FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

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.

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the provided text for clinical efficacy measures. The document states "A clinical evaluation was successfully performed and the results of which are provided in this application," implying the device successfully demonstrated its intended effects.	The Tända Max OTC System is as safe and effective as the prescriptive Tända Max System and the Light for Wrinkles (predicate devices), with similar indications, technological characteristics, and principles of operation. Performance data demonstrate substantial equivalence.

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.

Summary

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.