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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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The infrared thermometer (model of UFR102) is intended for measurement of ear and forehead temperature. It can be used for anybody, e.g. for new-born, for children and for adults.

The infrared non-contact thermometer (model of UFR107) is intended for measurement forehead temperature at home and hospital, for patients of all ages.

Not Found

The provided text describes a 510(k) premarket notification for an Infrared Thermometer, focusing on its regulatory status and indications for use. It does not contain any information about acceptance criteria, device performance testing, sample sizes for training or test sets, expert involvement, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance. Therefore, I cannot generate the requested information based on the provided text.

To answer your request, I would need a document that describes the clinical performance study or validation of the infrared thermometer.

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U60 Series Wrist Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

The proposed device, U60 Series Wrist Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

All the models included in this submission follow the same measurement principle and same specifications. The main differences are data storage and time display. These two differences will not affect the safety and effectiveness of the device.

The provided document is a 510(k) summary for a blood pressure monitor, which primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and international standards. It does not contain information about a clinical study involving human patients to directly "prove the device meets acceptance criteria" in terms of clinical accuracy or performance, as one would typically expect for a software-as-a-medical-device (SaMD) or AI-based device.

The "acceptance criteria" for this device are defined by its adherence to recognized industry standards for non-invasive sphygmomanometers, rather than specific clinical performance metrics derived from a dedicated study reported within this document.

However, I can extract the relevant information based on the context of this 510(k) and general FDA requirements for such devices:

1. Table of Acceptance Criteria and Reported Device Performance

For non-invasive blood pressure monitors, the acceptance criteria are generally defined by the accuracy requirements in standards like ANSI/AAMI/IEC 80601-2-30. The document states the device complies with this standard.

Note: The document lists the pulse rate range as 40-199 bpm for the proposed device, while the predicate is 30-180 bpm. It clarifies this difference is not considered to affect substantial equivalence as the differing ranges (30-40 bpm and 180-199 bpm) are "very rare and abnormal". However, a specific accuracy for pulse rate is not explicitly stated in the table for either the criteria or performance, but it would also be covered by the ANSI/AAMI/IEC 80601-2-30 standard.

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

The document does not describe a clinical study with a "test set" in the context of patient data to assess diagnostic or predictive accuracy. Instead, it refers to "bench tests" to verify design specifications and compliance with standards. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as there is no described clinical study involving human patients and expert review to establish ground truth for a diagnostic performance assessment. The "ground truth" for the device's accuracy is its measurement against a calibrated standard (presumably, an invasive BP measurement or a validated reference device) as part of the standards compliance testing.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring expert adjudication is described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The device is an automated blood pressure monitor and does not involve human readers interpreting output that would necessitate an MRMC study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

The device itself is a "standalone" system in the sense that it automatically measures blood pressure and pulse rate. The document states:

"The proposed device, U60 Series Wrist Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique."

The "standalone performance" is demonstrated through compliance with the ANSI/AAMI/IEC 80601-2-30:2009 standard, which dictates performance requirements for automated noninvasive sphygmomanometers. However, the details of the results of such testing (e.g., number of subjects, average difference, standard deviation) are not provided in this 510(k) summary; only that the device "complies."

7. Type of Ground Truth Used

For the accuracy claim of ± 3 mmHg, the ground truth would be established through comparison of the device's measurements against a standardized reference method for blood pressure measurement (e.g., auscultation with a mercury column sphygmomanometer performed by trained professionals, or more advanced invasive methods in controlled settings). This is an inherent part of the testing required by standards like ANSI/AAMI/IEC 80601-2-30. The document does not explicitly state the methodology for establishing this ground truth, but merely that the device complies with the standard.

8. Sample Size for the Training Set

This information is not applicable. The U60 Series Blood Pressure Monitor is an oscillometric device, which uses established algorithms for blood pressure determination. It is not an AI/ML device that requires a "training set" in the conventional sense of machine learning. The algorithms are typically developed and validated using physiological data but not in a way that is described as a "training set" for an AI model.

9. How Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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