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This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.

The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Using traditional UV light with the combination of red and blue light the user indulges in a new luxurious tanning experience. Optimal tanning results are achieved due to the synergistic combination of light spectra.

The provided text is a 510(k) Summary of Safety and Effectiveness for sunlamp products. It details comparisons between proposed devices and legally marketed predicate devices to demonstrate substantial equivalence, rather than providing an acceptance criteria table and a study proving a device meets those criteria in the context of an AI/algorithm-driven medical device.

The document does not contain information relevant to AI/algorithm performance, ground truth establishment, sample sizes for training/test sets, or expert review processes for such devices. Therefore, I cannot generate the requested table and study description based on the provided text.

The text focuses on hardware comparison and compliance with established performance standards for sunlamp products (e.g., IEC 60601-1 for electrical and mechanical safety, IEC 60601-1-2 for EMC, and U.S. performance standard 21CFR 1040.20 for irradiance ratio).

To summarize why I cannot fulfill your request:

• No AI/Algorithm Component: The submitted document describes sunlamp products, which are physical devices. There is no mention of any AI component, algorithm, or software that would require performance evaluation metrics like sensitivity, specificity, or AUC, nor would it involve concepts like "ground truth" derived from expert consensus or pathology for diagnostic purposes.
• Performance Testing Focus: The "Summary of performance testing" section clearly states that the devices were tested for "biocompatibility," "electrical and mechanical safety," and "EMC," and compliance with "U.S. performance standard 21CFR 1040.20" (which pertains to sunlamp products and their UV emissions). These are physical device performance criteria, not AI/algorithm performance.
• Comparative Approach: The entire document is structured as a comparison (substantial equivalence) to predicate devices, demonstrating that new models are similar in technology, intended use, and safety to already cleared devices, rather than a novel device proving its effectiveness against a set of performance criteria through a clinical study.

Therefore, the requested information (Acceptance Criteria Table, Sample Sizes for Test/Training, Expert Ground Truth, Adjudication, MRMC study, Standalone performance, Type of Ground Truth, Training Set Size, Training Ground Truth) is not present in the provided document because it describes a different type of medical device lacking an AI/algorithm component.

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This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.

The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface.

UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.

The provided text is a 510(k) summary for sunlamp products (Ergoline Inspiration 550 Hybrid Technology and Ergoline Planet Fitness 42/4 Hybrid Light Technology). It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance criteria through a clinical study or complex AI validation.

Therefore, many of the requested details, such as those related to AI algorithm performance (e.g., sample size for test/training sets, expert ground truth, MRMC study, standalone performance, validation of ground truth), are not present in this document because they are not applicable to the type of device and regulatory submission described.

The "performance testing" mentioned in the document refers to compliance with established electrical, mechanical, and safety standards for sunlamp products, not an AI-driven diagnostic or treatment device.

Here's an analysis based on the available information and an explanation of why other requested information is not present:

Device Description: Sunlamp products (Ergoline Inspiration 550 Hybrid Technology, Ergoline Planet Fitness 42/4 Hybrid Light Technology, and their variants).

Intended Use: Exclusively for aesthetic tanning of human skin, for one person at a time, at the age of 18 or above.

Regulatory Class: Class II

Predicate Device: Ergoline Inspiration 600 Dynamic Performance (K151400)

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for this type of device, as demonstrated in a 510(k), are primarily related to meeting established safety and performance standards for sunlamp products and demonstrating substantial equivalence to a predicate device. There aren't "performance metrics" in the typical sense of accuracy, sensitivity, or specificity as one would see for a diagnostic AI.

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. This document describes a submission for a sunlamp and does not involve AI or a complex test set of patient data. The "testing" refers to lab-based compliance testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. No patient data test set or ground truth establishment by experts for performance evaluation (e.g., diagnostic accuracy) is described.

4. Adjudication method for the test set:

• Not applicable / Not provided. No test set requiring expert adjudication for AI performance.

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. This is a sunlamp product, not an AI-assisted diagnostic device. MRMC studies are not relevant here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This relates to an AI algorithm, which is not part of this device or submission type.

