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K Number
K984428
Device Name
SULLIVAN AUTOSET NASAL CPAP SYSTEM
Manufacturer
RESMED LTD.
Date Cleared
1999-07-26

(234 days)

Product Code
BZD
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

Not Found

AI/ML Overview

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.

§ 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).