(237 days)
The PROFOUND MATRIX SYSTEM is intended for dermatological procedures, as follows:
The MATRIX PRO applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis.
The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV.
The SUBLIME applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/ cm3, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.
The Profound Matrix System combines three existing technologies and applications for dermatological procedures. Each respective technology is used in one of the three applicators designed for the Profound Matrix System. These three applicators are named: Matrix Pro, Sublative RF and Sublime.
The Matrix Pro applicator is designed to deliver bipolar, non-ablative radiofrequency energy through a 7x7 matrix/grid of sterile microneedles to the skin in a fractional manner. The microneedles can be set up to pulse a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm.
The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface viaan array of multi-electrode pin tips. The applicator delivers bipolar RF energy to the skin, which results in heating of demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins.
The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.
Here's a breakdown of the acceptance criteria and study information for the Profound Matrix device, based on the provided text:
Important Note: The provided document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results for a novel device. As such, information regarding acceptance criteria for a new clinical performance study, multi-reader multi-case studies, and detailed ground truth establishment for a training set are largely not applicable or not provided in this context. The document explicitly states that "no clinical or animal studies were needed to support this 510(k) Premarket Notification."
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" for a new clinical performance study with specific metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by demonstrating that the device's technical characteristics and performance are comparable to the legally marketed predicate device, and it meets relevant safety and performance standards.
| Acceptance Criterion (Implied by 510(k) for Substantial Equivalence) | Reported Device Performance (from Bench Testing) |
|---|---|
| Electrical Safety (IEC 60601-1) | Passed - Conducted testing and found to be acceptable. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Passed - Conducted testing and found to be acceptable. |
| High-Frequency Surgical Equipment Safety (IEC 60101-2-2) | Passed - Conducted testing and found to be acceptable. |
| Biocompatibility (ISO 10993) | Established based on predicate devices and results of ISO 10993 testing. |
| Software Verification & Validation (FDA Guidance) | Passed - Verification and validation testing conducted, results acceptable for software release, performed per FDA guidance. |
| Shelf-life and Transportation Testing | Performed. (Results are not explicitly detailed but are implied to be acceptable for substantial equivalence). |
| Human Factors Summative Usability | Performed. (Results are not explicitly detailed but are implied to be acceptable for substantial equivalence). |
| Thermal Testing (FDA Guidance for Electrosurgical Devices) | Performed. (Results are not explicitly detailed but are implied to be acceptable for substantial equivalence). |
| Applicator Cleaning and Disinfecting Validation (FDA Guidance) | Performed. (Results are not explicitly detailed but are implied to be acceptable for substantial equivalence). |
| Ex-Vivo Thermal Damage Equivalence (Matrix Pro vs. Predicate) | Showed similar thermal effects (collagen denaturation, voids, and compressed fat cells) at similar depths and (for some settings) widths compared to the predicate (Infini). Noted that Matrix Pro has better energy control due to impedance calculation. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the Ex-Vivo Thermal Damage Evaluation, the sample size was not explicitly specified numerically, but it involved "excised abdominal skin tissue." The samples were treated with "four RF energy levels (1), 2J, 3J and 4J) and included three treatment depths using two depth configurations (dense and spread)."
- For other bench tests (electrical safety, EMC, software, etc.), the "sample size" refers to the device units tested, which is typically a smaller number to demonstrate compliance with engineering standards.
- No clinical test set was required or used for this 510(k) submission.
- Data Provenance:
- Ex-Vivo Thermal Damage Evaluation: The tissue was "ex-vivo, excised abdominal skin tissue." The country of origin is not specified, but it was likely laboratory bench testing.
- For other tests like electrical safety, EMC, and software, the data provenance would be internal laboratory testing by Candela Corporation.
- Retrospective or Prospective: All testing described is prospective bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided in this context. Since no clinical studies were performed, there was no need for experts to establish ground truth on patient data. The "ground truth" for the ex-vivo thermal damage evaluation would be the observed histological changes, interpreted by the researchers conducting the bench test.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided in this context. As there were no clinical studies and no expert interpretation of patient data for performance metrics, no adjudication method was mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The 510(k) summary explicitly states, "Based on the similarities of the device specifications, intended use, indications for use between the Profound Matrix and its predicate device, no clinical or animal studies were needed to support this 510(k) Premarket Notification."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, in the context of device function. The "performance" described pertains to the standalone device functionality and its components (applicators, software, electrical systems) rather than an AI algorithm. The Ex-Vivo Thermal Damage Evaluation and other bench tests evaluate the device's inherent performance. There is no mention of an AI algorithm in the traditional sense (e.g., for diagnosis or prediction) and therefore no standalone algorithm performance in that context.
7. The Type of Ground Truth Used
- For Ex-Vivo Thermal Damage Evaluation: Histological observation of "collagen denaturation consistent with tissue heating" and "voids consistent with broken fat cells membranes and a surrounding layer of compressed fat cells" were the "ground truth" for evaluating the thermal effects. This is a type of laboratory/experimental observation.
- For other bench tests: The "ground truth" is adherence to established engineering and safety standards (e.g., electrical parameters, software functionality).
8. The Sample Size for the Training Set
- Not Applicable. As no clinical or animal studies were performed and no machine learning algorithm for diagnostic or predictive purposes was described, there was no training set in the typical sense for a medical AI device. The device's "training" would be its design and engineering based on existing knowledge and predicate devices.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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.