(195 days)
The DK50 D and DK50 DM Medical Compressors are indicated for supplying compressed air for medical ventilators.
The DK50 D and DK50 DM Medical Compressors are electric and produces air from the normal environment to supply compressed air for medical ventilators.
The provided text describes a 510(k) premarket notification for two medical compressors, DK50 D and DK50 DM. It details their intended use, describes them as substantially equivalent to a predicate device, and lists the standards they were tested against. However, the document does NOT contain information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for an AI/ML device.
This document is for a traditional medical device (compressors), not an AI/ML device, and therefore the concepts of "acceptance criteria" and "device performance" are addressed differently. The "study" mentioned is a general statement about adherence to industry standards, not a specific clinical or performance evaluation with statistical metrics.
Given the information provided, here's how the questions can be addressed:
- A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics in the document. The general acceptance criterion is that the device "meets its specifications and is safe and effective for its intended use" and is "substantially equivalent" to the predicate device.
- Reported Device Performance: The document states that "Comprehensive testing has been conducted on The DK50 D and DK50 DM Medical Compressors in accordance with various industry recognized standards, including: IEC 60601-1-2:2001, EN 55011:1998 &A1:1999." The outcome of this testing is that the device "meets its specifications." Specific performance metrics (e.g., flow rate, pressure, noise levels, durability) are not detailed in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1-2:2001, EN 55011:1998 & A1:1999 | Testing conducted; device meets specifications |
| Safety and Effectiveness for intended use (supplying compressed air for medical ventilators) | Deemed safe and effective; substantially equivalent to predicate |
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The testing mentioned refers to engineering and quality assurance testing against standards, not a clinical study with a "test set" of patients or data in the context of AI/ML.
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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)
- Not applicable / Not provided. Ground truth is not established in this context. The "truth" is whether the device adheres to engineering specifications and safety standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are relevant for interpreting complex data, often in clinical imaging or diagnostic studies, where human consensus is needed for ground truth. This is not
pertinent to the testing of an air compressor.
- Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are relevant for interpreting complex data, often in clinical imaging or diagnostic studies, where human consensus is needed for ground truth. This is not
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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
- Not applicable / Not done. MRMC studies are for evaluating human performance, often with or without AI assistance, usually in diagnostic tasks. This device is an air compressor, not a diagnostic tool, and has no human-in-the-loop AI component.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not done. This refers to AI algorithm performance. The device is a mechanical compressor.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. In the context of this device, "ground truth" would be the engineering specifications and performance parameters as defined by internal design documents and relevant industry standards. The summary does not provide specific details on how conformity to these was verified beyond stating "comprehensive testing."
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The sample size for the training set
- Not applicable / Not provided. This concept is for AI/ML models.
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How the ground truth for the training set was established
- Not applicable / Not provided. This concept is for AI/ML models.
§ 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.