(190 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flow Resistance | Found equivalent to the Laerdal Resusci™ Face Shield. |
| Effects of Temperature | Found equivalent to the Laerdal Resusci™ Face Shield. |
| Barrier Effectiveness | Found equivalent to the Laerdal Resusci™ Face Shield. |
| Biological Evaluation (Material Components) | Complies with ISO 10993-1 1992 Biological evaluation of medical devices (surface device, mucosal membrane, contact duration A). |
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.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).