(91 days)
The SYNERGY is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.
The SYNERGY is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and infrared spectrum for the treatment of wrinkles on the face. The SYNERGY components include an applicator, a charging station and an adaptor. The treatment surface is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user repairable components. The device is sold for Over the Counter (OTC) use.
The provided text is a 510(k) summary for the "SYNERGY" device, a red/IR light therapy device intended for treating facial wrinkles. It establishes substantial equivalence to a predicate device, "Elevare Plus" (K172909).
However, the provided document does not contain any information about acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction) or any study that proves the device meets such criteria (e.g., a clinical study with human subjects). It focuses primarily on the safety and technological equivalence to a predicate device.
The document details non-clinical testing for electrical safety, EMC, photobiological safety, battery safety, and biocompatibility, as well as software validation and skin temperature testing. These tests ensure the device is safe to use and performs within its design specifications, but they do not address the clinical effectiveness of wrinkle reduction or any acceptance criteria for that purpose.
Therefore, I cannot fulfill your request for:
-
A table of acceptance criteria and reported device performance
- The document does not provide acceptance criteria for clinical efficacy (e.g., quantitative wrinkle reduction) or corresponding performance data. The "performance testing" mentioned refers to software validation and skin temperature, not clinical outcomes.
-
Sample size used for the test set and the data provenance
- No human test set for clinical performance is described. The "test set" for non-clinical testing (e.g., electrical safety, temperature) would refer to the device units tested, not human subjects.
-
Number of experts used to establish the ground truth
- Not applicable, as no clinical efficacy study or ground truth establishment for clinical outcomes is described.
-
Adjudication method
- Not applicable.
-
MRMC comparative effectiveness study
- Not applicable.
-
Standalone performance
- Not explicitly described in terms of clinical efficacy. The standalone performance testing mentioned is for device safety and functional specifications (e.g., skin temperature).
-
Type of ground truth used
- Not applicable for clinical ground truth. For the safety tests, the "ground truth" would be established by the standards themselves (e.g., IEC 60601-1, IEC 62471).
-
Sample size for the training set
- Not applicable, as this is a physical device, not an AI/ML algorithm that requires a training set of data for clinical performance.
-
How the ground truth for the training set was established
- Not applicable.
Summary of Information Available Related to Safety and Technical Performance:
The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and safety standards.
- Acceptance Criteria (Safety/Technical Performance): The device conforms to several international consensus standards for electrical safety (ANSI AAMI ES60601-1, ANSI AAMI IEC 60601-1-2, ANSI AAMI IEC60601-1-11), photobiological safety (IEC 62471), battery safety (IEC 62133-2), and biocompatibility (ISO 10993-5, ISO 10993-10). Additionally, skin temperature testing ensured the device stayed within 41 ± 2℃ and did not elevate skin temperature above 43°C. Software validation was conducted per FDA guidance.
- Study Proving Acceptance Criteria (Safety/Technical Performance):
- The document states that "The SYNERGY has been tested and conforms to international consensus standards" and lists the specific standards.
- For skin temperature, it states "The test results concluded that the SYNERGY was within specification of 41± 2℃ and did not elevate skin temperature above 43°C."
- Sample size and data provenance for these technical tests: Not specified beyond the implication that device units were tested in a non-clinical setting. The data provenance would be from laboratory testing.
- Experts/Ground truth for technical tests: Ground truth is established by the specified international consensus standards for device safety and performance. No "experts" in the sense of clinical reviewers are mentioned for these technical tests; rather, certified testing laboratories and their protocols would be involved.
- MRMC/Standalone (clinical efficacy): Not relevant or discussed in this document.
In conclusion, the provided FDA 510(k) summary addresses the safety and technical specifications of the SYNERGY device, demonstrating its substantial equivalence to a predicate device. It does not include information on clinical efficacy studies or acceptance criteria related to the device's intended effect on wrinkles.
§ 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.