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The Shanghai Little Doctor Automatic Digital Blood Pressure Monitor LD6&LD7 is device intended to measure the systolic and diastolic blood pressure 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 device detects the appearance of irregular heartbeat during measurement, and gives a warning signal once the irregular heartbeat is detected.

Automatic Digital Blood Pressure Monitor, Model: LD6 & LD7

This document is a 510(k) clearance letter for a non-invasive blood pressure monitor, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study methodologies, or performance metrics from a clinical trial.

The document primarily focuses on:

• Device Identification: Automatic Digital Blood Pressure Monitor, Models LD6 & LD7.
• Regulatory Information: Regulatory Number (21 CFR 870.1130), Regulation Name (Non-Invasive Blood Pressure Measurement System), Regulatory Class (Class II (Two)), Product Code (DXN).
• Clearance Date: September 18, 2009.
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
• Indications for Use: To measure systolic and diastolic blood pressure and pulse rate of an adult individual using a non-invasive technique with an inflatable cuff around the upper arm. It also detects and signals irregular heartbeats.
• Usage: Over-The-Counter Use.

Missing Information:

The document does not provide any of the following requested details:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method for the test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of AI improvement.
6. Results of a standalone (algorithm only) performance study.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is a regulatory clearance document, which confirms that the device has met the requirements for market entry based on substantial equivalence, but it does not detail the specific clinical performance study that would establish the quantitative metrics of the device's accuracy or effectiveness against specific acceptance criteria. For that information, one would typically need to review the full 510(k) submission or any accompanying clinical study reports, which are not included here.

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