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The DeVilbiss DV5MB SmartLink II System can only be used in conjunction with the DeVilbiss DV51, DV53, DV54, DV55, DV56, and DV57 Series CPAP Systems for follow up of obstructive sleep apnea in patients weighing above 30 kg on nasal CPAP therapy. The system is to be used in home and healthcare environments.

The proposed DeVilbiss DV5MB SmartLink II System is an accessory to DeVilbiss IntelliPAP DV5x Series CPAPs, models DV51, DV53, DV54, DV55, DV56 and DV57. The proposed DeVilbiss DV5MB SmartLink II System connects physically and electrically to a DV5x Series CPAP for the purpose of collecting usage and performance data from the CPAP for subsequent download to PC software for storage, viewing and reporting.

The proposed DeVilbiss DV5MB SmartLink II System is identical to the predicate device with the addition of a Bluetooth Wireless connection. The Bluetooth radio used is a complete Bluetooth module with built in antenna and Bluetooth v2.1 + EDR. The maximum output power of the Bluetooth radio is +2.5 dBm, has a maximum range of 10 meters. The DeVilbiss DV5MB SmartLink II System wireless feature can be used in the home or in a healthcare setting.

This document is a 510(k) premarket notification for the DeVilbiss DV5MB Smartlink II System, which is an accessory to CPAP systems. It aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding device performance metrics in the way one might expect for a diagnostic or therapeutic medical device. Instead, the "acceptance criteria" are implied by the conformance to various international and national standards, and the "device performance" is stated as having "met the required performance criteria and functioned as intended."

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

This document describes a premarket notification for a medical device accessory (SmartLink II System) that collects usage and performance data from CPAP machines and adds Bluetooth wireless communication.

• Sample Size for Test Set: The document does not specify sample sizes related to patient data or clinical datasets for testing. The testing described is primarily non-clinical (bench testing, electrical safety, EMC, risk management, environmental, package, and RF compliance).
• Data Provenance: Not applicable in the context of this submission, as no clinical data or patient-specific data derived from human subjects is presented as a test set for the device's functionality. The "data" concerns the device's adherence to engineering and safety standards.

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

• Number of Experts: Not applicable. The ground truth for the non-clinical testing (e.g., whether a device complies with IEC 60601-1-1 or FCC Part 15) is established by the specifications of the standards themselves and the objective measurements performed by certified testing bodies or internal engineering teams.
• Qualifications of Experts: Not detailed, but implied to be qualified engineers and technicians performing the standard-based testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "test set" here refers to non-clinical tests against engineering and safety standards. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic outputs by human readers, which is not the nature of the testing described.

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

• MRMC Study: No. The document explicitly states: "No clinical testing or clinical performance evaluations were conducted on the proposed DeVilbiss DV5MB SmartLink II relating to clinical studies to demonstrate substantial equivalence to the predicate device." Therefore, no MRMC study or assessment of human reader improvement with or without AI assistance was performed or is relevant to this submission.

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

• Standalone Performance: Not applicable in the traditional sense of an AI algorithm's diagnostic or predictive performance. The SmartLink II system is an accessory for data collection and communication from a CPAP device; it does not perform diagnostic algorithms itself in a standalone capacity that would require such an evaluation. Its "performance" refers to its ability to reliably collect, transfer, and store data, and its compliance with safety and environmental standards.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical testing, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international standards (e.g., IEC 60601 series, ISO 14971, EN55011, IEC 529, IEC 68, ISTA Procedure 3A, FCC Part 15) and FDA guidance documents. Compliance is measured against these established technical benchmarks.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set of data. It is a hardware accessory with embedded software for data collection and communication.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.

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