(163 days)
The Alma Lasers ALEX755 Module to be used with the Harmony XL™ Multi-Application Platform is indicated for permanent hair reduction. Also indicated for the treatment of vascular lesions and benign pigmented lesions.
The Alma Lasers ALEX755 Module is an additional module to the existing Alma Lasers. Ltd. Harmony XLTM Multi-Application Platform (previously cleared under K072564). The pistol-shaped Alex755 laser module incorporates a solid state Alexandrite rod laser medium and a xenon flash lamp as the heart of the optical bench. The flash lamp pumped Alexandrite rod emits light through an aperture located on the module tip. The laser beam is delivered when the operator presses both the footswitch, and the handpiece trieger. The Alma Lasers ALEX755 Module is comprised of the following components; An 'umbilical' cable and connector, that is permanently attached to the ALEX755 module body and semi-permanently attached to the laser system. Electrical cables (to provide power to the light source and to connect to a memory device that identifies the module). A supply and return water line (to remove the heat generated). Module body (shells) housing the module internals and connecting to the umbilical. The operator holds the handpiece by its handle in order to position the module tip against the patient's skin. Optional air-cooling can be provided.
This 510(k) summary describes a medical device, the Alma Lasers ALEX755 Module. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than performance studies with defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can be inferred or what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not describe specific acceptance criteria (e.g., a certain percentage of hair reduction, lesion clearance rate) or any performance data from a study. The approval is based on substantial equivalence, implying that its performance is expected to be similar to its predicates without explicit new performance data provided in this summary.
2. Sample sized used for the test set and the data provenance
- Cannot be provided. No test set or clinical study data is reported in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. No test set or ground truth establishment is described.
4. Adjudication method for the test set
- Cannot be provided. No test set or adjudication is described.
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
- Cannot be provided. This device is a laser module for treatment, not an AI-assisted diagnostic or interpretation system. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a hardware laser module operated by a human. The concept of "standalone algorithm performance" doesn't apply.
7. The type of ground truth used
- Cannot be provided. No ground truth is described as no performance study is detailed.
8. The sample size for the training set
- Cannot be provided. No training set is described as no new algorithm development or performance study is detailed.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or ground truth establishment is described.
In summary, the provided text is a 510(k) summary for regulatory clearance based on substantial equivalence, not a report of a device performance study with 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.