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The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

• Rhytides of the face
• Superficial skin lesions
• Actinic Keratosis
• Viral papillomata
• Seborrhoeic Keratosis

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

• Rhytides of the face .
• Superficial skin lesions .
• . Actinic Keratosis
• . Viral papillomata
• Seborrhoeic Keratosis .

Accessories included with the generator are a cable assembly/instrument, power cable and a footswitch.

The provided document, K041999, is a 510(k) summary for the Gyrus Plasma Skin Resurfacing (PSR) System. However, it does not contain specific details about acceptance criteria, device performance metrics, or a detailed study summary that would typically prove a device meets acceptance criteria.

The document mainly focuses on:

• Identifying the device and its manufacturer.
• Stating its intended use and comparison to a predicate device.
• Confirming its substantial equivalence by the FDA.
• Listing the specific dermatological conditions it's intended to treat.

There are no tables of acceptance criteria nor detailed study results with sample sizes, expert qualifications, or ground truth methodologies. The statement mentions "clinical studies have been done to validate the performance of the device" and "The clinical data results presented in this 510(k) notification to the FDA show that the device is substantially equivalent," but these details are not provided within the given text.

Therefore, based solely on the provided text, I cannot fill in the requested table and answer the specific questions about acceptance criteria and study details. The input document is a summary statement for regulatory clearance, not a detailed scientific study report.

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The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

• Superficial skin lesions .
• . Actinic Keratosis
• Viral papillomata ●
• . Sceborrhoeic Keratosis

The-system-is-intended-for-use-by-qualified-medical-personal-trained in-the-use-ofelectrosurgical equipment.

The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

• Superficial skin lesions .
• Actinic Keratosis
• Viral papillomata ●
• Sceborrhoeic Keratosis .

Accessories included with the generator are a cable assembly/instrument, power cable and a footswitch.

This 510(k) summary does not contain the information requested for acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data Presented: The document describes the device, its intended use, and states it has been compared to predicate devices with "performance validation testing" done. However, it does not explicitly state any quantitative acceptance criteria for the device's performance, nor does it present any specific results from such validation testing in the summary provided.
• No Study Details: Without stated acceptance criteria and performance results, there is no study described that demonstrates the device meets these criteria. All of the specific points requested (sample size, data provenance, expert input, adjudication, MRMC, standalone, ground truth, training set details) are entirely absent because no study details are provided.

Based on the provided text, I cannot complete the requested tables and information. The document primarily focuses on:

• Identification of the device and manufacturer.
• Intended use and comparison to predicate devices.
• FDA's determination of substantial equivalence (without detailing how that equivalence was proven regarding performance metrics).

To answer your request, a document detailing the specific performance validation study, including its design, outcomes, and the acceptance criteria measured against, would be required.

Ask a specific question about this device