Search Results
Found 1 results
510(k) Data Aggregation
(45 days)
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
The device is intended to be used for the tanning of human skin.
The series of tanning bed/booths are available in four configurations. Units consist of LPI, Inc. branded and OEM tanning beds and booths.
- ESB -14, 16, 18, 24, and Oasis 36(booth)
- Solar Storm 16R, 24S, 24R, 24C, 32S, 32R, 32C, 36ST, 48ST(Booth)
- Solar Wave 16, 24
- . Sunco - 16XS, 24XS, 32XS, and 48Vertical (Booth)
Each configuration consists of a metal structure with lamps placed equally distant horizontally (booths) and arranged in manner to provide the tanner an even tan. The user of tanning beds lies down on the bench section and pulls down the canopy cover, which is equipped with a counterweighted gas springs/shocks in order for this section of the bed to open and close. The user of a tanning booth stands within the sections of the booth. The section of the booth (door) also has gas springs/shocks and wheels to close the door. All units have electronic type ballasts that powers the lamps. Each unit is also equipped with a settable electronic timer which is controlled by a time setting of 10, 15, or 20 minutes. Timers are also equipped with an "off" button to allow user to turn off the lamps any time prior to the duration of the set timer.
This document is a 510(k) summary for tanning units (tanning beds/booths). It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device. Instead, it demonstrates substantial equivalence to predicate devices and adherence to existing regulations for sunlamp products.
Therefore, many of the requested sections about specific acceptance criteria, study sizes, expert involvement, and AI performance metrics are not applicable to this document.
Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not available:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of acceptance criteria for a new performance claim, nor does it report device performance in terms of metrics like sensitivity, specificity, or accuracy (which would be relevant for an AI/ML device). Instead, it confirms adherence to established standards and guidelines for sunlamp products.
The key "performance criteria" that are implicitly met are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| UV irradiation exposure within allowable limits per 21 CFR 1040.20 and FDA Guidance letter dated August 21, 1986. | UV irradiance testing results confirm the dosage is within allowable limits. |
| Compliance of labeling and user manual contraindications/warnings with 21 CFR 1040.20. | Labeling and user manual contraindications and warnings are in compliance. |
| Timers function correctly and are set for specified intervals (10, 15, or 20 minutes). | Timers are set for the time interval and tested at 100% prior to installation. |
| Biocompatibility of materials in contact with skin. | Poly(Methyl methacrylate/Butyl acrylate) (CAS No. 25852-37-3) has been shown to be biocompatible via ISO 10993 and is identical to material in predicate devices. |
| Electrical Safety and Electromagnetic Compatibility (EMC). | IEC 60601-1 and 60601-1-2 testing were conducted and passed. |
| Software Verification and Validation. | Conducted and documented as recommended by FDA's Guidance for Industry, "Guidance for Industry, FDA Reviewers and Compliance on "Off-the-Shelf" Software used in Medical Devices." (Software considered "Minor Level of Concern"). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a test set of data as for an AI/ML device. The "testing" refers to quality control and compliance checks on the physical tanning units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment by experts is not described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This device is a tanning unit, not an AI-assisted diagnostic or interpretive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" implicitly used here relates to established regulatory standards and guidance for sunlamp products (e.g., maximum UV irradiance, electrical safety standards, biocompatibility standards). These are not clinical outcomes or expert consensus on clinical data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Ask a specific question about this device
Page 1 of 1