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K Number
K992743
Device Name
COLLINS CPL
Manufacturer
COLLINS MEDICAL, INC.
Date Cleared
1999-09-13

(28 days)

Product Code
BZG
Regulation Number
868.1840
Type
Special
Panel
AN
Reference & Predicate Devices
K925459
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Collins CPL Pulmonary Function Test System is intended as a configurable, noninvasive pulmonary function testing (PFT), and exercise/nutritional/metabolic testing system. Complete plethysmography capabilities are an optional module. These tests are suitable for both pediatric and adult patient testing.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification summary for the Collins CPL Pulmonary Function Test System. It contains information related to the device's intended use and FDA clearance but does not include any details about acceptance criteria, specific performance studies, sample sizes, or ground truth establishment.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample size used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  4. Adjudication method: Not mentioned.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not mentioned.
  6. Standalone performance study information: Not mentioned.
  7. Type of ground truth used: Not mentioned.
  8. Sample size for the training set: Not mentioned.
  9. How the ground truth for the training set was established: Not mentioned.

The document is a clearance letter and intended use statement, asserting substantial equivalence to a predicate device (GS Modular Pulmonary Function Test System, 510(k) K925459), rather than a detailed study report. To get the requested information, you would typically need to refer to the full 510(k) submission, which is often not publicly available in its entirety, or more specifically, to the performance testing section within that submission.

§ 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).