(184 days)
Pollogen's Surgen U system is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Surgen™ U system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface.
Acceptance Criteria and Study for Pollogen Ltd.'s Surgen U System
Based on the provided 510(k) summary for the Pollogen Ltd.'s Surgen U System, the following information can be extracted regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards rather than specific quantitative acceptance criteria for clinical outcomes of ablation and resurfacing. However, performance tests were conducted to ensure the device functions as intended within its design specifications.
| Acceptance Criteria (Implied/Tested) | Reported Device Performance |
|---|---|
| Bench Testing: | |
| Power control and accuracy relative to user input | Verified to validate Surgen U power control and accuracy. |
| Maximum energy per pin not higher than 62 mJ | Verified that maximum energy per pin is not higher than 62 mJ. |
| Applicator pins mechanical interface with disposable tip | Verified. |
| Applicator HE drop test | Verified. |
| Disposable tip packages durability after drop tests | Verified. |
| HE tips (gen 12 and gen 36) capable of performing 800 pulses | Validated; electrode pins and return were not affected and remained fully intact. |
| Pre-clinical Study (Safety): | |
| Inducement of expected fractional pattern at treatment site | Demonstrated. |
| Surrounding normal healthy tissue un-effected | Demonstrated. |
| Overall safety of fractional skin ablation treatment | Supported as safe and effective. |
| Compliance with Performance Standards: | |
| EN/IEC 60601-1 (General Requirements for Safety) | Complies. |
| EN/IEC 60601-1-2 (Electromagnetic Compatibility) | Complies. |
| EN/IEC 60601-2-2 (Safety of high frequency surgical equipment) | Complies. |
Overall Conclusion: "In all instances, the Surgen U system functioned as intended and observations were as expected."
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: No specific numerical sample sizes are provided for the individual bench tests (e.g., number of units tested for power accuracy, number of tips dropped). The tests were conducted internally by Pollogen. The data provenance is presumed to be from the manufacturer's internal testing facilities (likely Israel, as Pollogen Ltd. is based in Tel Aviv) and is retrospective in the sense that it's data generated for the submission.
- Pre-clinical Study: The study was conducted on "animal (pig) skin." No specific number of animals or treatment sites is provided. This was an experimental, prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the bench tests. For the pre-clinical study, the evaluation of "expected fractional pattern" and "normal healthy tissue" would typically involve pathologists or dermatopathologists, but their number and specific qualifications are not specified in this summary.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for either the bench testing or the pre-clinical study. The evaluation of results for bench tests would likely have been based on engineering and design specifications. For the pre-clinical study, the histology evaluation would typically be performed by a single pathologist or a small group, but no method for adjudication is detailed.
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 MRMC comparative effectiveness study was conducted or described in this 510(k) summary. The device is not an AI-assisted diagnostic or therapeutic tool; it is an energy-based medical device for dermatological procedures. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Surgen U system is not an algorithm-only device. It is a physical electrosurgical system that requires a human operator (physician) for its intended use. Therefore, a standalone (algorithm-only) performance study is not applicable and was not performed.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth for bench tests was based on engineering specifications, design parameters (e.g., maximum energy per pin), and established performance standards (e.g., ability to perform 800 pulses, durability after drop tests).
- Pre-clinical Study: The ground truth for the pre-clinical study was histology data from animal (pig) skin, assessing the "expected fractional pattern at the treatment site, surrounded by normal healthy tissue."
8. The Sample Size for the Training Set
The document does not mention a training set because the Surgen U System is a hardware device and not a machine learning or AI-based system that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.