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510(k) Data Aggregation
(324 days)
The Pro X OTC 5 is an Over-The-Counter device intended for use in the treatment of facial wrinkles. It is for people with wrinkles on their face and who have Fitzpatrick skin types I, II and/or III.
The Pro X OTC 5 is an Over-the-Counter device intended for use in the treatment of facial wrinkles. Facial wrinkles are lines on the skin that appear as you age. Facial wrinkles can appear anywhere on the face, such as on the forehead, around the eyes, and by the mouth. The Pro X OTC 5 is for people with wrinkles on their face and who have Fitzpatrick skin types I, II, and/or III.
The Pro X OTC 5 uses known LED light therapy technology. A combination of red light (620-630mm) and infrared light (855nm) is emitted. To use the Pro X OTC 5 device, users place the lightweight mask over the face and then press the "On" button on the controller to start treatment. The device will automatically turn off after each treatment cycle.
The Pro X OTC 5 device is designed to be used for 30 treatment sessions. The full treatment regimen for facial wrinkles includes 60 individual treatments, therefore purchase of two (2) devices is needed to receive the full treatment regimen.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Device Name: Pro X OTC 5 Light Therapy Device
Intended Use: Treatment of facial wrinkles in people with Fitzpatrick skin types I, II, and/or III.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds for clinical performance. Instead, it aims to demonstrate substantial equivalence to predicate devices and effectiveness through a clinical study. The primary measure of effectiveness is improvement in Fitzpatrick Wrinkle and Elastosis Scale scores.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical Effectiveness: | |
| Improvement in facial wrinkles (as measured by Fitzpatrick Wrinkle and Elastosis Scale). | Treatment Group (n=30): |
| Physician 1: | |
| - Baseline mean grade: 5.10 | |
| - 8-week mean grade: 3.86 (1.24 point improvement) | |
| - 20-week post-treatment mean grade: 3.83 (1.28 point improvement from baseline) | |
| Physician 2: | |
| - Baseline mean grade: 5.03 | |
| - 8-week mean grade: 3.83 (1.21 point improvement) | |
| - 20-week post-treatment mean grade: 3.90 (1.14 point improvement from baseline) | |
| Individual Improvement: Each subject in the treatment group demonstrated at least 1 point improvement (baseline vs. 20-weeks post-treatment). | |
| Statistical Significance: Treatment Group showed statistically significant improvement (p<0.001) at all evaluation periods and statistically outperformed the Control Group. | |
| Safety: | Conforms to IEC 60601-1 3rd edition, IEC 60601-1-2, and IEC 62471. |
| Usability: | Users can understand labeling and use the device appropriately. |
| Self-Selection: | External packaging provides sufficient information for users to self-select. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study: 50 subjects.
- Treatment Group: 30 subjects
- Control Group: 20 subjects
- Data Provenance: The document does not explicitly state the country of origin of the data. It is a prospective clinical study (subjects were assigned to groups and followed over time with interventions).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two (2) independent, blinded, licensed physicians.
- Qualifications: Licensed physicians. Specific experience (e.g., years of experience or specialization in dermatology) is not provided.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the physicians' evaluations. It states that photographs were evaluated by "two independent, blinded, licensed physicians." It then reports separate mean scores for "Physician 1" and "Physician 2," implying their individual assessments were used in the statistical analysis, rather than a consensus or adjudicated single score.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Was an MRMC study done? No, not in the typical sense of comparing human reader performance with and without AI assistance. This study evaluated the effectiveness of a device (Pro X OTC 5) itself, with physicians acting as evaluators of the clinical outcome, not as readers of AI output.
- Effect Size: Not applicable in this context. The study did not involve AI assistance for human readers. It reported the device's treatment effect on wrinkle scores.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The Pro X OTC 5 Light Therapy Device is a physical medical device (mask with LED lights) used by the patient, not a software algorithm. Therefore, there is no "standalone algorithm performance" to evaluate. The study assesses the device's efficacy when used by subjects.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Type of Ground Truth: The ground truth for the effectiveness of the device (i.e., the presence and severity of facial wrinkles and their changes) was established by the independent evaluation of standardized facial photographs by two licensed physicians using the 9-point Fitzpatrick Wrinkle and Elastosis Scale. This can be considered a form of expert assessment/consensus (though their scores were reported individually rather than adjudicated to a single "truth"). Outcomes data (i.e., direct patient experience/satisfaction) is not explicitly detailed as a primary endpoint beyond the physician evaluations.
8. The Sample Size for the Training Set
- Not applicable. The Pro X OTC 5 is a light therapy device, not an AI/machine learning algorithm that requires a training set of data. Its performance is based on the physical properties of the emitted light and its biological interaction with skin.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
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