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510(k) Data Aggregation
(98 days)
Superflow Prime Treatment System (ASP-1M)
Superflow Prime Treatment System is used in the removal and destruction of skin lesions and coagulation of tissue.
AIMIRA SFP consists of Three modules, the main body, a multi-spectral skin camera, and a plasma skin treatment handpiece. The main body includes a main cabinet, a touch screen display, a vacuum system, computer control system and power supply unit. The system runs on AiMIRA SFP software ASP-1M. The skin camera consists of multi-spectral imaging optics, and an electronic control circuit. The plasma skin treatment handpiece consists of high voltage plasma discharge circuit, high precision control electronics, a single patient use treatment probe unit, rechargeable battery system for power supply, and a wireless communication circuit to communicate with the computer in main body. A vacuum and illumination system are integrated into AIMIRA SFP to facilitate the treatment process. A multi-spectral imaging (MSI) camera is also into AIMIRA SFP system. The purpose of the MSI camera is to provide the doctor an imaging tool to record the patient's skin conditions before and after treatments as part of the patient's treatment data record.
The provided text is an FDA 510(k) Premarket Notification document for the "Superflow Prime Treatment System (ASP-1M)". This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of specifications.
Crucially, the document explicitly states "No clinical study is included in this submission." This means there is no data presented regarding acceptance criteria, device performance from a clinical study, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment methods for a clinical test set.
Therefore, I cannot provide the requested information from this document for a study that proves the device meets acceptance criteria in a clinical setting, as no such study is presented within the provided text.
The closest information available related to "acceptance criteria" would be the performance and safety specifications that were tested non-clinically to demonstrate substantial equivalence to the predicate device. However, these are engineering and technical specifications, not acceptance criteria for clinical performance regarding efficacy or diagnostic accuracy.
Here's what can be extracted regarding the device's technical specifications and the non-clinical testing performed:
1. A table of acceptance criteria and the reported device performance:
As no clinical study performance is reported, I will present the technical specifications and the conclusion that the non-clinical tests confirmed compliance with established safety and performance standards. These standards implicitly set the "acceptance criteria" for the non-clinical tests.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Non-Clinical Test Conclusion) |
|---|---|
| Medical electrical equipment - Basic safety and essential performance (IEC 60601-1) | Complies |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies |
| Usability (IEC 60601-1-6) | Complies |
| Secondary cells and batteries safety (IEC 62133-1) | Complies |
| Risk management of radio-frequency wireless coexistence (AAMI TIR69) | Complies |
| Biological Evaluation - In Vitro Cytotoxicity (ISO 10993-5) | No Cytotoxicity |
| Biological Evaluation - Skin Sensitization (ISO 10993-10) | No evidence of Sensitization |
| Biological Evaluation - Irritation (ISO 10993-23) | No evidence of Irritation |
| Functional Specifications (e.g., Output Power, Frequency, Impedance) | Meets specifications (as per comparison to predicate device, Table 2) |
| Electrical Safety and EMC (for different power supply) | Works normally, not affecting safety and effectiveness |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable as no clinical test set is used. The tests were non-clinical/bench testing.
- Data Provenance: Not applicable for a clinical study. The non-clinical tests were conducted internally or by accredited labs to verify compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical study for efficacy or diagnostic performance was conducted. The "ground truth" for non-clinical testing is adherence to international standards and internal design specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical study was conducted.
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, an MRMC study was not done. The device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as the device is not an AI algorithm. It is a medical device for physical intervention (skin lesion removal).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is compliance with recognized international standards (IEC, ISO, AAMI) and the device's technical specifications, as compared to a legally marketed predicate device.
8. The sample size for the training set:
- Not applicable. The device is not an AI/ML system that requires a training set in the typical sense. Its functionality is based on established physical principles of electrosurgery.
9. How the ground truth for the training set was established:
- Not applicable.
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