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The Radiant Renewal Skincare Wand (Models: HD-44, HD-44A, HD-44B, HD-69, HD-69A) is an over-the-counter device intended for the treatment of full-face wrinkles.

The Radiant Renewal Skincare Wand (Models: HD-44C, HD-69B) is an over-the-counter device intended for the treatment of mild to moderate inflammatory acne.

The Radiant Renewal Skincare Wand (Models: HD-44, HD-44A, HD-44B, HD-44C, HD-69, HD-69A, HD-69B) is a handheld rechargeable device powered by a Lithium-Ion battery, designed for single-patient use. It offers wrinkle reduction through the emission of red light (wavelength: 630nm±10nm) and infrared light (wavelength: 830nm±10nm), yellow light (wavelength: 590nm±10nm), acne treatment through the emission of blue light (wavelength: 415nm±10nm).

Model HD-44 offers red and infrared light for wrinkle reduction. Models HD-44A and HD-69A only provide red light for wrinkle reduction. Models HD-44B and HD-69 use only yellow light for wrinkle reduction. And models HD-44C and HD-69B offers blue light for acne treatment. The ergonomic design of the device ensures ease of use, making them suitable for daily home skincare routines.

The package includes the main unit, a charging cable, a user manual, a tray. Each model is equipped with a single button to turn the device on or off. The device will automatically shut down after 5 minutes of operation.

The provided FDA 510(k) clearance letter and summary for the Radiant Renewal Skincare Wand does not contain information about clinical performance, acceptance criteria for clinical efficacy, or a study proving that the device meets such criteria.

The document explicitly states:

"Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets those criteria from the input given. The clearance was based on non-clinical tests demonstrating safety and substantial equivalence to predicate devices, not on a clinical study evaluating the device's performance for its intended use (wrinkle reduction and acne treatment) against specific efficacy acceptance criteria.

However, I can still extract details about the non-clinical tests performed:

1. A table of acceptance criteria and the reported device performance (for non-clinical tests):

While explicit "acceptance criteria" and "reported performance" in a quantitative sense for efficacy are not present, the non-clinical tests performed aimed to demonstrate compliance with various safety and performance standards. The "performance" in this context is the statement of "compliance."

Missing Information (as per your request, not present in the provided text):

• 2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used. The "tests" refer to non-clinical laboratory and engineering assessments.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was used.
• 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 skincare wand, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is hardware, not an algorithm.
• 7. The type of ground truth used: Not applicable, as no clinical efficacy "ground truth" was established or used for clearance. The "truth" for substantial equivalence was comparison to predicate devices and compliance with non-clinical safety standards.
• 8. The sample size for the training set: Not applicable, as there is no mention of a training set, indicating no machine learning/AI component that would require one for efficacy.
• 9. How the ground truth for the training set was established: Not applicable.

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The Radiant Renewal Skincare Lid (Model: HD-59A. HD-72, HD-73A. HD-116. HD-53A) is intended for the treatment of wrinkles for over-the-counter cosmetic use.

The Radiant Renewal Skincare Lid (Model: HD-70) is intended for the treatment of wrinkles and the mild to moderate inflammatory acne for over-the-counter cosmetic use.

The Radiant Renewal Skincare Lid (Model: HD-59D, HD-72A, HD-73B,HD-116A,HD-53B) is intended for the treatment of the mild to moderate inflammatory acne for over-the-counter cosmetic use.

The Radiant Renewal Skincare Lid (Model: HD-59A, HD-59B, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) is a hand-held, rechargeable device powered by a lithium-Ion battery, designed for single-patient use. It offers wrinkle reduction through the emission of red light (wavelength: 630nm±10nm) and infrared light (wavelength: 830nm±10nm) and yellow light (wavelength: 630nm±10nm), and acne treatment through the emission of blue light(wavelength: 415nm±10nm).
There are 12 models of the device, each with similar core functionalities, but differing in the specific light treatments and additional features they offer.
Model HD-59A offers red and infrared light for wrinkle treatment, model HD-59B provides yellow light for wrinkle treatment, and model HD-59D uses blue light for acne treatment. These three models differ only in the light treatments they offer.
Model HD-70 features three treatment modes: mode 1: Red light and infrared light for wrinkle reduction; mode 2: Yellow light for wrinkle reduction; mode 3: Blue light for acne treatment.
Models HD-72, HD-73A, and HD-116 offer two treatment modes: mode 1: Red light for wrinkle reduction; mode 2: Yellow light for wrinkle reduction;
Models HD-72A, HD-73B, and HD-116A provide only blue light for acne treatment.
The difference between HD-72 and HD-72A, HD-73A and HD-73B, and HD-116 and HD-116A lies in the light treatments they offer. Apart from this, the HD-72 series, HD-73A series, and HD-116 series differ only in appearance.
Model HD-53A offers only red light for wrinkle treatment while model HD-53B provides only blue light for acne treatment.
The package includes the main unit, a charging cable, a user manual, a tray and a cosmetic container(only for model HD-70). An optional squeeze tube is also available but not included by default. Except for model HD-70, which features an additional rotating rock button, other models are equipped with a single button to turn the device on or off and switch treatment modes. The device can also be used with other skincare products such as face creams, eye creams, serums, etc.
The device will automatically shut down after the recommended duration of 2 minutes. If you wish to continue the treatment, simply press the button to turn the device back on.

