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The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.

The proposed device, Arm Blood Pressure Monitor, is an automatic noninvasive Blood Pressure Monitor which can be driven by dry batteries. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy.

The proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.

This blood pressure monitor has the memory function of 60 groups of measuring data of two people, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.

This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not according to the World Health Organization/ International Society for hypertension(WHO/ISH) guidelines on the treatment of hypertension dated in 1999.

This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.

Cuff supporting the use of Arm Blood Pressure Monitor is M5303(small adult)/M5304(adult)/ M5305(big adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).

The information provided primarily describes a 510(k) submission for an Arm Blood Pressure Monitor (model RN-032A, RN-032C), indicating its substantial equivalence to a predicate device. The document mentions a clinical trial conducted to prove its performance.

Based on the provided text, here's what can be extracted regarding the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria for the device's accuracy are based on a specific standard: ISO 81060-2:2018.

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

• Sample Size: 150 subjects.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical trial for device validation, it is generally assumed to be prospective.

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

The document states that "Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group". It does not specify the number or qualifications of the individuals performing the auscultation. For blood pressure measurement studies, the "experts" are typically trained operators using a standardized auscultation method.

4. Adjudication method for the test set

The document does not describe an adjudication method. For blood pressure studies using auscultation, there isn't typically an adjudication process in the same way there would be for image-based diagnostics. The auscultatory readings from the trained operators serve as the "gold standard" for comparison.

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, an MRMC comparative effectiveness study was not performed. This type of study is specifically relevant for AI-assisted diagnostic tools where human interpretation of images or data is a key component. This device is an automated blood pressure monitor, not an AI diagnostic tool.

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

• Standalone Performance: Yes, in essence, the clinical trial described assesses the standalone performance of the automated blood pressure monitor. The device's measurements (algorithm's output) were compared directly against the gold standard (auscultation). The accuracy result of "within ±3mmHg" is the standalone performance.

7. The type of ground truth used

• Type of Ground Truth: Expert consensus (specifically, auscultation by trained individuals or a qualified operator) using a qualified calibrated mercurial sphygmomanometer. This is the established clinical method for accurate blood pressure measurement.

8. The sample size for the training set

The document does not provide information on a training set sample size. This is a clinical validation study for a medical device's performance, not a study for a machine learning model that would typically have distinct training and test sets. The "clinical trial" described is the performance validation (test set).

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

Not applicable, as no training set (in the context of machine learning) is mentioned or implied for this type of device validation study.

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The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.

The Infrared Thermometer, Models RN-50A and RN-50B are hand-held device powered by 2*AA batteries and designed to measure human body temperature without contacting patient' forehead. The Infrared Thermometers RN-50A and RN-50B measure the temperature by using the principle of receiving infrared. An object with a temperature higher than absolute zero will radiate a certain amount of infrared energy. According to the infrared energy and wavelength, the surface temperature of the object can be determined. The temperature of human forehead is relatively constant, so the temperature of human forehead can be measured according to this principle. The thermometer adopts a new CMOS compatible thermopile sensor with good sensitivity. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then display on the LCD screen in digital form. The measurement distance of the subject device is 3~5 cm from the forehead. The only differences among the RN-50A and RN-50B thermometers are size, weight, shape of enclosure.

The provided document is a 510(k) premarket notification for an Infrared Thermometer (Models RN-50A, RN-50B). It describes the device, its intended use, a comparison to a predicate device, and the non-clinical and clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the infrared thermometer are primarily based on its accuracy and adherence to specific standards.

Study Details:

The document describes a "Clinical Accuracy Validation Test" as the primary study to prove the device meets acceptance criteria for accuracy.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: "consists of a 161 subjects which were divided into three group age ranges- A Infant group (Group A- (A1) 1 month up to 3 months; (A2)- 3 months up to 1 year), B Child group (greater than 1 to 5 years old) and C Over 5 years old (Above 5 years old). Each group at least has 35 subjects." (Page 9)
   • Data Provenance: Not explicitly stated, but given the manufacturer's address (Ningbo, China) and the correspondent's address (Shanghai, China), it can be inferred the study was likely conducted in China. The document does not specify if it was retrospective or prospective, but clinical trials are typically prospective.

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

   • This information is not provided in the document. For a thermometer, the "ground truth" would typically come from a highly accurate reference thermometer (e.g., a rectal thermometer for core body temperature, or a calibrated black-body source for non-contact measurements), not human experts.

3. Adjudication Method for the Test Set:

   • This is not applicable as the "test set" here refers to patient measurements compared to a reference standard, not images requiring expert interpretation and adjudication.

4. 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 is not applicable to this device. An infrared thermometer measures temperature; it does not involve human readers interpreting images or AI assistance.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • This is not applicable in the traditional sense of an "algorithm" in AI. The device itself is the "standalone" entity that measures temperature. Its performance is evaluated against a clinical standard.

