(155 days)
The NIRA Model 2 is indicated for the treatment of periorbital wrinkles.
The NIRA Model 2 is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a handheld piece and USB charging cable. The handheld fits in the hand and the laser light comes out of the tip. There is a single USB C connector for battery charging.
This document focuses on the NIRA Model 2, a non-fractional diode laser device intended for the treatment of periorbital wrinkles. It is classified as an Over-The-Counter (OTC) device.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
Important Note: The provided document is an FDA 510(k) summary, which largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance study results for the current device's clinical efficacy. Therefore, specific acceptance criteria and detailed performance metrics as one might see in a clinical trial report are not explicitly stated for the NIRA Model 2's wrinkle reduction efficacy. Instead, the focus is on safety, usability, and the justification for not needing a separate clinical trial due to its similarity to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) submission, the "acceptance criteria" for clinical efficacy (e.g., specific percentage reduction in wrinkles) are not explicitly defined for the NIRA Model 2. Instead, the acceptance is based on demonstrating safety, usability, and substantial equivalence to a predicate device that was previously cleared for the same indication and had its safety and efficacy assessed.
Below is a table reflecting the types of performance criteria assessed, primarily for safety and usability, and general statements about the device meeting those requirements.
| Acceptance Criterion Type | Specific Criterion (Implicit/Explicit) | Reported Device Performance for NIRA Model 2 |
|---|---|---|
| Bench Testing | Electrical Safety: Compliance with AAMI ANSI ES 60601-1:2005(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 and IEC 60601-1-11: 2015. | "The NIRA Laser meets electrical safety...requirements." |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2014. | "The NIRA Laser meets...EMC...requirements." | |
| Laser Safety: Compliance with IEC 60825-1: 2014 (in lieu of 21 CFR 1040.10 and 21 CFR 1040.11 per FDA laser notice #56). Also FCC requirements. | "The NIRA Laser meets...laser safety, and FCC regulations requirements." | |
| Software Documentation: Consistent with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11. 2005 (Moderate Level of Concern). | "Software documentation was provided consistent with FDA 'Guidance...'" | |
| Human Factors/Usability | Self-Selection: Lay persons can correctly determine appropriateness for use based solely on box labeling. | "A Self-selection study successfully assessed whether or not lay person could correctly determine (self-select) if they are appropriate candidates for use of the NIRA device based solely on reading the box labeling." |
| Usability: Device is usable by intended users in a simulated use environment; compliance with IEC 62366:2015 and IEC 60601-1-6: 2010 +A1:2013. | "A Usability study successfully assessed that the NIRA Laser is usable by the device's intended users in a simulated use environment." | |
| Clinical Efficacy & Safety | Substantial Equivalence: NIRA Model 2 should have substantially equivalent intracutaneous temperature elevation and therefore produce very similar biological effect on the skin tissue compared to the predicate device (K163137). | "Since the Model 2 has substantially equivalent intracutaneous temperature elevation for very similar time, no separate clinical trial was performed for the Model 2." "Differences between the NIRA Model 2 and the predicate device do not raise issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set for NIRA Model 2:
- Self-Selection Study: The document does not specify the sample size for this study, only that it "successfully assessed" lay persons' ability to self-select.
- Usability Study: The document does not specify the sample size for this study, only that it "successfully assessed" the usability.
- Clinical Efficacy: No separate clinical trial was performed for the NIRA Model 2. The clinical efficacy and safety assessment rely on the predicate device's clinical trial performed in 2016.
- Data Provenance (Predicate Device's Clinical Trial): The document does not specify the country of origin for the predicate device's clinical trial nor whether it was retrospective or prospective. It only states that the trial was "performed in 2016."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For NIRA Model 2 (Self-Selection & Usability Studies): The document does not specify the number or qualifications of experts involved in establishing ground truth for these studies. These studies typically involve human factors engineers or usability specialists assessing user performance against predefined tasks or criteria, but no details are provided here.
- For the Predicate Device's Clinical Trial: The document does not provide details on the number or qualifications of experts (e.g., dermatologists, clinical evaluators) who established the ground truth (e.g., wrinkle severity assessments) for the predicate device's clinical trial.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication methods (e.g., 2+1, 3+1, none) for the self-selection or usability studies of the NIRA Model 2, nor for the clinical trial of the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. Such studies are typically relevant for diagnostic imaging devices where human readers interpret images with and without AI assistance. The NIRA Model 2 is a therapeutic laser device for home use, not a diagnostic imaging AI, so an MRMC study is not applicable in this context.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The NIRA Model 2 is a hardware device (a laser) with software control. The "performance" in this context is the physical effect of the laser on tissue. The software documentation focused on compliance with FDA guidance for software in medical devices, indicating the software's functionality and safety rather than a standalone clinical performance.
7. Type of Ground Truth Used
- NIRA Model 2 (Bench Testing): Ground truth is based on established engineering and safety standards (e.g., IEC, AAMI, FCC, electrical safety tests, laser output measurements).
- NIRA Model 2 (Self-Selection & Usability Studies): Ground truth would be based on predefined success criteria for understanding instructions and performing device operations, observed during the studies.
- Predicate Device (Clinical Trial for Efficacy): The ground truth for wrinkle reduction efficacy in the predicate device's clinical trial would typically be based on:
- Expert Consensus: Clinical evaluators (e.g., dermatologists) assessing wrinkle severity through standardized scales (e.g., Fitzpatrick Wrinkle Scale, Global Aesthetic Improvement Scale, or photographic analysis ratings).
- Outcomes Data: E.g., photographic evidence reviewed by blinded evaluators.
The document does not explicitly state the specific ground truth method used for the predicate's 2016 clinical trial.
8. Sample Size for the Training Set
The NIRA Model 2 is a physical laser device, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for clinical interpretation. The document does not mention any AI/ML components requiring a specific training set of clinical data. If the "software documentation" (as described under performance testing) included any adaptive algorithms, details about their training would be in the software documentation, but this is not mentioned explicitly in the summary.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no mention of a "training set" in the context of AI/ML for the NIRA Model 2. Therefore, no information is provided on how such a ground truth would be established. The design and manufacturing process of the laser device itself would be guided by engineering principles and safety standards, rather than a clinical training set.
§ 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.