(127 days)
The Reverso is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
The Reverso device is a tabletop computerized system comprised a console (main unit) and Applicator with detachable single-use tips. The system delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin. The Reverso device provides individual adjustments of energy settings, tip pattern, pulse profile to achieve appropriate efficiency and safety for each eligible patient. The device console includes a power supply unit, controller card and LCD screen with touch panel. The Reverso device Applicator is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. The applicator is hand- held and ergonomically designed for the treatment requiring ablation and resurfacing of the skin. The applicator is connected to the system via a cable. When not in use, the applicator can be placed within the applicator holder positioned on the system console. The Reverso Applicator is compatible with two types of fractional RF tip heads; 80 pin tip head and 160 pin tip head.
The provided text is a 510(k) summary for the Reverso device, which is an electrosurgical device for dermatological ablation and resurfacing. It aims to prove substantial equivalence to a predicate device, the Venus Viva MD.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
Key Takeaway: This document is not about an AI/ML device where acceptance criteria would involve performance metrics like sensitivity, specificity, or AUC against a ground truth established by experts. Instead, it's a traditional medical device 510(k) focused on demonstrating substantial equivalence to an existing cleared device through engineering and performance testing, primarily with bench and ex-vivo studies. Therefore, many of the typical AI/ML-specific questions (number of experts, adjudication methods, MRMC studies, standalone performance metrics) are not applicable to this type of submission.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" in this context are not presented as a table of numerical thresholds for AI performance, but rather as meeting the design requirements and demonstrating similar performance characteristics to the predicate device. The primary goal is to show the Reverso device is "as safe and effective as the predicate device, and that no new safety or effectiveness issues are raised."
The document focuses on comparing the Reverso with the predicate device (Venus Viva MD) across various technical specifications and performance aspects.
Here's a table summarizing the "acceptance criteria" (implied equivalence to predicate) and the reported performance:
| Criterion/Characteristic | Implied Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance (Reverso) |
|---|---|---|
| Operational Principle | Same underlying technology of fractional RF | Fractional RF: Use of RF energy delivered through a matrix of multiple pin electrodes allocated on the applicator tip. Treatment is based on fractional sub-necrotic heating of papillary and reticular dermis triggering slow collagen remodeling. |
| Intended Use | Non-invasive dermatological procedures requiring ablation and resurfacing of the skin | "The Reverso is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin." (Identical to predicate's relevant indication) |
| RF Performance Specs | Identical/Equivalent RF output specifications (RF Frequency, Energy per pin) | RF Frequency: 0.46 MHz. Energy per pin: 62 mJ/pin (160 pin tip), 124 mJ/pin (80 pin tip). "The RF performance specifications... were shown to be identical to those of the predicate device as demonstrated in the bench performance testing." |
| Tissue Effect (Ex-vivo) | Similar ablation and coagulation characteristics / thermal effect on tissues | "The ex-vivo study results demonstrated that the Reverso device is safe for use and effective in achieving the specified indications of dermatological skin ablation and skin resurfacing. Furthermore, the histology results of the subject device tissue samples were compared with the histology results of the predicate device tissue samples. The comparison demonstrated an equivalency in ablation and coagulation characteristics." "similar thermal effect over ex-vivo human tissues following a single treatment performed under similar RF performance specifications and similar operation conditions." |
| Safety Features & Standards Compliance | Similar to predicate, compliance with relevant standards | Complies with ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6. "The safety features and compliance with safety standards in the subject device are similar to the safety features and compliance with safety standards found in the predicate device." |
| Biocompatibility | All materials are biocompatible | "All materials are biocompatible" (identical to predicate) |
| Sterility | Provided non-sterile; single-use tip head to be sterilized by user | "Provided non-sterile. The detachable, single use tip head is to be sterilized by the user close to treatment onset, using autoclaving sterilization technique." (identical to predicate) |
| Hazards/Risks | Low risk, no new safety/effectiveness issues | "All of the identified device related hazards are of low risk and are mostly related with transient symptoms of erythema and edema which are resolved 24-72 hours post treatment." "no new safety or effectiveness issues are raised in regard to the subject device functionality." |
Study Details (Applicable to this type of device)
The studies conducted are primarily for engineering validation and comparison to a predicate device, not for typical AI/ML performance evaluation.
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Sample Size and Data Provenance for Test Set:
- Bench Tests: No specific "sample size" for a data set in the AI sense is mentioned. These are engineering measurements.
- Ex-Vivo Tissue Testing: "The study was conducted on human abdomen tissues following an abdominoplasty surgery". A "single treatment" was performed. While it doesn't state the number of tissue samples or individual treatments, it implies a small, illustrative set rather than a large statistical sample.
- Data Provenance: Not specified, but standard for ex-vivo human tissue. Retrospective/Prospective is not applicable here as it's not a clinical study on living subjects. The tissues were obtained after abdominoplasty surgery.
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Number of Experts and Qualifications for Ground Truth:
- Experts: Not explicitly stated as "experts" for ground truth adjudication in the AI sense.
- Qualifications: The histology section mentions "biopsy sampling of slices trimmed along the pin's penetration path and collection immediately stained by H&E staining to visualize the tissue ablation and coagulation patterns." This implies histopathological analysis, which would typically be performed by trained personnel (e.g., pathologists or histotechnicians). There is no expert consensus or panel adjudication as would be common for subjective AI image analysis.
- Ground Truth Type: For the ex-vivo study, the ground truth was histology (H&E staining) to observe ablation and coagulation patterns. This is an objective measurement of tissue response.
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Adjudication Method for Test Set:
- Method: Not applicable. There was no expert panel or subjective assessment requiring adjudication. The comparison was based on objective histological findings.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Performed? No. This device is not an AI/ML diagnostic aid, so an MRMC study comparing human reader performance with and without AI assistance is not relevant or required.
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Standalone (Algorithm Only) Performance:
- Performed? Not applicable. This is a physical electrosurgical device, not a software algorithm providing diagnostic output.
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Type of Ground Truth Used:
- For the ex-vivo study, the ground truth was histology (H&E stained samples) to visually assess and compare tissue ablation and coagulation patterns between the subject and predicate devices.
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Sample Size for Training Set & How Ground Truth Was Established (for AI/ML):
- Not applicable. This document describes a traditional medical device, not an AI/ML algorithm that requires training data and ground truth labeling. The "training" here refers to the device's design, manufacturing, and internal testing, not machine learning model training.
§ 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.