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K Number
K131463
Device Name
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
Manufacturer
HONSUN (NANTONG) CO., LTD
Date Cleared
2013-07-08

(48 days)

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

The Wrist Automatic Blood Pressure Monitor LD-737 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 wrist.

Device Description

Wrist Automatic Blood Pressure Monitor Model: LD-737

AI/ML Overview

The provided text is a 510(k) summary for a Wrist Automatic Blood Pressure Monitor and primarily focuses on regulatory approval. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document lacks:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for any test set.
  • Information about multi-reader multi-case studies or standalone algorithm performance.
  • Details on the type of ground truth used or how it was established.
  • Sample size for a training set.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is expected to be similar to existing approved devices. However, it does not provide the actual performance data or the specific studies conducted to establish this equivalence, beyond simply stating it was reviewed.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method for the test set
  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
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

The document is purely a regulatory approval letter.

§ 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).