(293 days)
The CLEANE and the CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
The CLEANE and the CLEANE POP are potable had-held devices that produce accurately controlled low level sustained heat for use in treating mild to moderate acne. The devices are designed to treat individual acne blemishes for 2 1/2 minutes at a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish.
The provided text describes a 510(k) submission for the CLEANE and CLEANE POP acne treatment devices. This is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device, not necessarily to prove it meets specific performance criteria in the same way a clinical trial for a new drug might.
Therefore, the information requested in your prompt regarding acceptance criteria and a study proving those criteria are met is not explicitly detailed in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence, not on establishing and meeting acceptance criteria for device performance.
However, I can extract the available performance data and contextualize it within the framework of a 510(k) submission.
Here's an analysis based on the provided text, highlighting what is and is not present:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit acceptance criteria with numerical targets (e.g., "device must reduce acne by X% within Y weeks") are not provided in this 510(k) summary. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than defining new performance metrics or conducting extensive new clinical efficacy studies.
The performance aspects discussed are related to safety, usability, and regulatory compliance.
| Performance Aspect | Description from Submission | Relevance to "Acceptance Criteria" (in a 510(k) context) |
|---|---|---|
| Biocompatibility | Tested in accordance with ISO 10993. "The tip material is considered biocompatible." | Implies meeting the pass/fail criteria of ISO 10993. |
| EMI/EMC | Tested in accordance with IEC 60601. "They operate within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601 standard." | Implies meeting the pass/fail criteria of IEC 60601. |
| Self-Selection Study | Conducted to ensure usability of lay users. "Majority of study participants were able to properly self-select themselves using the box labeling." | Implies a high percentage of users successfully understood labeling for self-selection. No specific percentage is given as an "acceptance criterion." |
| Labeling Comprehension Study | Conducted to ensure usability of lay users. "Majority of study participants were able to properly use the device by reading the instructions for use without any assistance." | Implies a high percentage of users successfully operated the device based on instructions. No specific percentage is given as an "acceptance criterion." |
| Efficacy (Acne Treatment) | Indicated for "treatment of individual acne pimples in persons with mild to moderate inflammatory acne." | The 510(k) relies on the predicate device's established efficacy for this claim, rather than providing new clinical efficacy data for this device. No specific efficacy "acceptance criteria" or performance data for acne reduction are presented for this device itself. |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size:
- For biocompatibility and EMI/EMC testing, explicit sample sizes are not mentioned. These typically involve a small number of test units.
- For the Self-Selection Study and Labeling Comprehension Study, the sample size is not specified. The text only states "majority of study participants."
- Data Provenance: The text does not specify the country of origin for the studies mentioned (biocompatibility, EMI/EMC, self-selection, and labeling comprehension). It is assumed to be part of the manufacturer's testing (MEDICON Co., Ltd. in South Korea). The studies are inherently prospective as they were conducted to support this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided in the summary. For studies like biocompatibility or EMI/EMC, the "ground truth" is determined by established laboratory standards and measurements, not by expert consensus on clinical outcomes.
- For the self-selection and labeling comprehension studies, "ground truth" would likely refer to objective observation of user behavior and their ability to follow instructions/select correctly. This wouldn't typically involve "experts" in the clinical sense, but rather usability specialists or study administrators.
4. Adjudication Method for the Test Set
- This is not applicable or mentioned. Adjudication methods (like 2+1 or 3+1) are typically used in clinical trials where there's a subjective assessment of outcomes (e.g., disease diagnosis/severity by multiple clinicians). The performance data cited in this 510(k) (biocompatibility, EMI, usability) do not involve such subjective clinical assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant to diagnostic imaging devices where AI assists human readers. The CLEANE/CLEANE POP is an acne treatment device, not a diagnostic device.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. The CLEANE/CLEANE POP is a physical device, not an algorithm. Its performance is inherent to its physical operation (heat delivery). While there's no "algorithm," the device operates independently without human intervention during the 2.5-minute treatment once activated.
7. Type of Ground Truth Used
- Biocompatibility: In vitro and in vivo test results against ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization).
- EMI/EMC: Measured emissions and susceptibility data compared to limits defined in IEC 60601.
- Self-Selection/Labeling Comprehension: Objective observation of user behavior and task completion, likely based on predefined success criteria (e.g., correctly answering questions about the label, successfully activating the device).
- Efficacy (Acne Treatment): For the predicate device, efficacy would have been established through clinical trials. For this 510(k), the ground truth for efficacy is effectively the established efficacy of the predicate device, which this device claims substantial equivalence to. No new efficacy "ground truth" for this specific device is generated or presented.
8. Sample Size for the Training Set
- Not applicable. The CLEANE/CLEANE POP is not an AI/machine learning device that requires a "training set."
9. How Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of device.
Summary of Device Performance (Based only on the provided text):
The CLEANE and CLEANE POP devices perform as follows:
- Their tip material is biocompatible according to ISO 10993 standards.
- They comply with EMI/EMC standards (IEC 60601) for emission, susceptibility, and static discharge.
- A majority of lay users can properly self-select themselves using the device's box labeling.
- A majority of lay users can properly use the device by following the instructions for use without assistance.
The 510(k) submission relies on these safety and usability tests, as well as the principle of substantial equivalence to the predicate device (Zeno by Tyrell, Inc.), to support its indication for treating mild to moderate inflammatory acne. It does not present new, specific clinical efficacy data or defined "acceptance criteria" for acne reduction from a new study on this device.
§ 890.5740 Powered heating pad.
(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.