(260 days)
GE CRITIKON blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems. SOFT-CUF and CLASSIC-CUF cuffs and inflation systems are non-sterile and limited reuse (may be single-patient use or optional limited reuse). They are available in neonatal, pediatric and adult sizes. DURA-CUF and SENSA-CUF cuffs and inflation systems are non-sterile and may be reused. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated.
Non-Invasive Blood Pressure cuffs incorporate an inflatable non- distensible bladder, sized to encircle a patient's limb. This allows air to flow in and out of the cuff for inflation and deflation. Inflation allows for the occlusion of an artery. The Non-Invasive Blood Pressure Cuffs facilitate the measurement of automated and manual non-invasive blood pressure (NIBP).
This submission focuses on Non-Invasive Blood Pressure Cuffs, which primarily involves mechanical performance and functionality rather than complex AI algorithms. As such, many of the requested categories related to AI performance, such as MRMC studies, training set details, and ground truth establishment, are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with voluntary standards detailed in Section 9 of the premarket submission (likely related to blood pressure cuff standards like ISO 81060-1 or AAMI/ANSI SP10). | The Non-Invasive Blood Pressure Cuffs and their applications comply with voluntary standards as detailed in Section 9 of this premarket submission. |
| Performance testing (Verification) to ensure proper function and safety. | Performance testing (Verification) was applied to the development of the devices. |
| Risk Analysis conducted. | Risk Analysis conducted. |
| Requirements Reviews conducted. | Requirements Reviews conducted. |
| Design Reviews conducted. | Design Reviews conducted. |
2. Sample size used for the test set and the data provenance:
Not applicable in the context of an AI device. The submission describes non-clinical performance and safety testing. The number of samples for performance verification of the physical cuffs (e.g., number of cuffs tested for leakage, durability, or pressure accuracy) is not specified in the provided text. The data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for a physical device like a blood pressure cuff would typically be established by established engineering standards and validated measurement equipment, not clinical expert consensus in the same way as AI interpretation of medical images.
4. Adjudication method for the test set:
Not applicable. Adjudication methods are typically relevant for human review of AI output or for resolving discrepancies in expert interpretations, which is not the case for this physical device.
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. An MRMC comparative effectiveness study was not performed as this is not an AI-enabled device.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
No. This is not an AI-enabled device, so a standalone algorithm performance study was not applicable.
7. The type of ground truth used:
For a non-AI physical device like a blood pressure cuff, the "ground truth" for performance would be based on:
- Engineering Specifications and Standards: Conformance to established industry standards for blood pressure cuffs (e.g., accuracy against a reference manometer, durability tests, biocompatibility).
- Physical Measurement: Direct measurements using calibrated equipment to verify performance parameters like inflation/deflation rates, seal integrity, and pressure accuracy.
The provided text indicates "Performance testing (Verification)" and "compliance with voluntary standards," suggesting these types of ground truth were used.
8. The sample size for the training set:
Not applicable. This is not an AI-enabled device and therefore does not have a "training set" in the machine learning sense. The development process involved risk analysis, requirements reviews, design reviews, and performance testing, which are standard for medical device manufacturing.
9. How the ground truth for the training set was established:
Not applicable. As this is not an AI-enabled device, there is no "training set" or corresponding ground truth establishment in that context.
§ 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).