Search Results

The Mark 5 Nuvo (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

The Mark 5 Nuvo (M5C5) oxygen concentrator is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized rotary 4-way valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90 ±3% at a flow rate of 5 l/min ±10%. It is not a life-supporting, life-sustaining or sterile device.

The Mark 5 Nuvo (M5C5) oxygen concentrator is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 as appropriate to the area of usage. The Mark 5 Nuvo (M5C5) oxygen concentrator is intended to be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.

Here's a breakdown of the acceptance criteria and the study information for the Nidek Medical Products, Inc. Mark 5 Nuvo (M5C5) Oxygen Concentrator, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Nidek Mark 5 Nuvo (M5C5) Oxygen Concentrator primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and their direct fulfillment in a table. However, we can infer some key performance metrics and the reported device performance from the "Device Description" section and the "Nonclinical Performance" section.

Note on Acceptance Criteria: It's important to understand that for a 510(k) submission, the primary "acceptance criterion" is generally substantial equivalence to a predicate device. This means the new device performs as safely and effectively as a legally marketed device. The performance specifications listed above are the design specifications that were likely established to meet the intended use and demonstrate equivalence, rather than explicitly stated "acceptance criteria" against which a study was formally tested and presented in a table in this summary.

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

The document does not explicitly state a "test set" in the context of clinical studies with a specific sample size. The performance testing conducted was nonclinical.

• Sample Size: Not applicable for a traditional test set involving patient data. The testing was performed on the device itself. The number of units tested is not specified but would typically involve one or more production or prototype units under various conditions.
• Data Provenance: The testing was nonclinical, conducted at Intertek Testing Services NA Inc. located at Duluth, GA. This indicates laboratory-based testing, not human subject data.

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

Not applicable. The testing was nonclinical and involved adherence to recognized safety and performance standards. There was no "ground truth" derived from expert consensus on patient data. The "ground truth" for nonclinical performance is compliance with engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process for this nonclinical performance testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes a 510(k) submission for an oxygen concentrator, which involves a nonclinical performance evaluation against recognized standards and a comparison of technological characteristics to a predicate device. MRMC studies are typically used for diagnostic or screening devices where human readers interpret medical images or data, and an AI's impact on their performance is being evaluated.

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

Yes, in a conceptual sense. The "Nonclinical Performance" testing was a standalone evaluation of the device's adherence to applicable safety and electrical standards. The device itself (the oxygen concentrator) was tested independently without human-in-the-loop performance being a relevant parameter for its primary function of producing oxygen.

7. The Type of Ground Truth Used

For the nonclinical performance testing, the "ground truth" was compliance with established international and national electrical, medical device safety, and electromagnetic compatibility standards (EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999).

For the substantival equivalence comparison, the "ground truth" was the performance and design of the predicate device (Mark-5 (M5C5) Concentrator, K883591, and Model 590 Oxygen Concentrator, K895141).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (an oxygen concentrator) and does not involve AI or machine learning algorithms that would require a "training set" of data in the computational sense.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device