The provided document is a 510(k) premarket notification for cosmetic devices (LED light therapy for wrinkle reduction and acne treatment), not a medical device requiring clinical studies with AI, human readers, or complex ground truth establishment. Therefore, most of the requested information regarding AI performance, expert consensus, and multi-reader studies is not applicable.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an assessment based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in the format of a table with numerical thresholds for performance. Instead, it outlines the non-clinical tests performed to ensure safety and effectiveness, assuming compliance with these standards serves as the acceptance criteria.

2. Sample sizes used for the test set and the data provenance

The document primarily describes non-clinical performance testing (electrical safety, biocompatibility, software validation, usability validation). These tests are typically conducted on device prototypes or production samples rather than human test subjects in the context of a clinical study for AI model validation. Therefore, there isn't a "test set" in the sense of patient data.

• Sample size for non-clinical tests: Not explicitly stated as a number of devices, but typically involves a limited number of test units to demonstrate compliance with standards.
• Data Provenance: Not applicable in the context of patient data. The tests are performed on the device itself. The document mentions Shenzhen Nuon Medical Equipment Co., Ltd as the manufacturer in China, so the testing would likely have occurred there or at a certified lab contracted by them.
• The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." This confirms that no patient data was used for a clinical "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As clinical testing was not performed, there was no patient data requiring expert ground truth establishment for the test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication of findings.

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 direct-to-consumer cosmetic LED light therapy product, not an AI-assisted diagnostic or therapeutic device requiring MRMC studies for human reader performance.

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

Not applicable. There is no AI algorithm in this device, as described, that would require standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this specific device, "ground truth" refers to the established technical standards (e.g., IEC, ISO) and the device's ability to meet those specifications (e.g., emitting light at specified wavelengths and irradiance, safe electrical operation, biocompatible materials).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; hence, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. No training set for an AI model.

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The Hair Growth Comb (Model: SZ-23 ,SZ-23A,) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, Il-1, Il-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The Hair Growth Comb is (Model: SZ-23, SZ-23A) a comb-shaped device that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 650nm (±10nm) while the comb teeth simultaneously part the user's hair to ensure the light reaches the user's scalp. The device is designed as a handheld product, and it consists of the main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.

This document is a 510(k) Summary for a medical device (Hair Growth Comb, Models SZ-23, SZ-23A). It provides information regarding the device's substantial equivalence to previously cleared predicate devices, primarily focusing on its technical characteristics and safety testing.

Crucially, this document states: "Clinical testing was not needed for this 510(k)." This means that the submission does not include a clinical study designed to prove the device meets specific performance criteria related to the effectiveness of promoting hair growth. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document in the context of device performance regarding its intended clinical effect.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical testing for safety and electrical/software compliance, not clinical efficacy.

However, I can provide information based on the other aspects of the document:

Based on the provided 510(k) Summary, the following information can be extracted:

1. A table of acceptance criteria and the reported device performance:

As no clinical efficacy study was conducted for this 510(k), there are no clinical performance acceptance criteria and reported device performance related to hair growth in this document. The "acceptance criteria" mentioned are related to safety and functional compliance.

2. Sample size used for the test set and the data provenance:

• Clinical Test Set: Not applicable. "Clinical testing was not needed for this 510(k)." The testing described is non-clinical (electrical safety, EMC, biocompatibility, software).
• Data Provenance for Non-Clinical Tests: Performed by the manufacturer (Shenzhen Nuon Medical Equipment Co., Ltd) or contracted labs, adhering to international standards. The document doesn't specify countries of origin for test data, but the manufacturer is based in China. This is a pre-market submission, so the testing would be conducted retrospectively to the submission date.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable for clinical ground truth related to hair growth efficacy, as no clinical study was conducted.
• For non-clinical testing, the "ground truth" is established by compliance with international standards (e.g., ISO, IEC) and the expertise lies within the testing laboratories and their personnel. The document does not specify the number or qualifications of these experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for clinical efficacy. For non-clinical compliance testing, "adjudication" in the sense of expert consensus on ambiguous cases is not a relevant concept. Compliance is determined by meeting pre-defined test parameters outlined in the standards.

