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Manual ventilation and assist in verification of endotracheal tube placement

Manual Resuscitator with ACE

I am sorry, but the provided text from the FDA document (K982215) is a letter regarding the substantial equivalence determination for a "Manual Resuscitator with ACE" device. It does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or any performance metrics for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information. The document is a regulatory approval letter, not a scientific study report.

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The intended use for this device is to provide emergency respiratory support for Adult, Child and Infant.

The device is a disposable, single patient use manual resuscitator that includes a compression bag, intake and patient valve, and a closed vinyl oxygen reservoir bag, (options: open corrugated tubing or open expandable tubing in lieu of closed vinyl oxygen reservoir bag), and an optional peep valve and/or face mask.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BriGam Manual Resuscitator (K963848):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes tests performed on components of the manual resuscitator, rather than overall device performance metrics like efficacy in ventilation. The tests are focused on biocompatibility and physicochemical characteristics of materials in indirect contact with the patient.

Note: The acceptance criteria for "slight" cytotoxicity would need further context from the testing standard or internal protocols. It suggests that while some cytotoxicity was observed, it was deemed acceptable within a defined safety margin for the intended use and indirect contact. The "pertinent physiochemical extraction characteristics" are not detailed, but likely refer to the absence of excessive leaching of harmful substances.

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

The document does not specify the sample sizes used for the individual tests (Cytotoxicity, Physiochemical, ASTM Protein Analysis) of the components.

• Data Provenance: The tests appear to be conducted by or on behalf of the manufacturer, BriGam Medical Co. The country of origin for the data is not explicitly stated, but given the company's address in Newland, NC, USA, and the FDA submission, it can be inferred that the testing was likely performed in the USA. The data is prospective in the sense that these tests were performed specifically for the 510(k) submission to demonstrate substantial equivalence, rather than being collected retrospectively from existing records.

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

This type of information is not applicable to the tests described. The tests performed are laboratory-based material characterization tests (biocompatibility and physicochemical properties), not clinical studies requiring expert interpretation of diagnostic images or patient outcomes. The "ground truth" for these tests would be established by the results of standardized laboratory protocols and measurements, interpreted by laboratory technicians or scientists.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for interpreting ambiguous findings, typically by multiple experts.

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, an MRMC comparative effectiveness study was not done. The device is a manual resuscitator, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the tests performed is based on laboratory standards and measurements.

• For Cytotoxicity: This would typically involve visual assessment of cell morphology and viability relative to controls, following established standards (e.g., ISO 10993-5). The "scoring (reactivity)" as "slight" or "none" is a direct outcome of this assessment.
• For Physiochemical: This involves analytical chemistry techniques to identify and quantify extractables from the materials, with "ground truth" being the measured chemical profiles compared against known harmful substances or acceptable limits.
• For ASTM Protein Analysis: This involves a quantitative biochemical assay to measure protein concentration, with the "ground truth" being the measured protein level in micrograms per gram of material, compared against a specified threshold.

8. The Sample Size for the Training Set

There is no training set as this is a physical medical device, not a machine learning model.

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

This question is not applicable for the reasons stated above.

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