7. The type of ground truth used:

• Not applicable. No ground truth in the context of diagnostic accuracy is relevant. The "ground truth" for this device would be its adherence to specified physical and electrical parameters and safety standards, as verified through laboratory testing against those standards.

8. The sample size for the training set:

• Not applicable / Not provided. No AI training set is mentioned as part of this device submission.

9. How the ground truth for the training set was established:

• Not applicable / Not provided. No AI training set.

Summary of the Study (as described in the document):

The "study" presented in this 510(k) summary is not a clinical study in the traditional sense, nor is it an AI performance validation study. Instead, it is a design verification and validation process to demonstrate that the new sunlamp devices are substantially equivalent to a previously cleared predicate device and that they comply with applicable U.S. and international safety and performance standards.

The core of the "proof" the device meets acceptance criteria lies in:

• Comparison to Predicate Device: Showing that the proposed devices have identical intended use and similar technological characteristics, with any differences not raising new questions of safety or effectiveness. Key differences (e.g., number of lamps, wattage) are addressed by stating that irradiance characteristics are comparable and safety has been confirmed by corresponding tests.
• Compliance with Recognized Standards: Stating that the devices have been tested and comply with:
  • U.S. Performance Standard 21 CFR 1040.20 (Sunlamp Products)
  • ISO 10993-series (Biocompatibility)
  • IEC 60601-1 (Electrical and Mechanical Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)

The document concludes that the proposed devices are substantially equivalent to the predicate, do not introduce new indications or hazards, and fulfill all Special Controls.

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This sunlamp product is intended exclusively for aestetic tanning of the human skin, for one person at a time, at the age of 18 or above.

The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. UV-B radiation is primarily responsible for more long-term tanning results. The Ergoline Sunrise 7200 Hybrid Light Technology / Hybrid Technology provides tanning results by combining traditional UV light with red light in a synergistic combination of light spectra.

The provided text is a 510(k) summary for a sunlamp product. This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way an AI diagnostic device would.

Therefore, many of the requested sections about clinical study details (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this document as it describes a Class II sunlamp product, not an AI/ML-driven medical device.

The document primarily focuses on demonstrating that the new device, Ergoline Sunrise 7200 Hybrid Technology, is substantially equivalent to a legally marketed predicate device (Sunrise 6200 and Sunrise 7200, K173565) by comparing their technological characteristics, intended use, and compliance with relevant safety standards.

Here's an attempt to answer the questions based on the available information, noting the inapplicability of some points:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" and "reported device performance" are primarily demonstrated through compliance with established safety and performance standards rather than specific diagnostic metrics. The document asserts compliance with these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable: This document describes a sunlamp product, not an AI/ML diagnostic or predictive device that typically uses "test sets" of data. The "testing" referred to is for compliance with electrical, mechanical, and safety standards like IEC 62471, IEC 60601-1, IEC 60601-1-2, ISO 10993, and 21 CFR 1040.20. These are engineering/device performance tests, not clinical studies with patient data.

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: As above, this is not an AI/ML diagnostic device requiring expert-established ground truth from clinical data. Compliance is assessed against technical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: No clinical "test set" and thus no adjudication method for ground truth determination.

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 is not an AI-assisted diagnostic device, so no MRMC study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is a sunlamp product, not an algorithm, so "standalone performance" in this context is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable: The "ground truth" for this device's compliance is defined by the technical specifications and safety standards (e.g., measured irradiance levels, electrical safety parameters, biocompatibility test results). It is not based on clinical outcomes, pathology, or expert consensus on a diagnosis.

8. The sample size for the training set

• Not Applicable: This is a physical sunlamp product and does not involve AI/ML models that require a training set.

9. How the ground truth for the training set was established

• Not Applicable: As there is no training set, this question is not applicable.

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This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.

The primary technical components of sunlamp products are artificial sources of UV radiation and a mechanical structure. Different UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.

This document is a 510(k) summary for the Ergoline Prestige 1600 Hybrid Performance sunlamp product. It compares the proposed device to a predicate device, the Ergoline/Prestige 1400 Intelligent Performance, to demonstrate substantial equivalence.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (Ergoline/Prestige 1400 Intelligent Performance) and compliance with relevant safety and performance standards. The "Evaluation" column in the comparison table serves as the reported device performance against these criteria.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data for algorithmic performance. This device is a physical sunlamp, and the comparison is primarily based on technical specifications and compliance with established standards rather than diagnostic performance using a data set.

