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KFB290, KFB291:
Red light: Treatment of full-face wrinkles.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Red+Infrared Light: Treatment of full-face wrinkles.
Amber light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Mixed light(Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne.

KFB265, KFB293:
Red+Infrared Light: Treatment of wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Amber light: Treatment of wrinkles.

KFB290, KFB291:
LED Light Therapy Device(Models: KFB290, KFB291) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, Silicone eye protector, USB charging cable and straps. The LED Light Therapy Device have 4 kinds of light, which include Red light (wavelength 635nm ± 5mm), Blue light (wavelength 465 ± 5nm), Infrared light (wavelength 850mm ± 5mm), Amber light (wavelength 605 ± 5nm).

KFB 265, KFB 293:
LED Light Therapy Device(Models: KFB 265, KFB 293) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, USB charging cable and adapter. There are several kinds of light having medical effects: Red + Infrared (wavelength 637nm (±5nm), Blue light (wavelength 465nm), Amber light (wavelength 605±5nm).

This section provides information about the acceptance criteria and the study that proves the device meets those criteria for the LED Light Therapy Device (Models: KFB290, KFB291, KFB265, KFB293).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document details non-clinical performance data (biocompatibility, electrical safety, eye safety, and software verification/validation) and structural equivalence to predicate devices, rather than specific quantitative acceptance criteria for therapeutic efficacy tied to a clinical study. The device is cleared based on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable and acceptable for the stated indications.

The acceptance criteria here are implicitly met by demonstrating compliance with recognized standards and similarity to legally marketed devices.

• IEC 60601-1:2005+A1:2012+A2:2020 (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances)
• IEC 60601-1-11:2015+A1:2020 (Home healthcare environment)
• IEC 60601-2-83:2019+A1:2022 (Home light therapy equipment)
• IEC 60601-2-57:2011 (Non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
• IEC 62133-2:2017 (Secondary cells and batteries safety) |
  | Eye Safety | Compliance with IEC 62471:2006 (Photobiological safety of lamps and lamp systems). |
  | Software Verification and Validation | Consistent with a moderate level of concern. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
  | Technological Characteristics and Intended Use | Demonstrated to have the same intended use and similar technological characteristics, features, specifications, and materials as legally marketed predicate devices (K223544, K230351, K162489, K221151). Minor differences do not raise safety or efficacy issues. |

2. Sample Size Used for the Test Set and Data Provenance:

The provided document describes non-clinical performance data and a comparison to predicate devices, not clinical studies with human test sets. Therefore, details regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The evaluation relies on standardized testing (e.g., ISO, IEC) and technical comparisons.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not applicable as the submission focuses on non-clinical performance and substantial equivalence based on technical comparisons and compliance with recognized standards, rather than a clinical study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

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:

An MRMC comparative effectiveness study was not conducted or described in the provided document. The device is an LED Light Therapy Device, not an AI-assisted diagnostic or interpretable imaging device for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

A "standalone" performance evaluation in the context of an algorithm or AI was not performed or described. This device is a direct-use LED therapy device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• Compliance with recognized international standards: (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical and medical device safety, IEC 62471 for photobiological safety).
• Substantial equivalence to legally marketed predicate devices: The predicate devices themselves have established a safety and effectiveness profile for the indications.

There is no mention of expert consensus, pathology, or outcomes data from a clinical trial for establishing ground truth regarding therapeutic efficacy for this submission.

8. The Sample Size for the Training Set:

This information is not applicable as the submission is for a phototherapy device, not an AI/machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as point 8.

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ELIXIR MDTM use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The red light (633±10nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.

The blue light (417±10 nm wavelength); is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Yellow light (590±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.

The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The ELIXIR MD™ uses specific wavelengths of light, produced by LEDs (light emitting diodes), to manage aesthetic conditions.

The device produces light in the red-light region of the spectrum (633 ± 10m), in the blue light regions of the light spectrum (417 ± 10m), the yellow light area (590 ± 10nm) and the infrared light region of the light spectrum (835 ± 15m).

The ELIXIR MD™ is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, yellow light); The RBI irradiator has five panels. Each panel emits three different colors of light sources (red light, blue light, infrared light).

