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Noninvasive treatment of mild to moderate facial wrinkles and rhytides. This device has not been tested on darker skin subjects.

MINNIE is a noninvasive radiofrequency device consisting of:
• Touch Screen User interface
• Programmable Microcontroller
• RF Power Module
• 4 Treatment Handpieces with following characteristics
o Bipolar Handpiece Ø 36mm
o Unipolar Handpieces Ø 36mm, 60mm and 80mm
MINNIE is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.

MINNIE Device Performance Study

This response outlines the acceptance criteria and study details for the MINNIE device, based on the provided 510(k) summary (K133405).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set (Clinical Study): 52 subjects
  • Group A (Control): 8 subjects
  • Group B (Sham): 11 subjects
  • Group C (Radiofrequency Treatment): 33 subjects
• Data Provenance: Not explicitly stated, but the applicant (Elettronica Valseriana srl) is based in Italy, suggesting the study may have been conducted there. The study appears to be prospective as subjects were randomly assigned to groups and followed up.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: 3 physicians
• Qualifications: "Blind to the randomization group," implying independence and impartiality. Specific years of experience or subspecialty (e.g., dermatologist, plastic surgeon) are not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Implicitly, consensus or strong agreement. The summary states, "There were no differences in the scoring of the evaluators," suggesting that the 3 physicians' evaluations (on clinical photographs) matched the in-vivo scores made by the investigator. If there were discrepancies, an adjudication method was not explicitly described, but their agreement eliminates the need for one.

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

• **No, a specific MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done.
• The study involved human readers (3 blinded physicians and the investigator) assessing wrinkles using a standardized scale. The device itself is an energy delivery system, not an AI-based diagnostic or assistive reader tool. Therefore, an MRMC study in the typical AI context is not applicable here.

6. Standalone Performance Study (Algorithm Only)

• **No, a standalone (algorithm only) performance study was not done.
• The MINNIE device is a medical device that delivers radiofrequency energy, not an algorithm that interprets data or provides diagnostic output. The clinical study assessed the effect of the device on human subjects.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus (for evaluations from photographs by blinded physicians that confirmed the in-vivo scores by the investigator) and clinical assessment using a standardized scale (Fitzpatrick Wrinkle Scale - FWS).

8. Sample Size for the Training Set

• Training Set Sample Size: A separate training set for an algorithm is not applicable as the MINNIE device is a hardware-based radiofrequency treatment system, not an AI software. The provided document describes a clinical study to evaluate the device's safety and effectiveness in treating wrinkles, not to train a machine learning model.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable as there is no training set for an algorithm. The clinical study used the FWS as a measure to assess the device's effects on human subjects.

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The Minnie support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The Minnie support catheters also may be used to subselectively infuse/deliver therapeutic agents.

The Minnic Support Catheter is available in nine models. Each Minnie catheter is a single lumen polycthylenc tube that comprises the catheter shaft. To create a lower crossing profile, the shaft tapers at the distal end. A polyethylene hub is overmolded onto the shaft and each catheter has a printed strain relief component that is just distal of the hub. To confirm position and aid in estimating geometries in the vasculature, each device has three evenly-spaced, radiopaque marker bands at the distal end-the distal-most marker band is approximately 2.5mm from the distal tip. The 5700 and 5701 models have printed-positioning markers at 95cm and 105cm from the distal tip. A hydrophilic coating is applied to the distal-most 40cm of the shaft to provide a lubricious outer surface. Each Minnie catheter is compatible with ≥5F introducer sheaths and ≥6F guide catheters. The Minnie catheter is provided sterile and intended for a single-patient use.

The provided 510(k) summary is for the Minnie™ Support Catheter, a medical device. This type of device is not an AI/ML-driven product, but rather a physical catheter used in interventional procedures. Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment methods, expert panel details, MRMC studies, and standalone performance) are not applicable to this submission.

However, I can extract and present the information related to the acceptance criteria and the study that proves the device meets them, based on the provided document.

Minnie™ Support Catheter Acceptance Criteria and Performance Study

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

The document lists various bench tests conducted to assess the physical properties and intended use suitability of the Minnie™ Support Catheter. For each of these tests, the "reported device performance" is implicitly stated as having "confirmed the suitability of the device for its intended use" and "Bench tests confirmed the suitability of the device for its intended use." Specific quantitative acceptance criteria or detailed performance results for each test are not provided in this summary.

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 for Test Set: This information is not provided in the document. The tests conducted are "bench tests," implying laboratory testing of device samples. The exact number of samples tested for each criterion is not specified.
• Data Provenance: The tests are "bench testing," meaning in-vitro laboratory evaluations, not tests on human data. No country of origin for data is relevant in this context, nor is retrospective or prospective classification.

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)

This is not applicable. The "ground truth" for a physical medical device in bench testing is determined by established engineering and material science standards and measurement techniques, not by expert medical opinion in the same way an AI model's output might be adjudicated.

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

This is not applicable. Adjudication methods involving multiple expert readers are relevant for subjective interpretations of data (e.g., medical images) or algorithm outputs, not for objective physical bench tests of a device.

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 is not applicable. The Minnie™ Support Catheter is a physical medical device, not an AI/ML-driven system that would assist human readers in interpretation.

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

This is not applicable. The Minnie™ Support Catheter is a physical medical device and does not involve an algorithm.

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

The "ground truth" for the bench tests would have been established by objective measurements against predefined engineering specifications and industry standards. For example, "Distal outer diameter measurement" would have a specified tolerance, and the ground truth is whether the measured diameter falls within that tolerance. Similarly for "Flow rate" or "Kink resistance," there would be measurable standards.

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical medical device in the context of this 510(k) submission.

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

This is not applicable for the reasons stated above.

Summary of Study for the Minnie™ Support Catheter:

The study proving the Minnie™ Support Catheter meets its acceptance criteria was comprised solely of bench testing. These tests assessed the physical properties and functionality of the device against internal specifications, engineering standards, and performance expectations for its intended use. Clinical evaluations were explicitly stated as "not required" for this device. The conclusion of the submission is based on the findings from these bench tests, affirming the device's suitability for its intended use, and its substantial equivalence to predicate devices (Quick-Cross® Support2 Catheters and Skyway™ Support Catheter) based on classifications, indications, technological characteristics, and sterilization methods.

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