacy) are not reported. The document focuses on demonstrating substantial equivalence to predicate devices, implying that the device achieves performance comparable to those predicates for its stated indications for use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. No explicit quantitative or qualitative acceptance criteria (e.g., "achieve X% hair reduction in Y% of patients" or "achieve Z lesion clearance") are provided. | Not specified in this document. No quantitative performance results (e.g. from clinical trials showing efficacy percentages) are provided. The document generally states that the device is "substantially equivalent" to predicate devices for its intended uses. |
2. Sample sized used for the test set and the data provenance
Not provided. The document does not describe a "test set" in the context of an evaluative study with specific performance metrics. The 510(k) summary relies on comparison to predicate devices, not on a new clinical study with a specified test set patient cohort.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Since no specific test set and associated ground truth establishment process are described, this information is not available.
4. Adjudication method for the test set
Not applicable/Not provided. Since no specific test set and associated ground truth establishment process are described, this information is not available.
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 document describes a laser surgical instrument, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a laser surgical instrument, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. As there's no described new clinical study with a test set, the concept of "ground truth" for a new dataset is not discussed. The device's safety and effectiveness are established by demonstrating substantial equivalence to predicate devices, for which the "truth" of their efficacy would have been established through a combination of scientific understanding, previous clinical data, and regulatory clearance.
8. The sample size for the training set
Not applicable/Not provided. This document does not describe a machine learning algorithm or a "training set."
9. How the ground truth for the training set was established
Not applicable/Not provided. This document does not describe a machine learning algorithm or a "training set."
Summary of what the document does provide:
- Device Name: LucentLite Laser
- Intended Use: Surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. Specific indications for 1064 nm (hair reduction, vascular lesions, incision/excision of soft tissue) and 1320 nm (treatment of periorbital and perioral wrinkles).
- Predicate Devices:
- Rationale for Substantial Equivalence: The LucentLite Laser shares the same general indications for use, similar design features, and functional features as the predicate devices. The technological differences do not raise any new issues of safety, effectiveness, or performance.
§ 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.