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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.

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.

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The Venus Viva SR system is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Viva SR device is designed for non-invasive dermatological procedures requiring ablation and resurfacing of the skin. The system is designed to deliver RF energy to the skin in a fractional manner. The device is comprised of a console and an applicator. The applicator is connected to the system via a cable. The applicator (hand piece) includes a detachable electrode tip that is comprised of an array of small electrode pins. The radiofrequency energy is delivered from each of the tissue, heating the dermal layers beneath the pin with minimal injury to the epidermis layer.

This document is a 510(k) Summary for the Venus Viva SR Device, indicating that it has been determined to be substantially equivalent to a predicate device. As such, it does not contain the detailed acceptance criteria and a study dedicated to proving the device meets those criteria in the way one might expect for a novel device or a clinical trial. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.

However, I can extract information related to performance evaluations and the animal study that supports the device's safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific clinical outcome. Instead, it describes various tests and their "passing" or "as expected" results, demonstrating compliance with recognized standards and expected performance in a pre-clinical setting.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document mentions a "porcine study" (animal study). The specific number of animals or treatment sites is not specified.
• Data Provenance: The study was an animal study (porcine), which is a pre-clinical setting. The country of origin is not specified. It is implicitly a prospective study in the context of controlled experimental animal research.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The document states "Skin biopsies were submitted for pathologic review to assess the healing profile at sites following treatment."
• Number of experts: Not specified.
• Qualifications of experts: The experts are implicitly pathologists, but their specific qualifications (e.g., years of experience) are not detailed.

4. Adjudication method for the test set

• The document mentions "gross necropsy findings" and "pathologic review." It does not specify an explicit adjudication method like "2+1" or "3+1" for interpreting these findings. It implies a standard pathological review process.

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 comparative effectiveness study was not done. This document describes a medical device (Venus Viva SR Device) for dermatological procedures, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable to the information provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable. The Venus Viva SR Device is an energy-based medical device, not an algorithm. The performance evaluation focuses on the device's physical and biological effects, not on an algorithm's diagnostic accuracy.

7. The type of ground truth used

• For the animal study:
  • Direct observation: For erythema, edema, and microneedle pattern at specified time points (Day 0, Day 4, Day 14).
  • Histopathology: For assessing the healing profile of skin biopsies.
  • Gross necropsy: For evaluating overall findings.

8. The sample size for the training set

• This document describes a 510(k) submission for a medical device, not a machine learning algorithm. Therefore, there is no concept of a "training set" in this context. The device's design and parameters are based on engineering principles and comparisons to predicate devices, not on training data.

9. How the ground truth for the training set was established

• As there is no "training set" for this type of device, this question is not applicable.

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