(219 days)
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The provided document is a Pre-Market Notification Certification and Summary for medical devices (VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 and VM PLUS). It does not contain any information about acceptance criteria or a study proving device performance in the way requested for AI/machine learning model evaluation.
This document focuses on:
- Certification of awareness regarding safety and effectiveness problems for the listed devices.
- Assertions about the absence of reported safety problems for the intended use.
- Confirmation of compliance with a specific safety standard (International BS EN 1SO 60601-1).
- Instruction on general medical hygiene and sterilization of the mouthpiece.
- Identification of low battery power as an effectiveness issue, with a visual indicator provided.
Therefore, I cannot extract the requested information (Table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, or training ground truth establishment) from this document.
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Image /page/0/Picture/0 description: The image shows the word "INTERNATIONAL" in all caps. The word is in a sans-serif font and is black. The background is white. The image is cropped closely around the word.
Clement Clarke
APPENDIX 1
JAN - 2 1997
PRE-MARKET NOTIFICATION CERTIFICATION AND SUMMARY
I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for the VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 and VM PLUS. I further certify that I am aware of the types of problems to which the VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 AND VM PLUS is susceptible and that the following summary of the types and causes of safety and/or effectiveness problems about the VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 and VM PLUS is complete and accurate:
Safety Problems 1.
- No safety problems should be experienced during use of the device for its intended purpose, a) and none have been reported for either the VMX, VM1 or VM PLUS. The device complies fully with International BS EN 1SO 60601-1 Standard "MEDICAL ELECTRICAL EQUIPMENT; GENERAL SAFETY REQUIREMENTS".
- b) General Medical Standards of cleanliness should be observed in maintaining the instrument. and the mouthpiece should be routinely sterilised in accordance with the Users Instructions.
2. Effectiveness Problems
DATE: ...
Low battery power will prevent use of the instrument, but visual indication of this is shown on the instrument display, allowing time for a replacement to be fitted.
PRINTED NAME OF PERSON REQUIRED TO SUBMIT 510 (K)
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- SIGNATURE OF PERSON,REQUIRED TO SUBMIT 510 (K)
- ..............................................................................................................................................................................
- TITLE OF PERSON SUBMITTING 510 (K)
.......................QUALITY ASSURANCE MANAGER .............................................................................................................................
- NAME OF COMPANY : CLEMENT CLARKE INTERNATIONAL LIMITED
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).