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K Number
K170466
Device Name
Automatic Blood Pressure Monitor Model LD-518 & LD-537
Manufacturer
Honsun(Nantong) Co., Ltd.
Date Cleared
2017-10-27

(254 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Scian Automatic Digital Blood Pressure Monitor, Models LD-518 & LD-537, are devices 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. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the Scian Automatic Blood Pressure Monitor, Models LD-518 & LD-537. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study results, acceptance criteria, or the specific data requested in your prompt.

Specifically, the document does not provide:

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

This document is a regulatory approval letter, not a clinical study report. To obtain the information you're looking for, you would typically need to refer to the 510(k) submission summary or associated clinical validation studies that would have been part of the manufacturer's submission to the FDA.

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).