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The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The Air compression massager is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are powered by an internal IEC 62133-2 compliant lithium-ion battery. The user interface on the Air compression massager is a series of buttons with a small display screen to display the treatment time, pressure level, mode and chamber status. The user interface provides for: Starting and stopping the massage treatment; Adjusting treatment related parameters such as treatment time and pressure level etc.; Selection of the chamber to boost the pressure. In addition to the user interface on the devices, the subject device have Bluetooth capability that allows the use of a Beoka app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience. The product is provided non-sterile, and not to be sterilized by the user prior to use. All models in this submission are the same except for the color of controller and button shape.

The provided text describes a 510(k) premarket notification for an "Air compression massager." This document demonstrates the substantial equivalence of the new device to existing predicate devices, rather than proving that the device meets acceptance criteria through a specific study with clearly defined performance metrics, ground truth, and statistical analysis typically found for diagnostic or screening devices.

The document states: "No clinical test data was used to support the decision of substantial equivalence." This means there was no clinical study conducted to prove the device meets specific acceptance criteria related to its performance in a clinical setting (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance).

Instead, the acceptance criteria and study described here are focused on non-clinical safety and performance aspects to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an attempt to extract and describe the information requested based on the provided text, acknowledging the limitations due to the device type and the nature of the 510(k) submission:

Acceptance Criteria and Device Performance (Non-Clinical)

Since this is a massager and not a diagnostic device, the "acceptance criteria" and "performance" are framed around compliance with recognized safety and performance standards rather than typical diagnostic performance metrics (e.g., sensitivity, specificity, AUC).

1. Table of Acceptance Criteria and Reported Device Performance

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

For this type of device and submission, the "test set" refers to the specific physical units or components of the device that underwent the non-clinical tests. The text does not specify the exact number of units tested.

• Sample Size: Not explicitly stated as a number of tested units beyond "a series of safety and performance tests were conducted on the subject device."
• Data Provenance: The document is a submission from "Sichuan Qianli-beoka Medical Technology Inc." in China. The testing would have been conducted by or for this manufacturer. The nature of these tests is laboratory-based, non-clinical. It is not retrospective or prospective in the sense of a patient-based clinical study.

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

• Number of Experts: Not applicable. For non-clinical performance and safety testing against engineering standards, "ground truth" is established by the specifications of the standards themselves and the measurement protocols. There are no human experts classifying outcomes in a test set as would be the case for an AI diagnostic device.
• Qualifications of Experts: Not applicable in the context of diagnostic interpretation. The testing would be conducted by qualified engineers and technicians at certified labs.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As non-clinical engineering and safety tests, outcomes are determined directly by measurement against defined thresholds in the standards, not by human or consensus adjudication of interpretations.

5. MRMC Comparative Effectiveness Study

• MRMC Study: No. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This type of study is used for diagnostic devices to evaluate the impact of AI on human reader performance, which is not relevant for an air compression massager.

6. Standalone Performance (Algorithm Only)

• Standalone Performance: Not applicable. This device is not an AI diagnostic algorithm; it is a physical medical device (massager). Its "performance" is measured by its mechanical and electrical characteristics meeting specified standards.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the "ground truth" is adherence to the specified technical standards (e.g., IEC 60601-1, ISO 10993-1). This is essentially engineering and regulatory compliance, not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is for a physical medical device, not an AI model that requires a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI model, there is no ground truth to establish in this context.

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