(273 days)
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
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|
| Safety: Device is as safe as predicate devices. | The overall performance characteristics of the Matrix RF Applicator, including pulse parameters and depth of impact, are substantially equivalent to those of the predicate devices. Therefore, the Matrix RF Applicator should raise no new issues of safety and effectiveness. |
| Effectiveness: Device is as effective as predicate devices for indicated use. | The overall performance characteristics of the Matrix RF Applicator, including pulse parameters and depth of impact, are substantially equivalent to those of the predicate devices. Therefore, the Matrix RF Applicator should raise no new issues of safety and effectiveness. |
| Intended Use: Device performs its intended dermatological procedures (ablation and resurfacing of the skin). | "The Matrix RF Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin." (This matches the indication of the predicate devices by implication, though not explicitly stated for predicates in this summary). "The overall performance characteristics... are substantially equivalent to those of the predicate devices." |
| Technological Characteristics: Key technological characteristics (e.g., pulse parameters, depth of impact) are similar. | "The overall performance characteristics of the Matrix RF Applicator, including pulse parameters and depth of impact, are substantially equivalent to those of the predicate devices." |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.