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The Sullivan Mirage Mask System is indicated for use with nasal Continuous Positive Airway Pressure (CPAP) and Variable Positive Airway Pressure (VPAP) systems for the indications specified in the relevant system's labeling; and with other CPAP and bilevel systems recommended by a physician or respiratory therapist.

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Based on the document provided, this is a 510(k) clearance letter for the Sullivan Autoset Nasal CPAP System and a separate "Indications for Use" statement for the Sullivan Mirage Mask System. This document does not include acceptance criteria or the study details proving specific performance.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements...".

This means the device was cleared based on its substantial equivalence to a predicate device, not on specific performance criteria demonstrated through a new clinical effectiveness study with a predefined acceptance criterion.

Therefore, I cannot provide the requested information from the given document as it does not contain:

1. A table of acceptance criteria and the reported device performance: This information is not part of a 510(k) clearance letter that relies on substantial equivalence.
2. Sample size used for the test set and the data provenance: Not provided for a substantial equivalence claim.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of clearance.
4. Adjudication method: Not applicable.
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 is a CPAP system, not an AI diagnostic/imaging device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable for a substantial equivalence claim.
9. How the ground truth for the training set was established: Not applicable.

The document is a regulatory approval notice based on "substantial equivalence" to a predicate device, not a detailed technical report of a clinical performance study.

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Treatment of obstructive sleep apnea in adult patients.

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This document is a 510(k) clearance letter from the FDA for the "Sullivan AutoSet Nasal CPAP System" (K980721). It states that the device is substantially equivalent to legally marketed predicate devices for the "Treatment of obstructive sleep apnea in adult patients."

However, this document does not include information on acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These types of information are typically found in the 510(k) submission document itself, not in the clearance letter.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided input.

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TREATMENT OF OBSTRUCTIVE SLEEP APNEA IN ADULT PATIENTS

SULLIVAN® AutoSet™ Portable II Nasal CPAP System

The provided document is an FDA 510(k) clearance letter for the SULLIVAN® AutoSet Portable II Nasal CPAP System. It states that the device is substantially equivalent to legally marketed predicate devices for the treatment of obstructive sleep apnea in adult patients.

However, the document does not contain any information regarding:

• Acceptance criteria or reported device performance
• Details of a study proving the device meets acceptance criteria (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance studies)
• Training set information

Therefore, I cannot fulfill the request for a detailed description of the acceptance criteria and the study that proves the device meets them based on the provided text.

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Ask a specific question about this device