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

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

The provided text describes a 510(k) premarket notification for the "Sensa-Cuff Blood Pressure Cuff". The focus of the document is on establishing substantial equivalence to a predicate device, the Critikon DURA-CUF®, rather than a standalone clinical study proving performance against specific acceptance criteria with detailed statistical analysis.

Therefore, many of the requested details about a "study that proves the device meets the acceptance criteria" (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not present in the provided document, as it is a regulatory submission for a Class II medical device based on substantial equivalence.

However, I can extract the acceptance criteria related to general device characteristics and the study performed for comparison.

Here's the information that can be extracted or reasonably inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device and adherence to relevant standards. The "reported device performance" is essentially that the Sensa-Cuff is comparable to the predicate for these features.

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

• The document describes design validation testing according to specified standards (SP-9, BS EN 1060, ISO 10993) and a comparison to a predicate device. It does not describe a clinical "test set" in the context of a diagnostic algorithm or predictive model. The testing refers to physical and performance characteristics of the cuff itself, likely using laboratory methods.
• Sample Size: Not explicitly stated for specific tests, but would involve a sufficient number of cuffs or materials to confirm adherence to the mentioned standards and physical properties.
• Data Provenance: Not specified, but likely laboratory-based testing rather than clinical patient data. The manufacturer is GE Medical Systems Information Technologies, based in Tampa, FL, USA, so testing would likely be performed in the US or by accredited labs.
• Retrospective/Prospective: Not applicable in the context of device characteristic testing described.

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)

• This question is not applicable as the document is about a blood pressure cuff and its physical/performance characteristics, not a diagnostic algorithm requiring expert "ground truth" for a test set. The "ground truth" for the device's performance would be the objective measurements obtained during testing against the standards.

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

• Not applicable. This concept typically applies to discrepancies in expert readings for diagnostic images or complex clinical data, which is not the subject of this document.

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. This document is for a medical device (blood pressure cuff), not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers assisting with AI is not relevant and was not performed.

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

• Not applicable. The Sensa-Cuff is a passive accessory; it does not contain an algorithm or operate as a standalone diagnostic system in the way this question implies. Its function is to interface with a non-invasive blood pressure measurement system.

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

• The "ground truth" for this device's performance is adherence to recognized national and international standards for sphygmomanometers (SP-9, BS EN 1060) and biological evaluation of medical devices (ISO 10993), as well as the established physical and performance characteristics of the predicate device (Critikon DURA-CUF®). No clinical "ground truth" from pathology or outcomes data is mentioned or relevant for this type of device submission.

8. The sample size for the training set

• Not applicable. The Sensa-Cuff is a physical accessory and does not involve machine learning or a "training set."

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

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

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