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This oscillometric blood pressure monitor is intended to measure the systolic blood pressure, pulse rate and mean arterial pressure (MAP) in people aged 3 years or older. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.

This oscillometric blood pressure monitor is intended for measuring non-invasive blood pressure in people aged 3 years or older. It is clinically validated in patients with hypertension, hypotension, diabetes, pregnancy, pre-eclampsia, atherosclerosis, end-stage renal disease, obesity and the elderly. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.

The proposed device, oscillometric blood pressure monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure, pulse rate and mean arterial pressure of the person aged 3 years or older at upper arm within its claimed range and accuracy via the oscillometric technique.

The proposed oscillometric blood pressure monitor is available in one model, RBP 100.

Three sizes of cuffs are provided with proposed device, which are S size, M size and L-XL size: 1422cm; M size: 2232cm; L-XL size: 32~52cm).

The proposed device is intended to be used in medical facilities.

The provided text describes the regulatory clearance of an oscillometric blood pressure monitor (K190927) and references a clinical study conducted to demonstrate its accuracy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-invasive blood pressure monitor. The key performance acceptance criterion for such devices is accuracy as defined by the ISO 81060-2:2013 standard. This standard dictates limits for the difference between the device's measurements and reference measurements (typically from a mercury sphygmomanometer).

Note: While the document mentions "Blood Pressure Accuracy: ±3 mmHg" in the comparative table (Page 6), this is likely a more general specification for the device's internal accuracy, whereas the clinical validation against ISO 81060-2 is what demonstrates its performance in a clinical setting against a reference standard. The ISO standard has specific, more complex criteria involving mean difference and standard deviation of differences across subjects. The statement "The test results can meet the requirements of acceptance criteria and ISO 81060" confirms adherence to the ISO standard.

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

• Test Set Sample Size:
  • Adults: Three distinct groups were recruited: "Three 85 subjects (aged 54±19 years)", "33 subjects (aged 53±17 years)", and 41 children. It's unclear if the "Three 85 subjects" refers to 3 groups of 85, or if "85 subjects" is the total. However, the ISO 81060-2 standard typically requires a minimum of 85 subjects for a full validation. Given the multiple age ranges and types of subjects mentioned, it indicates efforts to cover the required demographic spread.
  • Children: 41 children (7.7±2.8 years).
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It was a primary clinical study conducted for the predicate device (WatchBP, K101275) and re-used for the current device due to identical blood pressure models. The study was conducted retrospectively in relation to the current device's submission, but was likely a prospective study at the time it was originally performed for the predicate device.

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

The context of the study is a comparison of an automated device against a reference method (likely a mercury sphygmomanometer as per ISO 81060-2). The "ground truth" for blood pressure measurements in such studies is established by trained oscillometric and auscultatory observers who follow strict protocols for manual blood pressure measurement to serve as the reference. The document does not specify the number or qualifications of these observers, but the adherence to ISO 81060-2 implies that appropriately trained personnel performed the reference measurements.

4. Adjudication Method for the Test Set

The study used the "same-arm sequential BP measurement method" which is a standard procedure in ISO 81060-2. This method involves taking alternating measurements from the test device and a reference device (e.g., a mercury sphygmomanometer) on the same arm. Adjudication in the typical sense (e.g., 2+1 or 3+1 reader consensus for imaging studies) is not applicable here as the ground truth is established by a direct physical measurement comparison. The ground truth itself is derived from the reference standard measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices where human readers interpret images with and without AI assistance. This submission pertains to a blood pressure monitor, which is a standalone measurement device, and the clinical study focuses on its measurement accuracy compared to a reference standard, not its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) was Done

Yes, the clinical study performed for the predicate device (WatchBP) and referenced here is effectively a standalone performance study. The study evaluated the accuracy of the oscillometric blood pressure monitor in measuring blood pressure values compared to a reference standard, independent of human interpretation or intervention beyond operating the device. The device itself performs the measurement and outputs the values.

7. The Type of Ground Truth Used

The ground truth used was reference blood pressure measurements obtained from a standard method (implied to be auscultatory measurements using a mercury sphygmomanometer) as mandated by the ISO 81060-2:2013 standard. This is a form of empirical measurement ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device described is a traditional oscillometric blood pressure monitor, not an AI/ML-driven device that typically requires a large training dataset. The "blood pressure model" refers to the underlying algorithm or method for oscillating blood pressure measurement, which would have been developed and refined through engineering, calibration, and clinical validation, not necessarily "trained" in the machine learning sense. The clinical study described is for validation/performance, not for training.

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

As there's no mention of a "training set" in the context of an AI/ML model, the concept of establishing ground truth for a training set is not applicable here. The "blood pressure model" was likely developed based on known physiological principles of oscillometry and extensively tested/calibrated using controlled experimental setups and initial clinical trials (which are distinct from the final validation study mentioned).