This document is a 510(k) Premarket Notification from the FDA for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on clinical performance. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or treatment efficacy, will not be present in this document.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance:

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device (K222751 LED Light Therapy Device, KN-7000L). The device's performance is not independently evaluated against pre-defined clinical success metrics. Instead, its technical specifications and intended use are compared to the predicate device.

The table in Section 8 provides a direct comparison demonstrating "same" or "—" (indicating a difference in proprietary name or manufacturer, not affecting substantial equivalence) across various parameters. This table serves as the performance "proof" by showing the proposed device matches the predicate.

Table of Acceptance Criteria (from a regulatory perspective - Substantial Equivalence) and Reported Device Performance:

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LED Light Therapy Device use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The red light (633±10mm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.

The blue light (417±10 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Yellow light (599±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.

The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain. arthritis and musele spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The LED Light Therapy Device uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm), in the blue light regions of the light spectrum (417±10mm), yellow light area (590 ± 10nm) and infrared light region of light spectrum (835±15nm).

The LED Light Therapy Device instrument is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, blue light, yellow light); RBI irradiator has five panels, each panel emits three different colors of light sources (red light, blue light, infrared light).

The instrument is mainly composed of a main frame, an irradiator, and a lifting stand.

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA regarding an LED Light Therapy Device (KN-7000L). It focuses on establishing substantial equivalence to previously cleared predicate devices, primarily through comparison of technical specifications and non-clinical testing.

Therefore, the document does NOT contain information regarding clinical studies, acceptance criteria for an AI/device performance, expert ground truth establishment, or multi-reader multi-case studies. The device in question is an LED light therapy device, not an AI-powered diagnostic or assistive device that would typically undergo such rigorous performance evaluation against patient data.

The document details the device's technical specifications and confirms compliance with electrical safety, electromagnetic compatibility, and photobiological safety standards.

As a result, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: No performance metrics beyond technical specifications (wavelength, irradiance, etc.) and compliance with safety standards are mentioned.
2. Sample sizes used for the test set and the data provenance: No clinical test sets or data provenance (country, retrospective/prospective) are discussed. The "test set" here refers to non-clinical tests (e.g., electrical, photobiological).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no ground truth established for clinical performance.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study was conducted or mentioned. This type of study is typical for AI devices assisting human readers in diagnostic tasks, which is not the function of this LED light therapy device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

However, I can extract the following information that is relevant to the type of acceptance criteria and "study" conducted for this device, which focuses on non-clinical performance and substantial equivalence:

1. Table of "Acceptance Criteria" (Non-Clinical Performance) and Reported Device Performance

For this type of device, "acceptance criteria" primarily relate to meeting established safety and performance standards rather than clinical efficacy metrics derived from patient data. The manufacturer asserts substantial equivalence based on these comparisons and non-clinical testing.

Summary of "Study" Proving Compliance:

The "study" in this context is a non-clinical testing and comparison study aiming to demonstrate substantial equivalence (SE) to predicate devices by verifying the new device shares fundamental technological characteristics and performs comparably in terms of safety and technical specifications.

• Type of "Study": Non-clinical performance testing and comparative analysis to predicate devices.
• Purpose: To demonstrate substantial equivalence (SE) for 510(k) clearance, indicating the device is as safe and effective as a legally marketed predicate device.
• Ground Truth: The "ground truth" for this regulatory submission is adherence to recognized medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471) and the established performance characteristics of the predicate devices. The device's measured technical specifications (e.g., wavelength, irradiance, power) were compared against these standards and predicate parameters.
• Data Provenance/Sample Size: Not applicable in the traditional sense of patient data. The "sample size" refers to the tested units of the KN-7000L device undergoing the specified non-clinical tests. The data provenance is from the manufacturer's internal testing. The document does not specify the exact number of units tested, but it is implied that the testing performed on the device samples confirmed compliance.
• Expert involvement for Ground Truth, Adjudication, MRMC, Standalone AI, Training Set: These concepts are not applicable to the non-clinical testing and substantial equivalence demonstration for a light therapy device. There is no AI component, and no human diagnostic performance is being evaluated.

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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):

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.

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