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The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager (Model: LY-670D)

This document is a 510(k) clearance letter from the FDA for a medical device called "Air Compression Leg Massager (Model: LY-670D)". It states that the device is substantially equivalent to legally marketed predicate devices.

The information provided describes the regulatory classification and indications for use of the device. However, it does not contain any details about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo clinical performance studies with specific statistical acceptance criteria for novel claims. For devices like this, the "study" demonstrating substantial equivalence likely involved a comparison of design, materials, performance specifications (e.g., pressure, cycle times), and intended use to an already cleared device.

Therefore,Based on the provided document, I cannot answer your request as the information about acceptance criteria and a study proving the device meets these criteria is not present in the FDA 510(k) clearance letter.

The 510(k) process for a device like an Air Compression Leg Massager typically relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with specific statistical acceptance criteria as would be seen for a novel diagnostic AI algorithm, for example.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the "proof" the device meets requirements is its similarity to a legally marketed device that the FDA has already deemed safe and effective for similar indications. The specific details you are asking for (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details) are typically found in submissions for more complex or novel devices, especially those involving AI/ML components for diagnostic or prognostic purposes, or those undergoing a De Novo classification.

The provided text only covers the regulatory clearance and the device's intended use (temporary relief of minor muscle aches and temporary increase in circulation).

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