(90 days)
The proposed devices are 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 proposed device 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 that are released when the pressure is vented to the atmosphere. This cycle is controlled by an electronic valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. The proposed device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg]. The device is available in both 115V and 230V models.
The device status indicators are controlled by a printed circuit board which is device model specific. For the OCSI model, device status indicators are mains power and oxygen concentration. For the STD model, device status indicators are mains power and system pressure.
The proposed device is not life supporting, life sustaining or sterile.
The proposed device may 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.
The provided text describes a 510(k) summary for the Mark 5 Nuvo Lite OCSI and Mark 5 Nuvo Lite STD oxygen concentrators. The information primarily focuses on regulatory approval, device description, and substantial equivalence to predicate devices, rather than a detailed study reporting acceptance criteria and device performance in the manner typically seen for clinical outcome-based or AI/software device studies.
Therefore, many of the requested categories for a study proving device performance are not explicitly detailed in the provided documents.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Nominal oxygen enriched gas concentration: 90% +6.5%/-3% | The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. (This is a design specification and also the stated performance characteristic). |
| Flow rate: 5 l/min ±10% | The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. (This is a design specification and also the stated performance characteristic). |
| Weight: Approximately 32 pounds [14.5 kg] | The proposed device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg]. (This is a design specification). |
| Compliance with ISO 8359:1996 | The device was tested to applicable requirements ISO 8359:1996. |
| Compliance with EN 60601-1-2:2001 | The device was tested to applicable requirements EN 60601-1-2:2001. |
| Compliance with IEC 60601-1:1988 + A1:1991 + A2:1995 | The device was tested to applicable requirements IEC 60601-1:1988 + A1:1991 + A2:1995. |
| Compliance with UL 60601-1:2003 | The device was tested to applicable requirements UL 60601-1:2003. |
| Compliance with CAN/CSA-C22.2 No 601.1-M90 | The device was tested to applicable requirements CAN/CSA-C22.2 No 601.1-M90. |
| Compliance with FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" | The device was tested to applicable requirements of FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate to the area of usage. |
| Substantial equivalence to predicate devices | The proposed devices are substantially equivalent to the legally marketed predicate devices (Nidek's Mark 5 Nuvo OCSI (K040892), Nidek's Mark 5 Nuvo (K032509), and Respironics' Everflo L4 (K061261)). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document describes nonclinical performance testing primarily focused on compliance with recognized standards (ISO, EN, IEC, UL, CAN/CSA, FDA guidance for EMI). It does not detail specific "test sets" or "data provenance" in the context of clinical studies with patient data. The testing mentioned would involve laboratory-based assessments of device specifications and safety standards, rather than tests on a "sample size" of patients or patient data.
3. 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. The document describes testing against engineering specifications and regulatory performance standards, not against expert-established ground truth from clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is relevant for interpreting clinical data, particularly in medical imaging or diagnostic contexts. The testing here is for engineering performance and regulatory compliance.
5. 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. The device is an oxygen concentrator, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is physical hardware (an oxygen concentrator), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on engineering specifications, direct measurements of oxygen concentration and flow rate, and compliance with established national and international safety and performance standards for medical electrical equipment and oxygen concentrators. There is no biological "ground truth" in the clinical sense mentioned.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning. The design and validation are based on engineering principles and regulatory standards.
9. How the ground truth for the training set was established
Not applicable.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).