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510(k) Data Aggregation
(175 days)
The Withings Blood Pressure Monitor, Upper Arm Type: BP-801 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9 to 17 inches (22cm-42cm) for Upper Arm type.
The Withings BP-801 is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 to 17 inches (22 - 42 cm) via an arm cuff. It is designed and manufactured according to IEC 80601-2-30, Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. The operational principle is based on oscillometric and silicon integrates pressure sensor technology it can calculate the systolic and diastolic blood pressure, the measurement results can also be classified by the function of blood pressure classification indicator. The Withings BP-801 is a blood pressure monitor achieves its function by integrate the device with an iPhone 4S. As it does not include a LCD or other display components, it is necessary for the new device to connect to an iPhone 4S containing a support software to constitute a complete blood pressure measurement system. And the new device connects iPhone 4S through Bluetooth or USB cable.
Here's a breakdown of the acceptance criteria and study details for the Withings Blood Pressure Monitor BP-801, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against the ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 & ANSI/AAMI/IEC 80601-2-30:2009 protocols.
| Acceptance Criteria | Device Performance - Systolic | Device Performance - Diastolic |
|---|---|---|
| Criterion 1: The mean error of determination for 108 individual paired determinations shall not be greater than 5.0 mmHg, with a standard deviation no greater than 8.0 mmHg. | Mean Difference: -0.242 mmHg |
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(135 days)
The YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W are noninvasive blood pressurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9.0" for Arm type.
YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Here's the breakdown of the acceptance criteria and study information for the YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Standard | Reported Device Performance |
|---|---|
| IEC/EN 60601-1:2007 (General Safety) | PASS |
| EN 1060-1:2009, EN 1060-3:2009 | PASS |
| IEC/EN 60601-1-2: 2010 (EMC Conformity) | PASS |
| ANSI C63.4: 2003 (FCC Conformity) | PASS |
| FCC 47 part 15 subject B class B | PASS |
| EN 30148-1:2008, EN 30148-17:2009 (ERM Conformity) | PASS |
| EN 300328:2006 (RF Conformity) | PASS |
| ANSI / AAMI SP 10: 2002 (Performance & Clinical Test) | Not explicitly stated as "PASS" but implied through the statement "YA HORNG Electronic Co. Ltd. believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent..." |
| ANSI / AAMI ISO 81060-2:2009 (Performance & Clinical Test) | Not explicitly stated as "PASS" but implied (see above). |
| EN 1060-4:2004 (Performance & Clinical Test) | Not explicitly stated as "PASS" but implied (see above). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the clinical test set. It mentions the application of standards like ANSI / AAMI SP 10: 2002 and ANSI / AAMI ISO 81060-2:2009, which typically outline sample size requirements for blood pressure monitor validation. However, the exact number of subjects tested is not provided.
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. 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 blood pressure monitor validation, ground truth is typically established by trained observers (healthcare professionals) using a reference method, but the details are absent.
4. Adjudication Method for the Test Set
The adjudication method is not described in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. This type of study is more common for diagnostic imaging AI systems to evaluate the impact of AI assistance on human reader performance. This document concerns a standalone blood pressure monitor.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was conducted. The device (BP-700NW and BP-700W) is designed to operate as a standalone device, taking measurements and displaying them. The performance tests against standards like ANSI / AAMI SP 10: 2002 and ANSI / AAMI ISO 81060-2:2009 are evaluations of its automated measurement capabilities. No human-in-the-loop component is described for its fundamental operation or accuracy evaluation.
7. Type of Ground Truth Used
The ground truth used for the performance and clinical tests (i.e. those conforming to ANSI / AAMI SP 10: 2002, ANSI / AAMI ISO 81060-2:2009, EN 1060-4:2004) would typically be invasive blood pressure measurements or auscultatory measurements by trained observers using a validated reference method. However, the document does not explicitly state the type of ground truth.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning, as this device uses the oscillometric method with microcomputer processing, not explicitly a deep learning or AI model that requires a separate training set. So, this information is not applicable in the traditional sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" described for a machine learning model, this information is not applicable. The oscillometric method relies on established physiological principles and algorithms, not necessarily on a training set in the AI sense.
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(52 days)
The Withings Blood Pressure Monitor, Upper Arm Type: HP-800 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9'' 7' (22cm42cm) for Upper Arm type.
Withings Blood Pressure Monitor, Upper Arm Type:BP-800 uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
The provided document is a 510(k) summary for the Withings Blood Pressure Monitor, Upper Arm Type: BP-800. It focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study report with specific acceptance criteria and outcome measurements as might be found in a clinical trial publication.
