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The DT Controlled Phototherapy Equipment devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

The DT Controller is a modernization of the DermaPal Controller (510(k) K073587). Like its predicate, the DT Controller is designed to turn a phototherapy device on and off based on time. It is designed to be installed in a wider family of devices. It uses the same 4 button UI with a larger backlit screen for better readability and is based on a more commercially available PIC16 processor. A modification to the way a prescription is entered was done to harmonize the process across different devices.

This is a 510(k) premarket notification for a phototherapy device, not an AI/ML device, therefore, many of the typical acceptance criteria and study attributes for AI/ML performance evaluation are not applicable. The device is a "DT Controlled Phototherapy Equipment" which is a modernization of a previous controller for phototherapy devices. The change is primarily to the controller unit's hardware and software (UI, processor, prescription entry method).

Here's an analysis based on the provided document:

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

The document does not specify quantitative acceptance criteria in the typical sense of AI/ML performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on the device performing as expected for a phototherapy controller and maintaining substantial equivalence to its predicates.

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

Not applicable for this type of device. The "test set" here refers to the functional testing of the controller, not a data set of patient cases or images. The testing would involve a rigorous set of test cases designed to exercise all functionalities of the controller. The document indicates "Functional testing in the form of Black Box testing."

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

Not applicable for this type of device. "Ground truth" for this device relates to whether the controller correctly performs its functions (e.g., sets time, turns on/off, displays correctly). This is typically verified by engineers and quality assurance personnel against design specifications, not clinical experts establishing medical ground truth.

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

Not applicable for this type of device. Functional verification and validation do not typically involve adjudication methods like those used for clinical image interpretation. Performance is assessed against predefined specifications.

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 phototherapy unit controller and does not involve AI or human "readers" interpreting medical data.

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

Not applicable. This is not an AI algorithm. Its performance is evaluated as a standalone electronic device controller.

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

The "ground truth" for this device's performance is its conformance to engineering specifications and regulatory standards (e.g., electrical safety, EMC, software validation). Functional tests ensure the device operates as designed and intended.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not have a "training set" in the context of machine learning.

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

Not applicable.

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The 3 Series Neolux devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

The 3 Series NeoLux device is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders. The 3 Series NeoLux device delivers a 360-degree full body treatment, with spectral output from UV through visible, through an array of 24-48 fluorescent lamps (Either F72 or F79 length). Treatments are controlled through the Smart Touch Controller Software interface, Flex Controller or ClearLink Controller interface. The Smart Touch Software interface is installed remotely on a custom-built computer. An "off the shelf" replacement is not possible. Replacement can only be obtained through Daavlin. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Furthermore, the physician can restrict the amount and type of access that is granted to each authorized operator. Each authorized operator is assigned an initial default pin number. The system requires each operator to select a new individual pin and change the default pin upon initial logon. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency. The Smart Touch equipped computer will interface with the 3 Series NeoLux device through a closed wired Ethernet connection and a Daavlin Distributing Company UV4001. While the Flex Controller is controlled by an integrated digital timer with an LCD segmented display and four membrane buttons as the interface, and ClearLink Controller is controlled by a microprocessor controlled with an LCD touch screen display. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light.

This document is a 510(k) summary for the Daavlin 3 Series NeoLux phototherapy equipment, seeking clearance from the FDA. It details the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided information, the 3 Series NeoLux device is a phototherapy equipment indicated for treating diagnosed skin disorders such as psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. This is not an AI/ML powered device, therefore the request for information on acceptance criteria and a study that proves the device meets the acceptance criteria is not applicable in the context of AI/ML performance.

The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness and is as safe and effective as a legally marketed device.

Here's an analysis of the provided information, structured as requested, with "N/A" for sections not applicable to this type of device or not explicitly mentioned in the provided text:

Acceptance Criteria and Device Performance Study for 3 Series NeoLux (Non-AI/ML Device)

The 3 Series NeoLux is a phototherapy device, not an AI/ML powered medical device. Therefore, the concept of "acceptance criteria" and "device performance" in the context of metrics like sensitivity, specificity, or image analysis accuracy typically associated with AI/ML studies is not applicable here.

