Search Results

The Portrait® PSR3 System is intended for treatment of the following dermatological conditions:

• Treatment of wrinkles and rhytides
• Superficial skin lesions
• Actinic Keratosis
• Viral Papillomata
• Seborrhoeic Keratosis
• Acne Scars

The Portrait® PSR3 System is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis. Similar biological changes are produced as with established laser-based and RF-based dermatological surgical and skin resurfacing technologies.
The system includes:

• Portrait PSR3 Generator a mobile unit comprising a trolley and lift-out section referenced to as a "generator section". Treatment parameters are displayed on the control panel. The unit is powered by a 110/230 VAC standard wall socket.
• Footswitch - single pedal unit for activation
• Handpiece and Cable Assembly carries RF power and Nitrogen gas to the Nozzle.
• Treatment Pack comprising a disposable Nozzle that is connected to the Handpiece and an electronic "treatment pack key" that is used by the generator to ensure the Nozzle is not used beyond its validated operational life. The instrument does not touch the skin during treatment.
• Nitrogen Gas Cylinder -- the gas is provided in a cylinder housed in the generator enclosure. Refill cylinders containing the required purity of Nitrogen are obtained by the user from a commercial gas supplier.

The document provided is a 510(k) summary for the Portrait® PSR3 System. It details a modification to an already cleared device (K073111). The primary goal of this submission is to demonstrate substantial equivalence to the predicate device, not necessarily to establish new clinical efficacy or safety from scratch. Therefore, the study described is a non-clinical test focused on the specific modification.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicit as the submission focuses on demonstrating substantial equivalence of a modification to a previously cleared device. The "product specification" for 4 Joules is not explicitly defined in the provided text (e.g., a specific tolerance range), but the reported performance states it was met.

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

• Sample Size: Not explicitly stated as a number of cycles or measurements, but it was a "Tests" (plural) conducted.
• Data Provenance: Not specified, but likely an in-house laboratory test conducted by Rhytec, Inc. ("Tests were conducted using a calorimeter..."). It is a non-clinical test, not involving human subjects or patient data.

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

Not applicable. The ground truth for this non-clinical test (energy delivery) was established by direct measurement using a calorimeter, a standard scientific instrument for measuring energy. No human experts were required to establish "ground truth" for the energy output.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical, objective measurement using a calorimeter. There was no need for adjudication as the outcome was directly measured by an instrument.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a modification to an existing device and focuses on non-clinical performance (energy delivery).

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

Yes, a standalone test was done, but it was a non-clinical test of the device itself, specifically its ability to deliver the specified energy output. The device (the Portrait® PSR3 System with the modified software/hardware) was tested in isolation using a calorimeter. There is no AI component or algorithm being evaluated for human-in-the-loop performance in this submission.

7. The Type of Ground Truth Used

The ground truth used was objective physical measurement of energy delivery by a calorimeter.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" in the context of this 510(k) submission. This is a modification to a medical device's functionality (delivery of 4 Joules as two consecutive pulses), not an AI/ML algorithm that requires training data.

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

Not applicable, as there was no training set.

Ask a specific question about this device

The Portrait® PSR3 System is intended for treatment of the following dermatological conditions:

• Treatment of wrinkles and rhytides
• Superficial skin lesions
• Actinic Keratosis
• Viral Papillomata
• Seborrhoeic Keratosis
• Acne Scars

The Portrait® PSR is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis. Similar biological changes are produced as with established laser-based dermatological surgical and skin resurfacing technologies.

The system includes:

• Portrait® PSR3 Generator
• Footswitch
• Handpiece and Cable Assembly
• Treatment Pack comprising a disposable Nozzle and an electronic "treatment pack key"
• Nitrogen Gas Cylinder

Here's an analysis of the provided text regarding the Rhytec, Inc. Portrait® PSR3 device, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) Summary) does not explicitly define specific "acceptance criteria" in terms of quantitative performance metrics (e.g., a specific percentage of improvement, a reduction in lesion size by X%). Instead, the acceptance is based on the demonstration of substantial equivalence to predicate devices and the safety and effectiveness for its stated indications for use.

Therefore, the "acceptance criteria" are implied by the regulatory standard for a 510(k) submission:

• Substantial Equivalence: The device must be as safe and effective as a legally marketed predicate device.
• Indications for Use: The device must be shown to be safe and effective for its stated indications.

The reported device performance is described qualitatively:

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

• Sample Size: The 510(k) Summary does not specify the sample size for the clinical studies. It mentions "Clinical studies... to improve acne scarring," but the number of subjects or cases is not provided.
• Data Provenance: Not explicitly stated. The studies were conducted "in compliance with the Code of Federal Regulations, as specified in 21 CFR 812," which governs investigational device exemptions in the US. This implies the studies were likely conducted in the United States and were prospective clinical studies.

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

• The 510(k) Summary does not provide any information on the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

• The 510(k) Summary does not provide any information on the adjudication method used for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• The 510(k) Summary does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The studies mentioned focus on evaluating the device itself, not comparing human readers with or without AI assistance. The device is a direct treatment device, not an AI-assisted diagnostic tool.

