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KD-5910 and KD-5918 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-5910 and KD-5918 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.

It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-5910 is 60 times, the memory capability of KD-5918 is 2×60 times. If any irregular heartbeat is detected, it can be shown on the LCD, KD-5918 also has the voice function.

This document describes a 510(k) premarket notification for the KD-5910 and KD-5918 Fully Automatic Electronic Blood Pressure Monitors. The submission focuses on demonstrating substantial equivalence to a predicate device (KD-5901) rather than a de novo clinical study with specific acceptance criteria and performance metrics against ground truth.

Therefore, many of the requested sections regarding acceptance criteria, study details, and ground truth establishment are not directly applicable or explicitly stated in this type of submission. The information provided heavily relies on comparisons to the predicate device and conformity to established standards.

Here's an attempt to answer the questions based solely on the provided text, highlighting where information is absent:

Description of Acceptance Criteria and the Study

The submission does not explicitly define specific numerical acceptance criteria for device performance (e.g., accuracy thresholds for blood pressure readings) in a format typically seen in clinical studies with a de novo device. Instead, the "acceptance criteria" are implied by conformity to established industry standards for non-invasive blood pressure monitors, specifically ANSI/AAMI SP10 and its amendments, and the demonstration of "substantial equivalence" to a predicate device.

The "study" conducted to prove the device meets these criteria is primarily through testing for conformity to these standards and showing that any differences from the predicate device "do not raise any new questions of safety and effectiveness." This is a comparative effectiveness claim based on technical characteristics and standards adherence, rather than a clinical trial where device performance is measured against an established ground truth in a patient population.

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

• IEC 60601-1 (Medical Electrical Equipment Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• AAMI SP10:2002 (Manual, electronic or automated sphygmomanometers)
• AAMI/ANSI SP10:2002/A1:2003 (Amendment 1 to SP10)
• AAMI/ANSI SP10:2002/A2:2006 (Amendment 2 to SP10)
  (Performance within the limits specified by these standards is implied.) |
  | Technological Characteristics Equivalence| The devices are "very similar" or "identical" to the predicate in: Design principle, material, energy source, applicable standards, biocompatibility, mechanical safety, electrical safety, EMC. ("Performance" is also listed as "identical" to the predicate, implying similar accuracy and function). |
  | Intended Use | Identical to the predicate device. |
  | Cuff Circumference | Limited to 22cm-48cm (new cuff compared to predicate, but still within a defined range). |
  | Irregular Heartbeat Detection | Capability to show irregular heartbeat on LCD (KD-5910 & KD-5918). |
  | Memory Capability | KD-5910: 60 times; KD-5918: 2x60 times. |
  | Voice Function | KD-5918 has voice function; KD-5910 does not. (This is a difference, not a performance metric per se, but part of functional comparison). |

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

The document does not provide details on a specific patient-based "test set" sample size or data provenance. The "test" mentioned in the submission is related to demonstrating conformity to standards, which typically involves laboratory testing and possibly limited clinical validation as part of the standard's requirements, but the specifics are not detailed here.

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

This information is not provided. The submission focuses on technical and standards conformity, and substantial equivalence, not a clinical study with expert-established ground truth for a test set.

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

This information is not provided.

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 comparative effectiveness study was performed or mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

Yes, the device is inherently a "standalone" system in the sense that it measures and displays blood pressure readings autonomously. The performance discussed is the device's intrinsic mechanical and electronic function according to established standards (e.g., AAMI SP10). However, a specific "standalone algorithm-only performance study" in a clinical context against a reference standard (like an arterial line) is not detailed beyond the general statement of conforming to AAMI SP10, which itself dictates clinical validation methods.

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

The ground truth implicitly used for a device like this, in the context of AAMI SP10, would typically be invasive blood pressure measurements (e.g., arterial catheter) in a clinical setting, or auscultatory readings from trained observers using a mercury sphygmomanometer as a reference standard. However, the document does not explicitly state which ground truth was used for specific tests, only that the device conforms to the AAMI SP10 standard, which requires such validation.

8. The sample size for the training set

This device is not an AI/ML device that requires a "training set" in the conventional sense. Its operational principle is based on oscillometric and silicon integrate pressure sensor technology, which are deterministic algorithms, not learned models.

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

Not applicable, as it's not an AI/ML device with a training set.

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KD-738 and KD-739 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.

KD-738 and KD-739 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches. It is designed and manufactured according to ANSI/AAMI SP10-manual, electronic or automated sphygmanometers. The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability is 60 times. If any irregular heartbeat is detected, it can be shown on the LCD.

The provided text describes a 510(k) summary for the KD-738 and KD-739 Fully Automatic Electronic Blood Pressure Monitors. However, it does not contain specific details about acceptance criteria or a dedicated study proving the device meets those criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (KD-7909) and conformity to recognized standards. It states: "However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies that the testing was primarily to confirm similar performance to the predicate and compliance with standards rather than a detailed study against specific acceptance criteria for a novel device.

Given the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the device conforms to "AAMI SP10:2002, Manual, electronic or automated sphygmanometers," and its amendments. This standard outlines accuracy requirements for blood pressure devices. For example, AAMI SP10 typically requires mean differences between the device and a reference method (e.g., auscultation) to be within ±5 mmHg with a standard deviation of no more than 8 mmHg. The document implies the device meets these types of criteria by stating conformity to the standard, but does not provide the specific numerical results from their testing against these criteria.

Missing Information:

The document primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards (IEC 60601-1, IEC 60601-1-2, and AAMI SP10). It does not detail a specific performance study with clearly defined acceptance criteria and corresponding results in the manner requested.

Therefore, the following information cannot be extracted from the provided text:

• 2. Sample Size Used for the Test Set and Data Provenance: Not specified.
• 3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not specified, as a direct comparative study against expert ground truth is not detailed.
• 4. Adjudication Method: Not applicable/specified for this type of submission.
• 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed or described. This type of study is usually for image-based diagnostic aids, not blood pressure monitors.
• 6. Standalone Performance (Algorithm Only): Not applicable for this device type, which is a physical measurement device.
• 7. Type of Ground Truth Used: Implied to be reference measurements as per AAMI SP10 (e.g., simultaneous auscultation by trained observers), but not explicitly detailed in the document.
• 8. Sample Size for the Training Set: Not applicable, as this is a traditional measurement device, not an AI/ML algorithm requiring a training set.
• 9. How the Ground Truth for the Training Set was Established: Not applicable.

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