(172 days)
Intended Use: The device is intended for use in dermatologic and general surgical procedures.
Indications for Use:
The Soprano trio Diode Laser Module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio Diode Laser Module include:
- Benign vascular and vascular dependent lesions removal.
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 indications for use for the 810nm Modified Diode Laser Module 1.2 cm' 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.
- The treatment of benign vascular and pigmented lesions.(The Laser Blanch (LB) Mode)
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and LB Modes)
Optional Tapered Light Guide: It is intended for the same use as the device.
The indications for use for the 810nm Modified Diode Laser Module 2 cm 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.
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
The indications for use for the 755nm 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.
- The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode)
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and Laser Blanch Modes)
NIR Modules
The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating.
The indications for use for NIR Modules are: - Elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness,
- . The temporary relief of minor joint pain associated with arthritis,
- The temporary increase in local circulation where applied, and
- The relaxation of muscles; may also help muscle spasms, minor sprains and minor muscular back pain.
The subject device, Alma Lasers Soprano Trio Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano platforms. 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, foot switch, 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 and adding a new device name (Soprano 100 Platinum) to the Soprano family name for marketing purposes. The footswitch and pre-existing modules are also unmodified from those cleared in K140009 and K170626.
The module's operation involves emission of laser (diode) energy through the hand piece to the patient's skin. The materials that could contact the patient during device use are as cleared in the predicate. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
The provided text describes a 510(k) premarket notification for a medical device, which is primarily a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove acceptance criteria in the typical sense of a clinical trial for a novel device. Therefore, much of the requested information (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth for training data) is not applicable or not provided in this type of regulatory document.
However, I can extract the relevant information regarding performance testing and the conclusion of safety and effectiveness.
Acceptance Criteria and Device Performance
The acceptance criteria here are implicitly tied to demonstrating substantial equivalence to predicate devices, ensuring that the modified device functions as intended and does not raise new safety or effectiveness concerns.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Adherence to relevant medical electrical equipment and laser safety standards. | The device was tested and found to comply with: |
- IEC 60601-1 (General Requirements for safety)
- IEC 60601-1-2 (General Requirements for basic safety and essential performance - EMC)
- IEC 60601-2-22 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)
- IEC 60825-1 (Safety of laser products - Part 1: Equipment Classification, requirements and user's guide) |
| Software functions as intended and is validated. | Software verification and validation testing was performed. |
| Biocompatibility established for patient-contacting materials. | Biocompatibility was established, as the materials contacting the patient are the same as those cleared in the predicate device. |
| No new safety or effectiveness issues raised by the modification (combining wavelengths into a single handpiece). | Animal histology testing was performed comparing the histology of individual wavelengths to the histology of combined wavelengths over a range of energies. Testing showed no significant differences between the individual tissue effects and the combined wavelength tissue effects.
"In all instances, the Soprano Trio Diode Laser Module functioned as intended and the results observed were as expected." |
| Equivalence in safety and effectiveness to predicate devices. | The conclusion states: "The Soprano Trio Diode Laser Module is as safe and effective as the primary predicate [...] and reference predicate [...]. The proposed Trio diode laser module has similar intended use and indications, similar technological characteristics, and same principle of operation as its predicate device. Combining different wavelengths in one module does not alter the intended use of the device and does not affect its safety and effectiveness when used as labeled. Thus, the Soprano Trio Diode Laser Module is substantially equivalent." No clinical studies were deemed needed due to similarities in safety and effectiveness profiles with predicate devices. |
Detailed Study Information (as applicable to this 510(k) submission):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No specific "test set" in the context of clinical data for algorithmic performance is mentioned. The performance testing described includes adherence to international standards and animal histology.
- For animal histology, the sample size is not specified, nor is the country of origin or whether it was retrospective/prospective. The text only states "animal histology testing was performed".
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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. The ground truth for device performance here is based on compliance with engineering standards and direct observation of tissue effects in animal models by the manufacturer or testing facility, not expert consensus on diagnostic interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No diagnostic interpretation or human reader-based assessment requiring adjudication is described.
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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 device is a laser surgical instrument, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not a standalone algorithm. Its performance is assessed through compliance with standards and tissue effects, not an algorithmic output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal histology study, the "ground truth" would be the observed histological changes and tissue effects, likely evaluated by a histopathologist, although this is not explicitly stated. The comparison was to the effects of individual wavelengths.
- For compliance with standards, the ground truth is the engineering specifications and safety requirements defined by the standards themselves.
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The sample size for the training set:
- Not applicable. No machine learning training set is mentioned as this is a laser device.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.