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The Essex MR Conditional CGA 870 pressure regulators are used with a portable oxygen delivery system intended to provide supplemental oxygen to adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and may be used during MR imaging for static magnetic fields of 3.0 T or less.

The Essex MR Conditional CGA 870 pressure regulator is designed to be installed on a medical CGA 870 post valve cylinder, regulate high pressure oxygen from 500 to 2,000 psig nominal, deliver a specific amount of oxygen to an attached flow selector, and be ignition resistant.
The device consists of:

• A yoke style inlet fitting per CGA 870.
• A pressure regulator section is to reduce the pressure from 500-2,000 psig to 50 psig nominal.
• A flow selector valve to control the flow at the regulated pressure between 0 and 25 L/min.
• Made of materials which meet the MR Conditional requirements of ASTM F2052-15.
  This is identical to our Class I, exempt model CGA 870 except for different materials to allow for the device to meet the ASTM F2052-15 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.

This document is a 510(k) Pre-market Notification for a medical device called the "MR Conditional CGA 870" pressure regulator. The device is intended for use with portable oxygen delivery systems for adults in various healthcare settings, including during MRI imaging.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a single, clear format as would typically be found in a study report. Instead, it lists various non-clinical tests performed according to recognized standards. The "acceptance criteria" are implied by compliance with these standards, and the "reported device performance" is indicated by the statement that the device meets or is found to be substantially equivalent to these standards and the predicate device.

However, based on the Non-clinical Testing Summary and the Bench Testing sections, we can infer some criteria and the device's claimed performance:

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

• Test Set Sample Size: The document does not specify exact sample sizes (e.g., number of devices tested) for the non-clinical tests performed. It generally states that "a number of tests appropriate for the proposed device" were performed.
• Data Provenance: The tests are "Non-clinical Testing" and "Bench Testing," implying they were conducted in a laboratory setting by the manufacturer (Essex Industries, Inc.). The data is prospective in the sense that it was generated specifically for this 510(k) submission. There is no mention of country of origin for the data other than the manufacturer being based in the U.S.

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

This information is not applicable as the document describes non-clinical, bench testing of a hardware device. Ground truth, in the context of expert review, typically applies to studies involving interpretation (e.g., medical imaging, clinical assessments) where human experts determine a definitive diagnosis or finding. For hardware performance, the "ground truth" is typically defined by the test methods and acceptance criteria within the referenced engineering standards.

4. Adjudication Method for the Test Set

This is not applicable for the same reason as above. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human assessment to resolve discrepancies in expert opinions. The testing described here is objective measurement against established engineering standards.

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

This is not applicable. An MRMC study is a type of clinical comparative effectiveness study, usually for diagnostic devices, that assesses the performance of human readers (e.g., radiologists) with and without the assistance of a new diagnostic tool (often AI). The "MR Conditional CGA 870" is a physical medical device (pressure regulator) and not an AI-powered diagnostic tool, nor does it involve human readers for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This question pertains to the performance of artificial intelligence algorithms. The device described in the document is a mechanical pressure regulator.

7. The Type of Ground Truth Used

For this device, the "ground truth" for evaluating its performance is based on established engineering standards and specifications. The device's performance characteristics (e.g., pressure regulation, flow rates, mechanical resistance, ignition resistance, MR-conditionality) are measured directly against the quantifiable requirements outlined in standards like CGA E-4, CGA E-7, ISO 10524, EN 738-1, and ASTM F2052-15. Biocompatibility was assessed against relevant criteria (VOC and PM2.5).

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This document describes the evaluation of a physical medical device.

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

This is not applicable for the same reason as above.

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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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The Remcore Remote Control Oxygen Delivery system is an adjunct to the use of supplemental oxygen prescribed by a physician for a patient whose lung disease limits his or her ability to adequately supply the body with oxygen. The amount of supplemental oxygen needed to continuously provide the oxygen saturation prescribed will vary with different degrees of exertion. Current oxygen delivery systems do not allow a patient to alter the flow rate of oxygen when the patient is not next to the oxygen source. The Remore Remote Control Oxygen Delivery System allows a patient to change the flow rate, as prescribed by the physician, in accordance with the activity of the patient. For example, a patient might require 2 liters/minute of supplemental oxygen at rest, but 5 liters/minute to climb the stairs. The Remcore system will allow the patient sitting downstairs to remotely increase the oxygen flow rate to 5 liters/minute, regardless of where in the house the oxygen tank or concentrator is located, and after arriving upstairs to remotely return the oxygen flow rate to 2 liters/minute.

