(225 days)
ThermaClear is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
ThermaClear™ is a portable hand-held device that uses a short thermal pulse to treat mild to moderate inflammatory acne. The treatment tip is comprised of biocompatible material and delivers a short duration thermal pulse that heats the area being treated. The device is powered by two AA alkaline batteries.
Acceptance Criteria and Device Performance for ThermaClear™
Based on the provided 510(k) summary, the ThermaClear™ device underwent clinical testing to confirm its safety and effectiveness. However, specific quantifiable acceptance criteria and detailed reported device performance metrics (e.g., percentage reduction in acne lesions) are not explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices, which primarily involves showing that the new device is as safe and effective without raising new issues.
The core acceptance criterion, though not quantitatively defined, is implicitly that the device is "as safe and effective as the predicate device" for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance and Study Findings |
|---|---|
| Device is safe and effective for its indicated use (treatment of individual acne pimples in persons with mild to moderate inflammatory acne). | "Clinical testing was conducted in both a controlled practitioner office environment and a consumer home-use environment and submitted as part of the 510(k) application to confirm that ThermaClear™ is as safe and effective as the predicate device." |
"Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed device has been shown to be safe and effective for its intended use." |
| No new issues of safety or efficacy are raised compared to predicate devices. | "The minor differences in the technological characteristics of ThermaClear™ and its predicate devices do not raise any new issues of safety or efficacy." |
| Operates within EMI emission, susceptibility, and static discharge levels (preclinical). | "ThermaClear™ operates within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601-1 standard." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical test set. It mentions "clinical testing was conducted."
Regarding data provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The "controlled clinical study design was a randomized, blinded study," which indicates a prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts, their qualifications, or how ground truth was established for the clinical testing.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to human readers improving with or without AI assistance. The device in question is a physical medical device, not an AI diagnostic tool, so an MRMC study in the typical sense would not be applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a hand-held thermal treatment device, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted. Its function is to be used by a human.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly defined. Given the nature of acne treatment, it would likely involve clinical assessment of acne pimples by a healthcare professional (in the office environment) or self-assessment (in the home-use environment). The "randomized, blinded study" design implies some form of objective assessment was intended.
8. Sample Size for the Training Set
The document does not mention or imply the existence of a "training set" in the context of an AI or algorithm. The device is a physical treatment device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI or algorithm mentioned, this question is not applicable.
§ 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.