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WEINMANNcompact is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients (>30kg). The device delivers a fixed treatment pressure within the range of 4 to 20 cmH2O. (Fooly). The oction action and click 2) is indicated for the humidification and warming of air from the WEINMANNcompact flow generator device. The WEINMANNcompact and WEINMANNclick 2 are for home and hospital use.

The WEINMANNcompact is a microprocessor controlled blower-based device that generates a Continuous Positive Airway Pressure (CPAP) from 4 to 20 cmH2O for the treatment of Obstructive Sleep Apnea (OSA). The system includes the flow generator, patient tubing, external power supply, and an optional heated humidifier WEINMANNclick 2. A radial compressor draws in ambient air via a filter and conveys it to the unit outlet. From here the air flows through the hose system and the mask to the patient. The WEINMANNcompact has one mode of operation (CPAP fixed-pressure mode). In this mode the flow generator provides a single fixed-pressure as set by the clinician. A softstart automatic system is installed to help the patient fall asleep more easily. The optional breath humidifier WEINMANNclick 2 can be snapped onto the therapy unit at the front. The air from the flow generator is directed over a water surface in the humidifier, which functions according to the pass-over principle.

The provided text is a 510(k) summary for the WEINMANNcompact CPAP device. It details the device's technical characteristics and claims substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or a dedicated study that proves the device meets those criteria in the way typically found for a new, non-equivalent device or a device with new performance claims.

The document states: "Design verification testing was performed based on risk analysis and product requirements to ensure that the WEINMANNcompact met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials of the device." This is a general statement and does not provide the specific details requested in your prompt.

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Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary for the WEINMANNcompact indicates that the device's acceptance criteria are based on its specifications, and these were verified through "Design verification testing" and "Biocompatibility testing." The core of the submission is a claim of substantial equivalence to existing predicate devices (ResMed S7 Elite CPAP System and WEINMANNcomfort 2). This means the device is considered safe and effective because its technological characteristics and intended use are the same or very similar to legally marketed devices.

The "study" to prove the device meets acceptance criteria primarily consists of demonstrating that the WEINMANNcompact shares the "same intended use, same operating principle, same technology, [and] same manufacturing process" as its predicates. Any minor differences (e.g., external power supply) were deemed not to affect safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Information (where available or explicitly not present in the document):

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

   • Sample Size: Not specified. The document primarily refers to "design verification testing" and "biocompatibility testing" without providing specific sample sizes for these tests. In the context of substantial equivalence, formal clinical trials with human subjects and specific test set sizes for performance evaluation against a gold standard are often not required if technological characteristics are demonstrably equivalent.
   • Data Provenance: Not specified. (e.g., country of origin, retrospective or prospective).

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

   • This information is not provided in the submission. For a 510(k) based on substantial equivalence, the "ground truth" is often established by adherence to recognized standards and engineering specifications rather than expert consensus on specific device output measurements against a clinical truth.

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

   • This information is not provided in the submission. The submission focuses on technical verification rather than human-read decision-making requiring adjudication.

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:

   • No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-assisted diagnostic or interpretive devices, which the WEINMANNcompact (a CPAP therapeutic device) is not. There is no AI component mentioned for human assistance.

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

   • This question is not applicable as the device is a medical therapy device (CPAP), not an algorithm for diagnosis or interpretation. The device operates independently to deliver a set pressure.

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

   • The "ground truth" for the WEINMANNcompact's performance appears to be its adherence to established engineering specifications for CPAP devices and its capability to deliver pressure within the stated range (4-20 cmH2O). For biocompatibility, the ground truth would be established by international standards (e.g., ISO 10993). However, specific details are not provided.

8. The sample size for the training set:

   • This information is not applicable as there is no mention of a "training set" in the context of machine learning or AI for this device. The device operates based on predefined engineering and thermodynamic principles.

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

   • This information is not applicable as there is no "training set."

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