Based on the information provided, here's a breakdown of the requested elements:
1. Table of Acceptance Criteria and Reported Device Performance
The document references "AAMI / ANSI SP10" as the performance standard. While it states "Withings believes this information and referred document to be sufficient...", it does not explicitly list the specific acceptance criteria defined by AAMI/ANSI SP10 or the device's reported performance against those criteria in a table format within this document.
AAMI/ANSI SP10 is a standard for automated sphygmomanometers, and it sets limits for accuracy (e.g., mean difference and standard deviation between the device and a reference method). However, these specific numerical criteria and the device's measured performance are not provided in this 510(k) summary. The summary only states "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10" implying that the device was tested per this standard, but the results are not detailed.
Key Missing Information: Specific numerical acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation as per AAMI/ANSI SP10) and the actual performance results of the BP-800 device against these criteria.
| Acceptance Criteria (AAMI/ANSI SP10 - Not explicitly stated in document) | Reported Device Performance (BP-800 - Not explicitly stated in document) |
|---|---|
| (e.g., Mean difference between device and reference ≤ ±5 mmHg) | (e.g., Mean difference = X mmHg) |
| (e.g., Standard deviation between device and reference ≤ 8 mmHg) | (e.g., Standard deviation = Y mmHg) |
2. Sample Size Used for the Test Set and Data Provenance
The document references "AAMI / ANSI SP10" for performance and clinical tests. This standard typically requires a specific number of subjects for clinical validation. However, the sample size used for the test set is not explicitly stated within this 510(k) summary.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide details on the number of experts used to establish the ground truth for the test set or their qualifications. For an AAMI/ANSI SP10 validation, typically multiple independent observers (often with specific training in auscultatory blood pressure measurement) are used to establish reference measurements.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set. In AAMI/ANSI SP10 validation, often a consensus of multiple observers or a specific protocol for resolving discrepancies between observers' measurements is employed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study, which typically evaluates human reader performance with and without AI assistance, is not applicable to this device. This is a standalone blood pressure monitor, not an AI-powered diagnostic imaging tool that assists human readers.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was done, implicitly, as the device is an automated blood pressure monitor. The "AAMI / ANSI SP10" standard is specifically for validating the accuracy of such automated devices against Riva-Rocci/Korotkoff auscultation (the traditional "human-in-the-loop" method with a stethoscope). The document states the device "uses the Oscillometric method... and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure." This describes its standalone algorithmic operation. The lack of specific results, however, prevents a quantitative answer here.
7. Type of Ground Truth Used
Based on the reference to "AAMI / ANSI SP10," the standard ground truth for automated blood pressure monitors is typically auscultatory blood pressure measurement performed by trained human observers using a stethoscope and sphygmomanometer, often referred to as the "reference method" or "gold standard" for non-invasive blood pressure.
8. Sample Size for the Training Set
The document describes the device as being "substantially equivalent" to predicate devices and mentions the use of the oscillometric method and microcomputer calculations. It does not mention or provide details about a "training set" in the context of machine learning or AI models. This device is a traditional electronic medical device, not one that relies on a machine learning model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" for a machine learning model, this question is not applicable in the context of this device's description. The device's operation is based on an established oscillometric algorithm rather than a data-trained AI model.
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(115 days)
The TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures, at hospital or professional environment by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
TYTAN Automatic Aneroid Sphygmomanometer A730 and TYTAN Manual Digital LCD Sphygmomanometer A830 series use the Auscultatory method to measure the blood pressure. It needs to use the stethoscope as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systelic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
The manufacturer tested the TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 for performance against the AAMI / ANSI SP10:2002 standard.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance & Clinical Test | AAMI / ANSI SP10:2002 standard | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the performance and clinical test, nor does it provide information on data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The devices are blood pressure monitors and do not involve AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This does not apply as the device is a sphygmomanometer, which is a hardware medical device for blood pressure measurement, not an algorithm. The "standing alone" performance would refer to the device's accuracy in measuring blood pressure against a reference method. The document states a clinical test was performed to AAMI/ANSI SP10:2002, which is a standard for automated sphygmomanometers, implying standalone performance was evaluated.
7. The type of ground truth used
For blood pressure monitors, the ground truth for clinical accuracy testing (such as that described by AAMI/ANSI SP10:2002) is typically established by simultaneous measurements using a clinically validated reference method (often a mercury sphygmomanometer or another auscultatory method performed by trained observers). The document does not explicitly state the specific ground truth method used, but compliance with AAMI/ANSI SP10:2002 implies such a method was utilized.
