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Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are used with identified devices intended for the non-invasive measurement of pediatric and adult human blood pressure.

Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are intended for use by or under the supervision of qualified medical personnel.

The Statcorp UltraCheck® Spacelabs ABP cuffs in this 510(k), are applied to a patient limb and connected pneumatically to an oscillometric blood pressure monitor to enable noninvasive blood pressure measurements. The cuff is made of flexible polymeric material, a section of which forms an integrated inflatable bladder. The cuffs in this 510(k) are secured by looping the cuff through an attached oblong ring back onto itself to enable easier selfapplication. These cuffs are connected pneumatically through a one piece tube to the Spacelabs ABP Monitor.

Here's a breakdown of the acceptance criteria and study information for the Statcorp Medical UltraCheck® Spacelabs ABP Cuffs, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document specifically refers to clinical accuracy testing performed "per the methodology and requirements of AAMI ANSI ISO 81060-2 (2013)." While the table below summarizes the core requirements of this standard, the document does not explicitly state the numerical acceptance criteria met by the device for each specific requirement. Instead, it generally concludes that the device performed per the methodology and requirements.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document does not specify the exact sample size (number of subjects/measurements) used for the clinical accuracy testing. AAMI ANSI ISO 81060-2 (2013) typically recommends a minimum of 85 subjects for validation studies.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide this information. For blood pressure cuff validation, ground truth is typically established by trained technicians using a reference device (e.g., mercurial sphygmomanometer with a stethoscope) following a strict protocol.

4. Adjudication Method for the Test Set:

The document does not provide this information. For blood pressure cuff validation, adjudication (e.g., by two independent observers measuring simultaneously) is often part of the AAMI standard's methodology.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done?: No, an MRMC comparative effectiveness study was not performed.
• Effect Size of Human Readers with/without AI: Not applicable, as this is a medical device (blood pressure cuff) and not an AI-assisted diagnostic tool for image or data interpretation.

6. Standalone (Algorithm Only) Performance:

• Was it done?: Yes, in essence, the clinical accuracy testing performed per AAMI ANSI ISO 81060-2 (2013) is a standalone performance evaluation of the device in its intended use. The device (cuff) is being tested for its ability to accurately measure blood pressure.

7. Type of Ground Truth Used:

For the clinical accuracy testing, the ground truth would be reference blood pressure measurements obtained simultaneously using a validated and calibrated reference device (e.g., a mercurial sphygmomanometer with auscultation by trained observers), as per the AAMI ANSI ISO 81060-2 standard.

8. Sample Size for the Training Set:

Not applicable. This device is a blood pressure cuff, which does not employ machine learning or AI algorithms requiring a "training set" in the conventional sense. Its function is based on mechanical properties and calibrated pressure readings.

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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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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