The testing mentioned (e.g., biocompatibility) refers to laboratory and bench testing of the components and the device itself, not a clinical study on human subjects with a test set of cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a device that generates diagnostic outputs requiring expert ground truth establishment.

4. Adjudication method 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 is not an AI/CADe/CADx device where human reader performance with or without AI assistance would be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

For the safety and performance evaluations, the "ground truth" is adherence to established international and national standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993-series, 21 CFR 1040.20) and the technical specifications of a predicate device. This is a form of benchmarking against established standards and predicate device characteristics.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a training set.

9. How the ground truth for the training set was established

Not applicable.

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This sunlamp product is intended exclusively for cosmetic tanning of the human skin, for one person at a time, at the age of 18 or above.

The primary technical components of sunlamp products are artificial sources of UV radiation (UV lamps) and a mechanical structure. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.

The provided text is a 510(k) summary for the JK-Holding GmbH's Sunrise 6200 and Sunrise 7200 tanning devices. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics are not available in this document. The document describes the device, its intended use, and compares it to a predicate device in terms of technical characteristics and compliance with electrical/safety standards.

Here's an attempt to answer the questions based only on the provided text, noting where information is absent:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for performance in terms of cosmetic tanning effectiveness. Instead, it focuses on compliance with established safety and electrical standards and showing that the proposed device is technologically equivalent to a predicate. The "performance" reported is compliance with these standards and similar technical specifications.

2. Sample size used for the test set and the data provenance

The document mentions "Summary of performance testing" and indicates that "The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2." and "The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20." It also refers to "section 18 for bench test report" regarding irradiance ratio.

• Sample Size: Not specified for any of the tests. This refers to physical devices tested, not clinical data sets.
• Data Provenance: The tests are likely conducted in a lab setting by the manufacturer or a third-party testing facility. The manufacturer is based in Germany. The document is for submission to the U.S. Food & Drug Administration (FDA). The nature of these tests (safety, electrical, EMC) implies them to be prospective, laboratory-based tests on the devices themselves. No human or patient data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The "ground truth" for this device relates to its compliance with technical standards (e.g., electrical safety, UV irradiance limits). This is measured through instrumental testing and adherence to published standards, not through expert human assessment of an outcome like a medical diagnosis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable and not provided. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of medical imaging or clinical cases where consensus is needed to establish ground truth for algorithm performance. For a tanning device, compliance is determined by instrumental measurements and adherence to engineering standards.

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 and not provided. This is a tanning device, not an AI-powered diagnostic tool requiring human-in-the-loop studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable and not provided. There is no mention of an algorithm or AI component in this device. The "performance" relates to the physical device's technical specifications and safety compliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed (biocompatibility, electrical safety, EMC, irradiance ratio) would be defined by the specifications and limits set forth in the referenced international standards (e.g., ISO 10993, IEC 60601-1, IEC 60601-1-2, 21 CFR 1040.20). Compliance is determined by direct physical measurement against these established benchmarks.

8. The sample size for the training set

Not applicable and not provided. This is generally a physical product, not a machine learning model. There is no mention of a training set.

9. How the ground truth for the training set was established

Not applicable and not provided, as there is no training set mentioned for this product.

Ask a specific question about this device

This sunlamp product is intended exclusively for cosmetic tanning of the human skin, for one person at a time, at the age of 18 or above.

The primary technical components of sunlamp products are artificial sources of UV radiation and a mechanical structure. Different UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification for sunlamp products, which primarily focuses on substantial equivalence to predicate devices and regulatory compliance rather than outlining detailed acceptance criteria, specific study designs, or performance metrics typically associated with medical device efficacy studies.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample sizes for test sets, data provenance, or details on training sets.
3. Information about experts establishing ground truth or adjudication methods.
4. Details of multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
5. The type of ground truth used (e.g., pathology, outcomes data).

The document is about sunlamp products and their regulatory clearance, not about an AI or algorithmic device.

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