8. The sample size for the training set
This information is not applicable as the devices are hardware medical devices for blood pressure measurement and are not described as using machine learning models that require a training set in the context of this 510(k) summary.
9. How the ground truth for the training set was established
This information is not applicable (see point 8).
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(104 days)
The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9.0" ~ 13.0" for Arm type.
YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700. BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
The provided document describes the 510(k) summary for the YA HORNG Digital Upper Arm Blood Pressure Monitor (models BP-700 series). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data for the device itself.
Based on the available information, here's an attempt to answer your questions, highlighting what is present and what is not:
Acceptance Criteria and Study for YA HORNG Digital Upper Arm Blood Pressure Monitor (BP-700 series)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific numerical acceptance criteria (e.g., mean difference, standard deviation thresholds for blood pressure accuracy) or quantitative performance data from a clinical accuracy study for the BP-700 series.
Instead, it refers to overall compliance with standards:
- General Safety: EN 60601-1:1990+A1+A2+A11+A12+A13 – Reported as "PASS".
- EMC Conformity: EN 60601-1-2: 1993 – Reported as "PASS".
- FCC Conformity: ANSI C63.4: 2003 – Reported as "PASS".
- Blood Pressure Measurement Standard: EN 1060-1:1995, EN 1060-3:1997 – Reported as "PASS".
- Performance & Clinical Test Standard: AAMI / ANSI SP10 – The document states that the company "believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent." This implies that the device was tested against AAMI/ANSI SP10, and it passed, thereby meeting the clinical accuracy requirements outlined in that standard, but no specific numerical results are provided.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the clinical test set (i.e., the number of subjects). It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the company is based in Taiwan, it is plausible that the testing occurred there, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide details on the number or qualifications of experts used to establish ground truth. For blood pressure monitors tested against AAMI/ANSI SP10, ground truth (reference blood pressure measurements) is typically established by trained and certified observers using auscultation with a mercury sphygmomanometer or validated reference device.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method. In clinical studies for blood pressure monitors, if multiple observers are used for reference measurements, their readings are usually averaged or handled according to the specific protocol of the AAMI/ANSI SP10 standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation improvements.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was implicitly done. The "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" indicates that the device's accuracy in measuring blood pressure was evaluated independently against reference measurements, without human intervention in the device's measurement process. The device operates as an "algorithm only" in generating the blood pressure readings.
7. Type of Ground Truth Used
The ground truth used for blood pressure monitors compliant with AAMI/ANSI SP10 would be reference blood pressure measurements obtained through a validated method, typically auscultation by trained observers using a mercury sphygmomanometer or an equivalent validated reference device.
8. Sample Size for the Training Set
Not applicable. This is an automated measurement device and the document does not suggest the use of a machine learning model that requires a separate "training set" in the conventional sense (e.g., for image classification). The device uses the Oscillometric method, which relies on a pre-programmed algorithm based on physical principles, not on a machine learning model trained on a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the machine learning context for this device. The oscillometric algorithm is developed based on physiological principles and validated against known reference measurements.
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(184 days)
The CalHealth Finger Blood Pressure Monitor, MDMouse is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the left index finger. The cuff circumference is designed for Left Index Finger circumference: 1.5' ~ 3.5' (3.7~8.8 cm) for finger type.
CalHealth Finger Blood Pressure Monitor, MDMouse uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
The provided 510(k) summary for the CalHealth, Inc. Finger Blood Pressure Monitor, MDMouse, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a standalone study proving the device meets those criteria.
However, based on the information provided, we can infer some aspects and identify what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions adherence to several standards related to safety, EMC, and performance. The "PASS" designation indicates the device met the requirements of these standards. While specific numerical acceptance criteria (e.g., accuracy ranges for blood pressure measurements) are not explicitly stated in the summary, they would be inherent to the AAMI / ANSI SP10 standard mentioned.
