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510(k) Data Aggregation
(402 days)
Apollo Duet (Model : APD-4000)
Apollo duet(RF Mode) is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
Apollo Duet has RF handpiece attached to the main body, and consists of an electrode cable and a power adapter. This equipment has RF mode, which is the main function, RF mode is a mode in which Radio-frequency is output in a bipolar method. An RF handpiece is used, and a high frequency is output through 4ea RF handpiece electrodes. In addition, the RF handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 45 C
The provided text describes the regulatory clearance of a medical device called "Apollo Duet" (Model: APD-4000) by the FDA. It does not contain information about a study that proves the device meets specific acceptance criteria related to its performance in terms of effectiveness for its intended use.
The document focuses on demonstrating substantial equivalence to a predicate device (InMode RF Pro System) based on technical, safety, and operational characteristics, rather than a clinical effectiveness study with defined acceptance criteria for efficacy.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The information requested regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets is not present in the provided text.
Here's what can be extracted regarding testing and related safety:
Acceptance Criteria and Study Information (Based on provided text)
The document outlines safety and performance bench testing and adherence to international standards to demonstrate substantial equivalence and safety, rather than effectiveness acceptance criteria for its therapeutic claims (relief of muscle aches, spasm, and improved blood circulation).
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied Safety/Technical) | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety (IEC 60601-1:2005, AMD1:2012) | Complies with standard |
| Electromagnetic Compatibility (IEC 60601-1-2:2014) | Complies with standard |
| High Frequency Surgical Equipment Safety (IEC 60601-2-2:2017) | Complies with standard |
| Nerve & Muscle Stimulators Safety (IEC 60601-2-10:2012/A1:2016) | Complies with standard |
| Risk Management (ISO 14971:2019) | Risk management recorded |
| Usability (IEC 60601-1-6:2010 + A1:2013) | Usability documented |
| Biocompatibility (ISO 10993-1) (Electrode: SUS 304, LED Display: PC (SR3108FM)) | Materials are biocompatible for intact skin, limited contact ( |
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