(60 days)
The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Modified Diode Laser Module (used with the Alma Lasers Family of Soprano XL Multi-Application Platforms):
- The HR Mode is intended for hair removal, permanent hair reduction. .
- . The SHR Mode is intended for hair removal, permanent hair reduction.
- The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented . lesions.
The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms, and the delivery accessories that are used with it, is comprised of the following main components:
- A module housing with: .
- Module trigger switch (must be pressed at the same time the Soprano system A footswitch is depressed to deliver laser energy to the treatment site);
- A Light guide
- TEC-cooled to provide contact skin cooling 9
- A Light guide retainer
- Umbilical cable and connector that attaches the Diode Laser Module to the Soprano . system console and includes the electrical and cooling connections to the Soprano system.
Here's a breakdown of the acceptance criteria and study information for K112031:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K112031 510(k) Summary) does not explicitly list "acceptance criteria" in a quantitative, measurable format for this device submission. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly defined by the safety and effectiveness demonstrated in peer-reviewed literature for similar technology.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (from literature) |
|---|---|
| Safe for dermatologic and general surgical procedures | Demonstrated safety and effectiveness in 2,879 patients. |
| Effective for hair removal | Demonstrated safety and effectiveness for hair removal. |
| Effective for permanent hair reduction | Demonstrated safety and effectiveness for permanent hair reduction. |
| Effective for treatment of benign vascular lesions | Demonstrated safety and effectiveness for treatment of benign vascular lesions (implied by predicate, not explicitly re-stated with data for this device). |
| Effective for treatment of pigmented lesions | Demonstrated safety and effectiveness for treatment of pigmented lesions (implied by predicate, not explicitly re-stated with data for this device). |
| Usable on all skin types (Fitzpatrick I-VI), including tanned skin | Demonstrated safety and effectiveness on Fitzpatrick skin types I-VI, including tanned skin. |
| Performance immediately following treatment | Studies reported safety and effectiveness immediately following treatment. |
| Long-term performance (1, 6, and 18 months post-treatment) | Studies reported safety and effectiveness at 1, 6, and 18 months following treatment. |
| Low fluence, high repetition rate, multiple-pass treatment regimen | Demonstrated safety and effectiveness using these parameters. |
Note: The FDA's substantial equivalence determination for this 510(k) means they found the device as safe and effective as legally marketed predicate devices. The acceptance criteria are therefore aligned with the demonstrated performance of those predicate devices and the clinical literature supporting the technology.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: 2,879 patients
- Data Provenance: The document states "published peer-reviewed medical literature provided device validation information." This indicates the data is retrospective, drawn from previously conducted clinical studies. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not provided or required for 510(k) submissions, especially when relying on published literature for substantial equivalence for a physical device like a laser. The evaluation of "ground truth" (e.g., successful hair removal, lesion treatment) would have been performed by the clinicians conducting the studies, but their specific number or qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable/Not specified. Given that the submission relies on existing published literature for device validation (rather than new clinical trials), there's no mention of a specific adjudication method for the "test set" in this context. The peer-review process of the scientific literature would have served as the form of validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Information
- MRMC Study Done? No. This type of study (comparing human readers with and without AI assistance on multiple cases) is typically associated with AI/CAD image analysis devices. This submission is for a physical laser device, not an AI diagnostic tool.
- Effect Size of Human Readers with vs. Without AI Assistance: Not applicable.
6. Standalone Performance (Algorithm Only) Study Information
- Standalone Performance Study Done? No. This concept is relevant for AI algorithms. This submission is for a physical laser device.
7. Type of Ground Truth Used
The ground truth was established by clinical outcomes observed and reported in the published peer-reviewed medical literature. This would include direct clinical assessment of:
- Hair removal status
- Degree of permanent hair reduction
- Effectiveness of treatment for benign vascular lesions (implied by predicate and technology type)
- Effectiveness of treatment for pigmented lesions (implied by predicate and technology type)
- Safety outcomes (adverse events, skin reactions, etc.)
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for the device's development would be through engineering and testing, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of machine learning for this physical device.
§ 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.