The ndd Medical Technologies EasyOne™ Spirometer is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.

Device Description

The ndd EasyOne™ Spirometer system consists of the following: EasyOne™ Spirometer (either the Frontline Model 2000 or the Diagnostic Model 2001) Disposable Spirette Cal coupler (used to connect the spirometer to the calibration syringe) EasyStart User Instructions EasyGuide Technical Information EasyOne™ Cradle (optional) Printer cable (optional) Two AA alkaline batteries

AI/ML Overview

Please note that the provided text is a 510(k) summary, which is a regulatory document. While it mentions performance testing and compliance with standards, it does not contain a detailed study report with all the requested information for a scientific paper.

Therefore, I can extract the available information but significant parts of your request, particularly regarding specific study designs, sample sizes for test/training sets, ground truth establishment methods, expert details, and MRMC studies, are not present in this regulatory summary.

Here's an attempt to answer your questions based only on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ATS standards)	Reported Device Performance (as implied by conclusion)
Requirements for accuracy defined by the American Thoracic Society (ATS)	Demonstrated compliance with ATS accuracy requirements.
Compliance with hardware and software requirements defined in the EasyOne™ Spirometer Requirements Specification	Demonstrated compliance with hardware and software requirements.
Conformance to applicable requirements in Section (h)(1)-(7) and Section (i) of Appendix A of 1993 Draft "Reviewer Guidance for Premarket Notification Submissions"	Demonstrated conformance to these specified sections.
Conformance with IEC601-1 requirements for electrical safety	Demonstrated conformance to IEC601-1.
Biocompatibility testing in accordance with G95-1 / ISO-10993	Demonstrated compliance with G95-1 / ISO-10993.

Note on "Reported Device Performance": The document states that testing was conducted and demonstrates compliance or conformance. It does not provide specific numerical performance metrics (e.g., specific accuracy percentages, standard deviations, or ranges of error) as a scientific study report would.

Additional Information Not Contained in the Document:

Due to the nature of a 510(k) summary (which focuses on regulatory compliance and substantial equivalence rather than detailed research study reporting), the following information is not available in the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no expert-based ground truth is explicitly mentioned for performance evaluation in this context. The "ground truth" for a spirometer is typically established by physical standards and calibrated devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the type of device and testing described.
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: Not applicable. This is a spirometer, not an AI-assisted diagnostic imaging device for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The spirometer itself is a standalone device in terms of measuring lung function. The testing described would inherently be evaluating the algorithm/device's standalone performance against known physical standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a spirometer, the "ground truth" for accuracy testing would typically involve comparisons to established physical standards (e.g., highly accurate flow/volume simulators or other calibrated spirometers). The document mentions "requirements for accuracy defined by the American Thoracic Society," implying that the ground truth is based on these established physiological and measurement standards.
The sample size for the training set: Not applicable. Spirometers are not typically "trained" using patient data in a machine learning sense. Their function is based on physical principles of flow measurement.
How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

Summary of what's available vs. what's missing:

The document clearly states:

The device is a spirometer.
It uses ultrasonic technology for flow measurement.
It claims substantial equivalence to predicate devices (Puritan-Bennett Renaissance Spirometer and others).
Performance testing was conducted to demonstrate compliance with ATS accuracy requirements, hardware/software specifications, specific FDA guidance sections, IEC601-1 for electrical safety, and ISO-10993 for biocompatibility.
The overall conclusion is that it is substantially equivalent and safe/effective.

However, it lacks the granular detail of a research study that would provide specific sample sizes, demographic information of a test set, detailed numerical performance results (e.g., mean absolute error, precision measurements), and specific methodologies for establishing ground truth beyond reference to general standards.

Summary

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K993921

510(k) SUMMARY

ndd Medical Technologies

ndd Medical Technologies EasyOne™ Spirometer

November 17, 1999

Submitter Information:

Submitter's Name:	ndd Medical Technologies17 Progress AvenueChelmsford, MA 01824
Telephone:	(978) 244-0620
Device Name:
Proprietary name:	ndd Medical Technologies EasyOne™ Spirometer

Spirometer Common Name:

Diagnostic spirometer Classification Name:

Predicate Device Equivalence:

Substantial equivalence is claimed to the Puritan-Bennett Renaissance Spirometer, cleared for commercial distribution per K944672, and other legally marketed devices.

Device Description:

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Intended Use:

Comparison of Technological Characteristics:

The device has the same technological characteristics as the predicate devices except for the use of ultrasonic technology for flow measurement. Testing was conducted that demonstrates this method of flow measurement is as accurate as the methods used in predicate devices and therefore substantially equivalent to the predicate devices.

Summary of Testing:

Performance testing was conducted to demonstrate compliance with the hardware and software requirements defined in the EasyOne™ Spirometer Requirements Specification, including requirements for accuracy defined by the American Thoracic Society.

The device was tested to demonstrate conformance to the applicable requirements contained in Section (h) (1) - (7) and Section (i) of Appendix A of the November 1993 Draft document "Reviewer Guidance for Premarket Notification Submissions".

The device was tested to demonstrate conformance with IEC601-1 requirements for electrical safety.

Biocompatibility testing was conducted in accordance with Office of Device Evaluation General Program Memorandum #G95-1, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing '

Conclusions:

Based on the above, we concluded that the ndd Medical Technologies EasyOne™ Spirometer is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2000

Mr. Oscar Kaelin CEO ndd Medical Technologies 17 Progress Avenue Chelmsford, MA 01824

K993921 Re: EasyOne™ Spirometer Regulatory Class: II (two) 73 BZG Product Code: Dated: March 10, 2000 March 14, 2000 Received:

Dear Mr. Kaelin:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your beceiver on we have determined the device is the device referenced above and wo have tions for use stated in the s Substantially equivalence (10) one caredicate devices marketed in enclosure) to regally marketed productions the enactment date of the interstate Commerce provices that have been reclassified Medical Device Imendales, I , i In accordance with the provision of therefore, market the device, subject to The general controls the general controls provisions of the Act. the general controls provisions of the entirements for annual registration, provisions of the nee on manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device ID Stablemarket Approval), it may be subject to such Controls) of Class III (Frediality of regulations affecting your device auditionar concreas. In of Federal Regulations, Title 21, Parts 800 can be round in the ood equivalent determination assumes compliance co oss. If babbeanedad as a manufacturing Practice requirements, as set with the Ourlows Sty System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocherar regaracter od and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Fraine of Stipen, FDA may publish further announcements concerning your device in the Federal Register. Please note: this concerning your action in motification submission does not affect any response to your premainedunder sections 531 through 542 of the Act obrigation you might well the electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Oscar Kaelin

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in your of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its be obtainsd from (300) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N. Milken

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name:

ndd Medical Technologies EasyOne™ Spirometer

Indications for Use:

The ndd Medical Technologies EasyOne™ Spirometer is intended for prescription use The ndd Medical Technologies Lasyone - Oplike and nediatric patients over
only to conduct simple diagnostic spirometry testing of adults and nospital settings only to conduct simple diagnostic spiromotive to addite the propositial settings.
4 years old, in general practice and specialty physician, industrial and hospital settings.

Muda A. Muhan
Division Sign Off

(Division Sign-Off Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number .

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).