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The Solarc/SolRx E-Series Ultraviolet Phototherapy Lamp Family is a wall-mounted or self-supporting ultraviolet phototherapy lamp unit used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use as a spot or full-body treatment device. It is intended for use on all skin types. (I -VI)

This device is intended for Prescriptive Use only, per Part 21 CFR 801 Subpart D.

A new family of medical devices that can be used singly, or ganged together in any number and combination of models. The devices use various numbers and lengths of tubular ultraviolet fluorescent bulbs. The model numbering system for single devices is as follows: Ehn0t-waveband-suffix. The proposed device is constructed primarily of sheet metal, and has provision for connecting additional lighting banks. The proposed device can be made in 2-foot, 4-foot and 2-metre lengths. The proposed device has provision for ultraviolet reflective side panel doors. The treatment area of the proposed device can be reduced by using the "Face Shield" accessory. The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs. The proposed device uses 2 to 12 bulbs per device, or multiples thereof when devices are ganged together. The proposed device uses a digital countdown timer. The proposed device has a keyed switchlock or timer password entry to prevent unauthorized usage, wire guards or an acrylic window to reduce the chance of bulb breakage, and FDA compliant ultraviolet protective goggles.

The provided text is a 510(k) Summary for a medical device called the Solarc/SolRx E-Series Ultraviolet Phototherapy Lamp Unit Family. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

The document does not include information about specific acceptance criteria or a study proving the device meets those criteria in the way you've outlined for performance studies. Instead, it focuses on demonstrating substantial equivalence to existing devices, primarily by comparing intended use, technological characteristics, and safety features.

Therefore, many of your requested items, such as a table of acceptance criteria and reported performance, sample sizes for test sets, ground truth establishment, MRMC studies, or standalone performance, are not present in this type of submission. This device is a phototherapy lamp, and its "performance" is generally related to its ability to emit specific UV light, which would be covered by technical specifications rather than diagnostic accuracy metrics.

Here's a breakdown of what can be extracted and what is not available from the provided text, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document states that the device "can be demonstrated that the proposed device is as safe and effective as the legally marketed devices and does not raise different questions regarding safety and effectiveness than the predicate devices." This is a general statement about substantial equivalence, not a report of specific performance metrics against defined acceptance criteria.

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

Not applicable/Not available. This is a device for delivering UV light therapy, not a diagnostic or AI-based device that would typically have a "test set" in the context of clinical performance evaluation. The substantial equivalence argument relies on comparison to predicate devices, not on a new clinical study with a test set of patient data.

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

Not applicable/Not available. See point 2.

4. Adjudication Method for the Test Set

Not applicable/Not available. See point 2.

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/Not available. This device is a UV phototherapy lamp and does not involve AI or human "readers" interpreting output in a diagnostic context. Therefore, an MRMC study is not relevant to its regulatory submission.

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

Not applicable/Not available. This device is a physical phototherapy lamp, not an algorithm.

7. The Type of Ground Truth Used

Not applicable/Not available. The submission focuses on demonstrating that the new device has "the same intended use and similar technical characteristics" as predicate devices, and that it is "as safe and effective." The "ground truth" here is essentially that the predicate devices are already deemed safe and effective for their intended use.

8. The Sample Size for the Training Set

Not applicable/Not available. This device is a hardware product, not a machine learning algorithm that requires a training set.

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

Not applicable/Not available. See point 8.

Summary of what the document does provide regarding substantial equivalence:

The document argues for substantial equivalence by comparing the proposed device to several predicate devices (e.g., Solarc/SolRx 1000 Series, Daavlin "7-Series," National Biological Corp. "Foldalite-32") across several characteristics:

• Intended Use: Identical – phototherapeutic treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) in home, physician's office, or clinic.
• Design Concept: Constructed primarily of sheet metal, with provision for connecting additional lighting banks, similar to predicate devices.
• Treatment Area & Anatomical Sites: Available in 2-foot, 4-foot, and 2-meter lengths for partial or full-body treatment (excluding eyes), similar to predicate devices. Includes reflective side panel doors and a "Face Shield" accessory, comparable to predicate features.
• Type of Ultraviolet Bulbs: Uses low-pressure mercury vapor fluorescent UV bulbs comparable to predicate devices in spectral distribution, irradiance levels, ballasts, and circuitry.
• Quantity of Ultraviolet Bulbs: Uses 2 to 12 bulbs per device (or multiples when ganged), within electrical current limits, compared to predicate devices using 1 to 48 bulbs.
• Electrical Rating: Voltage and frequency ratings are comparable, meeting industry and medical device standards for high voltage breakdown, current leakage, and EMC.
• Timer: Uses a digital countdown timer technically comparable to predicate devices.
• User's Manual: Written for layman users, provides comprehensive exposure guidelines, and is at least as effective as predicate devices.
• Safety Features: Includes a keyed switchlock or timer password, wire guards or an acrylic window, and FDA compliant UV protective goggles, all comparable to predicate device features.
• Regulatory Requirements: Designed and manufactured according to FDA GMP and ISO13485 (Solarc Systems Inc. is ISO-13485:2003 certified).

