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The Matrix RF Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles.

The Matrix RF Applicator is composed of a connector, cable, handpiece and disposable tips. Treatment using the Matrix RF Applicator is based on delivery of bipolar radio frequency to the skin surface via an array of electrode-pins.

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics in a structured format suitable for the requested table. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with discrete performance metrics against predefined acceptance criteria.

However, I can extract the information that is present and indicate where certain requested details are missing or not explicitly stated in this document.

Missing Information:

• Specific acceptance criteria (e.g., target accuracy, sensitivity, specificity, or changes in wrinkle severity by a specific percentage).
• Reported device performance against specific metrics (e.g., actual measured reduction in wrinkles, or success rates for ablation/resurfacing).
• The exact sample size used for any test set (since no explicit study is detailed with performance metrics).
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method for a test set.
• Whether an MRMC comparative effectiveness study was done.
• Whether a standalone algorithm performance study was done.
• The type of ground truth used for performance evaluation.
• Sample size for a training set.
• How ground truth for a training set was established.

Based on the provided text, here is what can be inferred and what remains unknown regarding acceptance criteria and study details:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in this 510(k) summary. The document does not detail a specific clinical study with a test set. It mentions "The device was found to be effective," implying some form of evaluation, but no specifics on patient numbers or methodology are provided.
• Data Provenance: Not specified.
• Retrospective/Prospective: Not specified.

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 specified. The document does not detail the establishment of a ground truth for a test set in the context of performance metrics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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 a medical applicator for dermatological procedures, not an AI-assisted diagnostic tool that would typically involve human readers.

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated. Given the claim of "effectiveness for the new indication," it would likely be based on clinical outcomes relevant to wrinkle treatment, ablation, and resurfacing, but the specifics are not provided.

8. The sample size for the training set

• Not applicable, as this is a physical device and not an AI algorithm requiring a training set.

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

• Not applicable.

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The Matrix RF Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Matrix RF Applicator is composed of a connector, cable, handpiece and disposable tips. Treatment using the Matrix RF Applicator is based on delivery of bipolar high frequency electrical current to the skin surface via an array of electrode-pins.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Matrix RF Applicator:

The provided 510(k) summary (K073572) for the Matrix RF Applicator does not contain explicit acceptance criteria or a detailed study description that proves the device meets specific performance targets in the way a clinical trial or a deep dive into algorithm performance would.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed device (predicate device) and does not raise new questions of safety or effectiveness. This is a common pathway for medical device clearances, especially for devices with well-understood mechanisms of action and indications.

Therefore, many of the requested categories about acceptance criteria, study details, ground truth, and expert involvement are not directly addressed in this type of submission.

Let's break down what can be extracted and what is missing:

Description of Acceptance Criteria and the Study that Proves the Device Meets Acceptance Criteria

Given the nature of a 510(k) summary based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as its predicates, and the "study" is the comparison made to these predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical safety thresholds (e.g., adverse event rates) or effectiveness metrics (e.g., percentage improvement in skin texture) that the device had to achieve. These are not typically part of a substantial equivalence claim unless a specific clinical study with endpoints was performed and detailed.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable/Not specified in this 510(k) summary. No specific test set of patients or data is detailed as part of an independent verification study. The "test" is the comparison of device specifications and intended use against the predicate devices.
• Data Provenance: Not applicable/Not specified. There's no mention of specific clinical data collected for this device for a "test set." The basis for comparison is the characteristics of the device compared to the characteristics and clearance information for the predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not applicable/Not specified. Since no independent "test set" requiring ground truth assessment is described, there's no mention of experts for this purpose. The substantial equivalence determination is made by the FDA based on the provided technical and descriptive information compared to predicate devices.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. No "test set" and thus no adjudication method is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is not mentioned as having been performed for the Matrix RF Applicator in this 510(k) summary. MRMC studies are typically for imaging devices or diagnostics where human reader performance is a key aspect.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable/No. The Matrix RF Applicator is a physical medical device (an applicator for an RF energy delivery system), not an algorithm or software requiring standalone performance evaluation in the context of AI. Its performance is tied directly to its physical characteristics and how it delivers energy.

7. The Type of Ground Truth Used

• Not applicable/Not specified. No specific "ground truth" (like pathology, expert consensus, or outcomes data) derived for a new dataset is detailed. The "ground truth" in substantial equivalence is essentially the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

• Not applicable/Not specified. No "training set" is mentioned. This device is not an AI/ML algorithm that requires a training set. The design and manufacturing would likely be based on engineering principles and existing knowledge of RF energy delivery, potentially informed by previous device development or literature (not a "training set" in the computational sense).

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not specified. As there's no training set, there's no ground truth established for it in the context of this document.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence. It does not present a detailed study with explicit acceptance criteria, performance metrics, ground truth, or expert involvement for a de novo clinical or technical evaluation. Rather, it asserts that the device's characteristics (pulse parameters, depth of impact) for its indicated use (dermatological ablation and resurfacing) are comparable to existing, legally marketed predicate devices, thereby establishing its safety and effectiveness.

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