(57 days)
The TRIMLINE Large Face Aneroid Sphygmomanometer: is a non-automated, mechanical blood pressure sphygmomanometer that is used for the non-invasive indication of blood pressure. may be used with neonatal, pediatric and adult patients
non-automated, mechanical blood pressure sphygmomanometer
I am sorry, but after reviewing the provided documents, I could not find information regarding the acceptance criteria or a study proving the device meets acceptance criteria for the TRIMELINE™ Large Face Aneroid Sphygmomanometer.
The documents primarily consist of:
- An FDA 510(k) clearance letter confirming substantial equivalence to a predicate device.
- Information regarding regulatory compliance and contact details for further inquiries.
- The "Indications for Use" statement for the device.
There is no mention of specific acceptance criteria (e.g., accuracy thresholds, precision values), performance metrics, study design, sample sizes, ground truth establishment, or expert involvement as requested. This type of detailed performance data is typically found in design validation reports or specific performance characteristic sections of a 510(k) submission, which are not present in the provided text.
§ 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).