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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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intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual who over the age of 12 in medical facilities or at home by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm).

The Subject device is not intended to be diagnostic device.

The device has four series : U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) , U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z) and U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ).

All of them have same Indications for use and similar technological characteristics. All the models in the same series have the same electrical circuit design, PCB layout, critical components and internal wiring. The differences between the four series are the appearance design, circuit diagram and the PCB layout. All of them have the same working principles, software design and the similar technical specification.

Urion Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff.

The provided text describes the 510(k) submission for the Shenzhen Urion Technology Co., Ltd. Upper Arm Electronic Blood Pressure Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a typical study report detailing the achievement of specific acceptance criteria for an AI/ML device.

Therefore, the information required to fully answer your request regarding acceptance criteria and the study proving the device meets them (especially in the context of an AI/ML device, as implied by your detailed questions about MRMC studies, ground truth establishment, etc.) is largely absent from this particular FDA submission document.

This document primarily focuses on demonstrating the device's adherence to established standards for non-invasive blood pressure monitors, rather than the performance of an AI/ML algorithm with specific accuracy metrics derived from large datasets, expert labeling, and adjudication.

However, based on the provided text, I can infer and extract the relevant information for the clinical validation of this blood pressure monitor, which is a key part of its performance evaluation.

Here's the analysis of what is and isn't available in the provided text:

1. A table of acceptance criteria and the reported device performance

The document references compliance with ISO 81060-2:2018+A1(2020) and IEC 80601-2-30:2018. These standards define the acceptance criteria for accuracy for non-invasive blood pressure monitors. While the explicit table of values isn't provided, the text states:

• Accuracy: Pressure: ±3mmHg; Pulse: ±5%

This is a general accuracy claim, and the clinical validation study is stated to have demonstrated that the Upper Arm Electronic Blood Pressure Monitor meets the requirements of these standards. The standards themselves would contain the specific statistical acceptance criteria (e.g., mean difference and standard deviation of differences between device and reference measurements within certain limits).

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 92 subjects were used for the clinical validation.
• Data Provenance: The document does not specify the country of origin. It implicitly describes a prospective clinical investigation ("This monitor is clinically investigated...").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts/Qualifications: Not specified. For blood pressure clinical validation studies following ISO 81060-2, the "ground truth" (or reference measurements) is typically established by trained observers (often two) using auscultatory methods with a mercury sphygmomanometer or validated equivalent. The qualifications of these observers (e.g., specific training, certification) are crucial but not detailed in this summary.

4. Adjudication method for the test set

• Adjudication Method: Not explicitly stated. For ISO 81060-2 studies, commonly two observers simultaneously take measurements, and their readings are averaged or adjudicated if they differ significantly. The standard outlines specific procedures for this.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic device that would involve human readers interpreting AI output. Therefore, an MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, the device's performance is inherently standalone. The clinical validation proves its accuracy as an automated non-invasive sphygmomanometer without human interpretation of its measurement results beyond reading the display. The "algorithm" here refers to the oscillometric method used by the device to determine BP and pulse.

7. The type of ground truth used

• Ground Truth Type: Clinical validation against reference blood pressure measurements (likely auscultatory method as per ISO 81060-2) and pulse rate from subjects. This is considered performance data directly from human subjects.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/not explicitly mentioned. This is a traditional medical device, not an AI/ML device that requires a separate "training set" in the machine learning sense. Its internal "algorithm" (oscillometric method) is based on established physiological principles and signal processing, not on training data from a large dataset. The "development" and "testing" are primarily against engineering specifications and clinical validation standards.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable. (See #8).

Summary of available information:

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Measure blood pressure(systolic and diastolic) and pulse rate.

Upper Arm Electronic Blood Pressure Monitor, Model U86E and TelliBP01 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a wellknown technique in the market called the "oscillometric method".

The main components of the Upper Arm Electronic Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately 22 cm to 42 cm, includes the inflatable bladder and fabric. The device consists of the main unit and cuff.

The product is provided non-sterile, and not to be sterilized by the user prior to use.

Model U86E and TelliBP01 in this submission follow the similar software, same measurement principle and similar specifications. The differences existed between different models included in this submission will not affect the safety and effectiveness of the device.

The model U86E embed an Bluetooth Wireless network connections module that allows it to send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments. The TelliBP01 embed a SIM card, which can send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments through 4G network. The wireless functions of U86E and TelliBP01 only have data transmission function, without any control feature.

Here's an analysis of the acceptance criteria and study details for the Upper Arm Electronic Blood Pressure Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The clinical study for the device refers to "Criterion 1" and "Criterion 2" of ISO 81060-2:2018/A1:2020. This indicates that these are the acceptance criteria. The ISO 81060-2 standard defines accuracy requirements for automated sphygmomanometers. Based on the document, the requirements for clinical validation are as follows:

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

• Sample Size: 93 qualified participants.
• Data Provenance: Not explicitly stated regarding country of origin. The study was a "clinical accuracy testing" and the language used in the document is English, but it's for a Chinese manufacturer. The study is prospective, as it's a "clinical study" performed for the purpose of validating the device.