Instead, the device's "performance" is demonstrated through its fulfillment of its intended use (delivering specific light spectrums for dermatologic treatment) and its substantial equivalence to previously cleared predicate devices. The "study" mentioned for phototherapy devices typically involves engineering and safety testing to ensure the device operates as intended and meets relevant safety standards (e.g., electrical safety, electromagnetic compatibility, radiation emission controls).

1. Table of Acceptance Criteria and Reported Device Performance

Note: For non-AI/ML devices like this phototherapy unit, the "acceptance criteria" are generally derived from recognized standards, predicate device characteristics, and safety/performance specifications rather than diagnostic performance metrics. The "reported device performance" is descriptive of its features and operational parameters, demonstrating its equivalence to predicate devices.

Proof of Meeting Acceptance Criteria:

The "study" demonstrating the device meets these criteria is the submission of technical documentation to the FDA as part of the 510(k) process. This typically includes:

• Engineering drawings and specifications.
• Risk analysis.
• Verification and validation testing results (e.g., electrical safety according to IEC 60601, electromagnetic compatibility (EMC), photobiological safety, power output measurements, controller function tests).
• Materials compatibility and biocompatibility if applicable.
• Software validation if software is involved in safety-critical functions (which it appears to be for the Smart Touch Controller).

The 510(k) summary explicitly states: "The 3 Series NeoLux device performance data is the same as or very similar to that of the claimed predicate devices. The lamps and construction used in the production of the predicate devices and the 3 Series NeoLux are the same. The devices materials, construction, treatment modality, patient safety, etc., is exactly the same or similar." This statement, backed by the detailed comparison table, is the core of how the device demonstrates it meets the "acceptance criteria" by being substantially equivalent to already cleared devices.

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

• Sample Size for Test Set: N/A. This is not an AI/ML device that uses a "test set" in the context of machine learning model evaluation. The "testing" involves engineering and functional validation of the physical device.
• Data Provenance: N/A. This information is not relevant for a phototherapy device's 510(k) clearance in the way it would be for an AI/ML diagnostic or prognostic tool.

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

• Number of Experts: N/A. Ground truth establishment is not relevant for this type of device clearance. The device treats conditions diagnosed by a physician, but the device itself does not make a diagnosis or prediction that requires "ground truth" to evaluate its performance.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. Not relevant for this type of device clearance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This is not an AI/ML diagnostic or interpretive device, so an MRMC study is not applicable.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: N/A. As this is not an AI-assisted device, this metric is irrelevant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Study: No. This device does not have an "algorithm" in the context of AI/ML; it is a physical medical device.

7. The Type of Ground Truth Used

• Type of Ground Truth: N/A. Not relevant for this type of device clearance.

8. The Sample Size for the Training Set

• Sample Size for Training Set: N/A. This is not an AI/ML device that uses a "training set."

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

• Ground Truth for Training Set: N/A.

Summary Conclusion:

The Daavlin 3 Series NeoLux phototherapy device obtained 510(k) clearance (K230382) by demonstrating substantial equivalence to its predicate devices (3 Series Phototherapy Unit K153749 and M Series Phototherapy Equipment K210881). The "acceptance criteria" and "performance study" for such a device primarily revolve around its technical specifications, safety, and functionality matching or being very similar to the predicate devices, ensuring it is as safe and effective. The provided document details these similarities across various features like intended use, patient population, technical characteristics (number of lamps, spectral output, power output, materials), and operational environment. It does not involve AI/ML performance metrics or studies.

