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Dräger cuffs are intended to be used for automatic non-invasive blood pressure measurement. Dräger cuffs are compatible with Dräger and Siemens patient monitors. Neonatal cuffs are designed for single-patient use.

The devices comprise tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook-and-loop fastener. The devices tubing is connected to a non-invasive blood pressure measurement system with an extension hose. The portfolio includes different standard sizes reusable and single-patient-use non-invasive blood pressure cuffs for adults, paediatrics, infants and single-patient-use NiBP-cuffs for neonates. Longer cuffs are marked with an additional range to which they can be safely used.

The provided 510(k) summary for the Dräger NBP Cuff (K092999) does not contain detailed information regarding specific acceptance criteria, a corresponding study, or performance metrics beyond a general statement of "product performance is given within the range the device can be used by clinicians."

This submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices based on design and intended use, rather than a detailed performance study with specific quantitative acceptance criteria.

Therefore, the requested information cannot be fully extracted from the provided text.

However, based on the context of a 510(k) submission for a non-invasive blood pressure cuff, we can infer general expectations and provide what little information is present:

1. A table of acceptance criteria and the reported device performance

"The technological characteristics and the results of the performance data demonstrated that the NBP cuffs issued no new risks during design verification and validation which could question device use." |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not mentioned. Given this is a medical device accessory (cuff) rather than an AI-driven diagnostic tool, "ground truth" in the AI sense would not typically apply here. Performance would be validated against established measurement standards and potentially clinical trials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/mentioned.

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, this is not an AI device. This question is not applicable.

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

• No, this is a physical medical device accessory (cuff). This question is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated. For a medical device like a blood pressure cuff, performance data would likely involve comparing measurements obtained with the cuff against a gold standard method (e.g., direct arterial line measurement), or against predicate devices in controlled clinical settings, rather than "ground truth" derived from expert consensus on diagnostic images or pathology.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a training set.

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

• Not applicable. This is not an AI/machine learning device that would require a training set.

Summary of available information:

The 510(k) submission for the Dräger NBP Cuff (K092999) primarily relies on demonstrating substantial equivalence to existing predicate devices. It states that "product performance is given within the range the device can be used by clinicians" and that "design verification and validation" showed no new risks. However, it does not provide specific quantitative acceptance criteria or detailed results from a performance study (e.g., sample sizes, specific performance metrics, or study methodology) that would typically be associated with such criteria. The submission confirms general safety, effectiveness, and substantial equivalence based on its intended use, general construction, materials, and technological characteristics being similar to predicate devices.

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