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The GH disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The GH reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Both devices comprise tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb, secured by hook and loop closure, and used to measure the patient's blood pressure. The device tubing is connected to a non-invasive blood pressure measurement system.

This document describes the premarket notification for GH Disposable and GH Reusable Blood Pressure Cuffs. However, it does not contain specific acceptance criteria or an explicit study proving the device meets acceptance criteria in the format requested.

The document states that "Both new devices were designed and manufactured in accordance with the following standards:" and lists several ISO and ANSI/AAMI standards. It concludes that "Based on the comparison of intended use, design, materials and performance, we conclude that the new devices are substantially equivalent to the predicates. The differences between the devices do not raise new questions of safety and effectiveness."

Without the full test report or direct mention of performance metrics in relation to acceptance criteria, I cannot provide the detailed information requested in your table format. The document implies that the device meets the standards cited, which would inherently include performance criteria, but these are not explicitly presented as "acceptance criteria" with "reported device performance."

Therefore, I cannot fulfill all parts of your request. I can, however, extract what information is present regarding testing and standards:

G. Summary of Testing indicates that the devices were designed and manufactured in accordance with the following standards:

• ANSI/AAMI SPIO, Manual, electronic or automated sphygmomanometers, 2002+AI.:2003+A2:2006+(R)2008: This standard sets requirements for the accuracy and performance of blood pressure measuring devices.
• ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, 2009: This standard outlines a framework for assessing medical device biocompatibility.
• ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for In Vitro cytotoxicity, 2009: This standard specifies test methods for assessing in vitro cytotoxicity of medical devices.
• ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity, 2002+A1 :2006: This standard describes test methods for assessing skin irritation and sensitization caused by medical devices.

Based on the provided document, the following information is available:

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

• This information is not explicitly provided in the document. The document states that the devices comply with specific standards (ANSI/AAMI SPIO, ISO 10993 series), implying they meet the performance and safety criteria outlined in those standards. However, the specific acceptance criteria and the measured device performance against those criteria are not detailed.

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

• Not provided in the document.

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 as this document does not describe a clinical study involving ground truth established by experts for a test set. The testing referenced relates to engineering and biocompatibility standards.

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

• Not applicable.

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 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.

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

• Not applicable in the context of diagnostic accuracy. For the device itself, the "ground truth" for compliance testing would be the specifications and requirements defined by the cited standards (e.g., accuracy limits for pressure, chemical composition for biocompatibility tests).

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable.

In summary, the provided document is a 510(k) summary indicating substantial equivalence to predicate devices based on design, materials, intended use, and compliance with general medical device standards. It does not provide specific performance data against explicit acceptance criteria in the format requested.

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