(239 days)
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano de, Soprano de and Soprano (5) is intended for use in dermatologic and general surgical procedures.
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano ^', Soprano * and Soprano "CE] includes Diode Laser and NIR Modules
Diode Laser Modules:
The indications for use for the 810mm Modified Diode Laser Module 1.2 cm² include:
- The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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 cm² include:
- . The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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 is 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) 트
- 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, 트
- The temporary relief of minor joint pain associated with arthritis,
- 프 The temporary increase in local circulation where applied, and
- 미 The relaxation of muscles; may also help muscle spasms, minor sprains and minor muscular back pain.
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano ™ and Soprano "CE] is a modification to previously cleared Soprano Family XL ™M Multi Application Platform [Soprano **] The relevant K number is K102716
Soprano 40, the new addition to the family has hand pieces with multiple wavelengths, spot sizes and supports both Diode Laser and Near Infrared (NIR) Technologies. The Soprano 40 comprises of the following major components:
- The main console unit
- Footswitch.
The provided document is a 510(k) premarket notification for a medical device (The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi-Technology Platforms). It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technical characteristics, and adherence to safety standards.
Crucially, this document does not contain information about acceptance criteria for device performance as typically understood for studies evaluating diagnostic or therapeutic efficacy (e.g., sensitivity, specificity, accuracy). Nor does it describe a study that proves the device meets such performance criteria by comparing it against a ground truth in a clinical setting.
Instead, the "acceptance criteria" and "study" described in this document are related to:
- Substantial Equivalence: The primary "acceptance criterion" for a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
- Safety and Performance Standards: The "studies" are tests conducted to ensure the device meets specified electrical, electromagnetic, and laser safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and software development and risk management standards (IEC 62304, ISO 14971).
Therefore, I cannot populate the table and additional information based on the typical understanding of "acceptance criteria" for a device's clinical performance. The document focuses on showing the device is substantially equivalent to existing devices and safe according to engineering and manufacturing standards.
However, I can extract the information relevant to these types of "acceptance criteria" and "studies" as presented:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type) | Reported Device Performance (as demonstrated for Substantial Equivalence and Safety) |
|---|---|
| Substantial Equivalence to Predicate Devices | The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano XLi and Soprano ICE] shares the same or similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices: K112031, K102716, K083848, K080318, K090571, K101916, K083207. Details are provided in Tables 1-5 comparing technical characteristics and indications for use. |
| Electrical Safety and Essential Performance | Tested and found compliant with IEC 60601-1: 1988+A1:1991+A2:1995: Medical Electrical Equipment Part 1: General Requirements for basic safety and essential performance. |
| Electromagnetic Compatibility (EMC) | Tested and found compliant with IEC 60601-1-2: 2001 + A1(4): Medical electrical equipment: Part 1-2: General requirements for safety- Collateral Standard: Electromagnetic compatibility - Requirements and tests. |
| Laser Safety (Diagnostic and Therapeutic Laser Equipment) | Tested and found compliant with IEC 60601-2-22:1995: Medical Electrical Equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment. |
| Laser Product Classification and Requirements | Tested and found compliant with IEC 60825-1:2007 (2nd edition): Safety of Laser Products-Part 1: Equipment Classification and Requirements. |
| Software Life Cycle Processes | Software documented, verified, and validated (test reports in submission) in accordance with IEC 62304:2006 - Medical Device Software: Software Life Cycle Processes. |
| Risk Management | Documented in accordance with ISO 14971:2012 – Application of Risk Management to Medical Devices. |
| Optional Tapered Light Guide Operation and Safety | Verified and validated (test reports in submission) in accordance with the design control and quality system principles of ISO 13485: 2012 - Medical Devices: Quality Management Systems and FDA federal regulation 21 CFR 820. |
Regarding the specific questions about clinical study design for performance:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document does not describe a clinical performance test set with human or biological data. The "tests" mentioned are engineering and software validation tests.
- 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. Ground truth for clinical efficacy is not discussed.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This device is a laser platform, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant in this context.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed clinical performance is not assessed in this document. The "ground truth" for the engineering/software tests would be the requirements of the standards themselves.
- 8. The sample size for the training set: Not applicable. There is no machine learning or AI model being trained discussed.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this regulatory document focuses on establishing the safety, essential performance, and substantial equivalence of a modified laser platform to existing devices, primarily through engineering tests and comparison of technical specifications, rather than clinical performance studies against a "ground truth" for efficacy.
§ 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.