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The CPR FILTERSHIELD is a highly portable, single use, physical barrier for use in performing mouth-to mouth resuscitation on adults and children by personnel train in CPR techniques.

The configuration of this device is a plastic PVC sheet with a hole in the center. Sealed around the hole is two plastic molded supports. An electret fiberous media filter is sealed to the proximal molded support.

This 510(k) summary does not contain the level of detail necessary to complete all sections of your request comprehensively. Specifically, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with quantified acceptance criteria and performance metrics.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Note: The document states the CPR FILTERSHIELD "was found equivalent to the Laerdal shield for the following." This implies the acceptance criterion for each aspect was likely "performance equivalent to the predicate device." The specific quantitative thresholds for "flow resistance," "effects of temperature," and "barrier effectiveness" are not detailed 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)

• Sample Size for Test Set: Not specified. The summary focuses on demonstrating equivalence through various tests, but the number of units or measurements included in these tests (e.g., for flow resistance or barrier effectiveness) is not provided.
• Data Provenance: Not specified. The document does not indicate the country of origin where the tests were conducted or if the data was retrospective or prospective. It implies internal testing by the manufacturer or a contracted lab.

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)

• Number of Experts: Not applicable/Not specified. This type of device relies on engineering and material science testing, not expert interpretation of outputs like radiological images. Therefore, the concept of "ground truth established by experts" as typically understood in AI/medical imaging studies is not relevant here. The "ground truth" for material compliance would be the results from standardized lab tests.
• Qualifications of Experts: Not applicable/Not specified.

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

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human reviewers (e.g., radiologists) in studies involving subjective interpretation. This is an engineering/performance test, not an interpretation study.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical barrier, not an AI diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

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

• Standalone Study: This question is not applicable to a physical medical device. The device itself is "standalone" in its function as a barrier, but it doesn't involve algorithms or human-in-the-loop performance in the context of AI.

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

• Type of Ground Truth: The "ground truth" for this device's performance would be derived from:
  • Validated engineering test methods: For properties like flow resistance, effects of temperature, and barrier effectiveness.
  • International standards compliance: For biological evaluation (ISO 10993-1).
  • Performance of the predicate device: The direct comparison to the Laerdal Resusci™ Face Shield served as the benchmark for "equivalence."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This summary describes a 510(k) submission for a physical device, not an AI/machine learning algorithm. Therefore, there is no "training set."

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for a physical device.

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A device used for mouth-to-mask treatment of respiratory failure.

The configuration of this pocket-sized device is a cushioned face mask used to enclose the patients nose and mouth. A one-way valve allows the rescuer to provide exhaled air to the patient. The oxygen port will allow oxygen enhancement of the rescuer's exhaled air. Expired air and/or fluids from the patient is vented away from the rescuer due to the one-way valve and an alternate venting route. The device comes in one size and is designed for adults but can be used on infants. By rotating the mask 180 degrees and placing the nose portion just below the infants lover lip, the wider portion of the cushion rests on the forehead. The repositioning of the mask and the soft material of the mask cushion allows for a complete seal of the mask cushion to an infants facial contours. The device is non-sterile. It normally will be packaged in a polybag which may be placed in a zippered nylon pouch. This device is not intended for use by persons not trained in basic life saving skills or those with only a basic bystander course.

The provided text describes a 510(k) summary for the "CPR MICROMASK with Oxygen Inlet" and asserts its equivalence to a predicate device, the "Laerdal Medical Pocket Mask." However, the document does not contain the specific information required to answer all parts of your request regarding acceptance criteria and a study demonstrating the device meets those criteria in detail.

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

The document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics for the CPR MICROMASK with Oxygen Inlet itself.

Here's the information presented in the format requested, with missing information noted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document states "The CPR MICROMASK with Oxygen Inlet was found equivalent to the Laerdal Medical Pocket Mack for the following..." implying tests were done, but no sample sizes for these tests are mentioned.
• Data Provenance: Not specified. It's unclear if this was prospective testing or based on existing data. The context (510(k) summary) suggests the testing would have been conducted by the manufacturer, Plasco, Inc. (USA, Gurnee, IL).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided in the document. The tests seem to be performance-based, likely involving engineering or physiological measurements, rather than expert judgment for ground truth.

4. Adjudication Method for the Test Set

• Not applicable / Not specified. The document describes performance tests against a predicate device, not a judgment-based assessment requiring adjudication.

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

• No, a MRMC study was not done. The device itself is a physical medical device (CPR mask), not an AI or imaging diagnostic tool that would typically undergo such a study.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a physical rescue mask and does not involve an algorithm.

7. Type of Ground Truth Used

• The "ground truth" here is implied to be the established performance and safety characteristics of the predicate device (Laerdal Medical Pocket Mask), against which the new device's performance was measured for equivalence. For biocompatibility, it's compliance with established biocompatibility guidance documents.

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

In summary, the provided text is a regulatory submission focused on demonstrating substantial equivalence to a predicate device through a series of performance tests. It does not detail specific acceptance criteria values (e.g., "flow resistance must be no more than X mmHg/L/s") or the methodologies and results of underlying studies in the way one might expect for a new diagnostic or AI-driven device, but rather asserts equivalence to the established performance of the legally marketed predicate device.

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