(256 days)
The Tända Skincare System is intended as an over-the-counter phototherapy device for the treatment of mild to moderate acne.
The Tanda 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 text describes the Tända Skincare System, its intended use, and a limited amount of information regarding safety data. However, it does not contain specific acceptance criteria for performance, nor does it detail a study that proves the device meets such criteria. The document focuses on regulatory approval (510(k) summary) and substantial equivalence to previously cleared devices.
Therefore, I cannot fully answer your request as the necessary information is not present in the provided text.
Based on the available text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not provided in the text.
- Reported Device Performance: The text states, "A clinical Study... was undertaken and shown to demonstrate that the Tända Skincare System can be used safely as a nonprescription device." This is a general statement about safety, not performance criteria or specific performance metrics (e.g., reduction in acne lesions, percentage of responders). There are no quantitative measures of effectiveness mentioned.
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 (Test Set): Not provided.
- Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). It only mentions "A clinical Study under the supervision of a Health Care practitioner (MD)".
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)
- Not provided. The text only mentions the study was "under the supervision of a Health Care practitioner (MD)."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
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 phototherapy system, not an AI-assisted diagnostic device. The study described focuses on the device's own safety as a standalone product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This refers to the device's performance as a standalone product, which is implied by the clinical safety study. However, specific performance metrics for "standalone" effectiveness are missing. The statement "can be used safely as a nonprescription device" focuses on safety, not efficacy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided. Given it's a treatment for acne, typical outcomes data (e.g., lesion count reduction, global assessment scores) would be relevant, but none are specified as "ground truth."
8. The sample size for the training set
- Not applicable. This device does not appear to involve AI/machine learning models that require a "training set."
9. How the ground truth for the training set was established
- Not applicable for the same reason as point 8.
§ 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.