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The Aneroid Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home. The device is for use in OTC.

The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure monitor that uses an occluding cuff, an aneroid Sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds. The Aneroid Sphygmomanometer with Stethoscope contains: 1. Adjustable D-ring Cuff (Adult Size) 2. Stethoscope (Attaches to the cuff) 3. Non-stop rotary pin, 300 mmHg gauge 4. Instruction booklet and record 5. Carrying case.

The provided text describes a 510(k) summary for an Aneroid Sphygmomanometer with Stethoscope, Model LD-100. This document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized standards for non-automated sphygmomanometers.

Based on the provided text, the following information can be extracted:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Conformance to AAMI/ANSI SP10:2002/A2:2006 Standard for Non-automated Sphygmomanometers	AAMI/ANSI SP10:2002/A2:2006 "Standard for Manual, Automated, and Semi-automated Sphygmomanometers" was used. The conclusion states "conformance to AAMI/ANSI SP10:2002/A2:2006".
   Non-clinical mechanical testing	Non-clinical mechanical testing was performed.

2. Sample size used for the test set and the data provenance:

   • The document does not specify sample sizes for any test sets.
   • The document does not specify data provenance (e.g., country of origin, retrospective or prospective) for clinical data. The studies mentioned are referred to simply as "studies" and "non-clinical mechanical testing." It's possible the AAMI/ANSI standard itself outlines testing methodologies that were followed, but the specific details of participants/data provenance are not in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The studies mentioned are non-clinical and based on a standard for manual/automated sphygmomanometers, which typically involves technical performance metrics rather than expert interpretation of results.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not provided in the document. Given the nature of a non-automated sphygmomanometer and the focus on technical standards, an adjudication method for a test set is unlikely to be relevant in the same way it would be for an AI diagnostic device.

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:

   • No, an MRMC comparative effectiveness study was not conducted. This device is a mechanical blood pressure monitor, not an AI diagnostic device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This device is a "non-automated, mechanical blood pressure monitor." It is not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done. The device's performance is inherently "standalone" in the sense that its measurements are direct, although it requires a human operator for proper use and interpretation of Korotkoff sounds via the stethoscope.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The document implies the ground truth for performance is established by the AAMI/ANSI SP10:2002/A2:2006 standard. This standard outlines performance requirements and test methods for accuracy and other characteristics of sphygmomanometers. The ground truth would therefore be derived from reference devices or established measurement protocols defined in the standard.

8. The sample size for the training set:

   • The device is a mechanical blood pressure monitor, not an AI/machine learning algorithm. Therefore, there is no training set in the context of machine learning.

9. How the ground truth for the training set was established:

   • As there is no training set (the device is mechanical), this question is not applicable.

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