FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

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

Acceptance Criteria Category	Reported Device Performance
Clinical Accuracy	- Manual, electronic, automated sphygmomanometers (AAMI/ANSI SP10: 2002, Am1: 2003): Clinical accuracy study showed the accuracy of the cuff is unchanged from the predicate device when used with manual or electronic sphygmomanometer. Results were compared to measurements collected using predicate cuffs.
Biocompatibility	- ISO 10993-1: 2009 Biological evaluation of medical devices: A biocompatibility study indicated no biocompatibility issues for the cuff material.
Shelf Life	- Not explicitly tied to a standard, but a specific test: A shelf life study indicated the cuff's performance did not degrade over a three-year shelf life.
Antimicrobial Efficacy	- FDA guidance on Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents: A textile test performed per Mil Std 810E 508.4 indicated the antimicrobial agent inhibited fungal growth in the cuff material.

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.

Summary

Regulation Number and Section

§ 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).