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The 7 Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

The 7 Series Phototherapy Equipment is a partial-body, ultraviolet light source emitting phototherapy panel. The physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. Its nominal size ranges from a 4 lamp no door; 74.5 In X 20 In X 24 In, 75 lbs (189.2 cm X 50.8 cm X 61 cm, 34 kg) to a 12 lamp with doors open; 74.5 In X 39.5 In X 24 In, 129 Lbs. (189.2 cm X 100.3 cm X 61 cm, 58.5 Kg) that is controlled by either an integrated digital timer with an LCD segmented display and four membrane buttons as the interface (the Flex Controller) or a microprocessor controller with an LCD touch screen display (the ClearLink Controller). When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light. The treatment area consists of 4, 6, 8, 10, or 12 100-watt lamps and reflective surfaces configured in a panel. The patient stands in front of the panel during treatment.

This document describes the 7 Series Phototherapy Device, which is a medical device and not an AI or software device. Therefore, the questions related to AI/software performance criteria (such as sample size, ground truth, experts, MRMC studies, or standalone performance) are not applicable.

The performance of the 7 Series Phototherapy Device is established through comparison to a legally marketed predicate device, the ClearLink Phototherapy Equipment (K182215). The submission states that the new device's performance data is "the same as or very similar" to the predicate.

Here's the information available regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and data provenance:
This information is not applicable as the device's performance is demonstrated through substantial equivalence to a predicate device, rather than a clinical trial with a distinct test set. The submission states that the 7 Series Phototherapy Equipment is constructed with "identical energy sources and materials of identical or similar composition" and that the "lamps and construction used in the production of the predicate devices and the 7 Series phototherapy equipment are the same."

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 establishment by experts is described for this type of device submission, as it relies on substantial equivalence to an existing device.

4. Adjudication method for the test set:
Not applicable. No test set requiring adjudication 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 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 AI algorithm.

7. The type of ground truth used:
Not applicable. Performance is established by demonstrating substantial equivalence to a predicate device, not by comparing to a "ground truth" in the context of diagnostic accuracy.

8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.

Study Summarized:

The study that proves the device meets the acceptance criteria is a substantial equivalence comparison study to a predicate device (ClearLink Phototherapy Equipment, K182215). The core of the evidence is that the 7 Series Phototherapy Equipment shares fundamental technological characteristics and performance features with the legally marketed predicate.

The 510(k) summary explicitly states that the 7 Series phototherapy equipment is constructed "in the same design configuration as the predicate device, utilizing identical energy sources and materials of identical or similar composition." It further asserts that the "spectral output, mode of operation, labeling, treatment area, treatment modality, patient safety, and general operating principals of the 7 Series phototherapy equipment is the same or similar to those of the predicate device."

This type of study does not involve prospective clinical trials with specific acceptance criteria in the typical sense of measuring efficacy against a clinical outcome. Instead, it demonstrates that the new device performs as safely and effectively as a device already on the market through direct comparison of its technical specifications and principles of operation.

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The M Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatiis (eczema) under the direction of a physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. The population may range from pediatric, when accompanied by a responsible adult to operate it, to geriatric.

The M Series Phototherapy Devices are intended to be used as a partial body therapeutic device. They are designed to be used under the direction of a physician for individuals who require phototherapy. Treatments are controlled through the ClearLink Software interface or the Smart Touch Software interface. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules or millijoules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

This document is a 510(k) Premarket Notification from the FDA regarding the "M Series Phototherapy Equipment." It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria for a new, innovative device.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of a novel diagnostic or AI-driven device, is not present in this document.

The document indicates that the M Series Phototherapy Equipment's performance data is "the same as or very similar to that of the claimed predicate device." It also states that the lamps and construction are the same, and the primary difference is an updated indication for use and intended use. This implies that the device is not being evaluated for new performance outcomes requiring extensive clinical studies with specific acceptance criteria that would typically be detailed in a submission for a novel technology. Instead, it relies on the established safety and effectiveness of its predicate devices.

Based on the provided text, the following information can be extracted/inferred:

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

   • This document does not specify quantitative acceptance criteria or detailed performance metrics for the M Series Phototherapy Equipment itself. The basis for clearance is substantial equivalence to predicate devices.
   • Implied "Performance": The document states: "The M Series phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The lamps and construction used in the production of the predicate devices and the M Series phototherapy equipment are the same." This implies that its performance is accepted as equivalent to the predicates (ClearLink Controlled Phototherapy Equipment K182215 & 1 Series Phototherapy Unit K100378).

