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K Number
K033939
Device Name
FLOSENSE II, MODEL 29-8040
Manufacturer
SDI DIAGNOSTICS, INC.
Date Cleared
2004-01-30

(46 days)

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

The Flosense II is intended to be used as a disposable pneumotach for the Puritan-Bennett Renaissance II Spirometers which currently use the Puritan Bennett FSII Flow Sensor.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA, which states that the device, FloSense II, Model 29-8040, is substantially equivalent to a legally marketed predicate device.

It does not contain specific acceptance criteria, detailed device performance data from a study, or information about sample sizes, ground truth establishment, or expert involvement in a study. The letter itself is part of a regulatory process and refers to a premarket notification, but the notification details are not provided here.

Therefore,Based on the provided document, the following information cannot be extracted:

  1. A table of acceptance criteria and the reported device performance: This document is the FDA's clearance letter, not the premarket notification submission itself. It states that the device is "substantially equivalent" to predicate devices, but does not provide specific performance criteria or a table of results.
  2. Sample size used for the test set and the data provenance: Not available in this document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
  4. Adjudication method for the test set: Not available in this document.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size of how much human readers improve with AI vs without AI assistance: This information is not typically found in a 510(k) clearance letter, and is not present here. The device described is a spirometer accessory, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not available in this document. As above, this is a spirometer accessory, not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in this document.
  8. The sample size for the training set: Not available in this document.
  9. How the ground truth for the training set was established: Not available in this document.

§ 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).