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UltraCheck® Curve Blood Pressure Cuffs are used with identified devices intended for the non-invasive measurement of adult human blood pressure.

UltraCheck® Blood Pressure Cuffs are intended for use by or under the supervision of qualified medical personnel.

The UltraCheck® Blood Pressure cuffs including the UltraCheck® Curve Cuffs in this 510(k), are applied to a patient limb and can be connected pneumatically to manual or oscillometric manometers to enable non-invasive blood pressure measurements. While the general shape of the other cuffs in the UltraCheck® product line is rectangular, the UltraCheck® Curve Cuffs in this 510(k) are conical in shape. They are made of flexible polymeric material a section of which forms an integrated inflatable bladder. A hook and loop closure system on each cuff may be used to secure the cuff around the patients limb. The cuff is connected pneumatically through a one piece lumen to a Patient Monitor or Sphygmomanometer.

Here's a summary of the acceptance criteria and the study that proves the UltraCheck® Curve Blood Pressure Cuff meets them, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

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

• Clinical Accuracy Study (for the cuff): The document does not specify the exact sample size for the clinical accuracy study. It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective.
• Biocompatibility Study: Not applicable (material testing).
• Shelf Life Study: Not applicable (product testing over time).
• Antimicrobial Efficacy (Textile Test): Not applicable (material testing).

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)

• The document does not specify the number or qualifications of experts used to establish ground truth for any of the studies mentioned. For a blood pressure cuff, the "ground truth" for accuracy is typically derived from direct measurement methods and comparisons to established, validated devices rather than expert consensus on interpretation.

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

• The document does not describe any adjudication method. This type of adjudication is typically relevant for studies involving human interpretation of medical images or diagnostic tests, which is not the primary focus for a blood pressure cuff's performance evaluation.

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 done. This is not applicable to a blood pressure cuff, as it is a physical medical device for measurement, not an AI-driven diagnostic tool.

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

• No, a "standalone algorithm performance" study was not done. The device tested is a blood pressure cuff, which is a hardware component used in conjunction with a sphygmomanometer (manual or electronic) to measure blood pressure. Its performance is inherent to its design and how it interacts with the patient and the measurement device.

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

• Clinical Accuracy Study: The ground truth for the clinical accuracy study would have been established by comparing the measurements from the UltraCheck® Curve Cuffs against measurements collected using the predicate cuffs and a reference method (likely a mercury sphygmomanometer or another highly validated method as per AAMI/ANSI SP10 standards). The standard typically defines the acceptable differences in mean and standard deviation of blood pressure measurements.
• Biocompatibility Study: Ground truth established through standardized material testing procedures and chemical analysis per ISO 10993-1.
• Shelf Life Study: Ground truth established by testing the device performance (e.g., accuracy, material integrity) at different time points across the claimed shelf life using established test methods.
• Antimicrobial Efficacy: Ground truth established by laboratory testing for the inhibition of fungal growth using standardized microbial testing methods (Mil Std 810E 508.4).

8. The sample size for the training set

• Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are validated through engineering and clinical testing.

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

• Not applicable, as there is no training set for this device.

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Philips Multi-Patient and Single-Patient cuffs are to be used with identified devices intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the non-invasive measurement of infant, pediatric and adult human blood pressure.

The device comprises tubing attached to an inelastic sleeve with an integral inflatable bladder that is wrapped around a patient's limb. It is secured by a hook and loop fastener. Device tubing is attached to an NIBP measuring system.

The provided text describes a 510(k) summary for Philips Multi-Patient and Single-Patient Cuffs. This document primarily focuses on establishing substantial equivalence to predicate devices and adherence to recognized standards for medical device safety and performance. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a study proving device performance in the context of AI studies.

Here's a breakdown of what can be extracted and what information is missing based on your template:

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

• Acceptance Criteria: The document lists several voluntary standards the cuffs were tested against (e.g., ANSI/AAMI SP10:2002 +A1:2003, EN 1060-1:1995 +A1:2002, IEC 60601-1:1988). The acceptance criteria are implicitly the requirements outlined in these standards for blood pressure cuffs.
• Reported Device Performance: The document states, "All tests passed." However, it does not provide specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) against these standards. It only indicates compliance.

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: Not specified.
• Data Provenance: Not specified. The document only mentions "Device testing was performed according to the Validation Traceability Matrix."

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 applicable/Not specified. This document is for a blood pressure cuff, not an AI-driven diagnostic device that would typically rely on expert-established ground truth in this manner. The "ground truth" for a physical device like a blood pressure cuff is its adherence to metrological and safety standards.

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

• Not applicable/Not specified.

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 MRMC study was done. This document is for a physical medical device (blood pressure cuff), not an AI-assisted diagnostic tool.

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

• Not applicable. This device is not an algorithm. It's a blood pressure cuff and requires connection to an NIBP measuring system for use by a healthcare provider.

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

• The "ground truth" for these physical cuffs is their compliance with established medical device standards for non-invasive blood pressure measurement devices.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

• Not applicable.

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