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The Barf Band is indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example: pregnancy (morning sickness), motion sickness, anesthesia and chemotherapy.

The Barf Band is a wristband with adjustable properties that operates by putting pressure on Nei Kuan acupressure point (also known as the P6 point) on each wrist by means of a plastic dome/stud. Barf Bands are made from PVC free polyurethane, ABS plastic covered with Santoprene and 100% cotton. The band itself is composed of polyurethane. The ABS plastic covered with Santoprene is used to construct the plastic dome/stud that applies the pressure to the P6 point. The cotton is used inside the band to make the band comfortable to the end user.

The provided text is a 510(k) summary for the "Barf Band" and a subsequent FDA letter of substantial equivalence. This type of document, particularly for an acupressure device, focuses primarily on establishing substantial equivalence to predicate devices rather than presenting detailed clinical study data with specific acceptance criteria, statistical analyses for performance, or ground truth establishment as would be seen for a more complex diagnostic or therapeutic device.

Therefore, many of the requested elements for a study proving acceptance criteria are not applicable or not present in this document. The submission relies on demonstrating similarity in intended use, technological characteristics, and principle of operation to existing approved devices (PSI Band and Sea Band), along with performance testing to show the applied force falls within the range of the predicates.

Here's an attempt to address your request based on the available information, indicating when information is not present:

Description of Acceptance Criteria and Study Proving Device Meets Criteria

Overview: The Barf Band's acceptance criteria and proof of meeting them are established primarily through demonstrating substantial equivalence to predicate devices (PSI Band and Sea Band). The key performance metric evaluated was the force applied by the wristband, which was shown to fall within the range established by the predicate devices. This approach is common for lower-risk devices where direct head-to-head clinical efficacy studies against specific criteria are not typically required for 510(k) clearance if substantial equivalence can be shown.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for performance testing. The document refers to "Performance testing conducted on the Barf Band and the predicate devices," implying a comparison. It does not appear to be a clinical trial with a "test set" in the traditional sense of patient data.
• Data Provenance: Not applicable. The testing described appears to be bench testing of the device's physical properties (force application) and a comparison of those properties to predicate devices, rather than clinical patient data.
• Retrospective/Prospective: Not applicable based on the nature of the described testing.

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

• Number of Experts: Not applicable. The "ground truth" for this submission revolves around the characteristics of the device itself and its comparison to predicate devices, not expert interpretation of clinical data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was not a study involving expert adjudication of patient cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission is for a physical acupressure device, not an AI-assisted diagnostic or therapeutic tool for which such a study would be relevant.

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

• Standalone Performance: Not applicable. The Barf Band is a physical device, designed for human use, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the physical properties and performance characteristics of the predicate devices (PSI Band and Sea Band) regarding the force applied to the acupressure point. The Barf Band's performance was compared to this established range.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for this type of device submission.

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