Search Results

THERE ARE NO INDICATIONS FOR USE OF THIS DEVICE BY ITSELF. THE DEVICE IS AN ORTIONAL COMPONENT OF THE OXYGEN DELI'VERY SYSTEM PRESCRIBED FOR USE USE PARTIENTS , SUFFERING FROM THE SOLE PURPOSE OF SYSTEM PRESCRIVED PULMONARY DISEASE. CHRONIC OBSTRUCTIVE PULMONARY DISENSE. THIS DEVICE IS TO CONSERVE OXYGEN BY STOPEN BY STOPPING THE FIOW WHEN THIS DEVICE IS TO CONSERVE OXYGEN BY STOPEN EXHALATION AND THE PATIENT IS EXHALING OR PAUSING BETWEEN EXHALATION AND . IS EXHALTIAC OK FRONING DEVICE SEMSES THE BECIMMING I NHAL ING. OF INHALATION BY THE USER.

OXYGEN CONSERVER (VENTILATOR - NON CONTINUOUS)

This document is a 510(k) cleared letter from the FDA for the FLOTEC Oxysavrr™, a noncontinuous ventilator. It primarily focuses on the regulatory clearance and a correction to a product code.

Based on the provided text, the following information regarding acceptance criteria and a study is available:

1. A table of acceptance criteria and the reported device performance:
   The document does not contain any acceptance criteria or reported device performance data. It is a regulatory clearance letter, not a study report.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not mention any test set sample size or data provenance.

3. 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):
   The document does not mention any experts used to establish ground truth or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   The document does not mention any adjudication method.

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:
   The document does not mention an MRMC comparative effectiveness study, nor does the device appear to be an AI-assisted device. The device is described as an "Oxygen Conserver" that stops oxygen flow during exhalation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document does not mention any standalone performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The document does not describe the type of ground truth used.

8. The sample size for the training set:
   The document does not mention a training set sample size. This device is a medical device, not an AI or machine learning algorithm, and thus the concept of a "training set" in this context is not applicable.

9. How the ground truth for the training set was established:
   The document does not mention how ground truth for a training set was established.

Summary of what is present in the document:

• Device Name: FLOTEC Oxysavrr™ (also referred to as FLOTEC OXYGEN CONSERVER)
• Regulation Number: 868.5905
• Regulation Name: Noncontinuous Ventilator
• Regulatory Class: II (two)
• Product Code: 73 NFB
• Indications for Use: "THE DEVICE IS AN OPTIONAL COMPONENT OF THE OXYGEN DELIVERY SYSTEM PRESCRIBED FOR PATIENTS, SUFFERING FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THIS DEVICE IS TO CONSERVE OXYGEN BY STOPPING THE FLOW WHEN THE PATIENT IS EXHALING OR PAUSING BETWEEN EXHALATION AND INHALATION. THE DEVICE SENSES THE BEGINNING OF INHALATION BY THE USER."
• Regulatory Status: Substantially Equivalent (510(k) clearance) to legally marketed predicate devices.

Conclusion:

This document is a regulatory approval letter and does not contain the detailed technical study information requested regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, or comparative effectiveness. The device described is a mechanical oxygen conserver, not an AI or diagnostics device that would typically involve many of the requested study elements.

Ask a specific question about this device