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510(k) Data Aggregation
(257 days)
The PRO Pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.
The PRO Pen microneedling system is a microneedling device and disposable 14-pin cartridges intended for use in adults. The device can be powered with a rechargeable battery or a provided power adapter. The device uses disposable single-use, sterile 14-pin (14-needle) cartridges made of polymer and stainless steel.
The provided FDA 510(k) Clearance Letter for the PRO Pen Microneedling System (K243800) does not describe specific acceptance criteria and the detailed study that proves the device meets those criteria in the way typically expected for an AI/CAD device. The document is a clearance letter for a physical medical device, a microneedling system, not an AI software.
Therefore, many of the requested items (like ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, and specifics about training/test sets for an AI) are not applicable to this type of device clearance document.
However, I can extract the information relevant to the performance tests conducted and the conclusions made regarding the device's adherence to regulatory requirements.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance tests in accordance with special controls for microneedling devices. While explicit numerical acceptance criteria are not provided in this summary, the conclusion of the testing is that the device "successfully passed all performance tests" and "complies with FDA requirements."
| Acceptance Criteria Category (based on special controls in 21 CFR 878.4430) | Reported Device Performance |
|---|---|
| Needle Penetration Depth Accuracy | Successfully passed. (Details not specified, but implies meeting the established accuracy requirements for microneedling devices). The device can be adjusted in 0.2mm increments up to a maximum penetration depth of 1.5mm. |
| Puncture rate characterization | Successfully passed. (Details not specified, but implies meeting the established rate charactersitics). |
| Vacuum and fluid ingress prevention evaluation | Successfully passed. Demonstrated reliable performance across all critical tests, including vacuum prevention and fluid ingress. |
| Sterility of patient contacting components | Successfully passed. |
| Aging distribution and shelf-life testing | Successfully passed. 14-pin cartridges have a shelf life of 3 years. |
| Electromagnetic compatibility and electrical safety | Successfully passed. Confirmed safe operation in healthcare environments. |
| In vitro cytotoxicity | Successfully passed. |
| Material characterization through extractables and leachables | Successfully passed. (Toxicological risk assessment of findings also passed). |
| Human patch testing for irritation | Successfully passed. No irritation reactions observed. Classified as non-irritating. |
| Human repeat insult patch testing (HRIPT) | Successfully passed. No sensitization reactions observed. Classified as non-sensitizing. |
| Cleaning and disinfection validation | Successfully passed. Procedures were validated, confirming the device can be safely cleaned and disinfected to reduce contamination risks. |
| Cross contamination protection | Complies with FDA requirements (Implied by Vacuum and fluid ingress prevention evaluation and Cleaning/disinfection validation). |
| Packaging durability | Complies with FDA requirements (Implied by aging/shelf-life testing and overall safety). Implied by successful vacuum and fluid ingress prevention which often relates to packaging integrity. |
| Needle retention | Demonstrated reliable performance. |
2. Sample size used for the test set and the data provenance
The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective) because this clearance is for a physical device, not an AI model. The "tests" mentioned are engineering and biocompatibility evaluations. For human patch testing (HRIPT), the sample size would typically be small (e.g., 50-200 subjects) for such tests, but no specific number is provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/CAD system requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the device's performance is established by objective engineering standards, biological assays (cytotoxicity, extractables/leachables), and clinical observation (human patch testing for irritation/sensitization).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not an AI/CAD system evaluating diagnostic images, there would be no adjudication method involving multiple human readers.
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
Not applicable. This is not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI system.
7. The type of ground truth used
The "ground truth" for the PRO Pen Microneedling System's performance is based on:
- Engineering Standards: For needle penetration depth, puncture rate, electrical safety, EMC.
- Biological/Chemical Testing Standards: For sterility, vacuum/fluid ingress, cytotoxicity, extractables/leachables, material characterization.
- Clinical Observation/Standard Dermatological Assessments: For human patch testing (irritation and sensitization reactions).
- Microbiological Standards: For cleaning and disinfection validation.
- Stability/Accelerated Aging Protocols: For shelf-life testing.
8. The sample size for the training set
Not applicable. This is not an AI system.
9. How the ground truth for the training set was established
Not applicable. This is not an AI system.
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