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K Number
K972833
Device Name
E100M VENTILATOR (E100M)
Manufacturer
NEWPORT MEDICAL INSTRUMENTS, INC.
Date Cleared
1999-09-23

(785 days)

Product Code
CBK
Regulation Number
868.5895
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Newport E100M is intended to provide positive pressure ventilation for neonatal, infant, pediatric and adult patients, for use in the hospital environment. The device is intended for use by or at the direction of a licensed practitioner.

Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for a medical device (Newport E100M Ventilator), not a study report describing acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, and ground truth establishment is not available in the provided document.

The document primarily focuses on FDA's determination of substantial equivalence for the device to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed technical or clinical study data that would typically include acceptance criteria and performance metrics.

However, I can extract the following limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

  • Not applicable. This document is a regulatory clearance letter, not a performance study report. It does not present specific acceptance criteria or reported device performance metrics in tabular form or otherwise.

2. Sample Size Used for the Test Set and Data Provenance:

  • Not applicable. The document does not describe a "test set" or any specific study involving data, sample sizes, or data provenance (country of origin, retrospective/prospective). The substantial equivalence determination is based on the comparison to a predicate device, as described in the 510(k) submission, not necessarily a new clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

  • Not applicable. No such information is present in this regulatory letter.

4. Adjudication Method for the Test Set:

  • Not applicable. No information on adjudication methods is present.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

  • Not applicable. There is no mention or indication of an MRMC study being conducted or its results in this document. The clearance is based on substantial equivalence, not necessarily a comparative effectiveness study showing improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study:

  • Not applicable. The device is a ventilator, not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant in this context and is not discussed.

7. Type of Ground Truth Used:

  • Not applicable. This document does not describe the establishment of ground truth for any study.

8. Sample Size for the Training Set:

  • Not applicable. There is no mention of a "training set" as this device is a physical ventilator, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established:

  • Not applicable. As above, no training set or ground truth establishment is mentioned.

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).