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The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip is indicated for the relief of emetic (nausea and vomiting) symptoms associated with Post-Operative Anesthesia.

The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.

The Pressure Right® device has a three-quarter wrist size design (5.50″ long X 1.0″ with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right® device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right® device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pressure Right® device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for clinical performance. Instead, it frames the evaluation in terms of "substantial equivalence" to a predicate device and "reducing postoperative nausea and vomiting." Therefore, the table below reflects the general claims and the study's aim rather than precise, pre-defined thresholds.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample size for the clinical study. It only mentions "Use of disposable acupressure device as part of a multi-model antiemetic strategy for reducing postoperative nausea and vomiting."
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not available in the provided text. The document refers to a "clinical study" but does not detail how "ground truth" (e.g., actual presence/severity of nausea/vomiting) was established or by whom.

4. Adjudication Method for the Test Set

This information is not available in the provided text.

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

• Was an MRMC study done? No, the device is a physical acupressure strip, not an AI or imaging device that would typically involve human readers interpreting cases.
• Effect size of human readers with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? No, the device is a physical medical device. The "clinical study" would inherently involve human subjects using the device.

7. The Type of Ground Truth Used

The type of "ground truth" for the clinical study would likely relate to the subjective experience of nausea and vomiting reported by patients, potentially measured through standardized scales. However, the document does not explicitly state the method for establishing ground truth or the specific outcome measures used to assess "nausea and vomiting relief."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The Pressure Right® device is a physical device, not an AI algorithm that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

• How ground truth was established: Not applicable. As it's not an AI device, there is no "training set" or corresponding ground truth establishment process in this context.

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