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Personnel properly trained in the use of blood pressurement devices use the GSIBP blood pressure cuff in conjunction with non-invasive blood pressure measurement systems. The device is non-sterile and is intended as a reusable multipatient device. It is available in child through large adult sizes.

The device is comprised of one or two tubes attached to an inflatable latex bladder, which is covered with a stitched nylon or cotton cover. The device is wrapped around a patient's limb and secured by a hook and loop closure. The tubing connects to a non-invasive blood pressure measurement system. Sizes will include child through large adult. Each cuff will be packaged in a polyethylene bag.

The GSIBP Blood Pressure Cuff was evaluated against the AAMI SP9: 1994 standard to confirm its functional and physical performance characteristics were equivalent to the predicate device, ADCUFF™.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided text. The document mentions "The cuffs were equivalent in performance," implying a comparative study was performed, but the number of cuffs or trials is not detailed.
• Data Provenance: Not explicitly stated. Given that it's a conformity assessment to a standard for a medical device submitted to the FDA, it is highly likely a prospective study was conducted by the manufacturer, or a third-party laboratory. The country of origin of the data is not mentioned, but the submitting company is Globalshop Inc. (USA) and the predicate device is from American Diagnostic Corp. (USA), suggesting a US-centric context.

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

This is not applicable as the study involved objective physical performance testing against a standard, not expert interpretation of results that would require ground truth establishment by experts in the typical clinical sense. The "ground truth" here is the adherence to the engineering and performance specifications outlined in the AAMI SP9: 1994 standard.

4. Adjudication method for the test set:

Not applicable. The performance criteria are objective and measurable against the AAMI SP9: 1994 standard, not subjective interpretations requiring adjudication.

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 is a comparison of two physical medical devices (blood pressure cuffs) against a technical standard, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used:

The ground truth used was the specifications and performance requirements outlined in the ANSI/AAMI SP9-1994 standard for non-invasive blood pressure measurement devices. The GSIBP cuff was compared to the ADCUFF™ predicate device to confirm equivalence against these criteria.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

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

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