(95 days)
The LED Light Therapy Device is indicated for the treatment of mild to moderate inflammatory acne.
The LED Light Therapy Device is a lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm) and/or in the blue light region of the spectrum (417±10nm), intended to help reduce the appearance of mild to moderate acne. This device is made up of a main unit and therapy head. The light gathering cover is also referred to as the snoot. The snoot helps to establish the correct treatment distance.
The document describes a 510(k) premarket notification for a medical device called "LED Light Therapy Device" (Models KN-7000C and KN-7000C2), indicated for the treatment of mild to moderate inflammatory acne. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with quantifiable metrics like sensitivity or specificity.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or effect size for AI improvement) is not present in the provided text. The submission relies on demonstrating similarity to already cleared predicate devices.
However, the document does contain information about non-clinical tests performed to ensure safety and usability. These non-clinical tests can be considered as acceptance criteria for regulatory compliance and device safety/functionality rather than clinical efficacy.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with "acceptance criteria" in terms of clinical performance metrics, nor does it report specific clinical performance against such criteria. Instead, it demonstrates compliance with recognized safety and electrical standards, and usability.
Non-Clinical Acceptance Criteria and Reported Performance (Based on provided text):
| Acceptance Criteria Category | Specific Acceptance Standard/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009/C1:2010 (Evaluation and Testing for devices in contact with intact skin, including in vitro cytotoxicity, skin sensitization, and skin irritation) | All tests passed: ISO10993-5:2009 (cytotoxicity), ISO10993-10:2010 (irritation and skin sensitization) |
| ISO10993-5:2009 (Biological evaluation of medical devices-Part 5: tests for in vitro cytotoxicity) | Passed | |
| ISO10993-10:2010 (Biological evaluation of medical devices-Part10: tests for irritation and skin sensitization) | Passed | |
| Electrical Safety & EMC | AAMI/ANSI ES60601-1: 2005/(R)2012 and A1:2012., C1:2009/(R)2012 and A2:2010/(R)2012 (Medical electrical equipment-Part 1: General requirements for basic safety and essential performance) | Complies with applicable requirements |
| IEC 60601-1-2:2014 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests) | Complies with applicable requirements | |
| IEC 60601-1-11:2015 (Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance - Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) | Complies with applicable requirements | |
| IEC 60601-2-57:2011 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests) | Complies with applicable requirements | |
| Photobiological Safety | IEC 62471:2006 (Photobiological safety of lamps and lamp systems, 1st edition, incorporating principles of ANSI IESNA RP 27.1, RP 27.2, and RP-27.3) | Complies with IEC 62471:2006 |
| Software V&V | Software documentation consistent with moderate level of concern; System validation testing to confirm all software requirement specifications are met and all software hazards mitigated. | All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
| Usability | Participants (lay users) able to correctly answer questions about the product, self-select appropriateness, and understand the user manual. | All participants correctly answered questions and self-selected; provided feedback for manual improvement. |
2. Sample Size for Test Set and Data Provenance
- Non-Clinical Tests (Biocompatibility, Electrical Safety, Photobiological Safety, Software V&V): The document does not specify a "sample size" in terms of number of devices for these tests. These are typically performed on a representative sample or prototype.
- Usability Study:
- Sample Size: "The required number of participants was obtained through networking, social media and advertising in the local newspaper." A specific number is not given, but implies a sufficient number for a usability assessment.
- Data Provenance: Conducted in Hudson Falls, NY, USA. The study appears to be prospective for evaluating the device's usability with human participants.
3. Number of Experts for Ground Truth & Qualifications
Not applicable. This was a non-clinical evaluation for regulatory compliance and substantial equivalence, not a clinical study requiring expert-established ground truth for performance metrics.
For the usability study, the "ground truth" was essentially the participants' ability to understand and use the device. The evaluators were the participants themselves, and the study was conducted by Dave Oberhelman, Plant/Compliance Manager at UVBioTek.
4. Adjudication Method
Not applicable. No clinical ground truth requiring adjudication methods was established.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document describes a 510(k) submission based on substantial equivalence and non-clinical testing. It does not include a comparative effectiveness study, especially one involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is an LED light therapy device, not an AI or software algorithm that would have "standalone performance" in the typical sense of diagnostic or prognostic AI. The "software verification and validation" (Section 9) refers to the embedded software in the device, ensuring its functional correctness and safety, not a standalone clinical performance evaluation.
7. Type of Ground Truth Used
- For Non-Clinical Tests: The "ground truth" was adherence to established international and national standards (ISO, IEC, AAMI/ANSI).
- For Usability Study: The "ground truth" was the participants' demonstrated ability to understand and operate the device correctly, and their feedback on the user manual.
8. Sample Size for Training Set
Not applicable. The document does not describe a machine learning algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
Not applicable. No training set for an AI algorithm was used.
§ 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.