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The M1 Capnography Mask is a single-use device intended for delivering supplemental oxygen and monitoring exhaled carbon dioxide in non-intubated spontaneously breathing patients. Standard oxygen tubing and two female luer ports for gas sample line attachment are included.

The M1 Capnography Mask is connected to a gas source for delivering low flow oxygen through flexible tubing to the patient, and at the same time provides a means to attach a capnograph for monitoring exhaled carbon dioxide during nose and mouth breathing. The capnograph gas sample tube attaches to a standard female Luer connector on either the left or right side of the M1 Capnography Mask. The M1 Capnography Mask will initially be made available in only one size, adult large (Model #001).

Here's a summary of the acceptance criteria and study information for the M1 Capnography Mask, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not specified for individual tests. The text indicates "a wide range of testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are non-clinical (bench testing, simulated use, biocompatibility).

3. Adjudication method for the test set: Not applicable. The studies described are non-clinical.

4. 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: Not applicable. This is a medical device (capnography mask), not an AI-powered diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.

6. The type of ground truth used:

   • Biocompatibility: Established by testing against ISO 10993-1 standards.
   • Functional Performance: Established by testing against ISO 594-2 standards.
   • ETCO₂ Sampling performance: Established by side-by-side bench testing with a legally marketed predicate device (Capnoxygen® Mask K971229) to demonstrate functional equivalence.
   • Device Shelf Life and Packaging: Established by testing against ASTM F 1980-07 and ASTM D 4169-09 standards, respectively.
   • Simulated Use and Mechanical Strength: Established by internal company protocols.

7. The sample size for the training set: Not applicable. This is a medical device, not an AI model requiring a training set.

8. How the ground truth for the training set was established: Not applicable. This is a medical device, not an AI model.

Summary of the "Study" (Non-Clinical Performance Data):

The M1 Capnography Mask did not require clinical testing because its indications for use were deemed equivalent to the predicate device, which has a proven safety and efficacy record. The demonstration of safety and effectiveness relied entirely on non-clinical performance data, primarily bench testing and simulated use testing.

The key study for comparison was a side-by-side bench test comparing the M1 Capnography Mask with the predicate Capnoxygen® Mask for CO₂ measurement performance. This testing found the two devices to be functionally equivalent in the detection of CO₂.

Other non-clinical tests included:

• Biocompatibility testing per ISO 10993-1.
• Functional performance testing per ISO 594-2.
• Simulated Use Testing per Monitor Mask Internal Company Protocol.
• Mechanical Strength Testing of Bonded Luer to Device.
• Device Shelf Life per ASTM F 1980-07.
• Device Packaging and Distribution per ASTM D 4169-09.

All these tests were successfully passed, indicating that the device design outputs meet the design inputs and user specification requirements for the M1 Capnography Mask.

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