(333 days)
The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 - 450 kPa, 3.5 - 4.5 bar). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is intended to be used for bedside application in a hospital environment. Compressor Mini is not intended to be used during in-hospital transportation or during ambulance or air transportation.
Compressor Mini will provide a supply of dry and filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vimin at 50-64 psi (350 - 450 kPa). The compressor is of light weight and compact design. It runs quietly, which makes it suitable for bedside use. It may be employed as a primary or secondary source of compressed air. The Standby function assures that if the central gas supply fails the Compressor Mini will start to deliver compressed air. The Compressor Mini is fitted with two alarm parameters, temperature and pressure. The Compressor Mini is designed with the similar materials and technology as the predicate device ALRECO 40400.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Compressor Mini:
The provided document describes a 510(k) submission for the Compressor Mini, a device intended to provide dry and filtered compressed air for medical respiratory ventilators or anesthesia machines. The submission claims substantial equivalence to a predicate device, the ALRECO 40400.
Crucially, the provided text DOES NOT contain a detailed study report with specific acceptance criteria, sample sizes, ground truth establishment methods, or statistical performance metrics (like sensitivity, specificity, AUC). This document is a 510(k) summary, which focuses on device description, intended use, and substantial equivalence to a predicate device, rather than a standalone performance study.
Therefore, many of the requested items cannot be answered directly from this document. However, I can infer some aspects based on the nature of a 510(k) submission and the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not present a formal table of acceptance criteria with specific performance metrics. The "performance" described is largely functional equivalence to the predicate device and the new device's specifications.
| Acceptance Criteria (Inferred from device description and substantial equivalence claim) | Reported Device Performance (From document) |
|---|---|
| Output Air Quality: Dry and filtered compressed air. | Stated as intended use: "provide a supply of dry, filtered, compressed air". (No specific filtration level or dryness metric provided). |
| Capacity: Sufficient flow and pressure for ventilator/anesthesia machine. | "Capacity is approximately 30 l/min at 50-64 psi (350 - 450 kPa)." |
| Operational Sound Level: Suitable for bedside use. | "It runs quietly, which makes it suitable for bedside use." (No specific decibel level provided). |
| Alarm Parameters: Functioning alarms for critical parameters. | "The Compressor Mini is fitted with two alarm parameters, temperature and pressure." (No performance details on alarm accuracy or trigger points provided). |
| Standby Functionality: Automatic switch to deliver compressed air if central supply fails. | "The Standby function assures that if the central gas supply fails the Compressor Mini will start to deliver compressed air." (No specific testing or reliability data provided here). |
| Materials/Technology: Similar to predicate device. | "The Compressor Mini is designed with the similar materials and technology as the predicate device ALRECO 40400." |
| Intended Use: Match predicate device and specified applications. | "The functionality for the Compressor mini is equivalent to the ALRECO 40400. Compressor mini and ALRECO 40400 have the same technological characteristics, intended use, materials, method of operation, performance claims and energy source..." |
| Physical Characteristics: More compact and lighter than predicate. | "A more compact design and lighter weight." (Specific dimensions or weight not provided, but stated as a design feature). |
| Power Consumption: Less than predicate device. | "Less power consumption." (No specific power consumption figures provided). |
| Flow/Reservoir: Lower continuous flow and smaller reservoir due to single ventilator focus. | "Lower continuous flow and smaller built-in reservoir, since the Compressor Mini is designed to supply only one ventilator with compressed air." (Specific flow/reservoir size not provided). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. As this is a 510(k) summary for a medical device (a compressor, not an imaging algorithm), the "test set" would likely refer to engineering verification and validation testing, not a diagnostic accuracy study with a "test set" of patient data.
- Data Provenance: Not specified. Based on the regulatory filing, the testing would generally be internal engineering and performance testing conducted by the manufacturer (Siemens), likely at their facilities in Sweden or another location where R&D/manufacturing occurs. It would be retrospective in the sense that the device was designed and then tested to meet specifications.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable / Not specified. For a device like a medical air compressor, "ground truth" is established through engineering specifications, validated test methods (e.g., pressure transducers, flow meters, air quality sensors), and compliance with international standards (e.g., for medical electrical equipment, compressed air quality). It would not typically involve human expert adjudication in the way diagnostic imaging studies do.
4. Adjudication Method for the Test Set
- Not Applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic studies. For a physical device, testing involves objective measurements against predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic algorithms or imaging systems where human readers interpret medical images or data. The Compressor Mini is a physical medical device (an air compressor) that supplies air; it does not involve human interpretation of output data in a diagnostic context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, a standalone performance assessment (device only) would have been performed. This is implicit in the device's development and regulatory submission. The device is designed to operate autonomously to provide compressed air. Its performance (flow, pressure, air quality, alarm functions, standby function) would have been validated independently through engineering tests without human intervention as part of its core functionality. While the document doesn't detail these tests, they are a fundamental part of a medical device submission.
7. The Type of Ground Truth Used
- Engineering Specifications and International Standards. The "ground truth" for the Compressor Mini would be defined by its design specifications, performance requirements (e.g., specific flow rates, pressure ranges, air quality parameters as per medical gas standards), and compliance with relevant healthcare device standards (e.g., IEC 60601 for electrical safety, specific standards for medical air compressors if applicable). These are objective, measurable criteria.
8. The Sample Size for the Training Set
- Not Applicable / Not specified. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the computational sense. The device's design and parameters are determined by engineering principles and iterative development, not by training on a dataset.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant. The device's "ground truth" (its optimal performance and validated parameters) would be established through a combination of engineering design calculations, component testing, sub-system testing, and full-device verification and validation against its specifications and relevant regulatory standards.
§ 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.