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The subjects are 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 Blood Pressure Monitors, Model LD1103 and LD 1133, are 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 cuff is wrapped around the upper arm. 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Digital BP Monitor, Model LD1103 and LD1133:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the modified devices (LD1103 and LD1133) are "identical in safety and effectiveness of the intended use to the 510(k) cleared device model LD578" and that "The modified devices are identical to the predicate in functionality and performance".

The primary acceptance criteria for blood pressure monitors generally revolve around accuracy against a reference measurement. The document explicitly references compliance with ANSI/AAMI SP10-2002, Manual, Electronic or Automated Sphygmomanometers. This standard outlines accuracy requirements for blood pressure devices.

However, the specific numerical acceptance criteria (e.g., mean difference and standard deviation of differences between the device and a reference standard) from ANSI/AAMI SP10-2002 are not explicitly detailed in the provided text. Instead, the document makes a blanket statement of compliance.

Therefore, based only on the provided text, the table would look like this:

Note: Without direct access to the ANSI/AAMI SP10-2002 standard and the full test report, the specific numerical accuracy criteria and performance for blood pressure measurement cannot be extracted directly from this summary. The manufacturer claims compliance with the standard, which implies meeting its accuracy requirements.

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

The provided text does not explicitly state the sample size used for the performance testing related to ANSI/AAMI SP10-2002. It only mentions, "The subjects have been tested...".

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention the number of experts used or their qualifications to establish ground truth for the performance testing. In studies complying with ANSI/AAMI SP10, ground truth for blood pressure is typically established by multiple trained observers (e.g., physicians or specially trained technicians) using a auscultatory method with a mercury sphygmomanometer. However, this detail is not present in the summary.

4. Adjudication Method

The provided text does not describe any adjudication method used for establishing ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No.
• Effect size of human readers with vs. without AI assistance: Not applicable, as this device is a standalone blood pressure monitor and not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The document focuses on the device's ability to measure blood pressure and pulse rate independently. The "Performance testing" section details various tests, including compliance with ANSI/AAMI SP10-2002, which is a standard for standalone blood pressure device accuracy. The modifications made to the device did not change the core "blood pressure measurement algorithm and its software codes."

7. Type of Ground Truth Used

The typical ground truth for validating automated blood pressure monitors against standards like ANSI/AAMI SP10 is auscultatory blood pressure measurements performed by trained observers using a mercury sphygmomanometer or an equivalent reference device. While not explicitly stated as "auscultatory," the reference to "the method to define systolic and diastolic pressure is similar to the auscultatory method" and compliance with SP10 strongly implies this type of ground truth.

8. Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning or AI algorithms that "learn" from data. While the device uses an "oscillometric method" based on an electronic semiconductor sensor and an algorithm, this submission focuses on a modification of an already cleared device where the "blood pressure measurement algorithm and its software codes of the modified devices remain unchanged." Therefore, there isn't a specific "training set" mentioned or relevant for this particular submission of a modified device. The original algorithm would have been developed and validated, but details of that process are not part of this 510(k) summary for a modified device.

9. How Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" is not relevant for this particular modification submission, as the core algorithm remained unchanged. Details on how the original algorithm's ground truth was established are not provided in this document.

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