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The subject is intended to be used for measuring blood pressure(systolic and diastolic pressure) and pulse rate, for adult, by oscillometric method, upon the upper arm and at home or in hospital.

The Digital Wrist Blood Pressure Monitor, Model LD1143, is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual adult by using a non-invasive technique in which an inflatable wrist cuff is wrapped around the wrist. The method to define systolic and diastolic pressure is. similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and to calculate pulse rate, which is a well-known technique in the market called the "oscillometric method". The device can analyze the signals promptly and display the results. The modified device has two new auxiliary features called WHO indication and date and time display.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD. Digital Wrist Blood Pressure Monitor, Model LD1143:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K092683) is a 510(k) summary for a modified device seeking substantial equivalence to a previously cleared predicate device. It primarily focuses on demonstrating that the modifications (new auxiliary features, dimensional changes, packaging) do not impact the device's safety or effectiveness. As such, explicit, quantitative acceptance criteria and detailed performance metrics in the format of a clinical study are not reported for the modified device itself in relation to specific blood pressure measurement accuracy.

Instead, the submission relies heavily on the "identical" nature of the core blood pressure measurement technology and the demonstration of compliance with general safety and performance standards. The "performance specifications" are stated as "Identical" to the predicate device.

However, based on the standards met, we can infer some implied performance criteria that would have been met by the predicate device and, by extension, are claimed to be met by the modified device due to the identical core technology:

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

The document does not describe a clinical study for the modified device (LD1143) with a dedicated test set involving actual patient measurements to assess blood pressure accuracy. The compliance is primarily demonstrated through:

• Identical core technology: The blood pressure measurement algorithm and software codes remain unchanged from the predicate device (LD8).
• Engineering and Bench Testing: "General Functions Test," "Reliability Test," "EMC Testing," and "IEC 60601-1 Safety Testing." The sample size for these engineering tests is not specified, but typically involves a limited number of devices.
• Compliance with standards: ANSI/AAMI SP10-2002 is crucial here, as it defines the clinical accuracy requirements for blood pressure devices. The implication is that the predicate device (LD8) would have demonstrated compliance with this standard using a clinical study.

Therefore, for the modified device LD1143, there is no new clinical test set size or data provenance provided for blood pressure measurement accuracy. The safety and effectiveness are supported by the predicate's prior clearance and the unchanged core technology.

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

As there is no new clinical test set described for the modified device's blood pressure accuracy, there are no experts mentioned as being used to establish ground truth in this 510(k) summary for the LD1143.

For the predicate device (LD8) to meet ANSI/AAMI SP10-2002, a clinical study would have been required, typically engaging trained observers (experts) for reference blood pressure measurements (e.g., using a mercury sphygmomanometer). However, details about such experts for the predicate are not in this document.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set for blood pressure accuracy is described for the modified device in this submission.

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

Not applicable. This device is a blood pressure monitor, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant to this submission.

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

Yes, in essence, the "performance specifications" being "Identical" and the "blood pressure measurement algorithm and its software codes...unchanged" effectively means the standalone algorithm performance (without human intervention in the measurement process beyond cuff placement and initiation) is considered equivalent to the predicate device. The device itself is an automated system for measurement.

7. The Type of Ground Truth Used

For the predicate device (and by extension, the core technology of the modified device), the ground truth for blood pressure measurement accuracy would have been established through expert-obtained reference measurements, typically using a calibrated mercury sphygmomanometer or another accepted reference standard, in a clinical study conforming to standards like ANSI/AAMI SP10.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device for direct physiological measurement, not a machine learning or AI model that requires a "training set" in the computational sense. The device's algorithm for blood pressure determination is based on the "oscillometric method," a well-established technique.

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

Not applicable, for the reasons stated in point 8.

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