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INTENDED USE: This ultraviolet lamp is intended for use in sunlamp products for tanning of the human skin.

This 510(k) applies to more than one hundred and sixty individual devices that fall into a generic class of ultraviolet lamps that have the same basic technological features and exactly the same intended use. The ultraviolet sunlamps of this 510(k) are classified scientifically as low pressure, mercury-rare gas discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the same as that of a common fluorescent lamp. The main differentiators for the various sunlamps of this 510(k) include: lamp length, lamp diameter, lamp wattage, spectral characteristics and private labeling thereof.

The ultraviolet lamps named herein comprise a tubular glass envelope, the internal surface of which is coated with a fluorescent phosphor. To each end of the tube, a glass mount is sealed. The main purpose of the mount is to provide 1) for a means of hermetically sealing the internal atmosphere of the tube, 2) a means of supporting an electrode and a means of 3) electrically accessing the internal atmosphere of the device via electrically conducting lead-wires. Once assembled as described, the envelope is evacuated of air, the air is replaced by an inert gas at a pressure significantly lower than that of the normal atmosphere, and a drop of mercury is injected into the enclosed envelope. Finally, the envelope is sealed.

In operation, the device, now called a "lamp", is connected to an electrical source typically in series with a ballast that provides for 1) ignition of a discharge through the inert-gas-mercury vapor mixture and 2) its subsequent stabilization and sustainment of the electrical behavior of the lamp. Once connected to the applied electric field, free electrons are accelerated through the mercury vapor wherein collisions take place with the mercury atoms. These collisions cause excitation of the electrons in the mercury (Hq) atom and the production of photons at various wavelengths. Certain of these photons travel to the bulb wall and excite the phosphor powder. The phosphor, in turn, emits radiation that is transmitted through the transparent glass envelope. The radiation that is emitted from a standard fluorescent general lighting lamp is primarily in the visible region of the spectrum (380nm-760nm). The radiation that is emitted from an ultraviolet sunlamp is primarily in the UV range of the electromagnetic spectrum (300nm-400nm). Modern day, low pressure ultraviolet sunlamps typically emit most of their energy in the wavelength range that is closest to the visible: that is, in the UVA range (320nm-400nm) range. The emission spectrum of sunlamps usually contains a relatively small proportion of UVB radiation. (260nm-320nm)

The provided document is a 510(k) premarket notification for "Cosmedico Ultraviolet Lamps of Various Models." It does not describe an AI/ML powered device, but rather conventional sunlamp products. Therefore, the specific information requested about acceptance criteria and studies related to an AI/ML device's performance, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not applicable to this document.

The document indicates that the device is a conventional sunlamp and relies on equivalence to legally marketed predicate devices rather than novel AI/ML technology requiring specific performance studies as outlined in the request.

However, I can extract the acceptance criteria and a summary of performance testing for the conventional device as described in the document:

1. Table of Acceptance Criteria and 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)

The document states: "According to a Quality Sampling Plan, lamps are tested in-process and / or post-production". It does not specify the exact sample size for the test set or the data provenance beyond "Quality Sampling Plan". Given the nature of the device (sunlamps), the tests are likely conducted on manufactured samples, which implies prospective testing during or after production. There is no information regarding the country of origin of the 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. The device is a conventional sunlamp, and its performance is measured against technical specifications and predicate device characteristics, not through expert-labeled ground truth for diagnostic purposes. Performance testing involves physical and electrical measurements.

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

Not applicable. Adjudication methods are typically relevant for subjective assessments by multiple human readers, often in image interpretation or clinical scenarios where ground truth is expert-derived. This device undergoes objective performance testing.

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 not an AI-powered system designed to assist human readers.

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

Not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for these sunlamps is their conformance to established technical specifications and performance characteristics, which are compared to legally marketed predicate devices. This includes objective measurements of electrical characteristics, dimensions, mechanical safety, UV radiation characteristics (UVA Irradiance, Erythemal Effective Irradiance, UVC/UVB ratio), and functionality. It is not an expert consensus, pathology, or outcomes data ground truth as would be used for a diagnostic AI device.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a training phase.

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

Not applicable. This device is not an AI/ML model.

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INTENDED USE: This ultraviolet lamp is intended for use in sunlamp products for tanning of the human skin.

This 510(k) applies to more 35 devices that fall into a generic class of ultraviolet lamps that have the same basic technological features and exactly the same intended use. The ultraviolet sunlamps of this 510(k) are classified scientifically as high pressure, mercury-metal halide discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the similar to that of commonly used metal halide lamps used for general lighting purposes. The main differentiators for the various sunlamps of this 510(k) include: lamp length, lamp diameter, lamp wattage, spectral characteristics and private labeling thereof. The ultraviolet lamps named herein comprise a tubular quartz envelope, filled with an inert gas (such as argon) and a mixture of mercury and metal halide salts and sealed at both ends.

The provided text describes the substantial equivalence of Ultraviolet Lamps intended for use in sunlamp products to legally marketed predicate devices. It does not contain information about a study with acceptance criteria, sample sizes, expert involvement, or AI performance that would be typically found in a clinical study report for a new medical device.

The document is a 510(k) summary for a Class II medical device, which seeks to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical setting. The "performance testing" mentioned refers to manufacturing quality control and verification that the new lamps meet the same characteristics as the predicate devices, not a clinical study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is the information that can be extracted, interpreted based on the provided document:

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

The document lists "Performance Testing Summary" which serves as the acceptance criteria for the manufactured lamps, demonstrating their equivalence to predicate devices.

