(37 days)
Aneroid Sphygmomanometer Model KT-A01 with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure. This device is sold with an adult D size cuff and suitable for use on adults.
The Aneroid Sphygmomanomefer Model KT-A01 with Stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff, an aneroid manometer to measure pressure, and a stethoscope for detecting Korotkoff sounds.
The provided document describes the Kindcare Aneroid Sphygmomanometer Model KT-A01 with Stethoscope, a non-automated blood pressure measurement system. The device's acceptance criteria and study information are summarized below based on the provided text.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are based on compliance with the ANSI/AAMI SP10: 2002 and ANSI/AAMI SP10: 2002/A1: 2003 standards for non-automated sphygmomanometers. The document states that all test results were satisfactory, indicating the device meets these standards.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10: 2002 | Satisfactory |
| ANSI/AAMI SP10: 2002/A1: 2003 | Satisfactory |
| ISO 10993: 2003 Biological Evaluation of Medical Devices | Satisfactory |
| Electrical safety | Satisfactory |
| Mechanical safety | Satisfactory |
| Environmental safety | Satisfactory |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Specific testing relating to Aneroid Sphygmomanometer equipment was use to verify performance to recognized standards." without detailing the methodology of these specific tests.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. This device is a mechanical blood pressure cuff, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
As this is a mechanical device, not an algorithm-based one, a standalone performance study in the context of "algorithm only" is not applicable and therefore not mentioned.
7. Type of Ground Truth Used
The ground truth for the performance claim appears to be established by compliance with recognized industry standards (ANSI/AAMI SP10 and ISO 10993). This implies that the device's accuracy and safety were verified against specified benchmarks and tolerances outlined in these standards, rather than against an expert consensus, pathology, or outcomes data in a clinical trial setting.
8. Sample Size for Training Set
The document does not mention a "training set" as it pertains to machine learning. The device's performance is verified through testing for compliance with established standards.
9. How Ground Truth for Training Set Was Established
Not applicable, as this device does not involve machine learning or a training set in the conventional sense. The "ground truth" for the device's design and manufacturing would be the specifications and requirements of the relevant safety and performance standards.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).