Remcore Remote Control Oxygen Delivery System

This document is a 510(k) clearance letter for the Remcore Remote Control Oxygen Delivery System. As such, it does not contain the detailed study information typically found in clinical trial reports or publications that would describe acceptance criteria, sample sizes, ground truth establishment, or multi-reader studies.

Instead, the FDA 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device. This means the manufacturer provides evidence that their new device is as safe and effective as a device already on the market, rather than conducting new clinical studies to prove absolute safety and effectiveness to predefined acceptance criteria.

Therefore, I cannot extract the requested information from the provided text because it primarily confirms the FDA's decision regarding the device's substantial equivalence and outlines regulatory requirements. The document does not contain information about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Cyl-Fil Oxygen System is intended to provide supplemental oxygen by prescription only. Cyl-Fil is a two component system. The first component consists of a high pressure regulator that delivers USP oxygen from a supply cylinder having two pressure settings. The second component is a light-weight portable, high pressure cylinder that is refilled by use of the Cyl-Fil pressure regulator.

The intended patient population is to supply, by prescription only, supplemental oxygen to patients requiring additional oxygen.

The Responsive Respiratory Cyl-Fil Oxygen System is a two component system. The first component is a high pressure regulator that delivers USP Grade oxygen at two pressure settings. The second component is a lightweight, portable high pressure cylinder with an oxygen specific post valve (similar to CGA-870 with an additional pin/hole location unique to the Cyl-Fil system) that incorporates a residual pressure retention device to insure that the USP oxygen is always retained in the cylinder. The portable cylinder is prepared and filled with USP oxygen according to industry and FDA requirements.

A supply cylinder supplies USP oxygen to the inlet connection (standard CGA-540) of the Cyl-Fil regulator. The Cyl-Fil regulator pressure setting delivers USP oxygen to the Cyl-Fil portable cylinder at a pressure and rate that does not exceed the safety rating of the cylinder, according to the cylinder manufacturer's specifications. The second Cyl-Fil regulator pressure setting delivers USP oxygen to an auxiliary outlet connection (CGA-1240) for continuous oxygen therapy support in the home.

The provided text describes a 510(k) premarket notification for the "Cyl-Fil Oxygen System," a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technological characteristics. It does not typically involve detailed clinical studies with human subjects, complex statistical analysis of performance metrics like sensitivity/specificity, or multi-reader, multi-case studies, as would be expected for a device relying on AI or requiring efficacy testing.

Therefore, many of the requested categories for a study proving acceptance criteria are not applicable to this document. The "acceptance criteria" here are essentially that the device performs its intended function safely and effectively, and is substantially equivalent to existing predicate devices, as demonstrated by the non-clinical tests listed.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No human subject "test set" data (e.g., patient cases) is mentioned. The testing refers to non-clinical, component-level engineering tests.
• Data Provenance: The data comes from non-clinical engineering tests performed on the device components (regulator, valve, cylinder) to ensure they meet specified standards and safety requirements. The specific testing facilities or retrospective/prospective nature of the engineering tests are not detailed beyond listing the types of tests and standards.

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

• Not Applicable: This type of information is pertinent to studies involving expert review of medical images or other diagnoses to establish a "ground truth" for evaluating an algorithm or human performance. This 510(k) concerns a physical medical device (oxygen system) and its non-clinical performance, not diagnostic accuracy requiring expert ground truth.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (like 2+1, 3+1) are used in clinical studies or algorithm evaluations where multiple experts provide opinions that need to be reconciled to establish a ground truth. This is not reported for the non-clinical engineering tests performed on the Cyl-Fil Oxygen System.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: A MRMC study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance across multiple cases. It is not relevant for a physical oxygen delivery system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No: This is not an AI/algorithm-based device. Therefore, a standalone algorithm performance study is not applicable. The listed "Performance Testing" are standalone tests of the device's physical components.

7. Type of Ground Truth Used

• Engineering Standards and Specifications: The "ground truth" for the non-clinical tests is adherence to established engineering standards (ISO, ASTM, CGA, DOT) and the manufacturer's own safety and performance specifications for the components (e.g., pressure ratings, material compatibility with 100% oxygen, cycle life). The objective is to demonstrate that the device meets these pre-defined technical criteria.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of an AI algorithm for this device. If interpreted as samples used for development/testing of the physical device components, the text does not specify quantities beyond referring to "all brass constructed regulators and brass post valves" and "components are designed for use in 100% pure oxygen applications and tested accordingly." This implies standard manufacturing and quality control sample sizes for component testing.

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

• Not Applicable: As there is no AI training set, this question is not relevant. The performance metrics for the device components are based on physical laws, material science, and established engineering standards.

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