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The Radio Frequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The Radio Frequency System consists of a host with an LCD touch screen control panel, moving base, treatment handle and pedal switch. The treatment handle includes a handpiece and a sterilized tip. And the sterilized tip is classified into two type, microneedle electrodes and RF electrodes. The treatment parameters are entered via the touchscreen control panel that also displays system output information during treatment. Microneedle electrodes come in light contact with the epidermis of the patient and minimally penetrate the epidermis while RF electrodes not penetrate. RF POWER, ON TIME (RF POWER×ON TIME = RF Energy), DEPTH, are user-selectable via the control panel. The RF Power output is controlled to insure for a given time that a determinate RF Energy is delivered to the bipolar electrodes. The handpiece is held at right angles to the target tissue. As the RF energy passes into the skin, it generates an electro-thermal reaction capable of coagulating the tissue surrounding the uninsulated portion of the electrodes.

The provided text describes a 510(k) summary for a "Radio Frequency System" and its substantial equivalence to a predicate device. However, the document does not contain any information about acceptance criteria or a study proving that the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by your request for information like "effect size of how much human readers improve with AI vs without AI assistance."

The device described is an electrosurgical cutting and coagulation device and accessories, not an AI/software-based diagnostic or assistive device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance with AI.

The document explicitly states:

• "No preclinical and clinical data was provided in this submission." This means there are no studies evaluating diagnostic performance, reader studies, or patient outcomes data.
• The comparison is based on technological characteristics (e.g., frequency, power, operation mode, tips, material) and performance data related to:
  • Biocompatibility (ISO standards)
  • Sterilization Validation (ISO standards)
  • Shelf-life Validation (ASTM standard)
  • Electrical safety and electromagnetic compatibility (IEC standards)
  • Software Verification and Validation Testing (FDA guidance for software, noting "moderate" level of concern)

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies proving the device meets those criteria in the context of AI/algorithm performance. The provided document concerns a hardware medical device cleared via a 510(k) pathway by demonstrating substantial equivalence to a predicate device through engineering and safety testing, not through AI performance evaluation.

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The LED Spectrum therapy instrument includes five models, which are PDT-I, PDT-J, PDT-K, PDT-L, PDT-M.

PDT-I:
Blue (420±10m) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Combination of Red (630±10mm) and Infrared (825±10mm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Combination of Red (630±10mm) and Blue (420±10mm) is indicated for the treatment of mild to moderate inflammatory acne.

PDT-J:
Combination of Yellow (590±10mm) and Infrared (825±10nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.
Combination of Red (630±10mm) and Infrared (825±10mm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

PDT-K:
Blue (420±10mm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Combination of Red (630±10mm) is indicated for the treatment of mild to moderate inflammatory acne.

PDT-L:
Combination of Red (630±10mm) and Infrared (825±10mm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

PDT-M:
Combination of Yellow (590±10mm) and Infrared (825±10nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; 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 LED Spectrum therapy instrument is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs).
The device produces light in the following regions of the light spectrum:

• Red (630±10nm) .
• Blue (420±10nm) .
• . Yellow (590±10nm)
• . Infrared (825±10nm)
  This device's main components are the stand, the head, color touch screen, and the power supply. User interface software allows the operator to access and control all device functions.

The provided document is an FDA 510(k) Premarket Notification for a medical device called "LED Spectrum therapy instrument." It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and comparison of specifications.

Crucially, this document explicitly states: "No clinical study is included in this submission." (Page 7, Section 8)

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study proving the device meets those criteria in the way requested by the prompt for the following reasons:

• No clinical trials: The submission did not include any clinical studies (human subject trials) to test the device's performance in achieving its intended medical outcomes (e.g., treating acne, reducing wrinkles).
• No acceptance criteria related to clinical performance: Since no clinical studies were performed for this submission, there are no acceptance criteria related to device performance in a clinical setting (e.g., accuracy, sensitivity, specificity, or improvement over human readers).
• No ground truth establishment for clinical performance: Without clinical data, there's no ground truth established to evaluate the device's efficacy for medical conditions.

The provided document details non-clinical tests (e.g., electrical safety, electromagnetic compatibility, photobiological safety, risk management) to ensure the device's safety and fundamental operation, and its equivalence to legally marketed predicate devices. The "acceptance criteria" discussed in the document are primarily related to compliance with these engineering and safety standards, as well as demonstrating comparable technical specifications (wavelengths, irradiance, etc.) to predicate devices.

However, to answer the prompt as best as possible, I will extrapolate what would typically be considered "acceptance criteria" and "proof" in this context, based on the information provided, recognizing that it pertains to non-clinical and comparative equivalence rather than direct clinical efficacy.

Based on the provided document, which focuses on substantial equivalence through non-clinical testing and comparison:

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

Since no clinical study was conducted in this submission, the "performance" here refers to meeting safety standards and having comparable technical specifications to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not applicable in the context of clinical human data. The "test set" here refers to the device prototypes themselves, not a dataset of patients.
• Data Provenance: Not applicable for clinical data. The non-clinical tests were presumably performed at the manufacturer's location (Shenzhen City, China) or accredited testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. No ground truth in the sense of expert medical diagnosis or interpretation was established for a clinical test set, as no clinical study was performed. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the relevant international standards (e.g., IEC, ISO). Compliance with these standards is assessed through measurement and engineering verification, not human expert consensus on medical images or outcomes.

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

• Not applicable. As no clinical image or outcome data was evaluated by human experts, there was no need for an adjudication method.

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:

• No. The document explicitly states "No clinical study is included in this submission." Therefore, no MRMC study or AI-assisted human reader performance evaluation was performed.

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

• No. This device is a light therapy instrument, not an AI or algorithm. Its performance is measured by its physical light output parameters and safety, not by an algorithm's diagnostic or predictive capabilities.

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

• For the purposes of this 510(k) submission, the "ground truth" for the device's safety and performance claim (substantial equivalence) is compliance with international safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-57, IEC 62471, ISO 14971) and comparison of technical specifications to legally marketed predicate devices. There is no clinical outcomes ground truth provided.

8. The sample size for the training set:

• Not applicable. This submission does not involve an AI or machine learning model that would require a training set.

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

• Not applicable. As there is no training set mentioned in the document for an AI/ML model, this question does not apply.

In summary, the provided document is a 510(k) notification for a physical medical device (LED light therapy instrument) demonstrating substantial equivalence to predicates primarily through non-clinical engineering and safety testing, and comparative analysis of technical specifications. It does not involve AI, clinical trials, human reader studies, or the establishment of ground truth for clinical outcomes in the manner typically associated with the detailed questions of the prompt.

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