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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) indicate that no clinical performance study was conducted to prove the device meets acceptance criteria. The summary explicitly states:

"7.2 Summary of Clinical Performance: 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, the following information cannot be extracted from the provided document as it pertains to clinical performance which was not performed or deemed necessary for this 510(k) clearance.

1. A table of acceptance criteria and the reported device performance (for clinical performance)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. 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 (This is typically for AI/imaging devices, not a light therapy wand)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable for this device type)
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

However, based on the non-clinical tests performed, we can infer the acceptance criteria for those tests and their reported performance:

Non-Clinical Acceptance Criteria and Reported Device Performance

Additional Information Not Applicable/Provided:

• Sample size used for the test set and the data provenance: Not applicable as no clinical study was performed. For non-clinical tests, these metrics are not typically reported in this format.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was performed.
• Adjudication method: Not applicable as no clinical study was performed.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is typically for AI/imaging devices.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is typically for AI/software devices.
• The type of ground truth used: Not applicable as no clinical study was performed.
• The sample size for the training set: Not applicable as no clinical study was performed.
• How the ground truth for the training set was established: Not applicable as no clinical study was performed.

In summary, the KALA Therapy Wand (Model: KALA-03) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and compliance with relevant safety and performance standards, without the need for a separate clinical effectiveness study.

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Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718)

Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation.

The Micro-current Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, cleaning flannelette, storage bag, instrument base and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

The device is only home environment use, which has two massage heads, and three LED light mode (Amber/ Red/ Blue lights are output independently) to provides following functions:

a. Amber, Red and Blue LED irradiation function. The device outputs amber light with the wavelength of 605±10nm, and red light with the wavelength of 630±10mm. It is used to illuminate facial skin with narrow spectral bandwidth light and treat facial wrinkles. Also, it outputs blue light with the wavelength of 415±10nm and is used to illuminate facial skin with narrow spectral bandwidth light and treat mild to moderate inflammatory acne. (Cleared under K241718)
b. Hot compress and vibration function. The device generates different intensity of vibration by a builtin motor to relax the facial skin, and also, the massage head is heated to 40±1℃, making the facial skin feel warm to relax and soothe the facial skin. (The vibration is classified as class I and not need for 510K, and the hot compress is not for medical purpose). (Cleared under K241718)
c. MS-Micro current stimulation function. The device has two electrode massage heads to do facial stimulation.

The provided text is a 510(k) Summary for a Micro-current Facial Beauty Device. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety standards. It does not describe the acceptance criteria and a study proving the device meets those acceptance criteria for efficacy or performance in terms of its intended medical use (treatment of facial wrinkles and mild to moderate inflammatory acne).

The "Performance Data" section primarily addresses safety and electrical compliance, not clinical efficacy or diagnostic accuracy. This is typical for Class II devices seeking 510(k) clearance, where substantial equivalence often relies on demonstrating similar safety and performance characteristics to previously cleared devices rather than new clinical trials demonstrating efficacy against specific metrics for the stated indications.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those acceptance criteria for its intended clinical use from the given document.

The document states:

• Intended Use: "Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne."
• Performance Data provided: Biocompatibility Testing, Electrical Safety, and Software Verification and Validation.

There is no mention of a study involving human subjects or data related to the actual treatment of wrinkles or acne using this device. The document focuses on demonstrating that the device is similar enough to existing cleared devices in terms of its technical specifications and general safety.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria for Efficacy/Performance: The document does not define specific clinical acceptance criteria (e.g., percentage reduction in wrinkles, improvement score for acne) that the device must meet to demonstrate efficacy for its intended use.
2. Study Proving Efficacy/Performance: There is no description of a clinical study or performance study that measures the device's ability to treat facial wrinkles or mild to moderate inflammatory acne.
3. Specifics of a Clinical Study (Sample Size, Ground Truth, Experts, MRMC): Since no such study is described, all related points (sample size, data provenance, number/qualifications of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, training set details) are absent.

What the document does provide in terms of "acceptance criteria" is largely related to safety and regulatory compliance:

• Biocompatibility: Adherence to ISO 10993 standards (e.g., passing tests for in vitro cytotoxicity, skin sensitization, irritation).
• Electrical Safety: Compliance with various IEC 60601 series standards for medical electrical equipment (general safety, electromagnetic disturbances, home healthcare environment, nerve/muscle stimulators, battery safety).
• Software Verification and Validation: Meeting software requirement specifications and mitigating hazards to acceptable risk levels (consistent with a "Basic Documentation Level of concern").

In conclusion, this 510(k) submission relies on demonstrating substantial equivalence to predicate devices, supported by engineering, electrical, and biocompatibility testing, rather than new clinical efficacy data for the treating indications.

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