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The RVS-100 vital signs monitor is intended to be used for monitoring, reviewing, storing and sending alarms regarding multiple physiological patient parameters, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Noninvasive Blood Pressure (NIBP), and Temperature (Temp).

The RVS-100 vital signs monitor is intended to be used in controlled, hospital environments. It is not intended for helicopter transport, hospital ambulance or home use.

The Riester RVS-100 vital signs monitor can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. The RVS-100 is a portable device, consist of main unit and accessories, including NIBP cuff, Temperature sensor, and SpO2 sensor.

RVS-100 vital signs monitor has a DC power connector, RVS-100 can connect with extension device RVS-200 and supply power for RVS-200 through the DC power connector.

The provided text is a 510(k) summary for the RVS-100 Vital Signs Monitor. This document focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical testing against recognized standards. It does not detail a clinical study with specific acceptance criteria, reported device performance metrics like sensitivity/specificity, or parameters related to AI/algorithm performance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

• Cannot be directly created. The document lists non-clinical standards the device complies with (e.g., IEC 60601-1, IEC 80601-2-30). These standards have their own acceptance criteria, but they are general safety and performance standards for vital signs monitors, not specific performance metrics (like sensitivity, specificity, or agreement with a gold standard) for a diagnostic algorithm. The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, specific quantitative performance data against acceptance criteria are not provided in this summary.

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

• Not applicable / Not provided. No clinical test set data is described. The non-clinical tests would involve testing against equipment and simulated conditions, not a "sample size" of patients or data in the typical sense of a diagnostic study.

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

• Not applicable / Not provided. No clinical test set or ground truth establishment by experts is described.

4. Adjudication method for the test set

• Not applicable / Not provided. No clinical test set or adjudication method is described.

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. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

• N/A. The device itself performs measurements; it's not an "algorithm only" device in the context of diagnostic AI. Its performance is evaluated against physical measurement standards.

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

• Not applicable (for a clinical context). For non-clinical tests, the "ground truth" would be established by reference measurement devices or calibrated standards as per the specific IEC/ISO standards mentioned (e.g., a calibrated pressure meter for NIBP, a reference oximeter for SpO2). The document explicitly states: "Non-clinical testing is included in this submission, because all modules have been previously cleared by FDA." This implies reliance on established methods for vital signs measurement.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that requires a training set in the typical sense.

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

• Not applicable / Not provided. As above, no training set for an AI/ML model is described.

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The device is used for measuring body temperature in the mouth (oral) in the anus (rectal) and in the armpit (axillary). It is intended for adults, children and infants.

The ri-former® Predictive Thermometer is a fast, highly accurate, and easy to use clinical instrument for measuring patient temperatures by oral, axillary or rectal means. The thermometer is driven by the power supply of our ri-former® diagnostic station. There are rectal (red) and oral, axillary (blue) probes available. To prevent from cross contamination the thermometer needs to be used with disposable probe covers. The thermometer can be used for the temperature measurement of all patients and is designed for the use in hospitals, clinics, medical practices or similar facilities.

This FDA 510(k) premarket notification for the "ri-former Predictive Thermometer" indicates that no clinical studies were performed. The device's substantial equivalence to a predicate device ("FILAC FAS TEMP ELECTRONIC THERMOMETER", K003313) was established through non-clinical performance data.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from the provided document.

However, based on the non-clinical testing performed, we can infer some performance criteria that the device met:

1. Table of Acceptance Criteria and Reported Device Performance

• ISO 10993-10:2013 (Tests for irritation and skin sensitization) compliant | Human contacting components (probe, probe cover) were tested in accordance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization). (Implies compliance as it was submitted in support of substantial equivalence). |
  | Electrical Safety | - IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 compliant (General Requirements for Basic Safety and Essential Performance) | Device was tested in accordance with IEC 60601-1. (Implies compliance as it was submitted in support of substantial equivalence and cited as evidence for different power source and materials). |
  | Electromagnetic Compatibility (EMC) | - IEC 60601-1-2:2007 (Third edition) compliant (Collateral Standard: Electromagnetic Disturbances -- Requirements and Tests) | Device was tested in accordance with IEC 60601-1-2. (Implies compliance as it was submitted in support of substantial equivalence and cited as evidence for different power source). |
  | Thermometer Performance (Overall) | - ISO 80601-2-56 First Edition 2009-10-01 compliant (Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement)
• ASTM E1112-00 (Reapproved 2011) compliant (Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature)
• Consistent with Predicate Device | Tests determined that the ri-former® Predictive Thermometer performance is substantially equivalent to the predicate device.
  The device was tested in accordance with ISO 80601-2-56 and ASTM E1112-00. (Implies compliance with these standards and substantial equivalence). |
  | Software Verification & Validation | - FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" compliant (Moderate Level of Concern)
• All software requirements met Pass/Fail criteria. | System level software verification and validation protocol developed. Results of each test recorded and compared to pass/fail criteria. All software verification and validation activities show that the software meets product requirements documentation. (Implies all requirements were met). |
  | Power Source (Differences from Predicate) | The difference in power source (ri-former diagnostic station vs. battery) does not raise issues of product's safety and effectiveness. Electromagnetic compatibility and electrical safety demonstrated by testing. | Demonstrated electromagnetic compatibility and electrical safety by testing (IEC 60601-1 and IEC 60601-1-2). Validated to be electrical safety. |
  | Enclose Cover Material (Differences from Predicate) | The ABS material is widely used in medical devices and does not raise issues of product's safety and effectiveness. | (Implied: ABS D-1000 is acceptable and does not raise new safety or effectiveness concerns, in line with its wide use in medical devices). |

