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510(k) Data Aggregation
(136 days)
Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
Fully Automatic Electronic Blood Pressure Monitor (KD-5810, KD5810B, KD-5811, KD-5920TL and KD-552) is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
The provided text describes a 510(k) premarket notification for Andon Health Co., Ltd.'s Fully Automatic Electronic Blood Pressure Monitor. The document indicates that the device's accuracy was verified by meeting criteria 1 and 2 of ISO 81060-2. However, the text does not explicitly provide a table of acceptance criteria and reported device performance for the subject device itself. Instead, it refers to prior clinical test reports for predicate devices (KD-5961, BP3, and BP5) as references.
Therefore, not all requested information can be extracted directly for the subject device from the provided text. I will answer based on the information available and will highlight where specific details are not provided for the subject device but are referenced through predicate devices.
1. A table of acceptance criteria and the reported device performance
The provided text states that the accuracy of the blood pressure monitors in the clinical test reports was verified by meeting Criteria 1 and Criteria 2 of ISO 81060-2. However, it does not provide a specific table with numerical acceptance criteria and the reported performance for the subject device models (KD-5810, KD-5810B, KD-5811, KD-5920TL, and KD-552). It refers to the clinical test reports of predicate devices.
Based on general knowledge of ISO 81060-2, the criteria typically involve:
ISO 81060-2 Criteria (General Reference, not explicitly stated in document for subject device):
| Acceptance Criteria (ISO 81060-2:2009) | Reported Device Performance (Reference to predicate studies) |
|---|---|
| Criterion 1: Mean difference and standard deviation | Not explicitly stated for the subject device. The document states that the clinical test reports of the predicate devices met these criteria. |
| The mean difference between the device measurements and reference measurements should be within ±5 mmHg. | |
| The standard deviation of the differences should be ≤ 8 mmHg. | |
| Criterion 2 (for device approval for general population): Distribution of individual differences | Not explicitly stated for the subject device. The document states that the clinical test reports of the predicate devices met these criteria. |
| For SYS/DIA, 65% of the differences should be within ±5 mmHg. | |
| 85% of the differences should be within ±10 mmHg. | |
| 95% of the differences should be within ±15 mmHg. |
2. Sample size used for the test set and the data provenance
For the subject devices (KD-5810, KD-5810B, KD-5811, KD-5920TL, and KD-552), the text does not explicitly state the sample size used for the test set or the data provenance directly for these devices.
It states:
- "The proposed devices KD-5810, KD-5810B, KD-5811 and KD-5920TL has the same algorithm and design principle with cleared device KD-5961 (K083246), so the clinical test report of KD-5961can be used as a reference when considering the clinical effect of KD-5810, KD-5810B, KD-5811 and KD-5920TL."
- "The proposed devices KD-552 has the same algorithm and design principle with cleared device BP3 (K102939) and BP5 (K120672), so the clinical test report of BP3 (K102939) and BP5 (K120672) can be used as a reference when considering the clinical effect of KD-552."
To determine the sample sizes and data provenance, one would need to access the clinical test reports for K083246 (KD-5961), K102939 (BP3), and K120672 (BP5). The provided document does not contain this information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The text does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical studies mentioned (those for KD-5961, BP3, and BP5). For blood pressure measurement validation studies, ground truth is typically established by trained observers (e.g., physicians or nurses) using a sphygmomanometer following a standardized protocol (such as auscultation with a mercury sphygmomanometer or an equivalent reference device).
4. Adjudication method for the test set
The text does not specify an adjudication method for the test set. In blood pressure validation studies, ground truth is usually established by highly trained technicians or physicians taking multiple reference readings, and often, paired readings are averaged or discrepancies between two observers are reconciled, but these specific methods are not described in this 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
The device described is a Noninvasive Blood Pressure Measurement System. This type of device is not typically evaluated using MRMC studies as it is a standalone measurement device, not an interpretive imaging or diagnostic system where human readers interpret results. Therefore, this section is not applicable. The document does not describe any MRMC studies or human reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the clinical validation referenced through the predicate devices (KD-5961, BP3, BP5) would assess the standalone performance of the algorithm in measuring blood pressure against a reference standard. The text states: "Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2." This implies a standalone performance assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood pressure monitors validated against ISO 81060-2, the "ground truth" (or reference measurement) is typically established by simultaneous or sequential measurements taken by trained observers using a calibrated reference sphygmomanometer (e.g., mercury or an equivalent validated device) using the auscultatory method. This is a direct expert measurement, not pathology or outcomes data.
