(51 days)
HEINE GAMMA aneroid sphygmomanometers are exclusively designed for measuring blood pressure at the upper arm or thigh on healthy skin.
The HEINE Gamma aneroid sphygmomanometers are non-invasive blood-pressure measurement devices to measure systolic and diastolic blood pressure in adults and pediatric patients. The HEINE Gamma sphygmomanometers consist of a large insufflation bulb, a gauge with a large diameter scale, a valve, and a single tube cuff with Velcro fastener.
The HEINE Gamma sphygmomanometers come in five models; G5, G7, GP, GST, and XXL LF. The models comprise either a push-button valve or a spin valve. The HEINE Gamma GST comprises an integrated stethoscope for self measurement. The HEINE Gamma XXL LF is a wall-, desk-, or rail-mounted devices and is available with a wheeled stand. HEINE Gamma G5, G7, GP, and XXL LF will be available in five cuff sizes; child small, child, adult small, adult, and thigh. The HEINE Gamma GST comes with an adult cuff.
The HEINE Gamma aneroid sphygmomanometers are intended for use in a wide variety of settings. This includes hospital departments, medical practices, and nursing homes, as well as home health care.
The provided text describes the HEINE Gamma aneroid sphygmomanometers and their substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a detailed study description with performance metrics in the format requested.
The document states:
- Bench Testing was conducted to demonstrate Safety and Effectiveness by conformance to the ANSI/AAMI SP9-1994 standard for non-automated Sphygmomanometers.
This indicates that the device's performance was evaluated against a recognized standard for non-automated sphygmomanometers. However, the specific acceptance criteria within that standard (e.g., maximum allowable error) and the reported device performance against those criteria are not detailed in the provided text.
Therefore, I cannot populate the table or answer most of the specific questions as the information is not present in the given document.
Here's a breakdown of what can and cannot be answered based only on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document states conformance to the ANSI/AAMI SP9-1994 standard, but it does not list the specific numerical acceptance criteria from that standard nor the actual measured performance of the HEINE Gamma devices against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot provide. The document mentions "Bench Testing" but does not detail the sample size or data provenance for any test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable for this type of device/study as described. For a blood pressure monitor, "ground truth" would typically come from a reference measurement (e.g., mercury sphygmomanometer) and not an expert consensus on interpreting images or clinical cases. The document does not describe such a process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot provide. Adjudication methods are typically used in studies involving expert review of ambiguous cases, which is not described for this device's testing.
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. This is not an AI-assisted diagnostic device, but a manual blood pressure monitor. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a manual, non-automated device, so there is no algorithm in the traditional sense or standalone performance to evaluate. The device itself is the "standalone" entity in terms of measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Inferred: For blood pressure monitors, "ground truth" for accuracy studies typically involves comparison against a reference standard measurement, often a mercury sphygmomanometer or another highly accurate calibrated device. However, the document does not explicitly state the method of ground truth establishment.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set.
§ 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).