(59 days)
The wrinkle treatment device (model: JM2) is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
The Wrinkle Treatment Device is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles. Light radiates from the inner surface of the face. This light is generated by LED with two different spectrum wavelengths: red (660nm) and infrared (850nm).
The device is powered by rechargeable Li-battery and controller that is connect to the main unit. The device's power-on/ off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Wrinkle Treatment Device (JM2), structured to address your specific points.
The provided document is a 510(k) Premarket Notification summary for a medical device. It primarily focuses on demonstrating "substantial equivalence" of the new device (Wrinkle Treatment Device JM2) to previously cleared predicate devices, rather than providing detailed clinical efficacy trial results. Therefore, many of your requested points, especially those pertaining to clinical study design (sample size, expert ground truth, adjudication, MRMC studies, effect size, standalone performance, training set details), are not present in this type of submission summary.
This document emphasizes non-clinical testing and comparison to predicates for safety and effectiveness, assuming that the predicate devices have already established their clinical efficacy.
Acceptance Criteria and Study Details for Wrinkle Treatment Device (JM2)
Based on the provided 510(k) Summary, the acceptance criteria are implicitly related to demonstrating compliance with relevant electrical and photobiological safety standards, biocompatibility, and software validation. The study primarily consists of non-clinical testing to meet these standards and to show substantial equivalence to predicate devices, especially regarding technology and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from Standards) | Reported Device Performance (Summary in Document) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2020 | Device complies with IEC 60601-1:2020 |
| EMC | Compliance with IEC 60601-1-2:2020 | Device complies with IEC 60601-1-2:2020 |
| Home Healthcare Env. | Compliance with IEC 60601-1-11:2020 | Device complies with IEC 60601-1-11:2020 |
| Light Therapy Safety | Compliance with IEC 60601-2-83:2019 | Device complies with IEC 60601-2-83:2019 |
| Photobiological Safety | Compliance with IEC 62471:2006 | Device complies with IEC 62471:2006 |
| Battery Safety | Compliance with IEC 62133-2:2017 | Device complies with IEC 62133-2:2017 |
| Biocompatibility | Compliance with ISO 10993-5 (Cytotoxicity) | Device complies with ISO 10993-5 |
| Compliance with ISO 10993-10 (Sensitization) | Device complies with ISO 10993-10 | |
| Compliance with ISO 10993-23 (Irritation) | Device complies with ISO 10993-23 | |
| Software Validation | Compliance with FDA Software Guidance | Software verification and validation conducted |
| Substantial Equivalence | Similar Indications for Use | Same Indications for Use as predicates |
| Similar Technological Characteristics | Shared mask design, energy source (LED, Li-ion battery), intended location (full face), similar wavelengths/intensity, same product code (OHS). Differences (treatment size, materials) addressed by testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The "test set" here refers to the actual device samples subjected to non-clinical engineering and biocompatibility testing, not a clinical trial cohort. The document does not specify the number of units tested.
- Data Provenance: The report is from Shenzhen Qianyu Technology Co., Ltd. in China. The testing itself would have been conducted in a lab setting, likely by the manufacturer or a contracted testing facility. The data is retrospective in the sense that it's reported after the tests were completed to support the submission. No patient data or clinical trial data provenance (e.g., country of origin, retrospective/prospective clinical study) is mentioned as no clinical study was conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. As no clinical study was conducted, there was no "ground truth" to be established by experts in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for the non-clinical tests would be the measured parameters against the specified standards (e.g., electrical leakage within limits, specific wavelengths emitted, no cytotoxicity).
4. Adjudication Method for the Test Set
- Not applicable. There was no human-read test set requiring adjudication in this non-clinical submission.
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. An MRMC comparative effectiveness study was not performed. The device is a direct-to-consumer light therapy device, not an AI-assisted diagnostic or imagıng device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI algorithm. Its performance is based on its physical properties and light emission, not computational algorithms analyzing external data.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on engineering and biocompatibility testing standards and specifications. For instance:
- Electrical safety: Measured electrical parameters (e.g., leakage current, insulation resistance) compared to IEC 60601-1 limits.
- Photobiological safety: Measured light output parameters (e.g., irradiance, spectral distribution) compared to IEC 62471 limits.
- Biocompatibility: In vitro cellular response (cytotoxicity), skin sensitization, and irritation tests results compared to ISO 10993 criteria.
- Software: Verification and validation against design specifications and FDA guidance.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the machine learning sense, as it is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set.
§ 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.