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KD-5962 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-5962 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 puise rate of on adult index malling in bon-mvasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48mm. 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 n.CD. The touch key button and the voice furnition make it more convertion of to use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-5962 Fully Automatic Electronic Blood Pressure Monitor:

Unfortunately, the provided text does not contain a detailed study description with specific acceptance criteria and performance data in the format requested. The document is primarily a 510(k) summary focused on establishing substantial equivalence to a predicate device based on adherence to recognized standards and technological similarities rather than a comprehensive clinical study report.

The text states that the device conforms to several standards, implying that meeting these standards serves as the acceptance criteria. However, it does not explicitly list numerical acceptance criteria (e.g., accuracy ranges for systolic/diastolic pressure) or show the device's actual performance against those criteria in a table format.

Therefore, many sections of your request cannot be fulfilled directly from the provided document. I will fill in what can be inferred and explicitly state where information is missing.

Acceptance Criteria and Device Performance

Detailed Study Information (Based on available text):

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document states "the test in this submission provides demonstration," but does not provide details of any specific clinical or performance test sample size. For AAMI SP10 validation, a minimum of 85 subjects is typically recommended, but this document does not confirm if such a study was performed or its specifics.
   • Data Provenance: Not specified. (e.g., country of origin, retrospective or prospective).

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

   • This information is not provided. For blood pressure monitors, "ground truth" typically involves simultaneous or near-simultaneous measurements by trained observers using a reference standard (e.g., mercury sphygmomanometer) following a specific protocol (like the AAMI SP10 protocol). The document does not describe such a process or the experts involved.

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

   • Not applicable/Not described in the provided text. Adjudication methods are typically used when subjective assessments are made (e.g., reading medical images). For blood pressure device validation, the protocol itself dictates how measurements are taken and compared, not typically an "adjudication" in this sense.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers and MRMC studies.

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

   • Yes, implicitly. The "device performance" in this context refers to the standalone performance of the blood pressure monitor's algorithm and hardware in accurately measuring blood pressure. The entire device functions as a "standalone" system for generating a blood pressure reading. The document states it "conforms" to AAMI SP10, which validates this standalone performance.

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

   • Not explicitly stated, but for blood pressure monitor validation (as per AAMI SP10), the ground truth is typically established by auscultatory measurements performed by trained observers using a reference standard (e.g., mercury sphygmomanometer), often involving multiple measurements and averaging. This is an expert-derived ground truth based on a standardized protocol.

7. The sample size for the training set:

   • Not applicable. This type of medical device (a blood pressure monitor) is not typically developed using a machine learning "training set" in the way an AI diagnostic algorithm would be. Its operational principle is based on oscillometric technology and direct pressure sensing, rather than being "trained" on a dataset of blood pressure readings.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the context of this device's development as described.

Summary of what's provided for acceptance criteria:

The primary acceptance criteria presented in this 510(k) summary are the conformance to several international and national standards, particularly AAMI SP10:2002 and its amendments for non-invasive blood pressure measurement systems, as well as IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC. The document explicitly states that the device "conforms to" these standards. This implies that the device underwent testing (likely by the manufacturer or a third-party lab) to demonstrate compliance with the performance and safety requirements outlined in these standards, meeting their inherent acceptance criteria, although the specific numerical results of these tests are not included in this summary. The general conclusion is that "the test in this submission provides demonstration that these small differences [from the predicate device] do not raise any new questions of safety and effectiveness."

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