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The DeVilbiss Intellipap2/DeVilbiss BLUE Series is intended for use in treating OSA in spontaneously breathing patients 30 Kg (66 lbs) and above by means of application of positive air pressure. The Device is to be used in Home and Healthcare Environments.

The proposed DeVilbiss Intellipap2/DeVilbiss BLUE are devices for treating obstructive sleep apnea by means of applied airway pressure. Predicates devices DeVilbiss IntelliPAP DV5 Series (K071689), and Respironics, Inc, Remstar Auto A-Flex HT (K113068) operate by the same basic principal of creating pressurized air that is delivered to the patient's airway by a nasal or oralnasal mask. The devices maintain a set pressure, prescribed by a physician, at the patient's mask for flow rates up to approximately 100 L/m.

The document K143677 describes the DeVilbiss Intellipap2/DeVilbiss BLUE device, which is intended for use in treating Obstructive Sleep Apnea (OSA). A clinical study was performed to validate the respiratory event detection and pressure change decisions made by the proposed device.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or a direct comparison of the device performance against specific numerical targets for the respiratory event detection algorithm. Instead, it states the study's primary objective was to "demonstrate effectiveness of therapy provided by the DeVilbiss AutoAdjust CPAP device as reported by an expert human reviewer" and to determine "whether the machine results are equivalent to hand scores." The conclusion states that the device is "substantially equivalent to the predicate devices in terms of meeting performance criteria and functioning as intended."

2. Sample size used for the test set and the data provenance

• Sample size for the test set: 28 subjects
• Data provenance: A single-center, prospective, controlled study in the U.S.

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

• Number of experts: The document mentions "an expert human reviewer" (singular) for assessing therapy effectiveness and "hand-scored PSG" for equivalence, implying one or more experts for scoring. However, a specific number and detailed qualifications are not provided beyond "expert."

4. Adjudication method for the test set

• The document implies that the "expert human reviewer" or "hand-scored PSG" served as the reference standard against which the device was compared. The method for resolving discrepancies among multiple experts, if multiple were involved, is not explicitly stated.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not described. The study focused on validating the device's algorithm against human-scored PSG.

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

• Yes, a standalone study of the algorithm's performance was done. The study "compared to hand-scored PSG to determine whether the machine results are equivalent to hand scores," which indicates an evaluation of the device's algorithm performance directly.

7. The type of ground truth used

• Type of ground truth: Expert human reviewer and hand-scored Polysomnography (PSG).

8. The sample size for the training set

• The document does not provide information on the sample size used for the training set.

9. How the ground truth for the training set was established

• The document does not specify how the ground truth for any training set was established. It only describes the validation study for the "new Respiratory event detection algorithm."

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