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The AUTOSET SPIRIT CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMDAIRE® 2[™) is indicated for the humidification and warming of air from the AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT CPAP System and HUMIDAIRE 2i are for home and hospital use.

The AUTOSET SPIRIT CPAP System is a non-invasive Continuous Positive Airway Pressure (CPAP) system. It includes the following system components:

• Flow generator device,
• . Humidifier
• Mask and air tubing.
• . Clinical Interface (AutoScan) Software.
  The flow generator device incorporates a blower (motor/fan assembly), sensors and processing electronics. The blower supplies pressurized air to the patient via the air tubing and a mask.
  The AUTOSET SPIRIT flow generator has two (2) modes of operation:
• (i) CPAP Mode
  In this mode the flow generator provides a single fixed-pressure as set by the clinician.
• Auto-titrating (AutoSet) Mode (ii)
  In this mode the pressure is automatically set in response to the patient's breathing patterns.
  The AutoScan software allows adjustment of parameter settings and viewing of flow generator-stored treatment data via a PC.

This document describes the AUTOSET SPIRIT CPAP System, a device for treating Obstructive Sleep Apnea (OSA). The information provided is primarily focused on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for medical devices in the US. This type of submission relies on showing that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical trials with pre-defined acceptance criteria based on performance metrics.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as it would apply to a novel device or a device requiring a specific performance study, is not explicitly present in the provided text. The submission focuses on compliance with standards and a comparison to predicate devices, rather than a standalone performance study with specific effectiveness endpoints.

However, I can extract information related to the device description, indications for use, and the regulatory pathway.

Here's an analysis based on the provided text, addressing the points where information is available and indicating where it is not:

Acceptance Criteria and Study for AUTOSET SPIRIT CPAP System

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

• Acceptance Criteria: Not explicitly stated as performance metrics in this regulatory filing. The "acceptance criteria" here are implicitly being "substantially equivalent" to predicate devices and meeting relevant safety and electrical standards.
• Reported Device Performance: No specific performance metrics (e.g., AHI reduction, adherence rates, specific pressure delivery accuracy under varying conditions) are reported in clinical study format in this summary. The performance is implied to be equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a "test set" of patients for evaluating device effectiveness. The "testing" mentioned refers to compliance with engineering and safety standards, not a patient-based performance study.
• Data Provenance: Not applicable.

3. 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. There is no mention of experts establishing ground truth for a clinical test set in this document. The "ground truth" for this submission revolves around technical compliance and equivalence to predicate devices, assessed by regulatory bodies and internal engineering teams.

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

• Not applicable. There is no clinical test set requiring adjudication in this submission.

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

• This device (CPAP system) is not an AI-based diagnostic tool that relies on "human readers." Therefore, no MRMC study, AI assistance data, or effect size is relevant or mentioned.

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

• Not applicable. This is a medical device for treatment, not an algorithm. The "Auto-titrating (AutoSet) Mode" has an algorithmic component, but its performance is demonstrated through comparison to a predicate device and compliance with standards, not a standalone algorithm study with specific metrics in this document.

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

• For the purpose of this 510(k) submission, the "ground truth" is largely established by:
  • Regulatory Standards: Compliance with established medical device standards (EN 60601-1, ISO 8185, etc.).
  • Predicate Device Performance: The established safety and effectiveness of the ResMed Sullivan AutoSet CPAP System (K980721) and the ResMed Sullivan HumidAire Heated Humidifier (K971260). The new device demonstrates "substantial equivalence" to these.
  • Engineering and Bench Testing: Implicit in the statement "This submission presents the results of this testing, and together with detailed descriptions demonstrate Substantial Equivalence..."

8. The sample size for the training set

• Not applicable. This document does not describe a machine learning algorithm that requires a "training set."

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

• Not applicable. This document does not describe a machine learning algorithm or a training set.

Summary of Device and Approval Process:

The AUTOSET SPIRIT CPAP System is a non-invasive Continuous Positive Airway Pressure (CPAP) system for treating Obstructive Sleep Apnea (OSA) in adults. Its approval via the 510(k) pathway was based on demonstrating "Substantial Equivalence" to two predicate devices: the ResMed Sullivan AutoSet CPAP System (K980721) and the ResMed Sullivan HumidAire Heated Humidifier (K971260). The submission included:

• Detailed descriptions of the device, highlighting shared design features with predicate devices.
• Results from testing against a series of international and FDA-recognized standards for medical electrical equipment, electromagnetic compatibility, enclosure protection, humidifiers, and sleep apnea therapy devices.

The FDA's finding of substantial equivalence (K013843) on July 16, 2002, indicates that the agency determined the AUTOSET SPIRIT CPAP System to be as safe and effective as its predicate devices, based on the provided technical and regulatory compliance information, rather than a new clinical effectiveness study with defined performance acceptance criteria.

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