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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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The DeVilbiss IntelliPAP/SleepCube Model DV57 Series Auto Bilevel is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The Device is to be used in home and clinical environments.

The role of the product from a patient's point of view is to provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea. Positive airway pressure is applied to the oropharynx to act as a pneumatic splint to prevent the collapse of the pharyngeal muscle, which occludes the patient airway during sleep. Auto Bilevel units are used over conventional CPAP units due to high pressures and/or patient intolerance to continuous pressure, making exhalation difficult.

The proposed DeVilbiss DV57 Auto Bilevel product is an addition to the sleep product line. The proposed Auto Bilevel device combines the functions of traditional (predicate) Bilevel and (predicate) Auto Adjust CPAP to provide bilevel pressure support therapy that responds to detected events and adjusts the IPAP pressure setting as the patient demand requires. The level of pressure support, difference between IPAP and EPAP is maintained at a level prescribed by a doctor.

Automatic and manual inhale/exhale trigger sensitivity is to be provided to allow the clinician to customize trigger parameters for specific operating conditions. The DeVilbiss Intellipap/SleepCube Auto Bilevel product is not intended to meet the needs for the "ventilator" market, which necessitates features such as alarms, higher operating pressures and other ventilator specific functions

Here's an analysis of the provided text regarding the acceptance criteria and study for the DeVilbiss Intellipap/SleepCube Auto Bilevel device:

Important Note: The provided document is a 510(k) Summary, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. It typically focuses on design, function, and performance comparisons to predicates rather than presenting detailed, comprehensive clinical study results for novel acceptance criteria. Therefore, much of the requested information (like specific effect sizes from MRMC studies, detailed training set information with ground truth establishment, or specific sample sizes for tests) is not explicitly present in this type of document.

Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of precise, quantifiable acceptance criteria with corresponding performance metrics like you might find for a novel device. Instead, it relies on demonstrating substantial equivalence to predicate devices. The acceptance is implicitly tied to meeting the performance characteristics and safety profiles of the already-cleared predicate devices.

Implicit Acceptance Criteria and Reported Performance (derived from the text):

Study Details

The document describes non-clinical testing rather than a clinical study with human patients comparing the device's diagnostic or therapeutic efficacy against a gold standard or human readers.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The testing described is non-clinical (bench testing) against standards and performance characteristics of predicate devices.
   • Data Provenance: Not applicable as it's non-clinical testing. It's likely internal laboratory testing data from DeVilbiss Healthcare LLC.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of this 510(k) summary for a CPAP-like device. Ground truth for performance would be based on engineering specifications and adherence to standards, which typically do not involve expert medical readers for establishing the truth, but rather engineers and quality control personnel for verification.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as this is non-clinical testing against engineering specifications and standards.

4. 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:

   • No MRMC study described. This device is a therapeutic device (CPAP-like) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, this type of study is not relevant to its clearance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Standalone performance testing was done in the sense that the device's operational performance was tested independently against engineering specifications and standards. The device itself operates autonomously to deliver therapy based on pre-programmed algorithms for auto-adjustment and bilevel pressure delivery. However, this is not "standalone algorithm performance" in the context of an AI diagnostic that might be compared to human performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical testing, the "ground truth" would be the established engineering specifications, regulatory standards (ISO, ASTM, IEC), and the known performance characteristics of the predicate devices. Essentially, the device was required to perform according to its design and functional requirements, which were verified against these benchmarks.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML device that requires a "training set" in the context of machine learning model development. Its algorithms are likely rule-based or control-loop-based, developed through engineering design and testing, not by training on large datasets in the way an image recognition algorithm would be.

8. How the ground truth for the training set was established:

   • Not applicable. (See point 7).

In Summary:

The K112220 510(k) submission for the DeVilbiss Intellipap/SleepCube Auto Bilevel focuses on demonstrating substantial equivalence to existing predicate devices (Resmed VPAP Auto - K082605, DeVilbiss Intellipap Bilevel S - K091919, DeVilbiss IntelliPAP Auto Adjust - K071689). The "acceptance criteria" are intrinsically linked to meeting the performance, safety, and functional characteristics of these predicates, as well as adherence to relevant industry standards. The testing described is primarily non-clinical bench testing to verify these characteristics, not clinical studies involving patient populations, expert readers, or AI algorithm training.

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