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The Omni-5 Total O2 Delivery System is intended to supply low-pressure supplemental oxygen for the treatment of Respiratory Diseases in children through adults in the home, health care facility or hospital and to supply pressurized oxygen to fill oxygen cylinders for patient's ambulatory use.

The Omni 5 Total O2 Delivery System is comprised of conventional pressure adsorption technology which supplies low pressure oxygen to a nasal cannula and/or an intensifier which compresses a small portion of the gas to pressures up to 2015 psig in an oxygen gas cylinder for ambulatory use. The Omni 5 Total O2 Delivery System has a unique cylinder fill mechanism, which allows it to be easily and safely connected to the patient's Total O2 oxygen cylinder. The unique cylinder fill mechanism ensures that Total O₂ oxygen cylinders can only be filled through the unique fill port with the Total O₂ Delivery System. The original Total O2 Delivery System allowed for continuous oxygen flows and settings from 0 - 3 liters per minute, the modified Total O2 Delivery System (Omni 5 Total O2 Delivery System) allows for continuous oxygen flows and settings from 0 - 5 liters per minute. Additionally, the Omni 5 Total O2 Delivery System incorporates an automatic cylinder filling restart feature, should the oxygen purity fall below acceptable limits (cylinder filling stopped), then recover above the acceptable limits (cylinder filling restarted).

The provided document is a 510(k) summary for the "Respironics Omni 5 Total O2 Delivery System." This is a premarket notification for a medical device modification, not a study evaluating an AI algorithm or a diagnostic tool. Therefore, much of the requested information, such as acceptance criteria for AI performance metrics, sample sizes for test sets in an AI context, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, is not applicable to this type of regulatory submission.

The document focuses on demonstrating substantial equivalence to a predicate device, meaning the modified device is as safe and effective as a legally marketed device. This is achieved through design verification tests and a comparison of technological characteristics.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states: "Design verification tests were performed on the Respironics Omni 5 Total O2 Delivery System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, the specific quantitative acceptance criteria and the detailed test results are not provided in this summary. The summary focuses on the modifications and their impact rather than a complete performance study for a novel device.

The key modifications and their implied performance improvements are:

2. Sample size used for the test set and the data provenance:

• This is not applicable as this is a device modification submission, not a study on an AI algorithm's performance on a dataset. The "test set" refers to design verification tests performed on the physical device and its software, not a dataset of medical images or patient information.
• The document mentions "Design verification tests," which implies physical and functional testing of the device itself.
• No information on data provenance (country of origin, retrospective/prospective) is provided, as it's not relevant to this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable. The "ground truth" for a physical device's performance against design requirements is established through engineering specifications, standards compliance, and measurement instruments, not expert consensus on medical data.

4. Adjudication method for the test set:

• Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI, where the effectiveness of human readers with and without AI assistance is compared. The device in question is an oxygen delivery system, not a diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This question is based on the premise of an AI algorithm. The device, while containing software, is a physical medical device. The software modifications are for control and functionality (like automatic restart), not for independent diagnostic or predictive tasks that would typically constitute "standalone algorithm performance" in the context of an AI submission.
• "Software verification and validation" were conducted, which assesses the software's performance against its requirements, but not in a "standalone algorithm" sense as applied to diagnostic AI.

7. The type of ground truth used:

• For the hardware modifications (e.g., flow rate), the ground truth would be established by direct measurement using calibrated equipment against engineering specifications.
• For software modifications (e.g., automatic restart), the ground truth would be established by testing the software's logic and behavior against its functional requirements and design specifications, simulating conditions where purity falls/recovers.
• This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI ground truth.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm developed through machine learning on a training set of data.

9. How the ground truth for the training set was established:

• Not applicable for the reasons stated above.

In Summary:

The provided document describes a 510(k) submission for a modification to a portable oxygen generator. The device's acceptance criteria are based on its mechanical performance, safety, and functionality, as demonstrated through design verification tests and comparison to a predicate device. The information requested regarding AI particularities (test set sample size, expert ground truth, MRMC, training sets) is not relevant to this type of medical device regulatory filing.

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The intended use of the Chad Total O2 Delivery System is to supply low-pressure supply pressurized oxygen to fill oxygen cylinders for patient's ambulatory use. The oxygen supplied by the Total O2 Delivery System is supplemental and is not life supporting and not intended to be used with or for any life support applications or in the presence of flammable anesthetics.

The modified Chad Total O2™ Delivery System is intended for use in the same manner as the unmodified device: The Total O2™ Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.

