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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) primarily focus on demonstrating substantial equivalence to predicate devices through non-clinical testing. This type of clearance generally does not require extensive clinical performance studies with detailed acceptance criteria and human reader studies as would be seen for a new or complex AI/ML-driven diagnostic device.

Based on the provided information, the device is a light-based therapy device for over-the-counter use, intended for aesthetic purposes (facial wrinkles and mild to moderate inflammatory acne). The "study" proving the device meets acceptance criteria is a non-clinical performance testing approach demonstrating compliance with relevant electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility standards. Software verification and validation, and usability validation were also performed.

Here's the breakdown of the information requested, as extractable from the provided document:

Acceptance Criteria and Device Performance

Since this is a non-clinical submission, the "acceptance criteria" are compliance with established safety and performance standards. There isn't a table of statistical performance metrics, but rather successful adherence to defined technical and safety requirements.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Compliance)

Study Details (as applicable for a non-clinical submission):

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Device Testing): The "test set" here refers to the device prototypes/units that underwent the non-clinical tests. The document does not specify the number of units tested for electrical safety, EMC, etc., which is typical for such submissions.
   • Data Provenance: The testing was conducted by or for the manufacturer (Shenzhen Kaiyan Medical Equipment Co., Ltd) in China, as indicated by the submitter's information. It's inherently "prospective" in the sense that the tests were performed on the device designed for submission.

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

   • This is a non-clinical submission for a device used for aesthetic purposes. The concept of "ground truth" established by medical experts (like radiologists for image analysis) is not applicable here. The "ground truth" for these tests is defined by the passing criteria of the international standards themselves (e.g., specific thresholds for electrical leakage, EMC emissions, irradiance, etc.). Compliance is assessed by qualified test engineers and labs.

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

   • Not applicable. Adjudication methods are typically used in clinical studies, especially those involving subjective assessments or disagreements among human readers. Non-clinical testing against objective standards does not involve expert adjudication in this manner.

4. 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. An MRMC study is not relevant for this type of aesthetic, light-based therapy device where the claim is not for assisting human readers in diagnosis. The clearance is based on safety and functional equivalence.

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

   • Not applicable. This device is not an algorithm for diagnosis or image analysis. It is a physical device providing light therapy. Its "standalone" performance refers to its ability to meet the specified technical parameters and safety standards.

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

   • The "ground truth" for demonstrating substantial equivalence and safety in this context is compliance with recognized international consensus standards (e.g., IEC, ISO). The performance is measured against these technical specifications, not against clinical outcomes or expert consensus on medical conditions.

7. The sample size for the training set:

   • Not applicable. This device does not involve a machine learning algorithm that requires a "training set" in the traditional sense of AI/ML software. The software component, as described, is for controlling device functions ("Basic Documentation Level software"), not for learning from data.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The semiconductor laser therapeutic device is mainly composed of a host, the treatment handle, foot switch, power cord, and accessories. The host consists of a control panel, cooling system, circuit control system, semiconductor laser power supply, etc.

The provided document is a 510(k) clearance letter for a Diode Laser Hair Removal Machine (QDTM-02), not a study report. It states that "No clinical study is included in this submission," and therefore, it does not contain the detailed information requested regarding acceptance criteria and a study proving device performance against those criteria.

However, based on the information available in the 510(k) summary, I can infer some aspects related to the intent of testing and acceptance criteria for demonstrating "substantial equivalence."

Inferred Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The submission aims to demonstrate substantial equivalence to predicate devices, meaning the acceptance criteria are implicitly tied to matching or falling within acceptable ranges of the predicate devices' specifications and performance, and complying with recognized safety standards.

1. Table of Acceptance Criteria and Reported Device Performance (Inferred)

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

• The document explicitly states: "No clinical study is included in this submission."
• Therefore, there is no information on a "test set" in the context of clinical performance data for hair removal.
• The testing mentioned (biocompatibility, electrical safety, EMC, laser safety) would involve samples of the device components or the entire device, tested in a laboratory setting. This is not performance data on patients.

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 for performance evaluation is reported.
• For the non-clinical tests (biocompatibility, safety standards), the "ground truth" is defined by the requirements of the standards themselves, not by expert consensus on clinical outcomes.

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

• Not applicable, as no clinical test set for performance evaluation requiring expert adjudication is reported.

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 laser hair removal machine, not an imaging diagnostic device or AI software that would involve human readers or AI assistance in interpretation.

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

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

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

• For the non-clinical tests conducted, the "ground truth" is compliance with established international standards (IEC for electrical and laser safety, ISO for biocompatibility). There is no "outcomes data" or "pathology" cited in the context of device performance on patients.

8. The sample size for the training set:

• Not applicable, as "training set" typically refers to data used to train an algorithm or AI model. This is a physical laser device.

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

• Not applicable for the same reason as above.

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The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type IVI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, Diode Laser Hair Removal Machine, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.

The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body.

The provided text is a 510(k) summary for a Diode Laser Hair Removal Machine. This document outlines the rationale for establishing substantial equivalence to a predicate device, focusing on non-clinical performance and safety data rather than a detailed study evaluating specific acceptance criteria for AI performance or clinical outcomes directly.

Therefore, many of the requested details regarding acceptance criteria, study design, expert involvement, and ground truth establishment (especially pertaining to AI/ML device performance or human reader improvement) are not present in this document. This document describes a medical device, but it is not an AI/ML device, and thus the acceptance criteria and study description won't align with questions about AI performance, human-in-the-loop studies, or extensive clinical trials as typically seen for AI-driven diagnostic tools.

Here's a breakdown of what can be extracted and what is missing based on the provided text:

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

The document doesn't present "acceptance criteria" in the traditional sense of a specific performance threshold (e.g., accuracy > X%). Instead, it demonstrates through non-clinical testing that the device meets safety and performance standards relevant to a laser hair removal machine by comparing it to a predicate device and showing compliance with specific technical standards (e.g., IEC standards, ISO for biocompatibility).

The "performance" is more about compliance with technical specifications and safety standards. The table "Table 1 Comparison of Technology Characteristics" (Page 7) serves as the primary comparison point.

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

• Test set sample size: Not applicable in the context of clinical performance testing for a device like this. The "test set" primarily refers to the device itself and its components undergoing non-clinical bench testing.
• Data provenance: The testing was non-clinical (bench testing, electrical safety, biocompatibility, software V&V). The document does not specify geographic origin for these tests. It states "No clinical study is included in this submission" (Page 6).

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 study or human reader interpretation for ground truth was performed or required for this 510(k) submission. Ground truth for non-clinical tests would be established by standard measurement equipment and lab protocols.

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

• Not applicable. This is not a study involving human reader interpretation or adjudication of medical images/data.

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, an MRMC study was not done. This is not an AI-assisted device.

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

• No, this refers to an AI/ML algorithm. This device is a laser hair removal machine, not an AI algorithm.

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

• For the non-clinical tests, the "ground truth" is based on engineering specifications, direct measurements of physical properties (e.g., wavelength, power output, dimensions), and established laboratory testing standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety). There is no "pathology" or "outcomes data" in this context as no clinical study was conducted.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As above, this is not an AI/ML device.

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