8. The sample size for the training set
The provided text does not provide any information regarding a "training set" or its sample size. Blood pressure monitors like this typically use established algorithms (oscillometric method) and are validated against clinical standards rather than being "trained" in the machine learning sense with a distinct training set. If the algorithm involved machine learning, this information would be critical, but the description ("operational principle is based on oscillometric and silicon integrates pressure sensor technology") suggests a traditional signal processing approach.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided document. The ground truth for the validation (test) set would be established as described in point 7.
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(309 days)
The Connect App for iHealth Next is intended for use in home settings as an aid for people to view vital signs which are measured by iHealth devices (noninvasive blood pressure monitor and pulse oximeter).
The Connect App for iHealth Next should not be used to either self-diagnose a disease state or exclude it. Please consult your physician if you find the reading is above a normal threshold.
The Connect App for iHealth Next is a software for using it with health devices, including iHealth medical devices such as Blood Pressure Monitor and pulse oximeter, etc. It can also be used with non-medical devices, such as active monitor, weight scale, etc.
The Connect App for iHealth Next can:
(1) Connect to blood pressure monitor and control the meter to complete measurement, and the data can be transferred to the Connect App for iHealth Next;
(2) Connect to pulse oximeter and transfer data from the pulse oximeter to the Connect App for iHealth Next.
This document describes the Connect App for iHealth Next, a data management software. No specific acceptance criteria for diagnostic or prognostic performance are described in the provided text, as this device primarily focuses on data management and control of other medical devices. Therefore, a comprehensive table of acceptance criteria and reported device performance related to diagnostic accuracy cannot be generated from this submission.
However, the document does describe validation activities for other aspects of the device:
1. A table of acceptance criteria and the reported device performance
As mentioned above, no specific diagnostic or prognostic acceptance criteria are provided in the text. However, a "Performance summary" section mentions non-clinical tests performed:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Software validation according to FDA guidance | "The result conforms that the proposed device is as safe and effective as the predicate device." |
| Usability for lay users and professionals in intended environments | "The study results demonstrate that the Connect App for iHealth Next are understood by a variety of users, and provide sufficient information for the safe and effective use of the device." |
| Wireless coexistence in intended environments | "Wireless coexistence test has been performed to verify that the proposed device can be used in intended environments." |
2. Sample size used for the test set and the data provenance
- Usability Study: 20 lay users and 20 professionals participated in the usability study. The provenance is not explicitly stated but implies testing in "their actual use environment such as home, hospital, clinic and office etc."
- For software validation and wireless coexistence, specific sample sizes (e.g., number of test cases) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as the device is data management software, and the "ground truth" for the usability study would be user feedback and successful task completion, not diagnostic ground truth established by medical experts for a clinical condition. The participants were "20 lay users and 20 professionals," with no further qualification details provided.
4. Adjudication method for the test set
Not applicable. The usability study involved observing user interaction and feedback, not a traditional adjudication process for clinical endpoints.
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 performed or described. This device is data management software, not an AI-powered diagnostic tool requiring human reader comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is software for managing data and controlling medical devices. Its "performance" revolves around software functionality, usability, and wireless connectivity, which were tested in a standalone manner (without continuous human interaction to refine its core functions) but with human users evaluating its user-facing aspects.
7. The type of ground truth used
- Software Validation: The "ground truth" for software validation would be adherence to specified requirements and established software engineering best practices, verified through testing against expected outputs.
- Usability Study: The "ground truth" was defined by successful task completion, understanding of warnings/precautions, and overall user experience as observed and reported by participants (lay users and professionals) against predetermined critical tasks and usability goals.