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

   • No specific "test set" or associated sample size is mentioned, as this is not a study validating a new performance claim. The submission relies on a comparison to predicate devices, not on new clinical data demonstrating specific performance numerically.

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

   • Not applicable, as no new test set requiring expert ground truth establishment for a novel performance claim is described.

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 device is phototherapy equipment, not an AI or diagnostic tool.

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, as new performance claims requiring ground truth establishment are not the basis of this submission. The "ground truth" for its safety and effectiveness is implicitly derived from the previously cleared predicate devices.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

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The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the treatment of mild to moderate acne vulgaris.

The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. The ClearLink Phototherapy Equipment delivers treatment, with Narrow Band UVB, Broad Band UVB and/or UVA ultraviolet light. Treatments are controlled through the ClearLink Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

The provided document is a 510(k) premarket notification for the "ClearLink Controlled Phototherapy Equipment." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific technical performance acceptance criteria through the kind of rigorous, independent study typically associated with AI/software as a medical device (SaMD).

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of an AI/SaMD. This device is a phototherapy unit, and its substantial equivalence is based on its construction, intended use, energy sources, and control system updates, rather than diagnostic performance metrics.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance (in the sense of AI performance metrics like sensitivity, specificity, AUC).
• Any details about a test set sample size, data provenance, or ground truth establishment by experts for diagnostic purposes.
• Information on Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.

The "Performance Standards" section (page 6) explicitly states: "The ClearLink controlled phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and cabinet construction used in the production of the predicate device and the ClearLink controlled phototherapy equipment are the same. The only difference between the predicate flex devices and the link devices is the substitution of the link controller for the flex controller for actual entry of doses. The rest of the devices (materials, construction, treatment modality, patient safety, etc., remains exactly the same."

This statement highlights that the performance here refers to the physical and functional constancy with the predicate device, not the diagnostic accuracy or efficacy evaluation of an AI component.

In summary, none of the requested information regarding acceptance criteria, study design parameters (sample size, experts, ground truth, MRMC), or training set details for an AI/SaMD are present in this document because it is not an AI/SaMD submission.

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The 3 Series NeoLux, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).

The 3 Series NeoLux Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. The 3 Series NeoLux Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and/or 350 nm (UVA), through an array of 24-48 fluorescent lamps. Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

The provided document describes the Daavlin 3 Series NeoLux Phototherapy Unit, a medical device for dermatologic disorders. However, it is a 510(k) summary for substantial equivalence to a predicate device, not a study demonstrating the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device. Therefore, a direct answer to the request to populate a table of acceptance criteria and reported device performance related to a diagnostic or clinical outcome study, and details about sample sizes, ground truth establishment, or multi-reader studies, cannot be fully provided from this document.

The document does however, provide information regarding performance standards and non-clinical testing for compliance with electrical and EMC standards.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a phototherapy unit based on substantial equivalence, the "acceptance criteria" are primarily related to safety, electrical performance, and functional equivalence to the predicate device. It is not a diagnostic device with performance metrics like sensitivity, specificity, or AUC.

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 medical device, not a diagnostic algorithm or AI system that uses medical image data for a test set. The substantial equivalence relies on design, function, and safety testing, not on a clinical test set of patient data with ground truth.

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

• Not applicable. As stated above, there is no test set of patient data requiring expert ground truth in this submission.

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

• Not applicable. No test set of patient data.

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.

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

• Not applicable. This is a phototherapy unit, not an algorithm.

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

• Not applicable. No ground truth for clinical outcomes data is discussed in this 510(k) summary, as it is based on substantial equivalence to a predicate device for its intended use, rather than proving new clinical efficacy through trials. The "ground truth" for the device's performance is adherence to electrical and safety standards, and functional equivalence to the predicate.

8. The sample size for the training set

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

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

• Not applicable. No training set exists for this device.