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

• Sample Size for Test Set: The document states, "All lamps are 100% tested for functionality at the end of the manufacturing process." For other tests, it mentions, "According to a Quality Sampling Plan, lamps are tested in-process and / or post-production." The specific sample sizes for these sampling plans are not provided.
• Data Provenance: The data appears to be from internal manufacturing and quality control testing, but the country of origin is not specified. It is prospective in the sense that it's an ongoing manufacturing process quality control.

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. The performance testing described is engineering and manufacturing verification against established technical specifications and regulatory requirements (21 CFR 1040.20), not a clinical evaluation requiring expert interpretation of results.

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

Not applicable. This concept is relevant for clinical studies with subjective assessments, which is not the nature of the described testing.

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-enabled device, nor is it a diagnostic device that would typically undergo an MRMC study. The device is an ultraviolet lamp for tanning.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance testing is based on the technical specifications and regulatory requirements for safe and effective sunlamp operation, as demonstrated by the predicate devices. This includes electrical characteristics, mechanical safety, dimensional integrity, and specific UV radiation characteristics (UVA Irradiance, Erythemal Effective Irradiance, UVC/UVB ratio per 21 CFR 1040.20).

8. The sample size for the training set

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

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

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INTENDED USE: This ultraviolet lamp is intended for use in sunlamp products for the exclusive purpose of cosmetic tanning of the human skin.

This 510(k) applies to more than one hundred and sixty individual devices that fall into a generic class of ultraviolet lamps that have the same basic technological features and exactly the same intended use. The ultraviolet sunlamps of this 510(k) are classified scientifically as low pressure, mercuryrare gas discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the same as that of a common fluorescent lamp. The main differentiators for the various sunlamps of this 510(k) include: lamp length, lamp diameter, lamp wattage, spectral characteristics and private labeling thereof.

The ultraviolet lamps named herein comprise a tubular glass envelope, the internal surface of which is coated with a fluorescent phosphor. To each end of the tube, a glass mount is sealed. The main purpose of the mount is to provide 1) for a means of hermetically sealing the internal atmosphere of the tube. 2) a means of supporting an electrode and a means of 3) electrically accessing the internal atmosphere of the device via electrically conducting lead-wires. Once assembled as described, the envelope is evacuated of air, the air is replaced by an inert gas at a pressure significantly lower than that of the normal atmosphere, and a drop of mercury is injected into the enclosed envelope. Finally, the envelope is sealed.

In operation, the device, now called a "lamp", is connected to an electrical source typically in series with a ballast that provides for 1) ignition of a discharge through the inert-gas-mercury vapor mixture and 2) its subsequent stabilization and sustainment of the electrical behavior of the lamp. Once connected to the applied electric field, free electrons are accelerated through the mercury vapor wherein collisions take place with the mercury atoms. These collisions cause excitation of the electrons in the mercury (Hg) atom and the production of photons at various wavelengths. Certain of these photons travel to the bulb wall and excite the phosphor powder. The phosphor, in turn, emits radiation that is transmitted through the transparent glass envelope. The radiation that is emitted from a standard fluorescent general lighting lamp is primarily in the visible region of the spectrum (380nm-760nm). The radiation that is emitted from an ultraviolet sunlamp is primarily in the UV range of the electromagnetic spectrum (300nm-400nm). Modern day, low pressure ultraviolet sunlamps typically emit most of their energy in the wavelength range that is closest to the visible; that is, in the UVA range (320nm-400nm) range. The emission spectrum of sunlamps usually contains a relatively small proportion of UVB radiation. (260nm-320nm)

This submission concerns Cosmedico Light Inc.'s Ultraviolet lamps, specifically for tanning purposes. The document states that the device's performance is not being proven by a study, but rather by demonstrating substantial equivalence to predicate devices that were legally marketed prior to September 2, 2014. The claim is that the contemporary ultraviolet lamps are identical to these predicate devices in terms of intended use, technological design characteristics, and conformity to special controls required by reclassification. Therefore, the "acceptance criteria" and "device performance" in the table refer to meeting the characteristics of these predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "As noted, the subject lamps of this 510(k) are identical to the predicate devices. Therefore, the subject lamps and the predicate devices have the same performance requirements."

This indicates that a separate "test set" in the traditional sense, involving a distinct validation study with a specified sample size of the new device, was not conducted because the claim is that the devices are fundamentally the same as already-marketed devices. Therefore, there is no specific sample size for a test set or data provenance mentioned for a new study. The performance is assessed against the established characteristics of the predicate devices.

The document mentions that all lamps are "100% tested for functionality at the end of the manufacturing process" and that a "Quality Sampling Plan" is used for in-process and post-production testing. However, this is described as routine quality control, not a specific "test set" for a device performance study as typically understood in regulatory submissions for new or modified devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

No experts were used to establish ground truth for a test set related to this submission because the device's performance is asserted to be identical to predicate devices. The "ground truth" here is essentially the established performance and safety characteristics of the legally marketed predicate devices, which are assumed to be known and accepted.

4. Adjudication Method for the Test Set:

Not applicable, as no separate test set requiring adjudication was conducted.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This submission focuses on demonstrating substantial equivalence based on identical technological characteristics and intended use, not on comparing performance with or without AI assistance.

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

Not applicable. This device is an ultraviolet lamp, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" implicitly used is the established performance and safety profiles of the legally marketed predicate ultraviolet sunlamps. The submission argues that the new devices are essentially the same as these predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is an ultraviolet lamp, not an AI/ML algorithm that requires a training set. The submission does not refer to any training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

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