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These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.

The Unilam Tanning lamps are high-pressure metal-halide lamps, each comprised of a quartz glass bulb filled with metal halide, mercury, and argon gas, and equipped with 2 electrodes and an electrical connector, to provide ultraviolet light in order to tan the human body.

The provided document is a 510(k) summary for a "Tanning Lamp" and focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving algorithms, AI, or human readers. Therefore, most of the requested information regarding acceptance criteria, study design for AI models, human expert involvement, and ground truth establishment for such studies is not available in the document.

However, I can extract the information related to the device's performance criteria mentioned in the document as part of its substantial equivalence claim.

Here's the relevant information based on the document:

1. Table of acceptance criteria and the reported device performance

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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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KBL Sunlamp Hybrid Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person.

KBL Sunlamp Hybrid Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources using the hybrid light technology. The hybrid light technology produces ultraviolet radiation and radiation in the visual range of the light spectrum. The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The user is lying on a bench.

The provided document is a 510(k) Pre-market Notification for KBL GmbH sunlamp products, specifically the KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, and KBL 8000 alpha hybridSun. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria for a novel AI/software medical device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically found in the context of validating performance for diagnostic or therapeutic AI/software, is not present in this document.

This document details the following for sunlamp products:

1. Device Type: Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
2. Regulation Number: 21 CFR 878.4635
3. Regulation Name: Sunlamp products and ultraviolet lamps intended for use in sunlamp products
4. Regulatory Class: Class II
5. Product Code: LEJ
6. Indications for Use: "KBL Sunlamp Hybrid Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person." This is identical to the predicate device.
7. Comparison to Predicate: The document largely focuses on comparing the technological characteristics (number of lamps, wattage, dimensions, etc.) of the proposed devices to predicate devices (KBL 6800 alpha and KBL 7900 alpha). The evaluation states that differences are "Equivalent" or "Identical" and do not impact functionality or safety.
8. Performance Data: Non-clinical performance tests were conducted to ensure compliance with relevant standards for sunlamp products, including:
   • Biocompatibility testing (DIN EN ISO 10993 series)
   • Electrical and mechanical safety testing (IEC 60601-1, IEC 60335-1, UL482)
   • Electromagnetic compatibility testing (IEC 60601-1-2)
   • Spectral emission measurement (IEC 60335-2-27)
   • Software verification and validation (FDA Guidance for Software in Medical Devices)
   • Performance Standards testing (21 CFR 1040.20)
   • Irradiance ratio limits (21 CFR 1040.20(c)(1))
   • Maximum timer intervals and exposure schedules (FDA policy)

Key takeaway: This 510(k) submission is for physical sunlamp devices, not an AI/software medical device. The "performance data" refers to compliance with safety and electrical standards for sunlamps, not the type of diagnostic performance (e.g., sensitivity, specificity) that requires the detailed study design elements you asked for. Therefore, I cannot extract the requested information from this document.

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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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Tanning Bed Systems are intended to provide tanning of the human skin.

The primary technical components of sunlamp products are whole body tanning devices consisting of a mechanical frame with Ultraviolet (UV) lamps providing an artificial source of UV radiation. The UV light is intended for irradiation of the human body to induce skin tanning. The user of the proposed devices device either lies in the horizontal tanning bed or stands in the vertical tanning booth.

Skin tanning varies with skin type and as the 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 fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.

This document describes ProSun International LLC's submission for their sunlamp products, establishing substantial equivalence to previously marketed predicate devices. This is a 510(k) submission for tanning bed systems, which are classified as Class II medical devices. The document does not describe an AI/ML powered device, therefore the typical acceptance criteria and study data for AI/ML devices involving human readers, test sets, ground truth, and training sets are not applicable.

Instead, the acceptance criteria for these devices revolve around compliance with established performance standards and safety regulations for sunlamp products.

Here's a breakdown of the requested information, adapted to the context of this device:

1. A table of acceptance criteria and the reported device performance

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

This information is not applicable as this is not an AI/ML study involving a test set of data. The devices themselves are the "test set" and their performance is evaluated against regulatory standards. The testing described is primarily non-clinical, evaluating the physical device characteristics and compliance with electrical, mechanical, and radiation emission standards.

