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510(k) Data Aggregation
K Number
K970771Manufacturer
Date Cleared
1997-06-20
(109 days)
Product Code
Regulation Number
868.5905Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
TREATMENT OF OBSTRUCTIVE SLEEP APNEA IN ADULT PATIENTS
Device Description
SULLIVAN® AutoSet™ Portable II Nasal CPAP System
AI/ML Overview
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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