(301 days)
The COSMED microQuark pulmonary function testing system is a modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation).
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Here's an analysis of the provided text regarding the COSMED microQuark device:
Based on the provided FDA 510(k) summary for the COSMED microQuark device, the information required to fully answer your questions regarding acceptance criteria and study details is not present. The FDA letter primarily states that the device is substantially equivalent to a predicate device and outlines general regulatory information. The "INDICATIONS FOR USE STATEMENT"
section only describes the intended use of the device.
However, I can extract what is available and indicate what information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document does not contain any specific acceptance criteria for the device's performance (e.g., accuracy, precision, sensitivity, specificity, or specific tolerances for pulmonary function measurements). Consequently, there is no reported device performance against such criteria.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not applicable. The device is described as a "Pulmonary Function Data Calculator" for "performing the basic lung function tests." This suggests it's a measurement device, not an AI-assisted diagnostic tool that would involve human "readers" or an "effect size of human readers improving with AI."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study: The document does not describe the methodology of any performance studies, standalone or otherwise. The device appears to be a hardware/software system for direct measurement, rather than a purely algorithmic diagnostic tool.
7. The type of ground truth used
- Type of Ground Truth: Not specified. For a pulmonary function device, ground truth would typically be established by established reference methods or highly accurate gold-standard equipment, but this is not detailed.
8. The sample size for the training set
- Sample Size for Training Set: Not specified. (It's unclear if a "training set" in the machine learning sense is even applicable, as the device is described as a "calculator" rather than a learning algorithm).
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not specified.
Summary of Missing Information:
The provided document is a boilerplate FDA 510(k) clearance letter and an "Indications for Use" statement. It confirms the device's regulatory clearance based on substantial equivalence to a predicate device but does not contain any details about the performance studies (validation, clinical, or technical) that would typically include acceptance criteria, test set sizes, ground truth methodology, or expert involvement. These details would usually be found in the 510(k) submission itself, which is a much more comprehensive document than the clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OSMED SRL C/O Dr. Robert Schiff President Schiff & Company 1129 Bloomfield Avenue West Caldwell. New Jersey 07006
Re: K020745
Trade Name: COSMED microQuark Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary Function Data Calculator Regulatory Class: II Product Code: 73 BZC, BTY Dated: December 17, 2002 Received: December 18, 2002
Dear Dr. Schiff:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Robert Schiff
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements; including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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). please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) PREMARKET NOTIFICATION COSMED SRL, ITALY COSMED microQUARK
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Device Name:
Not assigned yet k0207YS
COSMED microQuark
Indications for Use:
The COSMED microQuark pulmonary function testing system is a modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation).
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Per 21 CFER 801.109) (Optional Format 1-2-96)
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).