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510(k) Data Aggregation
(244 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Equivalence) | Reported Device Performance (Reference to Laerdal Pocket Mask) |
|---|---|---|
| Flow Resistance | Equivalent to predicate device | Found equivalent to Laerdal Medical Pocket Mask |
| Face Mask Transparency | Equivalent to predicate device | Found equivalent to Laerdal Medical Pocket Mask |
| Face Sealing | Effective sealing | Found equivalent to Laerdal Medical Pocket Mask |
| Effect of Vomitus | Barrier effectiveness for vomit | Found equivalent to Laerdal Medical Pocket Mask |
| Barrier Effectiveness | Effective barrier against patient's expired air/fluids | Found equivalent to Laerdal Medical Pocket Mask |
| Dead Space | Acceptable level of dead space | Found equivalent to Laerdal Medical Pocket Mask |
| Effects of Temperature | Performance maintained across a temperature range | Found equivalent to Laerdal Medical Pocket Mask |
| Possibility of Misassembly | Minimized risk of misassembly | Found equivalent to Laerdal Medical Pocket Mask |
| Human Factors Design & Instructions | User-friendly design and clear instructions | Found equivalent to Laerdal Medical Pocket Mask |
| Supplemental Oxygen | Accepts supplemental oxygen effectively | Found equivalent to Laerdal Medical Pocket Mask |
| Biocompatibility | Complies with Tripartite Biocompatibility Guidance | Major patient/rescuer contact components comply with guidance |
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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