(91 days)
The Hygia Health Services Reprocessed Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual or automatic sphygmomanometers as appropriate. The device is non-sterile and is intended as a single patient use device. It is available in neonatal through large adult size.
The Hygia Health Services Reprocessed Blood Pressure Cuff is an accessory used by trained personnel in conjunction with non-invasive blood pressure measurement systems, primarily in a clinical setting.
Per CFR 870.1120, a Blood Pressure Cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure.
The Hygia Health Services Reprocessed Blood Pressure Cuff comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to an appropriate non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes include neonatal through large adult. Each cuff is packed in a sealed polyethylene (non-sterile) bag and each cuff is marked with the effective size range of limbs on which it may be used.
The provided document is a 510(k) Pre-market Notification for a reprocessed blood pressure cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, a direct table of acceptance criteria and reported device performance, and details about a study designed to meet specific performance criteria using AI, are not present.
However, based on the information provided, here's a breakdown of what can be extracted and inferred regarding performance and testing:
1. A table of acceptance criteria and the reported device performance:
Since this is a reprocessed device seeking substantial equivalence, the "acceptance criteria" are implicitly the performance characteristics of the predicate devices. The performance reported centers on demonstrating that the reprocessed device matches these characteristics.
| Acceptance Criterion (Implicitly, from predicate devices) | Reported Device Performance (Hygia Reprocessed BP Cuff) |
|---|---|
| Functional and operational performance characteristics (compression, pressure control, leakage) | "functional and operational performance characteristics including compression, pressure control, leakage... were substantially equivalent." |
| Safety parameters | "safety and operational parameters used when connected to inflation and measurement equipment were substantially equivalent." |
| Operational parameters when connected to inflation and measurement equipment | "safety and operational parameters used when connected to inflation and measurement equipment were substantially equivalent." |
| Design, materials, energy source, mode of operation | "The technological characteristics... are identical to the originally manufactured Blood Pressure Cuff in design, materials, energy source, mode of operation, and performance characteristics." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Comparative bench testing," but does not provide details on the number of cuffs or tests performed.
- Data Provenance: Not explicitly stated. The testing was "Non-clinical Tests" and conducted by Hygia Health Services, Inc. within the USA. It appears to be prospective testing specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth for this device's performance is not established by expert consensus on clinical findings. Instead, it's established by comparing physical and functional characteristics to new, predicate devices.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable in the context of expert review. The "adjudication" was a comparison of physical and functional test results against established specifications or performance of predicate devices.
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:
- MRMC Study: No.
- Effect Size: Not applicable. This document is for a physical medical device (blood pressure cuff), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Study: Not applicable. This device is a blood pressure cuff and does not involve an algorithm or AI.
7. The type of ground truth used:
- Ground Truth: The "ground truth" for this reprocessed device is effectively the published specifications and demonstrated functional performance of the new, un-reprocessed predicate blood pressure cuffs. The study aimed to show that the reprocessed cuff performs identically or substantially equivalently. The "test conclusions" explicitly state: "Non-clinical test results...indicated substantial equivalence in the measured characteristics to the predicate devices, the as originally manufactured blood pressure cuffs."
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI algorithms, and therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is 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).