8. The sample size for the training set
Not applicable. This device is software for data management and device control, not a machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable (see point 8).
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(141 days)
KD-926 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
KD-926 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-926 Fully Automatic Electronic Blood Pressure Monitor:
No specific acceptance criteria or performance numbers are explicitly stated in the provided document. The document primarily focuses on the substantial equivalence argument, referencing standards and prior clearances.
However, based on the mentioned standards (IEC 80601-2-30), we can infer the implied performance criteria that the device must meet to conform to these standards.
Inferred Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:
Given the nature of the submission (510(k) for a blood pressure monitor) and the referenced standards, the primary acceptance criteria would revolve around the accuracy of blood pressure and pulse rate measurements.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from IEC 80601-2-30) | Reported Device Performance (Implied) |
|---|---|
| Accuracy of Systolic Blood Pressure: Mean difference and standard deviation between device and reference standard within specified limits (e.g., typically ≤ ±5 mmHg mean difference and ≤ ±8 mmHg standard deviation for individual measurements). | Not explicitly stated with numerical values in the provided text for KD-926. The document states "KD-926 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards: ... IEC 80601-2-30:2009 & A1:2013." Conformance to this standard implies meeting its accuracy requirements. |
| Accuracy of Diastolic Blood Pressure: Mean difference and standard deviation between device and reference standard within specified limits (e.g., typically ≤ ±5 mmHg mean difference and ≤ ±8 mmHg standard deviation for individual measurements). | Not explicitly stated with numerical values in the provided text for KD-926. Conformance to IEC 80601-2-30 implies meeting its accuracy requirements. |
| Accuracy of Pulse Rate: Mean difference between device and reference standard within specified limits. | Not explicitly stated with numerical values in the provided text for KD-926. Conformance to IEC 80601-2-30 implies meeting its accuracy requirements. |
| Safety: Compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC). | "Electrical safety according test to IEC 60601-1;" "Electromagnetic compatibility test according to IEC 60601-1-2;" "None of the test demonstrates that KD-926 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness." (Implies compliance). |
| Performance Characteristics (General): Compliance with IEC 80601-2-30. | "Safety and performance characteristics of the test according to IEC 80601-2-30." (Implies compliance). |
2. Sample size used for the test set and the data provenance
The document states: "The cuff and algorithm of KD-926 is the same as K102939 and K120672, so we use the clinical data of K102939 and K120672 as the clinical proof of the new device."
- Sample Size: The sample size for the clinical data used for K102939 and K120672 is not specified in the provided document.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only indicates that "clinical data of K102939 and K120672" were used.
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. For blood pressure clinical trials, ground truth is typically established by trained observers using mercury sphygmomanometers as per recognized protocols (e.g., ANSI/AAMI/ISO 81060-2). The number and qualifications of these observers are not detailed here.
4. Adjudication method for the test set
This information is not provided in the document. For blood pressure clinical trials, multiple observers may be used, and their readings are often averaged or assessed for agreement, but the specific adjudication method is missing.
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, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone (algorithm only) performance assessment was done. The clinical proof relies on the accuracy of the device itself (the "cuff and algorithm") against a reference standard, without human interpretation in the loop beyond initial application and reading of the reference. The device directly outputs blood pressure and pulse rate measurements.
7. The type of ground truth used
The type of ground truth used for validating blood pressure monitors is typically simultaneous measurements by trained observers using a reference standard device, such as a mercury sphygmomanometer or another validated oscillometric device, following an established protocol. While not explicitly stated, this is standard practice for devices conforming to IEC 80601-2-30.
8. The sample size for the training set
- Not applicable / Information not provided. As a standalone medical device measuring physiological parameters, it's unlikely to have a "training set" in the machine learning sense for the device's core function. The device's algorithm development involves calibration and validation against established physiological principles and clinical data, but not typically a "training set" for an AI model interpreting images or signals. The clinical data referenced (K102939 and K120672) serves as the validation/test set for the algorithm's accuracy.
9. How the ground truth for the training set was established
- Not applicable / Information not provided. See the explanation for point 8.
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