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510(k) Data Aggregation
(413 days)
Sunlamp product intended for use to tan the skin.
HPO Exotic: This model is a high pressure stand up appliance with tanning lamps located in four vertical columns. The high pressure lamps have a double filter: one blue cobalt filter in the inner part and one acrylic filter in the outer. The 1000 W lamps have an additional clear glass filter between the blue filters and the acrylic. The body frame is all in metal and it closes where it is possible all the electrical components. The body frame is covered by plastic thermoformed panels.
LP1: These suntan beds are three models with the same frame, aesthetic and with many common electrical parts. All the beds use the same low pressure lamps, the difference is the presence or not of the facial lamps. There are three versions: LP1-32/32EL, LP1-35/35EL, LP1-45/45EL. In all models the low pressure lamps are separated from the person by acrylic panels. The high pressure lamps have a double glass filter, one blue cobalt filter in the inner part and one clear filter in the outer. Every blue filter has a control switch. If the door is opened during the session or the filters are removed, the control switch interrupts the power supply on the control board and all lamps switch off. The body frame is all in metal and it closes where it is possible all the electrical components. The body frame is covered by plastic thermoformed panels.
LP2: This model is a bed with low pressure lamps in the base. The facial has 3 high pressure lamps. The low pressure lamps are separated from the person by acrylic panels. The high pressure lamps have a double glass filter: one blue cobalt filter in the inner part and one clear filter in the outer. Each blue filter has a control switch. If the door is opened during the session or the filter breaks the control switch interrupts the power supply and the lamp switches off.
LP3: These suntan beds are two models with the same frame, aesthetic and with many common electrical parts. The new models are similar to the current LP3, only the number of lamps was changed. There are two models: LP3-110 and LP3-140. Both models are beds with low pressure tanning lamps in the canopy and in the base and high pressure lamps in the facial area. The low pressure lamps are separated from the person by acrylic panels. The high pressure lamps have a double glass filter: one blue cobalt filter in the inner part and one clear filter in the outer.
Mastersun: This model is a bed with a high pressure tanning lamps located in five horizontal columns placed around the person body. Three columns are in the canopy, and two are in the bed, under the acrylic panel. The high pressure lamps have a double glass filter one blue cobalt filter in the inner part and one clear filter in the outer.
Vega: This model is a booth with low pressure lamps: the machine is mainly composed of three curved panels, two fixed and one is the door. Each panel has a set low pressure lamps separated from the person by acrylic panels.
The provided text is a 510(k) summary for several sunlamp products. It contains information about the device description, indications for use, comparison to predicate devices, and performance testing. However, it does not describe any acceptance criteria or a study proving a device meets those criteria in the context of a diagnostic or AI-powered medical device.
The document discusses:
- The devices: Various models of sunlamps (HPO Exotic, LP1, LP2, LP3, MasterSun 360, MasterSun 360 New Reflector, Vega Lux).
- Their intended use: To tan the skin.
- Their classification: Class II, Product Code LEJ (Ultraviolet Lamp For Tanning).
- Predicate devices: Other sunlamp models that were 510(k) exempt or previously cleared. The document explicitly states "The subject and predicate devices are identical."
- Performance: "The subject devices were tested to be in conformity with Performance Standard 21 CFR 1040.20. They are identical to the predicate." It also mentions "Usability data is included with the submission to support the conversion of indications from Rx to OTC."
- Biocompatibility: The polymethyl methacrylate (PMMA) material in contact with skin has been shown to be biocompatible via European standard 30993 (ISO 10993). No additional testing was done as the devices are identical to the predicate.
- Electrical safety and EMC: Testing was conducted, and devices passed. No additional testing was performed, as the devices are identical to the predicate.
- Software Verification and Validation: Conducted for "moderate" level of concern software.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, as this document does not contain such details for a diagnostic or AI-driven medical device. The context of this document is a 510(k) submission for tanning lamps, which are physical devices regulated for safety standards (like UV emission and electrical safety) rather than diagnostic accuracy.
There is no information on:
- A table of acceptance criteria and reported device performance (in the context of diagnostic accuracy).
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone (algorithm only) performance.
- Type of ground truth (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
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(173 days)
Sunlamp product intended for use to tan the skin.
The submission covers several models of sunlamp products: B-Phase, HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, and Vega Lux. These devices are either stand-up units (booths) or beds with UV low pressure or high pressure lamps intended for tanning the skin. Some models include visible red-light lamps or facial tanning lamps. The lamps are separated from the user by acrylic panels or glass filters. The devices have metal body frames covered by plastic panels and include electrical components and control boards. Safety features like control switches that interrupt power if doors are opened or filters are removed are present in some models. Associated sunlamps and protective eyewear are also mentioned.
This document is a 510(k) Premarket Notification from the FDA regarding several sunlamp products. It is not a study proving a device meets acceptance criteria. The document explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the FDA has determined these new devices are substantially equivalent to existing, legally marketed sunlamp products, not that a specific study was conducted to prove they meet novel acceptance criteria through a clinical trial or performance study against a defined set of metrics in a medical context.
Therefore, most of the information requested in your prompt (acceptance criteria, device performance, sample size, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) will not be present in this document because it describes a different kind of regulatory submission.
However, I can extract the limited performance and safety information that is mentioned:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Compliance) | Reported Device Performance |
|---|---|
| Performance Standard 21 CFR 1040.20 | Devices were tested to be in conformity with Performance Standard 21 CFR 1040.20. |
| Biocompatibility (for contacting materials) | The polymethyl methacrylate (PMMA) that contacts skin was shown to be biocompatible via European standard 30993 (which corresponds to ISO 10993). |
| Electrical safety | Electrical safety testing was conducted on all devices, which were shown to pass the tests conducted. |
| Electromagnetic compatibility (EMC) | EMC testing was conducted on all devices, which were shown to pass the tests conducted. |
| Software Verification and Validation | Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. |
2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for testing, nor does it refer to a "test set" in the context of clinical or performance data collection on human subjects or diagnostic samples. The testing appears to be primarily engineering and safety compliance. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for a test set in a medical diagnostic or treatment performance context is established or mentioned. The compliance is against engineering standards and material biocompatibility standards.
4. Adjudication method for the test set
Not applicable. No "test set" requiring adjudication in a clinical or diagnostic sense is described.
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 (a sunlamp) does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical sunlamp, not an algorithm.
7. The type of ground truth used
For the biocompatibility testing, the "ground truth" (or standard) used was European standard 30993 (corresponding to ISO 10993). For performance, electrical safety, and EMC, the "ground truth" was compliance with 21 CFR 1040.20 and successful completion of respective tests. For software, it was compliance with FDA's guidance for software in medical devices.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the document's purpose:
This document is an FDA 510(k) clearance letter, indicating that the listed sunlamp devices are "substantially equivalent" to predicate (already legally marketed) devices. The "study" mentioned is primarily a series of engineering and safety tests to confirm compliance with established regulatory standards (like 21 CFR 1040.20 for sunlamp products, ISO 10993 for biocompatibility, and general electrical/EMC safety standards), rather than a clinical trial or performance study against a specific disease or diagnostic outcome. The acceptance criteria relate to compliance with these standards and established safety guidelines, rather than metrics like sensitivity, specificity, or reader performance typical of diagnostic devices.
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