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K Number
K230649
Device Name
Arm Blood Pressure Monitor
Manufacturer
Alicn Medical Shenzhen, Inc
Date Cleared
2023-09-07

(182 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 Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.

Device Description

Arm Blood Pressure Monitor, Model: AES-U112, AES-U122, AES-U132, AES-U312, AES-U322, and AES-U332.

AI/ML Overview

Based on the provided FDA 510(k) clearance letter for the Alicn Medical Shenzhen, Inc. Arm Blood Pressure Monitor, I cannot extract the specific details requested regarding acceptance criteria and study data because this document does not contain that information.

The FDA 510(k) clearance letter is a regulatory document that confirms substantial equivalence to a predicate device. It indicates that the device has met the FDA's requirements for marketing, but it typically does not include the granular details of the performance study results, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications. These details are usually found in the manufacturer's 510(k) submission, which is not publicly available in this letter.

Therefore, many of your questions, particularly those related to the study design and results (points 1-9), cannot be answered from the provided text.

Here's what I can tell you based on the document:

  • Device: Arm Blood Pressure Monitor, Model: AES-U112, AES-U122, AES-U132, AES-U312, AES-U322, and AES-U332.
  • Intended Use: To measure systolic blood pressure and pulse rate via non-invasive oscillometric technique using an inflatable cuff on the upper arm. Can be used at medical facilities or at home. Suitable for adults and adolescents over 12, with an upper arm circumference of 22-42cm.
  • Regulatory Class: Class II
  • Product Code: DXN (Noninvasive Blood Pressure Measurement System)

Regarding your specific questions, and why I cannot answer them from this document:

  1. A table of acceptance criteria and the reported device performance: This information is not in the FDA clearance letter. It would be in the manufacturer's internal test reports and the 510(k) submission.
  2. Sample sized used for the test set and the data provenance: Not available in this document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
  4. Adjudication method for the test set: Not available in this document.
  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 is a blood pressure monitor, not an AI-assisted diagnostic imaging device.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI algorithm; this is a direct measurement device. Its performance is its "standalone" performance. The specific study details are not here.
  7. The type of ground truth used: Not specified in this document, but for blood pressure monitors, ground truth is typically established against a reference method, such as invasive arterial pressure measurement or a highly accurate auscultatory method performed by trained observers.
  8. The sample size for the training set: Not applicable and not mentioned. This device likely relies on a fixed algorithm based on oscillometric principles, not machine learning (training sets).
  9. How the ground truth for the training set was established: Not applicable for this type of device.

To obtain the detailed study information, one would typically need to refer to the full 510(k) submission (which is proprietary and not released publicly with the clearance letter) or a published clinical validation study by the manufacturer, if available.

§ 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).