(134 days)
Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids.
The Iskra Medical Green IRF Prestige system consists of a user interface, internal electronics controlled by microprocessor, RF generator, 2 treatment handpieces (small and large applicator), and reference electrode. The treatment parameters are selected and controlled via the touch screen.
This document is a 510(k) summary for the Iskra Medical Green IRF Prestige and Accessories, a device intended for non-invasive treatment of facial wrinkles and rhytids. The 510(k) submission primarily relies on substantial equivalence to predicate devices rather than presenting a standalone study with acceptance criteria and device performance metrics. Therefore, many of the requested details regarding acceptance criteria and study particulars are not explicitly provided in this document.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is absent:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or specific reported device performance metrics in terms of efficacy (e.g., reduction in wrinkle depth, patient satisfaction scores) from a dedicated study. The submission relies on demonstrating substantial equivalence to predicate devices based on indications for use, design, and functional features.
| Acceptance Criteria (Not explicitly stated/measured in this document) | Reported Device Performance (Not explicitly stated/measured in this document) |
|---|---|
| e.g., % reduction in wrinkle severity, safety profile, etc. | e.g., % of patients achieving a specific aesthetic outcome, adverse event rates |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This document does not describe a clinical study with a test set. The 510(k) summary focuses on demonstrating substantial equivalence.
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. As no clinical study is described, there is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is 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
Not applicable. This device is an electrosurgical unit and accessories, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to this medical device, which is an electrosurgical unit. It does not employ an algorithm that would have standalone performance in the context of AI or diagnostic imaging.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is established or used in this device's submission as it relies on substantial equivalence to predicate devices without presenting new clinical performance data for efficacy.
8. The sample size for the training set
Not applicable. No training set is mentioned as part of a study for this device.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for it is mentioned.
Summary of the document's approach:
The Iskra Medical Green IRF Prestige and Accessories device gained clearance based on the "V. Intended Use" and "VI. Rationale for Substantial Equivalence" sections.
- Intended Use: "The Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids."
- Rationale for Substantial Equivalence: The document states that the device "shares the same indications for use, similar design and functional features with predicate devices, and thus it has been found to be substantially equivalent to the predicate devices." The predicate devices listed are:
The FDA's letter (APR 17 2009) confirms this determination, stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
Therefore, the "proof" the device meets acceptance criteria, in this context, is the demonstration to the FDA that it is substantially equivalent to already legally marketed devices, rather than a clinical study establishing new performance metrics against predefined acceptance criteria.
§ 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.