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The Intelli-Ox is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.

The Intelli-Ox portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flow rate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.

Key specifications include hose barb connection, protective shroud, carrying handle, easy to read digital content gauge, indexed flow meter, integrated valve-regulator and user instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.

This document describes the regulatory submission for the Intelli-Ox portable oxygen delivery system, not a study evaluating its performance against acceptance criteria in the context of an AI/human-in-the-loop system. The document focuses on demonstrating substantial equivalence to a predicate device (EZ-OX Plus) for FDA clearance. Therefore, many of the requested categories related to AI/human performance studies and ground truth establishment are not applicable.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, nor does it provide reported device performance in that sense. Instead, it relies on demonstrating substantial equivalence to a predicate device through technological characteristics and compliance with recognized industry standards. The key "performance" reported is compliance with these standards.

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

This is not applicable as the submission is for a medical device (oxygen delivery system) and not an AI algorithm evaluated on a typical "test set" of data. The "test" involved physical and engineering evaluations against standards and comparison to a predicate device. Data provenance (country of origin, retrospective/prospective) is not mentioned for such testing.

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

Not applicable. There is no concept of a "ground truth" established by experts in the context of an image or data interpretation for this device. The evaluation is based on engineering specifications and compliance with standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 is not an AI-assisted device requiring a MRMC study.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" in this context is adherence to validated engineering specifications and recognized industry standards.

8. The sample size for the training set

Not applicable. No training set is involved for this type of device submission.

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

Not applicable.

Summary of the Study and Device Clearance:

The provided document (K143060) is an FDA 510(k) premarket notification for the "Intelli-Ox" portable oxygen delivery system. The "study" described is a demonstration of substantial equivalence to a previously cleared predicate device, the "EZ-OX Plus" (K053117).

The basis for substantial equivalence is primarily through:

• Comparison of technological characteristics: The Intelli-Ox is described as "very similar" to the EZ-OX Plus, with the main modification being the replacement of an analog gauge with a digital gauge. Both gauges serve informational purposes and do not control flow. The submission details a table (page 5) comparing various parameters (e.g., low flow settings, filters, pressure design, materials, dimensions) and states that the technological characteristics are the same.
• Compliance with recognized voluntary standards: The Intelli-Ox system complies with a list of industry and international standards applicable to medical gas regulators (listed on page 6). These include standards for risk management (ISO 14971), quality management (ISO 13485), electrical safety (IEC 60513, 60601-1-2), electromagnetic compatibility (IEC 61326-2-6-2, ISO 21730, IEC 61000-6-4, ISO 10651-3), and others like the United Nations Manual of tests and Criteria, IP rating, and 21 CFR regulations.

The ultimate conclusion is that "Based upon the performance testing and compliance with voluntary standards, the manufacturer believes that the Intelli-OX portable oxygen delivery system is substantially equivalent to the predicate device, and does not raise any new questions of safety and effectiveness."

This document does not describe a clinical trial or performance study against specific, quantified acceptance criteria in the manner one might find for a novel diagnostic or therapeutic device requiring clinical validation or an AI algorithm. Instead, it leverages the regulatory pathway of substantial equivalence based on established predicates and adherence to existing safety and performance standards for a well-understood type of medical device.

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The Portable Oxygen Unit SCA900 is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and oxygen cylinder fully integrated into single unit. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

The Portable Oxygen Unit SCA900 is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, regulator, nasal cannula and mask. The oxygen is delivered through the mask or nasal cannula with a range of user-selectable flow settings. This unit is suitable for use in all healthcare settings. including hospital and home healthcare.

This submission is for a Class I medical device, a Portable Oxygen Unit, which typically does not require extensive clinical studies to demonstrate effectiveness or safety. The FDA filing indicates a "substantial equivalence" determination to existing predicate devices based on design, materials, indications, intended use, packaging, labeling, and performance. Therefore, a formal study with defined acceptance criteria and detailed performance reporting as one might expect for a higher-risk device with novel technology is not present in this document.

The documentation provided does not contain specific acceptance criteria or a study designed to prove the device meets those criteria in the way a clinical trial would. Instead, the submission relies on demonstrating substantial equivalence to already legally marketed predicate devices.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a substantially equivalent device of Class I, specific, quantifiable acceptance criteria and corresponding performance metrics from a formal study are not explicitly stated or provided in the document. The acceptance is based on demonstrating equivalence in general aspects.

The phrase "Testing and other comparisons have established that the subject of Portable Oxygen Unit SCA900 is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S." (page 2) is the primary "proof" of meeting the (implied) acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable/not provided. This type of submission does not detail a "test set" in the context of clinical or diagnostic performance assessment.
• Data Provenance: Not applicable/not provided. The comparison is against predicate devices and likely relies on design specifications and engineering bench testing, rather than patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable/not provided. Ground truth in the context of expert review of images or clinical outcomes is not relevant for this type of device submission.
• Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not provided. There is no mention of a "test set" requiring adjudication in the provided documentation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices to assess human reader performance with and without AI assistance. It is not relevant for a portable oxygen unit.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No, a standalone performance assessment (in the context of an algorithm) was not done. This device is a mechanical system, not an AI or algorithmic device.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the traditional sense of clinical or diagnostic studies. The "ground truth" for this submission is based on the established safety and effectiveness of the predicate devices and the demonstration that the SCA900 is functionally equivalent to them. This would primarily involve engineering specifications, performance testing (e.g., flow rate accuracy, pressure regulation, durability), and compliance with relevant standards, rather than expert consensus on medical images or patient outcomes.

8. The Sample Size for the Training Set

• Sample Size: Not applicable/not provided. This device relies on established engineering principles and materials, not a "training set" for a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable/not provided. As there is no training set, there is no ground truth establishment for it.

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