Summary based on the provided document:

The Daavlin 3 Series NeoLux Phototherapy Unit is a medical ultraviolet device intended for the treatment of psoriasis, vitiligo, and atopic dermatitis. Its acceptance criteria for FDA clearance (via 510(k)) were primarily based on demonstrating substantial equivalence to a previously cleared predicate device (the 3 Series SP/PC Phototherapy Unit, K063621).

The study that proves the device meets the "acceptance criteria" (i.e., substantial equivalence) is the comparison of the new device's design, materials, manufacturing, indications for use, and performance characteristics (e.g., spectral output, electrical requirements) to that of the predicate device, along with non-clinical performance testing for adherence to recognized electrical and safety standards (IEC 60601-1-2:2007, IEC 60601-1:2012, and IEC 60601-2-57:2011). The document explicitly states that the new device is "identical in nearly every aspect" to the predicate, with the only differences being changes in exterior cosmetics and lamp covering. This implies that the performance in these non-clinical tests was successful and confirmed the device's safety and functional equivalence to the predicate.

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The ML24000 PC UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.

The ML24000 PC UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders. The ML 24000 PC UVA-1 Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 370-390 nm, through an array of 24 metal halide lamps in conjunction with a filtering system that absorbs infrared output and eliminated emissions below 320 nm. The 24 metal halide lamps are arranged in a four column modular design containing six lamps in each column.

Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

I am unable to provide the detailed information requested regarding acceptance criteria and study data for the ML24000 PC UVA-1 Phototherapy Unit. My analysis of the provided text reveals that the document is a 510(k) premarket notification letter from the FDA to Daavlin Distributing Company, confirming the substantial equivalence of the ML24000 PC UVA-1 Phototherapy Unit to a legally marketed predicate device.

The document does not contain:

• A table of specific acceptance criteria and reported device performance values. Instead, it states that "The ML24000 PC UVA-1 Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate device." This is a general statement of equivalence, not a presentation of detailed performance metrics against defined acceptance criteria.
• Details of a study proving the device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, largely based on similarities in design, materials, and intended use, rather than presenting a new clinical study with specific performance outcomes.
• Information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, or ground truth details for either a test or training set. These are typically elements of a clinical performance study, which is not described in this 510(k) summary.

Key points from the document relevant to your request, but not directly answering it, are:

• Predicate Device: ML24000 UVA-1 Phototherapy Unit (K103708)
• Core Equivalence Argument: The new device is "identical in nearly every aspect" to the predicate, with the only difference being the incorporation of a "Smart Touch Control System." This control system has been safely used in another legally marketed phototherapy unit (K063621).
• Performance Claim: The performance data for the subject device is "the same as or very similar" to the predicate, and "The ultraviolet lamps and cabinet construction used in the production of the predicate device and the ML24000 PC UVA-1 Phototherapy Unit are the same."

Therefore, based on the provided text, I cannot extract the specific acceptance criteria and study details you've requested. The document primarily serves to establish substantial equivalence based on a comparison to a predicate device, rather than presenting a self-contained performance study with defined acceptance criteria.

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The Smart Touch Multiple Machine Phototherapy System can be connected to the following Daavlin models:

3 Series Models 311-48, 311-24, 311/350-24/24, 350-48, 350-24

M Series Models 311-10, 350-10, 311/350-04/06

The Smart Touch Multiple Machine Phototherapy System is a medical ultraviolet light source system, which is intended for use by or under the direction of a licensed physician for the treatment of psoriasis, vitiligo and atopic dermatitis (eczema) on all skin types (I-VI).

The Smart Touch Multi Machine Software is used to control multi phototherapy devices from a custom built computer containing a UV3001 interface board supplied by Daavlin (schematics located in Device Specification of this 510(k) submission), with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA). An "off the shelf" replacement is not possible. Replacement can ONLY be obtained by Daavlin. It is intended for use by or under the direction of a physician, for the treatment of diagnosed skin disorders such as psoriasis, vitiligo, and atopic dermatitis (eczema).

