(58 days)
The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.
The proposed device includes disposable blood pressure cuff and reusable blood pressure cuff. Both disposable and reusable blood pressure cuff have the same structure, which contains Cuff with bladder and single-tube Air Hose.
This document is a 510(k) Premarket Notification from the FDA regarding a non-invasive blood pressure (NIBP) cuff. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of the device's accuracy or efficacy as one might find for a more complex AI-driven medical device.
Therefore, the requested information, particularly concerning "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-driven device (like an effect size of human readers improving with AI, or standalone algorithm performance), is largely not applicable to this document. This document primarily describes the physical characteristics, intended use, and manufacturing standards of a blood pressure cuff.
However, I can extract the relevant information where available, focusing on performance data related to blood pressure cuffs.
Here's an analysis based on the provided text:
Key Takeaway: This 510(k) submission primarily relies on physical and material testing and comparison to a predicate device to demonstrate substantial equivalence, not a clinical study proving its performance against specific physiological accuracy criteria in humans, nor an AI-driven system's performance.
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of acceptance criteria and corresponding reported device performance in the same way one would for an AI model's diagnostic accuracy. Instead, it refers to compliance with established standards for blood pressure cuffs.
- Acceptance Criteria (as implied by standards compliance):
- Max. Leakage:
§ 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).