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The Primaeva Medical Miratone System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.

The Primaeva Medical Miratone System is comprised of the following components: A reusable radiofrequency (RF) generator with user interface; a reusable cooler controller; cooler handpiece/applicator; a reusable reusable a electrode insertion device/applicator; and a single patient use, disposable electrode cartridge. RF energy is delivered from the RF generator through the electrodes into the target tissue.

The provided text describes the Primaeva Medical Miratone System and its 510(k) premarket notification. However, it does not contain specific acceptance criteria for device performance or a detailed study proving the device meets those criteria.

The document states:

• "Clinical performance testing demonstrated the Primaeva Medical Miratone System to be safe and effective in the percutaneous treatment of facial wrinkles." This is a general statement of an outcome, not a presentation of acceptance criteria or performance metrics.
• "In summary, the results of non-clinical mechanical, electrical and functional bench and/or animal testing, and clinical performance testing have demonstrated that the Primaeva Medical Miratone System meets established design specifications; functions as intended; and is considered to be substantially equivalent to the above noted predicate devices." Again, this is a summary statement without specific data or criteria.

Therefore, I cannot populate the table or provide detailed answers to most of your questions based solely on the provided text. The document confirms a clinical study was done, but it doesn't offer the details you've requested.

Here's what can be inferred and what is missing:

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

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The device manufacturer, Primaeva Medical, Inc., is based in Pleasanton, CA, USA, which might suggest the study was conducted in the US, but this is not explicitly stated for the clinical performance testing.

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 specified.

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

• Not specified.

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

• This device is an electrosurgical unit, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance would not be applicable. The document does not mention any AI component.

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

• This is an electrosurgical medical device; the concept of a "standalone algorithm" is not applicable here. Studies would focus on the device's physical performance, safety, and effectiveness in treating conditions.

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

• For "percutaneous treatment of facial wrinkles," the ground truth likely involves clinical assessment of wrinkle reduction, possibly using standardized photographic scales or other objective measures, alongside patient satisfaction and safety outcomes. However, the specific type of ground truth used is not specified in the document.

8. The sample size for the training set

• Not applicable as this is a medical device for treatment, not an AI model requiring a training set in the typical sense. The "training set" for physical devices would rather refer to engineering and clinical validation data.

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

• Not applicable for the same reason as above.

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The Primaeva Medical Finesse System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

The Primaeva Medical System is comprised of the following components: A reusable radiofrequency (RF) generator with user interface, a reusable cooler controller, a reusable cooling system handpiece, a reusable electrode insertion device and a disposable electrode cartridge. RF energy is delivered from the RF generator through the electrodes into the target tissue.

The provided text is a 510(k) summary for the Primaeva Medical System. It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not contain the type of detailed acceptance criteria or a specific study proving the device meets those criteria in human-centered performance metrics that your request is looking for (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, or ground truth details).

This document focuses on regulatory approval based on substantial equivalence to a legally marketed predicate device (Primaeva Medical Finesse System, K072261) through non-clinical testing.

Here's a breakdown of what the document does provide in relation to your request, and what it does not provide:

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

   • Not provided. The document states that non-clinical testing (visual, mechanical inspection, electrical and mechanical safety testing, functional performance testing) was conducted and that the device "meet established design specifications; function as intended; and are considered to be substantially equivalent to the above noted predicate device." It does not list specific numerical acceptance criteria or performance metrics for this device.

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

   • Not provided. The document mentions "bench and/or animal testing" for non-clinical tests but does not specify sample sizes or data provenance.

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/Not provided. This type of information is typically relevant for studies involving human interpretation or clinical outcomes. The provided document describes non-clinical (bench and animal) testing for an electrosurgical unit, not a diagnostic or AI device requiring expert ground truth establishment for a test set.

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

   • Not applicable/Not provided. Similar to point 3, this is not relevant for the type of non-clinical testing 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

   • No. This is not an AI device. The document is for an electrosurgical system. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

   • No. This is not an AI algorithm. It's a physical medical device (electrosurgical unit).

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

   • Not applicable/Not provided in detail. For the non-clinical tests, the "ground truth" would be engineering specifications, established safety standards, and the functional performance of the predicate device. The document states the tests "meet established design specifications; function as intended."

8. The sample size for the training set

   • Not applicable/Not provided. This information is for AI/machine learning models, which this device is not.

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

   • Not applicable/Not provided. This information is for AI/machine learning models, which this device is not.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through non-clinical bench and/or animal testing for an electrosurgical unit. It does not contain the detailed human-centric performance metrics, AI study methodologies, or extensive ground truth establishment details that your request outlines. The "study" referenced in the document is the "Non-Clinical Test Summary" which includes "visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench and/or animal testing." The acceptance criteria are broadly stated as meeting "established design specifications" and functioning "as intended," demonstrating substantial equivalence to the predicate device.

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The Primaeva Medical Finesse System is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

The Primaeva Medical Finesse System is comprised of four primary components; an RF Generator with User Interface Software, a Cooling System Hand Piece, a Cooler Controller, and a disposable Electrode Insertion Device with an integrated cable. RF energy is delivered from the RF Generator, through the electrodes, and into the target tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs. The RF Generator, Cooler Controller, and Cooling System Hand Piece are not disposable. Each Electrode Insertion Device is supplied sterile and is for single patient use only and cannot be re-sterilized. The insertion device is a hand-held mechanical device that is used to insert the electrodes, at an acute angle, into the target tissue. The device has ten (10) electrodes arranged in a single row array. The device has a mechanism to deploy and retract the electrodes when actuated by the user. There is a cable with a connector that connects to the RF Generator. The Cooler system comprises a solid state cooling device with a feedback loop to monitor and control temperature. The cooling device is placed on the tissue surface during the treatment cycle. The RF Generator is the energy source for the system. Accessory cables and power cords are also supplied with the system.

There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Primaeva Medical Finesse System, which outlines the device's description, intended use, and comparison to predicate devices for substantial equivalence. It also includes the FDA's clearance letter.

Therefore, I cannot provide the requested table or information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for acceptance criteria.

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