(194 days)
The S7™ Elite and AUTOSET® SPIRIT™ CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 2i™) is indicated for the humidification and warming of air from the S7™ Elite or AUTOSET® SPIRIT™ flow generator device. The S7™ Elite and AUTOSET® SPIRIT™ CPAP System and HUMIDAIRE® 2i™ are for home and hospital use.
The S7 Elite (K013909) and AutoSet Spirit (K013843) CPAP Systems are microprocessor controlled blower-based systems that generate Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA). The system includes the flow generator, patient tubing and a mask (patient interface). For additional humidification, several humidifiers, including the integrated HumidAire 2i, are designed to be compatible with the flow generators.
ResLink is intended to be used with the ResMed S7 Elite and AutoSet Spirit CPAP systems. ResLink provides collection, storage and transfer of treatment data for review by a clinician. In addition to storing treatment data, ResLink can also store pulse oximetry information if a pulse oximeter is connected to it.
ResLink is designed to attach to the flow generator using a docking mechanism. This mechanism allows the device to be electrically connected via a 15-pin expansion port located at the rear of the flow generator. A removable SmartMedia card (SMC) is inserted into ResLink prior to use. Patient data can then be automatically collected when the flow generator is in use. As instructed by the clinician, the patient will remove the SMC and return to the clinic, where the clinician can download the stored data onto a personal computer (PC). The clinician can view the data using AutoScan® software.
The provided text describes modifications to an existing CPAP system, primarily the inclusion of the "ResLink" accessory for data collection and an update to the system software. It states that "Design Verification and Validation were performed" and "All tests confirmed the product meets the acceptance criteria." However, the document does not provide specific details about the acceptance criteria or the study that proves the device meets those criteria.
Therefore, I cannot populate the requested table or answer most of the questions fully based on the provided text. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than detailing the full design verification and validation study results.
Here's a breakdown of what can be inferred or directly stated from the text, and where information is missing:
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A table of acceptance criteria and the reported device performance
- Not provided in the text. The document states "All tests confirmed the product meets the acceptance criteria" but does not define what those criteria are or report specific performance metrics against them.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the text. The text mentions "Design Verification and Validation were performed" but offers no details about sample sizes, data origin, or study design.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided in the text. The device described is a CPAP system and an accessory for data collection, not an AI/ML device that requires expert-established ground truth for performance evaluation in the context of the typical questions asked here. The "ground truth" for a CPAP system would generally relate to its physical performance, safety, and functionality in treating OSA, which is evaluated through engineering and clinical testing (though specific details are not here).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided in the text. See point 3.
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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
- Not applicable/Not provided in the text. This is not an AI/ML diagnostic or imaging device used by human readers in the way typically implied by MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided in the text. This device is a CPAP system, not an algorithm being deployed in a standalone manner for diagnosis or interpretation. Its "performance" is in delivering therapy and collecting data.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the text. For a CPAP system and data logger, ground truth relates to the accuracy of pressure delivery, leak detection, data recording, and overall safety and effectiveness for treating OSA. The document does not specify how these foundational aspects were "ground-truthed" beyond stating that "Design Verification and Validation were performed."
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The sample size for the training set
- Not applicable/Not provided in the text. This is not an AI/ML system that undergoes a "training" phase with a dataset in the typical sense.
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How the ground truth for the training set was established
- Not applicable/Not provided in the text. See point 8.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).