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Pressure Right® is a drug-free, Single-Use, Pressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion.

The Pressure Right device 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″ wide) 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.

This document describes a 510(k) submission for the "Pressure Right® Acupressure, Pressure-Sensitive Wrist Strip" (K142471). The primary goal of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, particularly the Sea-Band® (K033268) for over-the-counter (OTC) use and an earlier version of the Pressure Right® (K110563) for prescription use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly based on demonstrating performance equivalence to already cleared predicate devices, specifically regarding the pressure exerted and overall functionality. Since this is a 510(k) for an acupressure device, the primary performance measure highlighted is the typical contact pressure.

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

For the specific 510(k) submission K142471 describing the "Pressure Right® Acupressure, Pressure-Sensitive Wrist Strip," no clinical testing was performed. The non-clinical performance data relied on bench testing to evaluate the pressure equivalence between the Pressure Right device and the marketed predicate Sea-Band device. Therefore, there is no specified "test set" in terms of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective status for this submission.

The document states: "There was no new clinical testing required to support the medical device as bench testing was performed to evaluate the pressure equivalence of the Pressure Right acupressure device compared to the marketed predicate (Sea-Band) device."

However, it does mention that the predicate device, Pressure Right (K110563), was clinically tested, and that clinical data was included in its original submission (K110563). The details of the sample size and provenance for that predicate study are not provided in this document.

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

Not applicable, as no clinical test set was used for this specific submission (K142471). Bench testing was conducted to assess physical attributes.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for this specific submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A MRMC comparative effectiveness study was not conducted for this submission. The submission primarily relies on demonstrating substantial equivalence through non-clinical bench testing and comparison to predicate devices, including their existing clinical data.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, in a sense. The "device" in question is a physical acupressure wrist strip. The performance evaluation was essentially a standalone assessment of its physical characteristics (primarily pressure output) compared to a predicate device, without a human-in-the-loop performance study for this specific submission.

7. The Type of Ground Truth Used

For this specific submission (K142471), the "ground truth" for the non-clinical bench testing was the measured typical contact pressure of the predicate Sea-Band device (5-7 lbs/sq. in). The new Pressure Right device was expected to demonstrate equivalent pressure.

For the predicate Pressure Right device (K110563), the document states it was "clinically tested" and had "proven safety and efficacy for the use of the device." This implies an existing body of clinical outcomes data (e.g., reduction in nausea symptoms) served as the ground truth for that prior submission, but the specifics are not detailed here.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device requiring a training set. The device is a physical acupressure wrist strip.

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

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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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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