(353 days)
The Young Again is an over the counter device intended to emit energy in the red and IR region of the spectrum for use in dermatology for treatment of periorbital wrinkles.
The Young Again is a device which allows emission and treatment with LED light in the RED (634 nm ) and IR (830nm) spectrum. The Young Again devices include a main unit installed on a trolley support, that controls and manages the LED emission through the two facial masks. The facial masks are designed in two versions depending upon the features of the LED installed in the mask: Red or IR The control panel is placed in the main unit with all the circuitry necessary to control the device and the user interacts with the Young Again device through the touch screen panel of the main unit and through a specific software application that allow the precise control of the treatment time.
The provided 510(k) summary for the "Young Again" device, K124064, is a premarket notification for a medical device and therefore does not contain acceptance criteria for device performance in the same way a clinical study report would. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific performance criteria against a clinical gold standard through a detailed study.
However, based on the provided text, we can infer some "performance data" that were submitted to support the device's substantial equivalence and suitability for its intended use.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
Since this is a 510(k) submission and not a clinical study report with specific performance endpoints, there are no explicitly stated "acceptance criteria" for clinical efficacy in the traditional sense (e.g., target sensitivity, specificity, or reduction in wrinkle severity). Instead, the performance evaluations focused on the device's usability, safety, and technical characteristics to demonstrate substantial equivalence.
| Acceptance Criterion (Inferred from testing performed) | Reported Device Performance |
|---|---|
| Lay Person Self-Selection and Usability | |
| (Ability of lay persons to understand, select, and use the device appropriately for its OTC indication) | "Espansione Marketing has conducted a self-selection and usability test." |
| (The specific results or success metrics of this test are not provided in the summary beyond the statement that it was conducted.) | |
| Software Validation | |
| (Software functions as intended, adhering to regulatory guidance) | "The Young Again software was tested and validated in accordance with the FDA 'Guidance for the content of Premarket Submissions for Software Contained in Medical Devices'." |
| (Implies the testing confirmed the software met the requirements of the guidance, but specific validation results are not detailed.) | |
| Energy Density and Standard Dose Measurement | |
| (Device emits the expected and appropriate energy for its therapeutic claim) | "The Young Again energy density and the standard dose was measured for the Young Again device with the two Red & IR masks, in a specific performance test. The results of this test allow to confirm that the performance of the device with its masks are as expected." |
| (Confirms that the device's energy output is consistent with expectations for its intended therapeutic effect, but specific values or comparison to a predicate are not explicitly given.) | |
| Compliance with International Standards | |
| (Device meets recognized safety and performance standards) | "Young Again device has been developed and tested according to the following international standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO, ISO /FDIS 15223-1, and ISO 10993-1 recognized by FDA." |
| (Implies successful testing against these standards, demonstrating electrical safety, EMC, software lifecycle, and biocompatibility. Specific test results are not detailed.) | |
| Substantial Equivalence to Predicate Devices | |
| (Device is as safe and effective as legally marketed predicate devices) | "Espansione Marketing believes that no significant differences exist between the previously approved Espansione Marketing devices (E-light line K092734) and the Therapeutics Omnilux New-U (K072459) and Home other predicate devices Photo SkinovationsSilk'n FX (K110301)." |
| (This is the overarching conclusion of the 510(k), based on the performance data and technical comparisons. Specific comparative data beyond the energy measurements are not furnished.) |
Study That Proves the Device Meets the Acceptance Criteria:
The document describes several types of evaluations rather than a single unifying study to "prove" meeting acceptance criteria in a clinical sense. These evaluations are:
- Self-selection and Usability Test: Conducted by Espansione Marketing to evaluate lay person understanding and use of the OTC device.
- Software Validation: Performed in accordance with FDA guidance for medical device software.
- Performance Test for Energy Density and Standard Dose: Measured the energy output from the Red and IR masks.
- Testing against International Standards: Adherence to IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62304 (software lifecycle), ISO 15223-1 (symbols), and ISO 10993-1 (biocompatibility).
2. Sample Size Used for the Test Set and Data Provenance
- Self-selection and Usability Test: The sample size for this test is not specified in the provided summary.
- Data Provenance: The summary does not provide details on the country of origin or whether the data was retrospective or prospective. It only states that Espansione Marketing "conducted" the test, implying it was likely prospective and carried out by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For the self-selection and usability test, it is implied that the "ground truth" was established by observing and evaluating the lay persons' interactions with the device. There is no mention of external experts or their qualifications being used to establish ground truth for this usability assessment.
- For the software validation and energy density/standard dose measurements, the "ground truth" would be established by reference to engineering specifications and regulatory guidance, carried out by qualified engineers/testers. The number and qualifications of these individuals are not specified.
4. Adjudication Method for the Test Set
- There is no information provided regarding an adjudication method for any of the described tests. Given the nature of a usability test and technical performance measurements, a formal adjudication process (like 2+1 or 3+1 for clinical endpoints) is typically not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The device is an energy-emitting device for personal use, not an imaging device requiring human reader interpretation. Therefore, a study comparing human reader performance with and without AI assistance is not relevant to this device's intended use.
6. Standalone Performance Study
- Yes, standalone performance was assessed through the "energy density and standard dose measurement" test which confirmed the device's technical output. The "self-selection and usability test" could also be considered a standalone assessment of the device's usability by its intended users.
- The 510(k) process itself largely focuses on demonstrating standalone performance and substantial equivalence without necessarily requiring a head-to-head clinical efficacy trial against a predicate.
7. Type of Ground Truth Used
- Usability Test: The ground truth would be based on observational data of lay person behavior and feedback in response to the device, potentially against predefined usability metrics.
- Software Validation: The ground truth would be established by software specifications and regulatory guidance.
- Energy Density/Standard Dose: The ground truth would be based on engineering specifications and physical measurements (e.g., expected output for the given LED wavelength and power).
- Standards Compliance: Ground truth is defined by the requirements of the international standards themselves.
8. Sample Size for the Training Set
- The summary does not mention a training set in the context of machine learning or AI. This device does not appear to involve AI or machine learning algorithms that would require a dedicated training set. The "software" mentioned refers to the device's control software, not an AI component.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a training set for AI/machine learning, this question is not applicable based on the provided text.
§ 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.