The core of the submission is that because these characteristics are similar or equivalent, the new device is "as safe and effective" as legally marketed predicate devices and "does not raise different questions regarding safety and effectiveness." There is no detailed performance study presented because the device type and the regulatory pathway chosen (510(k)) emphasize comparison to existing devices rather than de novo clinical efficacy trials for a novel technology.

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INDICATIONS FOR USE: The MediLED Phototherapy Lamp is intended for the treatment for neonatal hyperbilirubinemia. The device is intended for use by healthcare professionals in a clinical setting.

The Medix MediLED is neonatal phototherapy equipment with blue and white LEDs, incorporating height and angle adjustments. The device is labeled and indicated for: treatment for neonatal hyperbilirubinemia. The device is intended for use in healthcare professionals in a clinical setting.

Fitted with a rolling base with brakes, column, and mobile head containing the equipment's electronics. The design allows the equipment to be used with incubators, infant warmers or cradles of all type and brand.

Features:

• Microprocessor mobile phototherapy equipment. (mobile stand with brakes) .
• Ideal for use in incubators, cribs and infant warmers .
• High brightness LED technology: led quantity 492 Blues ,108 whites. .
• Total Hour meter (LED useful life) and partial time (treatment). .
• Technical Service Indicator. .
• Examination light. .
• It is possible to maneuver with all LEDs on. .
• Continuous height shift by means of an actuator .
• Headlight positioning without the use of a tool .

Commands are found on the front of the equipment's head, consisting of three keys, two of which allow to operate separately blue from white LEDs, making it possible to check the patient's real skin color or perform interventions under white light. By turning on the blue LEDs, total and treatment counters are enabled. These indicate the total and treatment time of the phototherapy unit. The third key (reset) is used to restore the treatment counter. It also has two indicators; a green one showing the equipment is connected to the power supply and ready to be used, and a yellow one indicating the need of technical service assistance.

Blue LEDs do not emit significant ultraviolet (UV) neither infrared (IR) energy, resulting in no risk of UV, IR exposure nor excessive warming up for the patient.

The provided text describes the MediLED Phototherapy Lamp and its substantial equivalence to a predicate device, as opposed to presenting a study proving a device meets specific acceptance criteria based on its performance metrics. The information focuses on regulatory approval rather than a clinical or performance study with detailed acceptance criteria and results.

Therefore, many of the requested fields related to a specific study and performance metrics cannot be filled from the given text.

However, I can extract the information available from the document:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics for the MediLED Phototherapy Lamp in the context of a dedicated performance study. Instead, it states that the device "meets the requirements of the following Standards" and lists IEC 60601-1-2, IEC 60601-1, and EN 60606-1-2-50. These are likely safety and essential performance standards, not necessarily clinical effectiveness criteria in terms of hyperbilirubinemia treatment outcomes for a specific study.

The document provides the following "Treatment Light" and "Examination light" specifications:

Treatment Light Performance:

Note: The document does not specify "acceptance criteria" for these performance characteristics, but rather reports the device's measured performance.

Examination Light Performance:

Note: Similar to the treatment light, "acceptance criteria" for these values are not provided, only the reported performance.

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. The provided text describes a 510(k) submission focused on substantial equivalence to a predicate device, specifically regarding design, materials, and compliance with general safety standards. It does not detail a clinical or performance study involving a patient-based test set.

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 document does not describe a study that used experts to establish ground truth for a test set.

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

Not applicable. There is no mention of an adjudication process for a test set.

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 document pertains to a medical device approval for a phototherapy lamp, not an AI-assisted diagnostic tool or an MRMC study.

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

Not applicable. This is not an algorithmic device. The information details the physical and functional characteristics of a phototherapy lamp.