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

• Number of Experts: Not explicitly stated. The document mentions "A Mercury Sphygmomanometer was used as a reference device" which implies human observers for the reference measurements.
• Qualifications of Experts: Not explicitly stated. For a clinical validation of blood pressure devices using a mercury sphygmomanometer, it is generally understood that trained medical professionals or observers are required to take the reference readings and usually two observers are used for comparison, but the document does not specify their roles or qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. For clinical validation of blood pressure monitors, if multiple observers are used for the reference method (e.g., auscultatory method with mercury sphygmomanometer), their readings would typically be averaged or adjudicated if they differ significantly. However, the document only mentions "A Mercury Sphygmomanometer was used as a reference device," which doesn't detail the number of observers or any adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, a standalone performance study was done. The clinical testing performed according to ISO 81060-2:2018/A1:2020 evaluates the accuracy of the automated device (algorithm only) against a reference standard (mercury sphygmomanometer). The device is designed to provide readings automatically without human-in-the-loop interpretation once the measurement is initiated.

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus via a reference device (Mercury Sphygmomanometer). The document states: "A Mercury Sphygmomanometer was used as a reference device." This is standard clinical practice for validating automated blood pressure monitors.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not provided in the document. The document describes clinical validation testing, which is separate from the training of the device's algorithms. The "oscillometric method" is a well-known technique, implying the core algorithm is established, but details of its training data (if any specific to this model's algorithm rather than general knowledge) are not included.

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

• Ground Truth for Training Set: Not provided. As stated above, the document focuses on the clinical validation of the device, not the development or training of its internal algorithms. The "oscillometric method" is a fundamental principle, and any specific training data and its ground truth establishment for this device's implementation of that method are not discussed.

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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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The U80 Series Upper Arm 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 upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36cm.Suitable for adults who over the age of 12.

The proposed device, U80 Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm 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 appearance, data storage and time display. These three differences will not affect the safety and effectiveness of the device.

The provided text describes a 510(k) premarket notification for a medical device, the "Upper Arm Electronic Blood Pressure Monitor U80 Series." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove efficacy and safety from scratch.

Therefore, the document does not contain the detailed information typically associated with a study proving that a device meets specific acceptance criteria for AI/ML performance (e.g., number of experts, adjudication methods, MRMC studies, ground truth establishment for AI training/test sets). Instead, it relies on bench testing and comparison to an existing device.

Here's an analysis based on the available information and an explanation of why certain information requested is not present:

Context: The device is a non-invasive blood pressure monitor. The "acceptance criteria" discussed here are primarily related to meeting recognized performance standards for blood pressure measurement and demonstrating equivalence to a predicate device, not necessarily AI/ML performance criteria.

1. A table of acceptance criteria and the reported device performance

The document presents a "Substantially Equivalent Comparison" table (Table III-1) which serves as the primary way the device's performance is compared against regulatory and predicate device benchmarks. The "acceptance criteria" are implicitly defined by the predicate device's performance and relevant standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on bench tests and compliance with recognized standards for its performance evaluation, rather than a clinical "test set" in the context of AI/ML validation involving patient data.

The standards cited include:

• ANSI/AAMI/IEC 80601-2-30:2009 "Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers."
• ANSI/AAMI/ISO 81060-2:2009 "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

These standards outline clinical testing requirements, including sample sizes for validation studies for blood pressure monitors. For instance, ISO 81060-2 typically requires a certain number of subjects (e.g., usually around 85 subjects with specific age and BP distribution) for clinical validation. However, the specific sample size used in the company's validation study or its provenance for this specific submission is not explicitly detailed in the provided 510(k) summary. It is stated that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards." This implies the tests mandated by these standards were performed, but the summary does not include the raw results or the clinical trial specifics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not present in the document. The device is a blood pressure monitor, not an AI/ML diagnostic imaging device that requires radiologist interpretations for ground truth. The "ground truth" for a blood pressure monitor is established through a reference measurement method (e.g., auscultation by trained observers with mercury sphygmomanometers) as per the mentioned ISO/AAMI standards. The document does not detail the specifics of such clinical validation for this particular submission, only that the device "complies" with the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as it pertains to expert consensus on diagnostic images, not a standard blood pressure measurement device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This question refers to AI-assisted diagnostic tools. The device is an automated blood pressure monitor; there are no "human readers" interpreting its output that would be assisted by AI in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a "standalone" automated blood pressure monitor in that it measures blood pressure directly via an oscillometric technique. Its performance is evaluated purely on its ability to accurately measure BP, as detailed by the standards it claims compliance with (e.g., accuracy of ±3 mmHg). There isn't an "algorithm only" component separate from the integrated device for this type of product that would typically necessitate such a study as posed in the context of complex AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For blood pressure monitors, the "ground truth" for clinical validation is typically established through simultaneous auscultatory measurements performed by trained human observers using a validated reference method (e.g., mercury sphygmomanometer or another agreed-upon reference device), following the protocols outlined in standards like ANSI/AAMI/ISO 81060-2. The exact specifics of how this ground truth was established for this specific device's compliance are not detailed in the provided 510(k) summary, beyond stating compliance with the standard that mandates such methods.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that undergoes training on a large dataset in the way a deep learning model would. Its "training" or development process would involve traditional engineering and calibration.

9. How the ground truth for the training set was established

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

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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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