| Standard/Test | Acceptance Criteria (Inferred from Standard) | Reported Device Performance |
|---|---|---|
| IEC/EN 60601-1:1990+A1+A2+A11+A12+A13 | General Medical Electrical Equipment Safety | PASS |
| EN 1060-1:1995, EN 1060-3:1997 | Non-Invasive Sphygmomanometers | PASS |
| IEC/EN 60601-1-2: 1993 | Electromagnetic Compatibility (EMC) | PASS |
| FCC conformity / ANSI C63.4: 2003 | Radio Frequency Device Emissions | PASS |
| AAMI / ANSI SP10 | Non-Automated Sphygmomanometer Performance | PASS |
Missing Information: Specific acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation between device and reference method) as defined by AAMI / ANSI SP10 were not detailed in the summary. The summary only states "PASS" for AAMI / ANSI SP10.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10," implying a clinical validation study was conducted. However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
The document does not provide any information on the number of experts used or their qualifications for establishing ground truth, as is common in AI/ML device studies. This is expected since this device predates the widespread use of advanced AI in medical devices and its submission is based on traditional medical device validation. For blood pressure monitors, the "ground truth" is typically established by trained technicians following a standardized protocol using a reference auscultatory method.
4. Adjudication Method for the Test Set:
This information is not applicable or provided. For traditional blood pressure monitor validation per AAMI / ANSI SP10, the comparison is typically against a standardized reference method (e.g., mercury sphygmomanometer with trained observers), not expert adjudication of images or diagnoses.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or reported. This type of study is primarily relevant for AI devices that assist human readers in tasks like image interpretation, not for automated measurement devices like a blood pressure monitor.
6. Standalone (Algorithm Only) Performance Study:
A standalone study of the algorithm's performance was done in the sense that the device itself, the "CalHealth Finger Blood Pressure Monitor, MDMouse," was subjected to performance testing against established standards (AAMI/ANSI SP10). The device operates as a standalone system to measure blood pressure. The summary indicates that the device's "Oscillometric method" automatically senses pulse signals and calculates blood pressure. This implies the algorithm within the device was validated to perform these measurements.
7. Type of Ground Truth Used:
For blood pressure monitors, the ground truth is typically established by simultaneous measurements using a reference auscultatory method (e.g., using a mercury sphygmomanometer or an equivalent reference device) performed by trained observers. The AAMI / ANSI SP10 standard specifies the methodology for this.
8. Sample Size for the Training Set:
This information is not applicable or provided. Blood pressure monitors using the oscillometric method are typically based on well-established algorithms derived from physiological principles and extensive empirical data, not from machine learning models requiring a "training set" in the modern AI sense. The algorithms are usually pre-determined and validated against clinical data, rather than being "trained" iteratively.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or provided for the same reasons as #8. The "ground truth" for developing such an algorithm would have been based on extensive physiological and clinical studies over many years by the broader scientific community, rather than a specific training set constructed for this particular device's development.
In summary, the 510(k) emphasizes compliance with recognized standards for safety and performance (AAMI/ANSI SP10) to demonstrate substantial equivalence. It does not provide the detailed breakdown of clinical study parameters (sample size, ground truth specifics, etc.) that would be expected in a pre-market submission for a novel AI/ML-based device.
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(143 days)
The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J and Digital Wrist Blood Pressure Monitor BP-500, BP-510 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" ~ 8.5" for Wrist type and 9.0" ~ 13.0" for Arm type.
YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J. BP-110J; and Digital Wrist Blood Pressure Monitor BP-500. BP-510 use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
The provided 510(k) summary for the YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J and Digital Wrist Blood Pressure Monitor BP-500, BP-510 primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and EMC standards. It makes a general claim about clinical performance but lacks detailed reporting to fully answer all the questions.
Here's a breakdown of what can be gleaned and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that the device meets AAMI / ANSI SP10 standards for performance and clinical testing. While it doesn't provide a table of precise acceptance criteria values and reported performance metrics for accuracy (e.g., mean difference and standard deviation in mmHg for systolic and diastolic pressure, as typically required by AAMI/ISO 81060-2), it implies that these standards have been met.
| Acceptance Criteria (Implied by AAMI / ANSI SP10 Adherence) | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy: | |
| Mean difference and standard deviation for systolic BP | Met AAMI / ANSI SP10 |
| Mean difference and standard deviation for diastolic BP | Met AAMI / ANSI SP10 |
| (Specific thresholds for mean difference and standard deviation are not provided in this document, but are defined by AAMI/ANSI SP10.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the clinical test (PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10). AAMI SP10 typically requires a minimum of 85 subjects for validation.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It just mentions "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10".
3. 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 510(k) summary. For AAMI SP10, ground truth is typically established by trained observers (e.g., physicians or nurses) using a reference sphygmomanometer following a specified auscultatory method. The number and qualifications of these observers are usually detailed in a full clinical study report, which is not available here.