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)

This information is not applicable. The "ground truth" for sunlamp products relies on established engineering and medical device safety standards and regulations (e.g., IEC, UL, 21 CFR). Expert review would be conducted by regulatory bodies and internal engineering teams to ensure compliance, rather than clinical experts establishing a ground truth for a diagnostic AI.

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

This information is not applicable. This is not a study requiring adjudication of interpretations from multiple readers.

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

This information is not applicable. This submission is for sunlamp products, not a device with AI assistance for human readers.

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

This information is not applicable. These are physical sunlamp devices, not software algorithms.

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

The "ground truth" in this context is the set of established safety and performance standards, regulations, and internationally recognized testing procedures for sunlamp products. This includes:

• 21 CFR 878.4635 (Regulation for Ultraviolet Lamp for Tanning)
• 21 CFR 1040.20 (Performance standards for sunlamp products)
• 21 CFR 1002, 1010-1050 (Electronic product radiation control)
• IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)
• IEC 60335-2-27 (Household and similar electrical appliances - Safety - Part 2-27: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation)
• UL 482 (Standard for Portable Sun/Health Lamps)
• DIN EN ISO 10993 (Biological evaluation of medical devices)
• CISPR 14-1 and 14-2 (Electromagnetic compatibility for household appliances, electric tools and similar apparatus)
• FDA Guidance documents (e.g., "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" and "Policy on maximum timer interval and exposure schedule for sunlamp products")

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that requires a training set.

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

This information is not applicable. There is no training set for this device.

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The Fiji Sun Fluorescent Tanning Unit device (FIJI Sun) is intended to provide ultraviolet light for the purpose of stimulating a tanning response in the skin.

The FIJI Sun Fluorescent Tanning Unit (FIJI SUN) is a small tabletop sunlamp product which uses four Sperti brand ultraviolet lamps (model number: FRT20TI21BUHO) manufactured for KBD. The FIJI Sun Fluorescent Tanning Unit uses a mechanical timer with a maximum timer interval of 15 minutes and a minimum timer interval of one minute. The maximum timer interval error as a percent of that interval is +/- 6%. Output performance testing and FDA performance standards were used to determine the maximum timer interval and the recommended exposure schedule which is on the device labeling and in the user instructions. Two pair of protective eye wear are supplied with the device. The spectral transmittance to the eye of the protective eyewear is 0.0008 in the wavelength range from 200 nm to 320 nm and 0.0004 in the wavelength range from 320nm to 400 nm and is sufficient over the wavelengths greater that 400nm to enable the user to see clearly enough to reset the timer. In order for the product to fulfill its function it emits UV light In the wavelength range from 290 nm to 400 nm and the emission level is one SED (100 J/m²). The minimum use distance specified in the product labeling and the user instruction is 18 inches. Adequate directions for use, warnings and contraindications are included in user instructions provided with the device and in the device labeling. There is no software contained in the device. The device is sold as Over the Counter (OTC).

This document describes a 510(k) premarket notification for the "Fiji Sun Fluorescent Tanning Unit (FIJI Sun)." This device is a tanning unit, not an AI/ML powered medical device, therefore the typical acceptance criteria and study information related to AI/ML software (like sensitivity, specificity, AUC, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The "acceptance criteria" and "device performance" in this context refer to compliance with established safety and performance standards for sunlamp products.

Here's a summary of the relevant information provided:

Acceptance Criteria and Reported Device Performance

Study Information (Applicable to Non-AI/ML Device)

• Sample size used for the test set and the data provenance: No "test set" in the context of an AI/ML study. The device itself (the Fiji Sun Fluorescent Tanning Unit) underwent performance testing to ensure compliance with relevant standards. The data provenance is internal testing performed by the manufacturer KBD, Inc.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a tanning unit involves physical measurements and compliance with regulatory limits, not expert interpretations of medical images or data.
• Adjudication method for the test set: Not applicable.
• 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/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is objective physical measurements and established regulatory limits for UV emission, timer accuracy, and protective eyewear transmittance as defined by the Federal Food, Drug, and Cosmetics Act (specifically 21 CFR 1040.20) and international electrical safety standards (IEC/EN 60601-1).
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the "study" demonstrating the device meets "acceptance criteria" involved specific performance testing of the physical device to ensure it conforms to established regulatory standards for sunlamp products, particularly regarding UV radiation emission, timer accuracy, and protective eyewear safety. The submission claims "Specific performance testing (spectral analysis) was done on these devices to measure irradiance" and "Specific performance testing was done on the included protective eyewear (goggles)."