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

• This question is not applicable as the Portrait® PSR3 System is an electrosurgical device for dermatological treatment, not an algorithm or AI-based diagnostic tool. It requires human operation.

7. The Type of Ground Truth Used

• The ground truth for the clinical studies evaluating "acne scarring" would typically be based on clinical assessment/outcomes data by clinicians (e.g., visual grading scales, objective measurements of scar reduction, patient satisfaction). The summary states "Clinical studies... conclude that the Portrait® PSR³ is safe and effective for treating acne scars," implying clinical endpoints were used.
• For the claim of "producing tissue effects similar to that seen with carbon dioxide laser treatment," the ground truth would likely involve histopathological analysis (biopsies) of treated tissue, potentially compared to tissue treated with CO2 lasers.

8. The Sample Size for the Training Set

• The 510(k) Summary does not mention a "training set" in the context of machine learning or AI algorithms. The device described is a physical medical device, not an AI model requiring a training set.

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

• This question is not applicable as the device is not an AI model that would require a training set and associated ground truth establishment.

Ask a specific question about this device

The Portrait® PSR³ is indicated for treatment of the following dermatological conditions:

• Treatment of wrinkles and rhytides
• Superficial skin lesions
• Actinic Keratosis
• Viral Papillomata
• Seborrhoeic Keratosis

The Portrait® PSR³ is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the handpiece of precisely controlled energy and Nittrogen gas, individual plasma pulses are produced that will give predictable tissue effects.

The provided 510(k) summary for the Rhytec, Inc. Portrait® PSR3 indicates that no new performance data or clinical studies were required or performed for this specific submission (K071786).

The statement "The device modifications did not raise new questions of safety or efficacy, no performance data is required" directly addresses this. This implies that the device is considered substantially equivalent to a previously cleared predicate device (K060948 - Portrait® PSR3), and therefore, the acceptance criteria and supporting studies would have been established during the clearance of that predicate device.

Therefore, it is not possible to provide the requested information based solely on the provided document for this specific 510(k) submission.

If information about the acceptance criteria and studies were available, it would have been from the original 510(k) submission for the Portrait® PSR3 (K060948).

However, based on the principle that the current device is substantially equivalent to a predicate, we can infer that the predicate device likely met certain performance criteria for the indicated dermatological conditions.

Without access to the K060948 submission, I cannot populate the table or answer the specific questions comprehensively. The provided document explicitly states that for this 510(k) (K071786), no new performance data was required.

Ask a specific question about this device

The Portrait PSR3 is indicated for treatment of the following dermatological conditions:

• Treatment of wrinkles and rhytides .
• . Superficial skin lesions
• . Actinic Keratosis
• . Viral Papillomata
• . Seborrhoeic Keratosis

The Rhytec, Inc. Portrait PSR3 is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the handpiece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that will give predictable tissue effects.

Here's an analysis of the provided text regarding the Rhytec, Inc. Portrait PSR3 device, focusing on acceptance criteria and the supporting study:

The provided document, K060948, is a 510(k) summary for the Rhytec, Inc. Portrait PSR3 device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a full Premarket Approval (PMA) process. As such, the information on "acceptance criteria" and a detailed "study that proves the device meets the acceptance criteria" is less comprehensive than what would be found for a novel device or a PMA submission.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific numerical acceptance criteria (e.g., "90% sensitivity" or "reduction of X points on a scale") are not explicitly stated or defined in the manner commonly seen for diagnostic or AI-driven devices.

Instead, the "acceptance criteria" appear to be implicit in the demonstrated "significant improvement" in dermatological conditions, which aligns with the device's stated indications for use.

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

• Sample Size (Test Set): 10 subjects, treated in 30 anatomical sites.
• Data Provenance: Not explicitly stated (e.g., country of origin). No mention of retrospective or prospective nature; however, a "clinical study was conducted," implying a prospective design.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method:

• Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• No, an MRMC comparative effectiveness study is not mentioned in the provided text. The study described focuses on the device's performance alone, not in comparison to or with assistance from human readers.

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

• This device is an electro-surgical device, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply to this device. The clinical study described evaluates the direct physical effect of the device on the human body.

7. Type of Ground Truth Used:

• The ground truth appears to be based on clinical observation of "significant improvement," "reduction in skin dyspigmentation," and "reduction in wrinkle severity." The specific methods for quantifying these improvements (e.g., grading scales, photographic analysis, physician assessment scores) are not detailed in this summary. It is likely direct clinical assessment by a qualified physician.

8. Sample Size for the Training Set:

• This device is an electro-surgical device; it does not involve a "training set" in the context of machine learning or algorithms. The clinical study with 10 subjects and 30 anatomical sites serves as the primary performance evaluation.

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

• Not applicable, as there is no "training set" for this type of device.

Summary of Limitations Based on Provided Text:

The 510(k) summary is designed to establish substantial equivalence, not to provide exhaustive detail on clinical trial methodology as would be required for a PMA. Therefore, many standard details regarding study design, ground truth establishment, reader qualifications, and statistical methodologies are not provided in this document. The "Performance Data" section is very brief, indicating a clinical study showed "significant improvement" but lacking specific metrics or detailed methodology.

Ask a specific question about this device