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

Not applicable. The document does not describe a clinical study requiring ground truth for diagnosis or outcome assessment. The "truth" in this context refers to the device meeting engineering and safety standards.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/ML device or a clinical outcome study.

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

Not applicable. Same as above, there is no training set mentioned.

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The Solarc/SolRx 500 Series is an ultraviolet phototherapy lamp unit used for the physician prescribed treatment of psoriasis, vitiligo, atopic dermatitis (eczema). It is intended for use as a spot treatment device, or as a hand & foot device. It is intended for use on all skin types. (I-VI)

A new medical device family consisting of 5 models: 510UVB-NB, 520UVB-NB, 530UVB-NB, 540UVB-NB, 550UVB-NB. The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs. It has a digital timer, a keyed switchlock, wire bulb guards, FDA compliant ultraviolet protective goggles, and a removable hood.

The provided text is a 510(k) summary for the Solarc/SolRx 500 Series Ultraviolet Phototherapy Lamp Unit Family. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the sense of a clinical or performance study with numerical metrics.

Therefore, the specific information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not present in this document.

The 510(k) summary instead details areas of comparison to predicate devices to establish substantial equivalence. It focuses on similar intended use and technical characteristics.

Here’s a breakdown of what can be inferred from the document in relation to your request, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Missing: There is no table of quantitative acceptance criteria or reported (numerical) device performance metrics in the provided text.

• Present (Implicit Acceptance Criteria): The document establishes "comparability" to predicate devices as the primary acceptance criterion for substantial equivalence. The "reported performance" is essentially the statement that the device is comparable in various aspects to the predicates.

  Acceptance Criterion (Implicit)	Reported Device Performance (Claimed Comparability)
  Intended Use: Same as predicate devices.	"The proposed device family has the same intended use... as predicate devices."
  Technical Characteristics: Similar to predicate devices.	"The proposed device family has... similar technical characteristics as predicate devices."
  Safety & Effectiveness: As safe and effective as predicates.	"It can be demonstrated that the proposed device is as safe and effective as the legally marketed devices..."
  Treatment Area: Comparable to predicate devices.	"The proposed device has a treatment area of approximately 2 square feet and is comparable to the predicate devices, with treatment areas of 3 to 4 square feet."
  Ultraviolet Bulbs: Comparable to predicate devices.	"The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs that are comparable to that of the predicate devices, as are the spectral distribution and irradiance levels."
  Electrical Rating: Comparable to predicate devices.	"The voltage, frequency, current ratings and other electrical characteristics are comparable. High voltage breakdown and current leakage specifications meet current industry and medical device standards."
  Digital Timer: Technically comparable to predicate devices.	"The proposed device uses a digital timer that is technically comparable to that of the predicate devices."
  User's Manual: At least as effective as predicate devices.	"The User's Manual... is at least as effective as the predicate devices."
  Safety Features: Comparable to predicate devices.	"The proposed device has a keyed switchlock..., wire bulb guards..., and FDA compliant ultraviolet protective goggles; all comparable to those of the predicate device."
  Regulatory Compliance: Designed and manufactured to standards.	"The proposed device is designed and will be manufactured according to the FDA Good Manufacturing Practices and ISO13485. Solarc Systems Inc. is ISO 13485 certified."

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

• Missing: No "test set" in the context of a performance study is described. The comparison is made against existing predicate devices and industry standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Missing: Not applicable for this type of submission. Ground truth in a clinical sense is not being established or validated.

4. Adjudication Method:

• Missing: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• Missing: No MRMC study was conducted or reported. This submission does not involve AI or human reader performance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Missing: Not applicable. This is a phototherapy lamp, not an algorithm.

7. Type of Ground Truth Used:

• Missing (in the clinical study sense): The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices and adherence to relevant industry and regulatory standards.

8. Sample Size for the Training Set:

• Missing: Not applicable. There is no concept of a "training set" for this type of device comparison.

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

• Missing: Not applicable.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence of a phototherapy lamp to predicate devices. It does not contain the details of a clinical performance study with specific acceptance criteria, sample sizes, and expert validation as would be found for, for instance, an AI-powered diagnostic device. The "proof" is based on comparing technical characteristics and intended use to already approved devices and adhering to manufacturing standards.

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Medela's phototherapy lamp is intended for the treatment of excessive serumbilirubin concentrations in newborn babies.

Not Found

I am sorry but this document does not contain the requested information. This document is a 510(k) clearance letter from the FDA for a phototherapy lamp and does not contain details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

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