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The Hospitech AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways).

The Hospitech AG Cuffill is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated.

The AG Cuffill is a disposable hand held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheotomy and LMAs tubes. AG Cuffill is configured as a syringe and consists of a sensitive pressure gauge embedded within the syringe plunger. AG Cuffill is battery powered. AG Cuffill is intended for one patient; it is limited to 100 operations and can be cleaned with disinfectant.

Here's an analysis of the provided text regarding the AG Cuffill device's acceptance criteria and study findings:

Acceptance Criteria and Device Performance Study for Hospitech AG Cuffill

The Hospitech AG Cuffill is a disposable, hand-held device designed to measure and manually regulate intra-cuff pressure of endotracheal, tracheotomy, and Laryngeal Mask Airway (LMA) tubes. The device's performance was evaluated through non-clinical testing to demonstrate its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

Note: The document specifies that "AG Cuffill accuracy is within its specifications and is better than the Posey Cufflator." This implies that "better than" the predicate is a form of acceptance criterion, or at least a favorable outcome.

2. Sample Size and Data Provenance for Test Set

The document is a 510(k) summary for the AG Cuffill and primarily focuses on non-clinical performance testing. It does not describe a clinical study with a "test set" in the context of patient data. Instead, it refers to tests conducted on the device itself.

• Sample Size for Test Set: Not applicable in the context of human subjects or patient data. The tests were performed on the device.
• Data Provenance: Not applicable in the context of human subjects or patient data (e.g., country of origin, retrospective/prospective). The data originated from internal performance testing conducted by the manufacturer, Hospitech Respiration Ltd.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth for the device's performance (e.g., accuracy against a known standard) would have been established through calibrated reference instruments and defined specifications, not expert interpretation of patient data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. Device performance tests rely on objective measurements against pre-defined specifications or calibrated reference standards, not on adjudication of subjective interpretations.

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

• Was an MRMC study done? No. The document describes non-clinical performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Algorithm Performance Study

• Was a standalone study done? Yes, in a sense, as the performance tests listed are for the device's inherent functionality. The "Accuracy Verification Performance Test" and "Comparison Test with predicate device" provide standalone performance data for the AG Cuffill as a device, showing its accuracy (within ±1 mmHg) and comparison to a predicate.

7. Type of Ground Truth Used

The ground truth for the stated performance metrics was established through device specifications and calibrated measurement standards. For example, the accuracy was determined by comparing the AG Cuffill's readings against a precise, calibrated pressure measuring system across different pressure ranges. The "Comparison Test with predicate device" used the predicate device's measured performance as a comparative 'ground truth' or benchmark.

8. Sample Size for Training Set

The document does not describe a machine learning algorithm that requires a "training set." Therefore, information on a training set sample size is not applicable.

9. How Ground Truth for Training Set Was Established

As there is no mention of a training set for a machine learning algorithm, this is not applicable. The device's functionality is based on direct physical measurement, not on AI algorithms trained on data.

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