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The Mercury Medical Negative Inspiratory Force (NIF) Disposable Manometer is used to indicate inspiratory force.

The Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer is designed to connect to an endotracheal tube. To record the maximum inspiratory pressure, the occlusion knob is held down during patient inhalation. The knob is released immediately after measurement. A memory pointer identifies and remains at the maximum inspiratory pressure to -60cm H2O. Rotating the memory pointer knob counterclockwise resets the memory pointer.

The provided text describes a Premarket Notification (510(k)) for the Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics of a novel device. As such, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is not explicitly present in the provided text.

Specifically, the document states:

• "Non-Clinical Data: Performance and specifications of the device are consistent with all requirements for this device type specified by ISO 5356-1: 1987 - Anesthetic and Respiratory Equipment-Conical connectors-Part 1: Cones and Sockets. ASTM F1054 - Standard Specification for Conical Fittings of 15mm and 22mm sizes."
• "The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device."

This indicates that the "acceptance criteria" are adherence to established standards (ISO 5356-1 and ASTM F1054) and demonstrating substantial equivalence to the DHD Medical Products Negative Inspiratory Force Monitoring Kit. The "study" proving this seems to be a comparison to the predicate device and adherence to these standards, but the specifics of how this comparison was performed, what data was collected, or what quantitative acceptance thresholds were used (beyond general consistency with the standards) are not detailed.

Therefore, many of the requested points cannot be answered from the provided text.

Here's a breakdown of what can be inferred or explicitly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative thresholds or detailed performance metrics required by ISO 5356-1 and ASTM F1054 are not elaborated upon in this summary.

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

• Not provided. The text does not detail any specific clinical or non-clinical test set, sample sizes, or data provenance for a study. It refers to adherence to standards and comparison to a predicate device.

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)

• Not applicable/Not provided. This type of information is typically relevant for studies involving subjective human assessment (e.g., image interpretation). For a manometer, ground truth would likely be established by calibrated instruments, not expert consensus in the human sense. The text does not mention any expert involvement in establishing "ground truth" for performance.

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

• Not applicable/Not provided. Given the nature of the device (a pressure manometer) and the focus on standards and substantial equivalence, an adjudication method for a "test set" in the context of human interpretation is not relevant here and is not mentioned.

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 device is a simple mechanical manometer, not an AI-powered diagnostic tool. MRMC studies are not applicable.

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

• Not applicable. This device is a physical, disposable manometer, not an algorithm. Its "standalone" performance would be its inherent accuracy and compliance with standards, which is generally what the non-clinical data section alludes to. No specific "standalone study" akin to an algorithm's performance is described.

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

• Inferred: Calibrated measurement devices and established industry standards. For a manometer, the "ground truth" for negative pressure measurements would be provided by highly accurate and calibrated reference instruments. The text mentions consistency with ISO and ASTM standards, which would define the acceptable performance against such a ground truth.

8. The sample size for the training set

• Not applicable/Not provided. This device does not involve machine learning or a "training set."

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

• Not applicable/Not provided. This device does not involve machine learning or a "training set."

In summary, the provided document focuses on demonstrating that the Mercury Medical NIF Disposable Manometer is "substantially equivalent" to an existing legally marketed device (the DHD Medical Products NIF Monitoring Kit) and adheres to relevant international and industry standards. It does not provide details of a quantitative study with specific acceptance criteria and performance metrics in the way one might expect for a novel or more complex device. The "proof" lies in its conformance to these established benchmarks and standards.

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