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This ultraviolet lamp is intended for use in sunlamp products for tanning of human skin.

The component ultraviolet lamp model family or part numbers are for use in sunlamp products to tan human skin. They fall into a generic class of UV lamps that have the same basic technological features, characteristics, except for power rating, diameter and length, with the exact same intended use. The UV sunlamp model family are for tanning human skin use. They vary in brand ID and unique lamp ratings accordingly. These sunlamps fit into a wavelength range of 200-710nm and operate from the end product ballast supply.

There are individual component sunlamps listed in the exhibit page. They are classified as low pressure, mercury rare gas discharge devices and generally have the same construction and technical principals of operation as that of a common fluorescent lamp. The UV lamps have a tubular glass envelope with internal surface coated with fluorescent phosphor. The sealed lamps include the composition and electrical means to activate the UV light within the wavelength specification. The construction is controlled by production procedures and test methods defined in the QMS. The UV radiation is controlled by these methods to assure safe use.

This document is a 510(k) summary for UV Lamps for Sunlamp Products (K180581). It describes the device, its intended use, predicate devices, and the performance data and design control activities. However, it does not contain the information required to answer your specific questions relating to acceptance criteria and a study that proves the device meets the acceptance criteria in the context of clinical performance or algorithm evaluation.

This document is a regulatory submission for a physical device (UV lamps), not an AI/ML software device. As such, concepts like "acceptance criteria and reported device performance" as you've framed them (often related to diagnostic accuracy, sensitivity, specificity), "sample size for test set," "data provenance," "ground truth experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details" are not applicable to this type of device and submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications, compliance with international consensus standards, and a quality management system.

Here's a breakdown of what is available in the document and why other requested information is not present:

Information Present in the Document (and its interpretation for this context):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (as regulatory compliance): The device (UV Lamps) must comply with:
     • IEC/EN 61195:2014 - Double Capped Fluorescent Lamps Safety Specifications
     • IEC/EN 60355-2-27:2013 - Particular Appliances Safety Requirements for Skin Exposure to UV and IR Radiation
     • EN60081:1998 - Double Capped Fluorescent Lamps - Performance Specifications
     • EN61228:2008 - Fluorescent Ultraviolet Lamps Used for Tanning. Measurement and Specification Method
     • EN62471:2008- Photobiological Safety of Lamps and Lamp Systems
     • EN50581: 2012 - Technical Documentation for the Assessment of Electrical and Electronic with Respect to the Restriction of Hazardous Substances
     • 21 CFR 1040.20 - Performance standard for sunlamp products and ultraviolet lamps intended for the use in sunlamp products (FDA mandatory standard).
     • ISO9001 Quality Management System.
   • Reported Device Performance (as compliance with the above): The document states:
     • "The Feilo Sylvania UV lamps are intended for use in sunlamp products for tanning of human skin comply with the consensus standards and specifications listed below and are therefore validated as safe for the intended use."
     • "Specific performance testing (spectral analysis) data is submitted to CDRH for the component UV lamps with measurement of irradiance to verify compliance with radiation limits defined in 21CFR1040.20."
     • "The control activity shows that there are no new questions of safety and effectiveness for the described UV Sunlamps."
     • "Inspection verification procedures assure performance concerns are compliant to QMS specifications."
     • The comparison table (page 5) lists "Radiation 21CFR1040.20" for the Feilo Sylvania device and "CDRH compliant" for predicate devices, implying adherence.

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/Not mentioned in the document. This is not a study involving human subjects or data sets in the typical sense of software or diagnostic device evaluations. Performance testing would be on the physical lamps themselves, but sample sizes for this are not specified.

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. This is a physical device, not an AI/ML or diagnostic tool where expert ground truth is typically established.

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 is not an AI-assisted device.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable in the typical sense. The "ground truth" here is compliance with established engineering and safety standards (e.g., spectral characteristics, irradiance limits as defined in 21CFR1040.20, safety specifications for lamps).

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

   • Not applicable.

In summary, this 510(k) pertains to a hardware device (UV lamps) and therefore the questions are largely incongruent with the information and type of study presented. The "study" here is essentially the demonstration of compliance with established engineering and regulatory performance standards through internal testing and external certifications, rather than a clinical trial or algorithm validation study.

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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:

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.

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