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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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