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K Number
K041057
Device Name
FLO-RITE
Manufacturer
AMERIFLO CORP.
Date Cleared
2004-08-12

(111 days)

Product Code
NFB
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Flo-Rite Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for supplemental oxygen therapy for in-home or ambulatory application.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the Flo-Rite and Flo-Rite II devices. This type of letter generally does not contain acceptance criteria or study results because it is not a clinical study report.

The letter states that the FDA has "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, based on the provided document:

  1. A table of acceptance criteria and the reported device performance: Not available in this document. The 510(k) process focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance acceptance criteria from a pre-defined study.
  2. Sample sized 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a noncontinuous ventilator, not an AI-assisted device, and does not describe comparative effectiveness studies of human readers.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document is for a noncontinuous ventilator, not an algorithm.
  7. The type of ground truth used: Not available in this document. The 510(k) pathway for this device would typically rely on engineering testing and performance data to demonstrate equivalence, not ground truth established by expert consensus or pathology in the context of clinical interpretation.
  8. The sample size for the training set: Not applicable as this is not an AI/ML device. Information about training sets would not be present.
  9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

Summary from the provided document:

The document is a 510(k) clearance letter for a noncontinuous ventilator, the Flo-Rite and Flo-Rite II. The FDA determined the device is substantially equivalent to legally marketed predicate devices. The letter does not detail specific acceptance criteria, study designs, sample sizes, expert involvement, or ground truth establishment, as these are typically part of the regulatory submission itself rather than the clearance letter. The regulatory pathway for this device (Class II for a noncontinuous ventilator) focuses on demonstrating equivalence to predicates through engineering and performance data, rather than clinical studies with "ground truth" as might be seen for diagnostic devices or AI applications.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).