Search Results

The blood pressure cuff is an accessory used in con-invasive blood pressure measurement systems. It is non-sterile, single-patient use. It is available in pediatric and adult sizes. The cuff is not designed, sold or intended for use except as indicated.

ONE-CUF blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems to obtain a blood pressure measurement. Blood pressure cuffs are non-sterile and single-patient use and may not be reprocessed for use on additional patients. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated. Blood pressure cuffs do not include serviceable parts or components. Non-Invasive Blood Pressure Cuffs incorporate an inflatable non-distensible bladder, sized to encircle a patient's limb. The cuff includes one or two flanges for attaching flexible tubing. This allows air to flow in and out of the cuff bladder for inflation and deflation. Inflation allows for occlusion of an artery to facilitate the measurement of automated noninvasive blood pressure (NIBP). The cuff tubes are terminated with connectors that allow for attachment to a blood pressure hose. This cuff will be offered with two different connection systems, bayonet and DINACLICK.

The information provided describes the ONE-CUF blood pressure cuff and its path to substantial equivalence, primarily based on non-clinical testing and comparison to a predicate device. It explicitly states that no clinical or animal studies were required to support substantial equivalence. Therefore, there is no study described that proves the device meets specific acceptance criteria related to a model's performance in a diagnostic or predictive context (e.g., accuracy, sensitivity, specificity for an AI algorithm).

The "acceptance criteria" referred to in this document are primarily related to product performance specifications and compliance with voluntary standards for a mechanical medical device, rather than the performance metrics of an AI model.

Here's an attempt to structure the answer based on the provided text, recognizing the limitations regarding AI-specific criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable. The reported studies are non-clinical, focusing on device performance and safety specifications rather than a diagnostic model's performance on a test set of patient data. There is no mention of a "test set" in the context of an AI algorithm or diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a blood pressure cuff and does not involve AI or diagnostic interpretation requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable. There is no test set for diagnostic performance or AI algorithm output.

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

Not applicable. This device is a non-AI blood pressure cuff. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a non-AI blood pressure cuff. No standalone algorithm performance was evaluated.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is established by adherence to documented test procedures, engineering specifications, and established international standards (e.g., ISO, IEC) for medical device performance and biocompatibility.

8. The sample size for the training set

Not applicable. This device is a non-AI blood pressure cuff. There is no training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. This device is a non-AI blood pressure cuff. There is no training set for an algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The “study” proving the ONE-CUF meets its acceptance criteria is a compilation of non-clinical performance testing and biocompatibility testing, along with compliance with relevant voluntary standards. The documentation states:

• Non-Clinical Testing: This included evaluations for Environmental Conditioning, Leak, Pressure Capacity, Mechanical Strength, Tensile Testing, and other performance aspects. While specific results are not detailed in the summary, these tests were submitted to support substantial equivalence.
• Biocompatibility Testing: This was performed in accordance with ISO 10993-1:2018 ("Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") and included Chemical Characterization, Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity.
• Compliance with Voluntary Standards: The device was designed and tested for compliance with IEC 80601-2-30:2018 (for automated noninvasive sphygmomanometers) and ISO 81060-1:2007 (for non-automated sphygmomanometer test methods).
• Human Factors Validation: Summative usability testing was performed.

The conclusion is that based on these non-clinical performance data, biocompatibility results, and compliance with standards, the device is considered substantially equivalent to a legally marketed predicate device (SOFT-CUF K120125). No clinical or animal studies were required or performed to support this determination.

Ask a specific question about this device