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The Air Compression Leg Massager is used to temporarily relieve mild muscle pains and discomfort, and temporarily increase blood circulation to the treatment areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The models include UM605, UM606, UM607, UM608，UM609，UM610, UM611, UM617. All of them have same Indications for use, technological characteristics and similar device appearance. And they have the same electrical circuit design, PCB layout, critical components and internal wiring. The differences for them are software function, operation method for mode adjustment and the shape of compatible inflatable garment. Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled leg wraps actuated by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of the main body. The main body and the inflatable garment are not detachable. Function buttons and light emitting diode (LED) indicators on the main body make up the user interface. Each inflatable garment is connected to the main body by air hoses and encase a 2-chamber air bladder inside. Calves can be wrapped and massaged separately by the two chambers. The main unit is directly installed on the inflatable garment through tubes and fixing buckles, and there is no need for users to install it again. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance. In operation, the user turns the power on via the Power button. Then the main body controls the inflating and deflating of the air bladders according to preset program.

The provided FDA clearance letter for the Air Compression Leg Massager (UM605, UM606, UM607, UM608, UM609, UM610, UM611, UM617) does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Instead, this document is a 510(k) summary for a physical, non-AI medical device (Air Compression Leg Massager). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the Substantial Equivalence (SE) determination based on comparison to a predicate device and compliance with recognized performance and safety standards, rather than an AI model's performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot extract the information required for your specific prompt which is tailored for AI/ML device studies. The information you are seeking (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable or present in this type of FDA clearance for a non-AI physical device.

Here's how the provided information relates to a non-AI device clearance:

• Acceptance Criteria & Reported Performance: The "acceptance criteria" for this device are primarily satisfying the safety and performance requirements of the relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2) and biocompatibility standards (ISO 10993-5, ISO 10993-10, ISO 10993-23). The "reported device performance" is that the device "conforms" to these guidances and standards, and the manufacturer has demonstrated "substantial equivalence" to a predicate device.

  Acceptance Criteria (from Standards/Predicate Comparison)	Reported Device Performance
  Power Source Safety: Compliance with IEC 60601-1 & IEC 62133-2 for internal rechargeable Lithium Battery	"Battery both of them are complied with the 60601-1 standard." "This difference will not affect the safety and effectiveness." (referring to difference from predicate)
  Physical Parameters (Dimensions, Weight, Appearance) Impact on Safety/Effectiveness	"The physical parameters (dimensions, appearance,) have minor differences with predicate device. They will not affect the safety and effectiveness of the subject device."
  Application Area: Covered by predicate device's application	"The application area of subject device is covered in predicate device. It will not affect the safety and effectiveness of the subject device."
  Timer Settings: Functionality for varied treatment times	"The proposed device just offers three timing settings (15min, 30min, 45min), which are more convenient for patients to use, while the predicate only has one time setting." Implied compliance with safety.
  Working Mode Equivalence: Similarity of compression modes	"The subject device has only one working mode, and it is substantially equivalent to the second working mode 2 of the predicate device."
  Noise Level: No exceedance of acceptable noise limits	"＜55dB" (compared to predicate's ≤ 65 dB). "The acceptance criteria of subject device is included in predicate device. It will not raise any safety and effectiveness issue of the subject device."
  Operating Conditions: Device safely operates within specified environment	"The operating condition and the transportation &storage environment of subject device has passed the safety test, and the Instructions for Use provides the operating condition, so the difference in operating condition between subject device and predicate device will not affect the safety and effectiveness of subject device."
  Electrical Safety & EMC: Compliance with IEC 60601-1, 60601-1-2, 60601-1-11	Explicitly stated: "IEC 60601-1", "IEC 60601-1-2", "IEC 60601-1-11", "IEC 62133-2"
  Biocompatibility: Absence of adverse biological reactions	"The biocompatibility evaluation for the device was conducted in accordance with... ISO 10993-1," including "Cytotoxicity," "Sensitization," "Irritation."
  General Safety and Effectiveness: Non-inferiority to predicate	"The subject device... is substantially equivalent to the predicate device (K222991)."

The requested information points (2-9) are specific to the evaluation of AI/ML models in medical devices. Since this is a traditional, non-AI device, these sections are not applicable and are not present in the provided document.

To reiterate:

• No AI/ML Performance Study Conducted: This clearance is for a physical device, not an AI/ML algorithm.
• No Test Set/Training Set: These concepts are not applicable to the clearance of this type of device.
• No Experts for Ground Truth: Ground truth (e.g., for disease detection) is not established for this device as it does not perform diagnostic or screening functions.
• No MRMC Study: This is a human-use device, but it does not involve human readers interpreting images with or without AI assistance.
• No Standalone Algorithm Performance: The device itself is the product, not an algorithm.
• No Clinical Tests: As stated directly: "No Clinical Test conducted."

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