(90 days)
Intended Use: The additional Soprano 1064nm Diode Laser Module is intended for use in dermatologic and general surgical procedures.
Indications for Use: The indications for use for the Soprano1064nm Diode Laser Module include:
- The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6.9 and 12 months after the completion of a treatment regimen.
- Treatment of Pseudo folliculitis Barbae (PFB)
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The subject device, Alma Lasers Soprano 1064nm Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano 100 platform. Consistent with the previous clearance the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are still the main console unit, footswitch, and individual modules. No change has been made to the main console unit except for incorporation of the software needed to run the new module; the footswitch and pre-existing modules are also unmodified from those cleared in K140009.
The module's operation involves emission of laser (diode) energy through the handpiece to the patient's skin. The materials that could contact the patient during device use are sapphire, aluminum, and plastic; these would all have limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
This document describes the marketing authorization for a medical device and does not include information about specific acceptance criteria or performance studies of the kind typically associated with AI/ML-driven devices.
The device in question, the "Modified Alma Lasers Soprano XL Family Of Multi-application & Multi-technology Platform, Soprano Yag Hand Piece" (specifically, the additional 1064nm Diode Laser Module), is a laser surgical instrument. The FDA review is for a 510(k) premarket notification, which establishes substantial equivalence to existing legally marketed predicate devices.
Therefore, most of the requested information (like performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this document as it pertains to a traditional medical device approval based on technological equivalence and established safety standards rather than AI/ML performance.
However, I can extract the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance:
This document does not specify "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML device. Instead, the "acceptance criteria" for this 510(k) clearance are based on substantial equivalence to predicate devices in terms of:
- Intended Use: Dermatologic and general surgical procedures.
- Indications for Use: Permanent reduction in hair regrowth (HR and SHR modes), treatment of Pseudofolliculitis Barbae (PFB), and use on all skin types (Fitzpatrick I-VI), including tanned skin.
- Technological Characteristics: Wavelength (1064nm), laser media (Solid State), mode (HR, SHR), spot size, pulse width, pulse repetition rate, energy density, user interface, delivery device type, and compatible laser system.
- Safety and Effectiveness: Demonstrated through compliance with recognized device standards and comparison to predicate devices, without raising new questions of safety or effectiveness.
The "reported device performance" is essentially that the device functioned as intended and the results observed were as expected during performance testing against established electrical safety, electromagnetic compatibility, and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-1-6, IEC 60825-1).
Table Summarizing Equivalence:
| Characteristic | Proposed Soprano 1064nm Diode Laser Module | Predicate Family of Coolglide Aesthetic Lasers (K153671), (K132185) |
|---|---|---|
| Intended Use | Dermatologic and general surgical procedures. | Dermatologic and general surgical procedures. |
| Indications for Use | • Permanent reduction in hair regrowth (HR and SHR Mode) | |
| • Treatment of Pseudo folliculitis Barbae (PFB) | ||
| • Use on all skin types (Fitzpatrick I-VI), including tanned skin | • Permanent reduction in hair regrowth | |
| • Treatment of Pseudo folliculitis Barbae (PFB) | ||
| • Treatment of vascular and pigmented lesions | ||
| • Treatment of wrinkles | ||
| • Treatment of mild to moderate inflammatory acne vulgaris | ||
| • Use on all skin types (Fitzpatrick I-VI), including tanned skin | ||
| Wavelength [nm] | 1064 | 1064 |
| Laser Media | Solid State | Solid State |
| Mode | HR, SHR | Not explicitly detailed for 1064nm predicate, but implied to encompass HR/SHR functions given the hair regrowth indication. |
| Spot Size | 10mm * 10mm (1cm²), Optional tapered tip 6mm (0.28 cm²) | K153671: 3mm-18mm; K132185: 3mm-12mm |
| Pulse Width [msec] | 3.3-280 | K153671: Not available; K132185: 0.1-300 |
| Pulse Repetition Rate [Hz] | 0.5-3, 5-10 | ≤ 10 Hz and single shot |
| Energy Density (Fluence) [J/cm²] | 2-120, 2-20 | K153671: Not Available; K132185: Up to 300 |
| User Interface | LCD Color Touchscreen | Push Button Control or LCD Color Touchscreen |
| Delivery Devices | Non-Sterile, reusable, cleanable | Non-Sterile, reusable, cleanable |
| Compatible Laser System | Family of SopranoXL, SopranoXLi and SopranoICE (cleared K 14009) | Coolglide System |
| Safety Testing | IEC 60601-1, 60601-1-2, 60601-2-22, 60601-1-6, 60825-1, Software verification/validation, Biocompatibility. Functioned as intended; results as expected. | Not explicitly detailed in this document but subject to similar safety standards for initial clearance. The document states "The Soprano 1064nm diode laser module also has fewer indications for use as compared to the primary predicate at 1064nm, but this omission does not impact the subject module's safety or effectiveness since all of its proposed indications are encompassed by the predicate." and "The primary predicate's clearance includes use of laser energy at 1064nm for the same indications as are proposed for the Soprano 1064nm Diode Laser Module." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No clinical studies (test sets on patients) were deemed necessary for this 510(k) submission. "Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission." Therefore, this information is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical test set was required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set was required.
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:
Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no new clinical ground truth data was generated for this submission. The "ground truth" for the device's functionality is its adherence to established engineering and safety standards and its equivalence to already cleared predicate devices for the specified indications of use.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML 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.