(66 days)
LMNT O2 is an over-the-counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. In addition, LMNT O2 indicated to emit energy in the blue region of the spectrum for use in dermatology for the treatment of mild to moderate acne.
LMNT O2 is a hand held device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±15nm, 830 ±15nm distribution with no hot spots for the treatment of periorbital wrinkles. The device also uses blue LED, at wavelength of 415 ±15nm emitting optical power in a uniform distribution with no hot spots for the treatment of acne.Designed for home-use.
Please note: The provided FDA 510(k) clearance letter and summary discuss a device for dermatological treatment of wrinkles and acne, which is not related to AI/ML or diagnostic imaging as typically implied by "acceptance criteria" and "ground truth" in the context of advanced AI medical devices. The document details non-clinical testing for electrical safety, EMC, biocompatibility, and physical performance parameters of a light-based therapy device.
Therefore, a significant portion of your requested information (e.g., MRMC study, human reader improvement with AI, number of experts for ground truth, adjudication methods, training/test set data provenance, sample size for training and testing AI models) cannot be extracted from this document because the device is a physical therapy device, not an AI/ML diagnostic or assistive tool.
However, I will extract and present the relevant information about the acceptance criteria and performance as much as possible, focusing on the available physical and performance testing data.
Acceptance Criteria and Device Performance (Based on provided document)
The acceptance criteria for the LMNT O2 device are primarily met through performance testing related to its physical outputs and safety standards. The document doesn't present a table of "acceptance criteria" vs. "reported device performance" in the typical AI/ML sense (e.g., sensitivity, specificity, AUC). Instead, it states conformity to international consensus standards and specific physical measurements.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Implied from standards/tests) | Reported Device Performance (from document) |
|---|---|---|
| Electrical Safety | Conforms to ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Evaluated and conforms to the standard. |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 Edition 4.1 2020-09 | Evaluated and conforms to the standard. |
| Home Healthcare Environment Safety | Conforms to IEC 60601-1-11 Edition 2.1 2020-07 | Evaluated and conforms to the standard. |
| Electromagnetic Immunity Guidance | Conforms to IEC TR 60601-4-2 Edition 1.0 2016-05 | Evaluated and conforms to the standard. |
| Photobiological Safety | Conforms to IEC 62471 First edition 2006-07 | Evaluated and conforms to the standard. |
| Biocompatibility - Cytotoxicity | Conforms to ISO 10993-5 Third edition 2009-06-01 | Evaluated and conforms to the standard. |
| Biocompatibility - Skin Sensitization | Conforms to ISO 10993-10 Fourth edition 2021-11 | Evaluated and conforms to the standard. |
| Biocompatibility - Systemic Toxicity | Conforms to ISO 10993-11 Third edition 2017-09 | Evaluated and conforms to the standard. |
| Biocompatibility - Irritation | Conforms to ISO 10993-23 First edition 2021-01 | Evaluated and conforms to the standard. |
| LED Wavelength (Red) | 633 ±15nm | 633 ±15nm (Stated as characteristic, implies measured performance meets this range) |
| LED Wavelength (IR) | 830 ±15nm | 830 ±15nm (Stated as characteristic, implies measured performance meets this range) |
| LED Wavelength (Blue) | 415 ±15nm | 415 ±15nm (Stated as characteristic, implies measured performance meets this range) |
| Energy Density (633nm) | Sufficient for indicated use (not explicitly stated as a numerical criterion from the document) | 69mW/cm² |
| Energy Density (830nm) | Sufficient for indicated use | 53mW/cm² |
| Energy Density (415nm) | Sufficient for indicated use | 49mW/cm² |
| Skin Temperature | Safe and within specified limits | Tested (implies within safe limits, though specific data not provided) |
| Hot Spots | No hot spots detected | Tested (implies no hot spots detected) |
2. Sample Size for Test Set and Data Provenance
This information is not applicable or available from the provided document as the device is a light therapy device, not an AI/ML algorithm requiring a data-based test set in the conventional sense. The "testing" refers to non-clinical bench testing of the physical properties and safety.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable or available. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or measurements against which an algorithm's performance is compared. For this physical device, "ground truth" is established by adhering to recognized international engineering and safety standards.
4. Adjudication Method for the Test Set
This information is not applicable or available. Adjudication methods are typically used in clinical studies or AI/ML ground truth establishment to resolve discrepancies among expert readers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for comparing diagnostic performance, often with and without AI assistance, or comparing different diagnostic methods. This device is a therapeutic light device, and the clearance is based on its physical properties and safety, demonstrating substantial equivalence to predicates, not a diagnostic performance comparison.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable or available. The device is a standalone physical product, not a diagnostic algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance validation is based on engineering standards, physical measurements, and safety compliance. This includes:
- Conformity to international consensus standards (e.g., IEC 60601 series, ISO 10993 series, IEC 62471).
- Bench testing results for specific physical characteristics (e.g., LED wavelengths, energy density, skin temperature, hot spots).
- Demonstration of substantial equivalence to legally marketed predicate devices with established safety and efficacy profiles for similar indications.
8. The Sample Size for the Training Set
This information is not applicable or available. The device is not an AI/ML algorithm that is "trained" on a dataset.
9. How the Ground Truth for the Training Set was Established
This information is not applicable or available. As stated above, there is no AI/ML training set for this 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.