(59 days)
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 at hospitals or at home to monitor both systolic and diastolic pressure.
The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Nonautomated Sphygmomanometer uses an occluding cuff, an aneroid sphygmomanometer to measure pressure, and a stethoscope for detecting Korotkoff sounds. The Aneroid Sphygmomanometer with Stethoscope contains: Adjustable D-ring Cuff (Adult Size), Stethoscope (Attaches to the cuff), Non-stop rotary pin. 300 mmHg gauge, Instruction booklet and record, Carrying case.
This document is a 510(k) summary for the Aneroid Sphygmomanometer with Stethoscope, Model HS-50A. It does not describe a study to prove a device meets acceptance criteria. Instead, it demonstrates substantial equivalence to a predicate device through conformance to a recognized consensus standard.
Therefore, many of the requested data points (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training) are not applicable or extractable from this type of document, as they pertain to clinical or performance studies rather than compliance with a standard.
However, I can extract the following information relevant to demonstrating conformance to a standard:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Conformance to ANSI/AAMI SP-9-1994 (Standard for Non-automated Sphygmomanometers) | "The Aneroid Sphygmomanometer with Stethoscope, Model HS-50A, has been tested to and conforms with ANSI/AAMI SP-9-1994 Standard for Non-automated Sphygmomanometers." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. Conformance to a standard typically involves specific testing protocols, but the number of devices or measurements isn't detailed in this summary.
- Data Provenance: Not specified. The testing likely occurred in China, where the manufacturer is located, but this is not explicitly stated for the test data itself. The document does not indicate if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a conformance to a standard for a non-automated medical device, not a performance study requiring human expert ground truth. The "ground truth" here is the adherence to the technical specifications and accuracy requirements outlined in the ANSI/AAMI SP-9-1994 standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for conformance to a standard.
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 device is an aneroid sphygmomanometer (manual blood pressure cuff), not an AI-powered diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone, non-automated mechanical device. Its performance is inherent to its design and manufacturing, tested against the standard. There is no "algorithm only" component as it's not a software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the technical specifications and accuracy requirements defined by the ANSI/AAMI SP-9-1994 Standard for Non-automated Sphygmomanometers. Performance is measured against these established engineering and clinical specifications.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.
§ 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).