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The Tända Max OTC System is intended to be used for the treatment of wrinkles, rhytides, and fine lines in the periorbital region.

The Tända Max OTC System is a modular system that offers simplicity in use and convenience. The system can operate while connected directly to an electrical outlet or can be used in cordless mode drawing upon its rechargeable batteries to deliver the treatment. The system components include the control unit, the treatment head, recharging stand, AC adapter, and goggles. The Tända Max OTC System utilizes red light at 660 nm. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The surface that comes into contact with the skin has been selected to ensure the light is administered to the skin while providing a smooth surface for cleaning.

Based on the provided text, the Tända Max OTC System is a light therapy device intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for de novo device approval.

Therefore, the information available is limited regarding specific acceptance criteria and the detailed methodology of the clinical study. However, I can extract the available information and highlight what is not present.

Here's the breakdown of the information requested, based on the provided text:

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

The provided document does not explicitly state specific quantitative acceptance criteria for clinical efficacy (e.g., "X% reduction in wrinkle depth"). Instead, it broadly states that "A clinical evaluation was successfully performed and the results of which are provided in this application." This implies that the clinical evaluation demonstrated a positive outcome consistent with the intended use, but the specific metrics and targets are not detailed in this summary.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text only mentions "A clinical evaluation was successfully performed."

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)

• This information is not provided in the text. Given the nature of wrinkle treatment, ground truth for efficacy would typically be established by dermatologists or plastic surgeons, but the number and qualifications are not mentioned.

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

• This information is not provided in the text.

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 MRMC comparative effectiveness study was mentioned or implied. This device is a light therapy device, not an AI-assisted diagnostic or interpretive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

• This question is not applicable as the Tända Max OTC System is a physical light therapy device, not a software algorithm. Its performance is inherent in its direct application and physiological effect, not in an interpretive algorithm.

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

• The specific type of ground truth used to assess the efficacy of wrinkle reduction is not explicitly stated. For wrinkle treatment, this typically involves photographic analysis, grading scales (e.g., Fitzpatrick Wrinkle Scale, photonumeric scales), and possibly patient self-assessment, often evaluated by expert clinicians (dermatologists/plastic surgeons). The summary only states "A clinical evaluation was successfully performed."

8. The sample size for the training set

• This information is not provided in the text.
• Note: For a medical device like this, the term "training set" is usually not applicable in the same way it is for machine learning algorithms. If there was any "training" data, it would refer to data used during early R&D or pilot studies, which are distinct from the formal clinical evaluation.

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

• This information is not provided and is largely not applicable in the context of this device as explained in point 8.

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The Tända Max System is intended for the treatment of wrinkles, rhytides and fine lines in the periorbital region.

Tända Max is a modular system that offers simplicity in use and convenience. The system can operate while connected directly to an electrical outlet or can be used in cordless mode drawing upon its rechargeable batteries to deliver the treatment. The system components include the control unit, the treatment head, recharging stand, Pre-treatment gel, AC adapter and goggles.

Tända Max utilizes red light at 660 nm. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The surface that comes into contact with the skin has been selected to ensure the light is administered to the skin while providing a smooth surface for cleaning.

The provided text describes the Tända Max System, an LED light system intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. However, the document explicitly states that "additional clinical information is not necessary" and therefore no clinical study was performed to demonstrate device effectiveness.

The submission focuses primarily on comparing the Tanda Max System to predicate devices based on technological characteristics and non-clinical testing.

Given this, I cannot provide detailed information for many of your requested points as a clinical study proving the device meets acceptance criteria was not conducted or reported in this document.

Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed, there are no specific clinical acceptance criteria or reported device performance metrics from such a study. The "acceptance criteria" appear to be met by demonstrating substantial equivalence to predicate devices and adherence to non-clinical safety standards.

Study Details (Not Applicable/Information Not Provided):

1. Sample size used for the test set and the data provenance: Not applicable, no clinical test set mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set mentioned.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no clinical test set mentioned.
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: Not applicable, no clinical study was done, and this device is not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no standalone performance study was done as it's not an algorithm-only device.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth established or used.
7. The sample size for the training set: Not applicable, no training set for a clinical study or AI algorithm mentioned.
8. How the ground truth for the training set was established: Not applicable, no training set or ground truth established.

Summary of Determination:

The FDA's review concluded that the Tända Max System is substantially equivalent to legally marketed predicate devices based on its intended use, technological characteristics (output, wavelength, treatment duration, regimen), and adherence to safety and biocompatibility standards. This substantial equivalence determination allowed the device to be marketed without requiring new clinical data, as explicitly stated in section 9: "Based on the above information, additional clinical information is not necessary."

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