(50 days)
The Aneroid Sphygmomanometer 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 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 non-automated sphygmomanometer uses an occluding cuff, an sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds.
The Aneroid Syphygmomanometer contains:
a. Blood Pressure Cuff
b. Stethoscope, which is use to detect the Korotkoff sounds;
c. Rotary Pin, 300 mmHg gauge, which is use to indicate the measurement result;
d. Air pump bulb, which is use to inflate the blood pressure cuff;
e. User Manual, which is use to instruct the user;
The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor the pressure of flowing blood that is exerted against the arteries at highest (systolic or contraction) and lowest (diastolic or relaxation) pressure.
The proposed device has three models, ZF-113/ZF-114/ZF-115, in this submission, the three models has same intended use, same design and measuring principle, same accessories and same measuring range. The only difference between the models is appearance of gauge.
The provided text describes a 510(k) premarket notification for an Aneroid Sphygmomanometer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria through a clinical or algorithmic performance study in the way one would for an AI/ML medical device.
Therefore, many of the requested points regarding acceptance criteria, study design, ground truth establishment, and expert involvement are not applicable to this type of submission, which relies primarily on bench testing and comparison to an existing predicate device's specifications and performance.
However, I can extract the relevant information regarding acceptance criteria as defined by the device's specifications and compliance with standards.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document states compliance with EN ISO 81060-1:2012 Non-Invasive Sphygmomanometers – Part 1: Requirements and Test Methods for Non-Automated Measurement Type and includes specific accuracy figures.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Measuring Range | Pressure: 0 - 300 mmHg |
| Accuracy | Pressure: +/- 3 mmHg |
| Cytotoxicity | Not cytotoxic (based on ISO 10993-5) |
| Irritation | Not an irritant (based on ISO 10993-10) |
| Sensitization | Not a sensitizer (based on ISO 10993-10) |
2. Sample size used for the test set and the data provenance:
- The document states: "No clinical study is included in this submission."
- The "tests" referred to are "Non-Clinical Tests" which include bench testing for performance and biological evaluation (cytotoxicity, irritation, sensitization).
- The sample size for these non-clinical tests is not specified in the provided text.
- Data provenance (country of origin, retrospective/prospective) is not applicable or specified as there's no clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no clinical study involving experts establishing ground truth for performance comparison. Performance was assessed via bench testing against established standards (e.g., ISO for accuracy and biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical data requiring expert adjudication was submitted.
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, a mechanical blood pressure monitor, not an AI/ML-driven diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm. Its performance is inherent to its physical design and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For accuracy: The ground truth is the reference standard measurement obtained during bench testing, often against a calibrated master device or a known pressure standard, as outlined in EN ISO 81060-1.
- For biocompatibility: The ground truth is determined by the results of in vitro and in vivo tests conducted according to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization), which define acceptance criteria for these biological responses.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML model was involved.
§ 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).