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The provided 510(k) summary for "The Buzz Facial Toning System" does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Here's why and what can be extracted from the document:

Why the requested information is largely absent:

Substantial Equivalence Pathway: This 510(k) application is based on substantial equivalence to existing predicate devices (K011935, K040871, K072260, K070217, K070250, K071573). This pathway typically does not require new clinical performance studies to demonstrate safety and effectiveness if the device is sufficiently similar to legally marketed devices.
"Cosmetic Use" Indication: The device is indicated for "cosmetic use." Devices for cosmetic purposes often have less rigorous performance study requirements compared to devices making medical claims (e.g., treating a disease, diagnosing a condition).
Explicitly Stated "N/A" for Performance Testing: The document explicitly states "N/A" (Not Applicable) for "Performance Testing - Bench," "Performance Testing - Animal," and "Performance Testing - Clinical." This confirms that specific performance studies, as one might expect for a new medical claim or a device not relying on substantial equivalence for performance, were not conducted or submitted.

Despite the lack of a traditional performance study, I will structure the answer based on your request, explaining why certain sections are empty and what little information is available.

Acceptance Criteria and Study for The Buzz Facial Toning System

The 510(k) summary for "The Buzz Facial Toning System" does not present specific acceptance criteria or a dedicated study to prove the device meets these criteria in terms of performance for its stated cosmetic indication. The submission relies on demonstrating substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Performance Criteria: No specific performance criteria (e.g., metrics for "facial toning," improvement in skin appearance) are defined or measured in this submission.	Performance (via Substantial Equivalence): The manufacturer states, "The Buzz Facial Toning System employs the same indications for use and technological characteristics, including design materials, and power output as the predicates listed on the chart specifically K011935 Salton's Rejuvenique... The manufacturer believes that no significant differences exist between the device and the predicates listed in Section 3." This implies that its performance is considered equivalent to the predicates, which are already legally marketed for similar cosmetic uses.
Safety Criteria: Biocompatibility of patient contact materials.	Safety (via Biocompatibility Review): Patient contact materials (stainless steel nodules, ABS plastic body, Collagen Conductive Gel) were reviewed. Stainless steel and ABS plastic are "well known and considered safe." The Collagen Conductive Gel was determined to be "the same material, follows the same manufacturing process, is the same chemical composition, and has the same body contact as the legally marketed predicate device, Dezac, Conductive Gel, K022006 and therefore Biocompatibility Requirements are met."
Electrical/Mechanical Safety: Compliance with relevant standards.	Electrical/Mechanical Safety: "EN Standards testing reports are attached." (The specific standards and results are not detailed in this summary).

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

Sample Size: Not applicable. No dedicated clinical or performance test set was used, as performance was established through substantial equivalence.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There was no clinical study requiring expert assessment for ground truth establishment.

4. Adjudication Method

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not conducted. The submission specifically states "Performance Testing - Clinical - N/A."

6. Standalone Performance Study (Algorithm Only)

No. A standalone performance study was not conducted for the device. The device is a physical TENS device, not an algorithm, and its performance was not evaluated independently of human use in a specific study within this submission.

7. Type of Ground Truth Used

Not applicable for performance. The "ground truth" for the device's marketability and safety was based on the regulatory precedent of the predicate devices a.k.a. Substantial Equivalence. For biocompatibility, the ground truth was the established safety of the materials and a legally marketed predicate conductive gel.

8. Sample Size for the Training Set

Not applicable. As no new performance study was conducted, there was no "training set."

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

Not applicable.

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