The provided text describes a 510(k) submission for the "Smart Touch Multi-Machine Software" by The Daavlin Distributing Company. This submission aims to demonstrate substantial equivalence to a predicate device, the "Spectra 3 Series PC & SP Ultraviolet Phototherapy Cabinet (K063621)".

Here's an analysis of the acceptance criteria and the study (or lack thereof) based on the provided information:

Acceptance Criteria and Reported Device Performance

Study Information

Based on the provided document, the "study" conducted for this 510(k) submission is a comparison to a predicate device rather than a new performance study with a dedicated test set, training set, or expert ground truth adjudication as one would expect for an AI/ML device.

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

   • N/A. The document does not describe a performance study with a test set that generates specific performance metrics like sensitivity, specificity, or accuracy. The submission relies on claiming substantial equivalence based on the device's fundamental design, intended use, and technological characteristics being very similar to a legally marketed predicate device.

2. 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):

   • N/A. No ground truth establishment by experts is described, as no specific performance study requiring such assessment was conducted for this submission.

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

   • N/A. No adjudication method is mentioned, as there is no test set in the context of an AI/ML performance evaluation.

4. 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. An MRMC study was not done. This device is software for controlling phototherapy devices, not an AI/ML diagnostic or assistive tool that would typically involve human readers.

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

   • N/A. This is not an AI/ML algorithm in the context of typical standalone performance evaluation. The "software" is a control system for hardware. The document states: "The Smart Touch Multi Machine Software performance data is the same as or very similar to that of the claimed predicate device. The control system hardware used is the same." This implies that the performance is derived from the established safety and effectiveness of the predicate device's hardware and the similar control system.

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

   • N/A. No new ground truth data was generated or used. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device, which the new device is claimed to be substantially equivalent to due to identical or very similar operating principles and components.

7. The sample size for the training set:

   • N/A. There is no mention of a training set, as this is not an AI/ML device that undergoes machine learning training.

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

   • N/A. As there is no training set, there is no ground truth establishment for it.

Summary of Device Evaluation Method

The submission for the Daavlin Smart Touch Multi-Machine Software relies on demonstrating substantial equivalence to an existing predicate device (Daavlin Spectra 3 Series PC & SP Ultraviolet Phototherapy Cabinet K063621). The core argument is that the new software is an update to the control system of a device that is already deemed safe and effective, and that its fundamental characteristics, intended use, and operational principles remain unchanged. Therefore, a separate, extensive clinical or performance study with new data, test sets, or expert ground truths was not deemed necessary by the submitter (and implicitly accepted by the FDA for clearance). The performance data cited is comparative, referencing the predicate device's established performance rather than new empirical data for the software itself.

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The 4- Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.

The 4 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light. The spectral output at peak wavelengths of 305nm,311nm,350nm,or 365nm depending on lamp. The 4 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.

This document describes a 510(k) premarket notification for the Daavlin Distributing Company's 4 Series Phototherapy Unit. The primary argument for substantial equivalence relies on the device being nearly identical to a previously cleared predicate device, the Daavlin 1 Series Phototherapy Unit (K100378).

Here's an analysis of the provided information regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a test set or clinical study in the traditional sense (e.g., patient data, prospective/retrospective studies). The claim of equivalence is based on the technical and design similarities to a predicate device. Therefore, information about sample size and data provenance for a test set is not applicable here.

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

Not applicable. No test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence through design and technical specifications, not human reader performance with or without AI assistance.

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

No, a standalone performance study was not done. This device is a phototherapy unit (medical equipment for light therapy), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this submission is the established performance and safety of the predicate device, the Daavlin 1 Series Phototherapy Unit (K100378). The entire argument revolves around demonstrating that the new device is fundamentally the same and performs identically or equivalently to this predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a physical phototherapy unit; it does not involve machine learning algorithms or a "training set" in the computational sense.

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

Not applicable. As noted above, there is no training set for this type of device. The ground truth for the predicate device would have been established through its own regulatory clearance process, likely involving engineering testing and demonstrating safety and effectiveness for its intended use.

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