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

Not applicable. No clinical test set was used. The substantial equivalence was based on non-clinical performance data and comparison to a predicate device.

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

Not applicable. No clinical test set was used, and thus no ground truth established by experts for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "No clinical testing data is included in this submission."

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

Not applicable in the context of an AI/ML algorithm. This device is a predictive thermometer, which is a hardware device with embedded software, not typically evaluated as a standalone AI algorithm in the same way imaging or diagnostic AI is. The software was verified and validated to meet product requirements.

7. The Type of Ground Truth Used

Not applicable in the context of clinical "ground truth" derived from patient data. For the non-clinical performance tests, such as those against ISO and ASTM standards, the "ground truth" would be established by the reference conditions and measurement techniques defined within those standards (e.g., calibrated water baths for temperature accuracy, standard test procedures for electrical safety).

8. The Sample Size for the Training Set

Not applicable. The document does not describe an AI/ML model that would require a "training set" in the conventional sense. The device is a "predictive thermometer," suggesting a model or algorithm for temperature prediction, but information on how this internal prediction algorithm was developed or trained is not provided in this 510(k) summary. The software verification and validation focused on meeting product requirements rather than describing a training process for an AI model.

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

Not applicable, as a training set for an AI/ML model is not described.

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Precisa-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)

Precisa-N is a sphygmomanometer

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a blood pressure cuff (Precisa-N). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

However, this document does not contain any information about:

• Acceptance criteria or reported device performance in a table.
• Details of a study (sample size, data provenance, number/qualifications of experts, adjudication method).
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Standalone performance (algorithm-only).
• Type of ground truth used.
• Training set size or how its ground truth was established.

Therefore, I cannot fulfill your request based on the provided text.

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Ri-Mega is a sphygmomanometer and is intended to measure the blood pressure

Ri-Mega is a sphygmomanometer

This looks like a 510(k) clearance letter from the FDA for a blood pressure measuring device (sphygmomanometer) called "RI-Mega."

Unfortunately, the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a regulatory approval letter, specifically a 510(k) clearance, which states that the device is "substantially equivalent" to a legally marketed predicate device. This type of letter generally references the 510(k) submission, where the performance data and acceptance criteria would typically reside.

Therefore, I cannot provide the requested table and study details based solely on the provided text.

To answer your questions, I would need access to the actual 510(k) submission document for K972377, which would include the performance data, acceptance criteria, study design, and ground truth information.

However, I can deduce some general characteristics about this type of device and its typical evaluation:

Given it's a sphygmomanometer, the performance criteria would likely revolve around:

• Accuracy: How close the device's blood pressure readings are to a reference standard.
• Precision/Reproducibility: How consistent the device's readings are when measured multiple times under similar conditions.
• Bias: Systematic deviation from the reference.
• Safety: General safety characteristics, though for a manual sphygmomanometer, this is generally well-established.

The studies would typically involve:

• Comparing the device's readings against a recognized standard (e.g., auscultatory method by trained observers).
• Recruiting a diverse range of subjects.

Without the actual 510(k) submission, I must state that the requested information is not available in the provided text.

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Sanaphon-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)

Sanaphon-N is a sphygmomanometer

The provided text does not contain information on acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device named SanaPhon-N, indicating its substantial equivalence to a predicate device. It defines the intended use as a sphygmomanometer for self-measurement of blood pressure.

Therefore, I cannot provide the requested information about acceptance criteria or study details from this document.

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Big Ben Square and Big Ben Round models are sphygmomanomter and are intended to measure the blood pressure.

Not Found

This document is an FDA 510(k) clearance letter for a blood pressure measuring device (sphygmomanometer). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device marketed before May 28, 1976, but does not detail performance testing. Therefore, I cannot extract the requested information from this document.

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