(214 days)
The Tända Skincare System is a device intended to administer phototherapeutic light to the body in order to treat Acne.
The tända Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.
The Tända Skincare System is a modular platform which uses light treatment heads combined with onboard electronic controls and intelligence designed to offer solid state light source treatments for mild to moderate inflammatory acne.
The provided 510(k) summary (K070185) for the Tända Skincare System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. This document primarily focuses on establishing substantial equivalence to a predicate device (BLU-U, MODEL 4170, K031805) and detailing safety certifications.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred/stated based on the provided document:
1. Table of acceptance criteria and the reported device performance
The 510(k) summary does not mention specific quantitative acceptance criteria for treating acne or report detailed device performance metrics in relation to such criteria. The document states the device's intended use is "to treat Acne" and indicates that "Blue light modules are indicated to treat mild to moderate inflammatory acne."
2. Sample sized used for the test set and the data provenance
Not mentioned in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned in the document.
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 mentioned in the document. This device is not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is a light therapy device, not an algorithm. Performance assessment typically involves clinical studies on patients, which are not described here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not mentioned in the document. For a physical therapy device like this, ground truth would typically refer to clinical improvement or clearance of acne based on dermatologist assessment or objective metrics.
8. The sample size for the training set
Not applicable/mentioned. This is a physical device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not applicable/mentioned.
Summary of what is present in the document regarding "proof" of meeting criteria:
The document focuses on establishing substantial equivalence to a predicate device (BLU-U, MODEL 4170, K031805) based on "virtually identical" intended use and technological characteristics. It also states that "Any differences... have no significant influence on safety or effectiveness."
Additionally, it provides safety data demonstrating compliance with:
- IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- ISO 10993 (Biocompatibility)
- IEC 60825-1 (Laser Safety), with an Accessible Emission Limit (AEL) below the Class I threshold.
- Evaluation of ocular hazard levels, concluding no risk of retinal injury from blue-light phototoxic effect, thermal damage, or additive effects.
These safety certifications and comparisons to the predicate device form the basis for the FDA's 510(k) clearance, indicating that the device is deemed as safe and effective as the legally marketed predicate. However, it does not detail specific clinical performance criteria or a study that quantitatively measures the device's efficacy against those criteria.
§ 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.