4. Adjudication Method for the Test Set
This information is not provided. For AAMI SP10 validation, typically two or more trained observers measure blood pressure concurrently, and their readings are compared to ensure agreement, establishing a "ground truth" reference measurement. The adjudication method would describe how discrepancies between observers are handled, but this level of detail is absent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned. This type of study (comparing human readers with and without AI assistance) is not typically performed for a standalone blood pressure monitor like this, which operates without human interpretation of complex medical images or data. The device provides a direct measurement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this device is a standalone blood pressure monitor. The clinical performance refers to the device's ability to accurately measure blood pressure independently, without human interaction beyond operating the device. The "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" would assess this standalone performance against a clinical reference standard.
7. The Type of Ground Truth Used
Based on the reference to AAMI / ANSI SP10, the ground truth would have been established by expert auscultatory measurements (using a mercury or validated aneroid sphygmomanometer) typically by trained clinical personnel. This is the standard reference method for validating automated blood pressure devices.
8. The Sample Size for the Training Set
This information is not provided. Oscillometric blood pressure monitors rely on algorithms derived from physiological principles and extensive empirical data. There isn't typically a "training set" in the sense of machine learning models for image analysis. Instead, the algorithms are developed and refined using a large dataset of pressure waveforms and corresponding auscultatory reference measurements. The size of this underlying dataset used during the design and development of the oscillometric algorithm is not disclosed here.
9. How the Ground Truth for the Training Set Was Established
As with the test set, the ground truth for any data used in the development or "training" of the oscillometric algorithm would have been established through expert auscultatory measurements synchronized with cuff pressure oscillations.
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(50 days)
The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes.
The TYTAN blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes. Each cuff will be packaged in a polyethylene bag.
The acceptance criteria, study details, and ground truth establishment for the Tytan Blood Pressure Cuff are derived from the provided 510(k) summary (K062238).
1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used
The Tytan Blood Pressure Cuff sought substantial equivalence to a predicate device (TRICOT BLOOD PRESSURE CUFF, K0515339) by demonstrating equivalent functional and physical performance characteristics. The primary ground truth for evaluating performance was the ANSI/AAMI SP9:1994 standard.
| Acceptance Criteria (Based on AAMI SP9:1994 Standard) | Reported Device Performance (Tytan Blood Pressure Cuff) |
|---|---|
| Functional Performance - Dimension | Equivalent to predicate device (TRICOT Blood Pressure Cuff) |
| Functional Performance - Pressure Capacity | Equivalent to predicate device (TRICOT Blood Pressure Cuff) |
| Functional Performance - Cuff Closure | Equivalent to predicate device (TRICOT Blood Pressure Cuff) |
| Biocompatibility (for new outer material) | Passed three Biocompatibility tests, considered substantially equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical "sample size" in terms of number of cuffs tested for the performance evaluations. Instead, it states that "The TYTAN blood pressure cuff was compared to the TRICOT blood pressure cuff to confirm its functional and physical performance characteristics were equivalent." This implies a comparative testing methodology was used.
The data provenance is prospective testing conducted by the manufacturer for the purpose of demonstrating substantial equivalence. The country of origin for the device's manufacturer is Taiwan, but the testing details (where, by whom) are not specified beyond the reference to the AAMI standard.
3. 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 given document. The ground truth for performance was established by the ANSI/AAMI SP9:1994 standard itself, which is a published consensus standard. The process of developing such a standard typically involves numerous experts in the field, but this document does not detail their involvement in this specific submission. The manufacturer performed tests to show adherence to this standard.
4. Adjudication Method for the Test Set
This information is not provided. Given that the evaluation was based on compliance with a specific engineering standard (AAMI SP9:1994), an "adjudication method" in the sense of expert review committees is unlikely for these technical performance attributes. Compliance would typically be determined by meeting predefined thresholds and specifications outlined in the standard.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation is a critical component. For a blood pressure cuff, the performance evaluation focuses on physical and functional characteristics, not human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was implicitly done. The "performance data" section describes the evaluation of the cuff's characteristics (dimension, pressure capacity, cuff closure, biocompatibility) based on the AAMI SP9:1994 standard. This testing focuses solely on the device's intrinsic physical and functional properties, independent of human interaction during the measurement process, beyond proper training of personnel for its use.
8. The Sample Size for the Training Set
This concept is not applicable to this device. Blood pressure cuffs are mechanical devices, not AI/algorithm-driven systems that require "training sets" in the conventional machine learning sense. The "study" for this device involved physical and functional testing against a standard, not training a predictive model.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable (see point 8).
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