6. The Type of Ground Truth Used:

   • The ground truth for the clinical accuracy validation test was derived from a reference standard as defined by ASTM E1965-98 (Reapproved 2016). This standard outlines procedures for determining the accuracy of infrared thermometers against a "core body temperature" reference, often involving concurrent measurements with highly accurate methods like rectal thermometers in a controlled clinical setting. While not explicitly stated as "rectal" or "oral" in this document, adherence to the ASTM standard implies the use of a validated, highly accurate measurement method as the ground truth.

7. The Sample Size for the Training Set:

   • This device is a physical thermometer, not a machine learning model that requires a distinct "training set." The concept of a "training set" is not applicable here. The 161 subjects are for the validation of the device's accuracy.

8. How the Ground Truth for the Training Set Was Established:

   • As there is no "training set" in the context of an AI/ML model for this device, this question is not applicable. The device's design and calibration would have been based on physics principles and engineering, not data-driven training.

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The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.

The Infrared Thermometer, Models RN-60A and RN-60B are hand-held device powered by 2*AAA batteries and designed to measure human body temperature without contacting patient' forehead. The Infrared Thermometers RN-60A and RN-60B measure the temperature by using the principle of receiving infrared. An object with a temperature higher than absolute zero will radiate a certain amount of infrared energy. According to the infrared energy and wavelength, the surface temperature of the object can be determined. The temperature of human forehead is relatively constant, so the temperature of human forehead can be measured according to this principle. The thermometer adopts a new CMOS compatible thermopile sensor with good sensitivity. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then display on the LCD screen in digital form. The measurement distance of the subject device is 3~5 cm from the forehead. The only differences among the RN-60A and RN-60B thermometers are size, weight, shape of enclosure.

The provided document describes the FDA 510(k) clearance for an Infrared Thermometer (Models RN-60A, RN-60B). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a novel device meets specific performance criteria against a predefined standard of care.

Therefore, the information required to fully describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device (as implied by the detailed questions about sample size for training/test sets, expert adjudication, MRMC studies, etc.) is largely not applicable (N/A) to this specific device (an infrared thermometer) or the type of 510(k) submission described.

However, I can extract the relevant performance data for the infrared thermometer and discuss the "acceptance criteria" and "study" as presented in the document for this traditional medical device.

Key points from the document regarding "acceptance criteria" and "study":

• Acceptance Criteria: For this device, the primary "acceptance criteria" are compliance with established performance standards for infrared thermometers, specifically ASTM E1965-98 (Reapproved 2016), and demonstrating substantial equivalence to a predicate device (Shenzhen Calibeur Industries Co., Ltd. Infrared Thermometer, Model DT-8836T, DT-8836P, K191251).
• Study Proving Acceptance: A "clinical accuracy validation test" was conducted per ASTM E1965-98.

Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for a non-AI device:

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

For a traditional device like a thermometer, "acceptance criteria" are typically defined by recognized standards and "reported device performance" demonstrates adherence to these.

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

• Sample Size for Test Set: A clinical study included a minimum of 178 subjects. These subjects were divided into three age groups:
  • Group A1: 1 month up to 3 months
  • Group A2: 3 months up to 1 year
  • Group B: greater than 1 to 5 years old
  • Group C: Above 5 years old
  • Each group had at least 30 subjects.
• Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from a Chinese company (Ningbo Ranor Medical Science & Technology Co., Ltd.) and the correspondent is in Shanghai. The study design is described as a "randomization, simple blind homologous control, pairing design of clinical investigation." It is not specified if it was retrospective or prospective, but clinical accuracy studies for new devices are typically prospective.

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

• N/A. For an infrared thermometer, "ground truth" for body temperature measurement typically involves a highly accurate reference thermometer (e.g., a rectal thermometer for core body temperature) used in a clinical setting, rather than expert interpretation of images or data. The document does not mention the use of experts in this capacity.

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

• N/A. This concept is primarily relevant for studies involving human interpretation (e.g., radiologists reading images). For a thermometer's accuracy study, the "ground truth" is typically a direct physiological measurement, and adjudication methods like 2+1 are not applicable.

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

• N/A. This is a traditional thermometer device, not an AI/ML device. Therefore, no MRMC study involving human readers or AI assistance was conducted or is relevant.

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

• Yes, in concept. The "clinical accuracy validation test" described for the thermometer is essentially a standalone performance evaluation of the device itself against a reference standard, without human-in-the-loop assistance for measurement interpretation (as the device provides a direct digital readout). There is no "algorithm" in the AI/ML sense, but the device's internal processing to convert infrared signals to temperature is tested.

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

• The ground truth for the clinical accuracy validation test would be established using a highly accurate reference thermometer (e.g., a rectal thermometer or other core body temperature measurement device) as per the requirements of ASTM E1965-98. The document specifically states "Clinical tests were conducted per ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature," which outlines the methodology for ground truth establishment.

8. The sample size for the training set

• N/A. This is a hardware device (infrared thermometer) with no mention of machine learning or deep learning algorithms that would require a "training set" in the context of AI.

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

• N/A. As no training set for AI was used.

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