(107 days)
The Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV.
The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cord. The electrode is spring mounted into the handle. All materials used in the manufacture of the device are suitable for the use in the device and are the same materials used in the predicate product. As with the predicated device, the device is activated using a hand or footswitch based on user preference and is intended for use with the Ellman Radio-Frequency generators (K082834) labeled for the treatment of wrinkles and rhytides.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
This 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices. It does not contain detailed information about specific acceptance criteria, comprehensive performance outcomes, or a dedicated clinical study report in the way one might expect for a novel device undergoing extensive clinical trials. The provided document is a regulatory submission demonstrating similar safety and effectiveness to already cleared devices.
Given the nature of the document, much of the requested information about a specific "study proving acceptance criteria" is either not explicitly stated or not applicable in the context of a substantial equivalence claim for a minor technological improvement.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Safety: Device materials suitable for use | All materials suitable for use (same as predicate). Device functioned as intended. |
| Safety: Device functions as intended | Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System functioned as intended and in conformance with anticipated results. |
| Effectiveness: Same intended use as predicate devices | Same indication for use as predicate: non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV. |
| Technological Characteristics: Similar to predicate devices | Same technological characteristics and principles of operation as predicate device, with minor improvements not altering fundamental scientific technology. |
| Performance: Meets required specifications | All appropriate testing performed and all components, subassemblies, and/or full devices met required specifications. |
Explanation: The document emphasizes substantial equivalence, meaning the acceptance criteria are implicitly met by demonstrating that the new device is as safe and effective as the predicate devices, sharing similar indications for use and technological principles. Specific quantitative acceptance thresholds (e.g., "90% reduction in wrinkles") and their corresponding measured performance are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on a specific "test set" sample size or data provenance (country of origin, retrospective/prospective). It only states that "All appropriate testing has been performed." For substantial equivalence based on minor technological changes, the testing might have been limited to engineering, bench, and potentially animal testing, rather than a large-scale human clinical trial with a defined "test set" for performance evaluation in the usual sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not available in the provided 510(k) summary. The document does not describe a clinical study that required expert consensus for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not available in the provided 510(k) summary. Given the absence of a described clinical test set, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done/described in this 510(k) summary. This type of study is not relevant for a non-AI, energy-based medical device like the Pellevé GlideSafe™ System.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done/described. This device is not an AI algorithm but a physical electrosurgical system.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically applied to diagnostic algorithms or imaging interpretation is not directly applicable or mentioned in this 510(k) summary for this device. The evaluation focuses on engineering specifications, intended function, and comparison to predicate devices, rather than a diagnostic output requiring ground truth validation.
8. The Sample Size for the Training Set
This information is not available in the provided 510(k) summary. This device is not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
§ 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.