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The Sleepstyle™ 200 Auto Series HC254 is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory.

The Sleepstyle™ 200 Auto Series HC254 is a non-invasive auto-adjusting Continuous Positive Airway Pressure (CPAP) flow generator, incorporating a heated respiratory humidifier. The HC254 is comprised of two functional units. One is a motorised fan assembly that provides positive air pressure. The fan speed is directly related to air pressure, and is controlled by software. The blower assembly output connects directly to a humidification chamber at the front of the device. The second functional unit of the HC254 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects directly to the blower assembly via a port at the back of the chamber. Ambient temperature is monitored in order to reduce breathing tube condensation in cooler operating conditions. The Sleepstyle ™ 200 Auto Series HC254 detects apneas, and flow-limitation. To this end the HC254 contains a breath detection algorithm and event detection algorithms. The apnea and hypopnea detection algorithms are time-domain based algorithms that compare the patients breathing and/or flow to thresholds dependent on the patient's peak inspiratory flow. The flow-limitation detection algorithm analyzes the patients breathing in the frequency domain and determines the presence or absence of flow-limitation. The HC254 also contains an algorithm, called SensAwake™, that is capable of detecting breathing patterns that are indicative of the "anxious" awake state. If SensAwake™ detects this "anxious" awake state then the pressure is reduced to help facilitate the patients return to sleep. An available treatment efficacy reporting software accessory is PerformanceMaximizer™, The package offers detailed reporting on therapy effectiveness, including compliance, AHI. leak and pressure. The supplied SmartStick™ fitted at the rear of the device transfers this information via USB technology.

The provided text describes a 510(k) summary for the Sleepstyle™ 200 Auto Series HC254, an auto CPAP humidifier. The document focuses on establishing substantial equivalence to a predicate device and details non-clinical and clinical testing, but it does not contain detailed acceptance criteria or a study proving the device specifically meets quantified acceptance criteria related to its software algorithms (breath detection, event detection, SensAwake™).

The "Clinical Tests" section mentions efficacy was shown by "reduction of the obstructive indices to below 15/hour, improvement in oxygen saturation 90% (this is usually a target, not a threshold 90% (implies successful treatment) |
| | Reduction of arousal index from baseline | Observed reduction of arousal index from baseline (implies successful treatment) |
| Device Safety | Lack of adverse events | Demonstrated safety by a lack of adverse events |
| Functional Verification & Performance | Compliance with IEC 60601-1 (Electrical Safety) | Complies with IEC 60601-1 |
| | Compliance with IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2 |
| | Compliance with 17510-1 (Sleep Apnea Therapy Devices) | Complies with 17510-1 |
| Mechanical, Electrical, Thermal Safety | Not explicitly stated (e.g., temperature limits, pressure accuracy) | Non-clinical testing carried out covering mechanical, electrical and thermal safety; reports included in Appendix E. |
| Environmental Conditions | Not explicitly stated (e.g., operating temperature, humidity) | Non-clinical testing carried out covering environmental conditions; reports included in Appendix E. |
| Electromagnetic Compatibility (EMC) | Not explicitly stated (e.g., emissions limits, immunity levels) | Non-clinical testing carried out covering electromagnetic compatibility; reports included in Appendix E. Complies with IEC 60601-1-2. |
| Software Algorithm Performance | Explicit, quantified acceptance criteria for breath detection, apnea/hypopnea, and flow-limitation detection algorithms are not provided in this document. | The device "detects apneas, and flow-limitation," using "time-domain based algorithms" and "frequency domain" analysis. SensAwake™ detects "anxious" awake state. |

Missing Information:

• Explicit, quantitative acceptance criteria for the accuracy, sensitivity, or specificity of the breath detection, apnea/hypopnea detection, flow-limitation detection, or SensAwake™ algorithms are not provided in this summary. The provided text only states that these algorithms exist and what they aim to detect.

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

• Sample Size for Test Set: The document mentions "clinical testing" and a "clinical study report is included in appendix F," but it does not specify the sample size of patients or cases used in this clinical study (which would serve as the test set for overall device efficacy).
• Data Provenance: The document does not specify the country of origin of the data. The study is described as "Clinical Tests" and refers to "patients," implying a prospective clinical study, but it does not explicitly state this.

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

• This information is not provided in the given text. While a clinical study report is mentioned (Appendix F), the details about how the obstructive indices, oxygen saturation, and arousal index were determined or adjudicated, or the qualifications of those experts, are not included.

4. Adjudication Method for the Test Set

• This information is not provided in the given text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study is mentioned. The study described focuses on the device's clinical efficacy and safety, not on comparing human readers' performance with and without AI assistance. Therefore, no effect size for human reader improvement with AI assistance is provided.

6. Standalone (Algorithm Only) Performance Study

• The document describes the presence of various algorithms (breath detection, apnea/hypopnea detection, flow-limitation detection, SensAwake™). It states that non-clinical tests included "functional verification and performance." However, it does not explicitly describe a standalone study specifically evaluating the performance metrics (e.g., sensitivity, specificity, accuracy) of these algorithms in isolation from the overall device's clinical impact on patients. The clinical study focuses on patient outcomes.

7. Type of Ground Truth Used

• For the clinical efficacy outcomes, the ground truth appears to be derived from clinical measurements and assessments from a prospective clinical study. The "obstructive indices," "oxygen saturation," and "arousal index" relate to physiological measurements typically used in sleep studies. It's implied that these formed the basis for evaluating treatment efficacy. The document does not specify if these were confirmed by a consensus of experts, pathology, or direct outcomes data beyond the physiological measurements.

8. Sample Size for the Training Set

• The document does not provide any information about a training set size. The algorithms are described as being present in the device, but details on how they were developed or trained (if machine learning based) are absent. This 510(k) summary focuses on the end-device performance and substantial equivalence.

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

• Since information on a training set is not provided, how its ground truth was established is also not available in the given text.

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