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 physical comb that emits LED light, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. This device is a physical therapeutic device, not an algorithm.

7. The type of ground truth used:

• Clinical Ground Truth: Not applicable, as no clinical efficacy study was conducted for hair growth. The substantiation for efficacy relies on substantial equivalence to predicate devices which were presumably cleared based on prior clinical data or deemed effective through other means (historical data, published literature, etc.).
• Non-Clinical Ground Truth: Established by adherence to recognized international standards for electrical safety (IEC 60601 series, IEC 62471), battery safety (IEC 62133-2), biocompatibility (ISO 10993 series), and software validation (IEC 62304, FDA Guidance).

8. The sample size for the training set:

• Not applicable for clinical efficacy, as no clinical study was conducted. For non-clinical tests, "training set" is not a relevant concept.

9. How the ground truth for the training set was established:

• Not applicable.

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The Cold Sore Device is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.

The Cold Sore Device is a solid state opto-electronic device that emits a controlled quantity of 1072nm +/- 12nm peak wavelength near infrared light for a period of approximately 3 minutes. The maximum peak light intensity across the treatment surface is 20mW/cm². The light output and duration are monitored by a microprocessor. The tip of the device that contacts the patient is made out of Acrylonitrile Butadiene Styrene (ABS) + PC. Treatment with the device is commenced at the first symptoms of a cold sore 3 times a day with 4 hours in between each treatment for 2 consecutive days. The treatment area is approximately 3 cm². There are 2 light emitting diodes (LEDs) in the treatment area. The light within the device is activated by opening the cover of the device and automatically shut down after the pre-programmed treatment time (3 minutes). The device is designed for external, limited duration skin contact in an environment free from fluids and is provided non-sterile. The LEDs do not come in direct contact with the patient based upon the design of the device. The device is for OTC use and single patient use as described in the patient and box labeling.

The provided text is a 510(k) summary for the Cold Sore Device (QPZ-03) and does not contain the specific information requested about acceptance criteria and a study proving device performance in the context of clinical efficacy (shortening time to healing).

Instead, the summary focuses on demonstrating substantial equivalence to a predicate device (QPZ-01) based on non-clinical tests, physical characteristics, and intended use. The core argument for equivalence is that the subject device's technical parameters (wavelength, treatment time, etc.) are "highly consistent" with the predicate device, which presumably had clinical data supporting its efficacy.

Therefore, many of the requested fields cannot be filled directly from this document. I will highlight what information is available and what is explicitly stated as not performed or applicable.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance Study (as described in the document):

The document does not detail specific acceptance criteria for clinical effectiveness (e.g., a target reduction in healing time) that the new device directly met through a clinical study. Instead, it relies on demonstrating substantial equivalence to a predicate device which implies the predicate device had met such criteria. The reported "performance" for the subject device is largely in terms of its technical specifications aligning with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Usability Study:

  • Sample Size: 45 subjects for self-selection, reduced to 42 subjects for usability and label comprehension.
  • Data Provenance: Not explicitly stated, but implies a prospective study conducted by the manufacturer for regulatory submission. Country of origin not specified, but the manufacturer is based in China.

• For Clinical Efficacy (if a separate study existed): Not applicable, as the document explicitly states "So, there is no clinical test on our device" (referring to the subject device for clinical efficacy). Efficacy is established through substantial equivalence to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• For Usability Study: The document mentions "researchers" and "investigator recorded the operation of the subject" but does not detail the number or qualifications of experts involved in objectively establishing "ground truth" (e.g., whether a correct operation was performed). It appears the researchers/investigators themselves made these judgments based on whether the instructions were followed.
• For Clinical Efficacy: Not applicable, as no clinical study was performed on the subject device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• For Usability Study: No formal adjudication method like "2+1" or "3+1" is described. The "researchers" and "investigators" are implied to have made direct observations and judgments.
• For Clinical Efficacy: Not applicable, as no clinical study was performed on the subject device.

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 light-based treatment device, not an AI-assisted diagnostic tool involving "human readers."

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

• Not applicable. This is a physical treatment device, not an algorithm. Its operation is standalone in the sense that once activated, it delivers light therapy for a set duration, but this does not equate to "algorithm only performance" in the context of diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For Usability Study: The "ground truth" was whether subjects could correctly follow instructions for self-selection, device operation, and label comprehension, as judged by the "researchers/investigators."
• For Clinical Efficacy: Not applicable for the subject device. For the predicate device, it is implied that the clinical ground truth for "shortening the time to healing of herpes simplex labialis lesions" would have been patient-described re-epithelialization or similar clinical outcomes data.

8. The sample size for the training set

• Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set in that sense.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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