The Chad Total O2 Delivery System addresses several needs of patients and homecare providers. The Total O2 Delivery System has been designed to reduce the need for built storage and transport of liquid oxygen as well as the storage and transport of high-pressure oxygen gas cylinders for ambulatory use. The Total O2 Delivery System is comprised of conventional procedures and/or an integral pressure intensifier which supplies low pressure oxygen to a nasal cannula and/or an integral proposition of the oxygen gas cylinder for ambulatory use. The Total O2 Delivery System has a unique cylinder fill mechanism, which allows it to be easily, and safely connect to the patient's Total O2 oxygen cylinder. The unique cylinder fill mechanism ensures that Total O2 oxygen cylinders can only be filled by the Total O2 Delivery System. The Total O2 oxygen cylinders will be offered in two versions: 1. The original Total O2 cylinders with built in pressure reducer. 2. The Total O2 Post Valve cylinders with the same unique fill port as the original The Total O2, no built in pressure reducer but with a unique post valve outlet. The Total O2 post valve incorporates an internal mechanism to prevent filling the cylinders through the unique post valve port. Furthermore the Total O2 post valve would incorporate an index pin in the CGA V-1 number 13 position to prevent CGA-870 accordators, conserving devices, etc. from attaching to the unique post valve.

The provided document K013472 describes a Special 510(k) for the Modified Chad Total O₂™ Delivery System. Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modification does not affect the device's indications for use or its fundamental scientific technology. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting a full de novo study with extensive performance metrics against a predefined set of acceptance criteria.

Based on the provided text, the document states:

"Performance, mechanical, electrical, electromagnetic compatibility and r onomance, moshal testing was conducted to demonstrate that the Chad Total O₂ Delivery System would perform as intended."

However, there are no specific acceptance criteria or detailed results of these tests provided in the document. The rationale for substantial equivalence primarily relies on the device having the "same technological characteristics" and the "hardware portion of the device is identical to the predicate device" with only modifications to the cylinder adapters and a unique post valve outlet for new cylinder types.

Since specific acceptance criteria and detailed study results are not present, much of the requested information cannot be extracted from this document.

Here's what can be inferred or explicitly stated from the provided text:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in the document. For a Special 510(k), acceptance is typically based on demonstrating that the modifications do not alter the safety or effectiveness compared to the predicate device, often through bench testing validating specific changes.
• Reported Device Performance: The document only generically states that "Performance, mechanical, electrical, electromagnetic compatibility and r onomance, moshal (sic) testing was conducted to demonstrate that the Chad Total O₂ Delivery System would perform as intended." No specific performance metrics (e.g., flow rates, oxygen concentration, battery life, fill times, pressure retention) or their values are provided.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The testing mentioned appears to be bench testing on the device prototypes, not a clinical trial with human subjects.
• Data Provenance: Not specified, but implied to be internal testing conducted by Chad Therapeutics, Inc. (the manufacturer).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a modified oxygen delivery system, and the testing described is technical/engineering performance testing, not a diagnostic or AI-driven system that requires expert ground truth for interpretation.

4. Adjudication method for the test set:

• Not applicable. As above, this type of testing (mechanical, electrical, performance) does not typically involve adjudication by experts in the way clinical diagnostic studies do.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. An MRMC study is not mentioned as this is not a diagnostic imaging device or an AI-assisted interpretation system requiring human reader comparison.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical oxygen delivery device, not an algorithm.

7. The type of ground truth used:

• Not explicitly stated/applicable for this context. For mechanical and electrical performance, the "ground truth" would be engineering specifications and established standards for oxygen delivery systems. The document states testing was done to ensure the device "would perform as intended," implying comparison against these internal specifications and safety standards for the device type.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

In summary, the provided document is a regulatory submission for a device modification, focusing on demonstrating equivalence to an existing predicate device rather than detailing a comprehensive new product validation study with specific acceptance criteria and performance data. The "Summary of Testing" section is very brief and high-level, indicating only that various types of engineering tests were conducted without providing any specific results or acceptance thresholds.

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The TOTAL O,TM Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.

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This document is an FDA 510(k) clearance letter for the Chad TOTAL O2™ Delivery System. It primarily addresses the regulatory approval of the device and does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance.

The letter only includes:

• Device Name: Chad TOTAL O2™ Delivery System
• Indication for Use: "Supplemental Medical Oxygen for treatment of Respiratory Diseases."
• Regulatory Class: II
• Product Code: 73 CAW
• 510(k) Number: K971889

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design verification/validation report, or the actual study report submitted to the FDA for review. These documents typically contain the detailed information about performance criteria, study design, sample sizes, and ground truth establishment.

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