(169 days)
The Precision Medical, Inc. Minimate compressor is intended to provide compressed air to a hand held medication small volume nebulizer. The device is not intended as a life supporting device.
The compressor is made up of three basic sections - l. Electrical motor - 2. Compressor - 3. Housing. A 1/30 hp electrical motor drives the air compressor. The compressor is a piston type, which is self lubricating, thus providing a oil free, air supply to the nebulizer. The housing provides protection for the components, reduces noise, and dampens the vibration from the compressor. The housing also protects the end user from the components of the device.
This 510(k) summary for the Precision Medical PM5 MiniMate Compressor primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria or a study designed to rigorously prove device performance against specific metrics. The provided text is a regulatory submission, not a scientific study report.
Therefore, many of the requested sections cannot be filled based on the provided document.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document implies the acceptance criterion is that the device passes specific tests. However, the quantitative thresholds for these tests are not provided.
Reported Device Performance:
"The Precision Medical, Inc. Minimate compressor PM5 successfully passed tests in the following areas; Mechanical / Climatic Electrical Device Performance"
No specific quantitative performance metrics are provided.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not provided in the document) | Reported Device Performance |
|---|---|---|
| Mechanical | (e.g., Durability, Vibration, Load-bearing capacity) | "Successfully passed tests" |
| Climatic | (e.g., Temperature tolerance, Humidity tolerance) | "Successfully passed tests" |
| Electrical | (e.g., Power consumption, Electrical safety, EMC) | "Successfully passed tests" |
| Device Performance | (e.g., Airflow rate, Pressure output) | "Successfully passed tests" |
2. Sample Size Used for the Test Set and Data Provenance
Not provided in the document. This is a regulatory summary, not a detailed test report.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a compressor, not a diagnostic imaging or AI device that would require expert-established ground truth for performance evaluation in the way described. Its performance is measured against engineering specifications.
4. Adjudication Method for the Test Set
Not applicable for this type of device and submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical compressor, not an algorithm.
7. The Type of Ground Truth Used
For a device like a compressor, "ground truth" would be established by engineering standards and specifications, validated through laboratory testing using calibrated equipment. The document states it "successfully passed tests" in Mechanical, Climatic, Electrical, and Device Performance areas, implying these engineering standards were met.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Its design and manufacturing processes are subject to quality system regulations, but there's no "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
Summary of available information:
The provided document is a 510(k) summary for a medical device (a portable nebulizer compressor). Its purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to present a detailed scientific study with AI-specific performance metrics. The "study" referenced is general performance testing (mechanical, climatic, electrical, device performance) that the device successfully passed, but no specifics on methodologies, sample sizes, or quantitative results are included in this summary.
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.