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The Respond OC Conserving Regulator (130-0800) is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use. It may also be used to deliver a constant flow of oxygen to the patient.

The Respond OC Conserving Regulator (130-0800) is a dual mode high pressure oxygen regulator and conserving device that allows for either a continuous or conserve flow of medical grade oxygen to the patient. The device is designed with a CGA 870 style yoke for use with ambulatory oxygen cylinders. The integrated regulator reduces cylinder pressure to 22psig (+/-3psi) to the sensing diaphragm which allows the Respond OC to sense the start of inhalation by the patient and release a controlled amount of oxygen by pneumatic timing in short bursts into the lungs via an oxygen cannula. The Respond OC supports a delivered oxygen equivalency of 1 to 5 LPM in the conserve mode, which extends the ambulatory time of cylinders up to 6:1 based on the cylinder pressure and selected setting. The continuous flow mode offers settings of 2, 3 and 4 LPM if the patient requires a constant flow of oxygen.

The provided FDA 510(k) clearance letter and summary for the Respond OC Conserving Regulator (K250322) outlines the device, its intended use, and its substantial equivalence to a predicate device. However, this documentation does not contain the detailed information typically found in a clinical study report or a comprehensive test report regarding acceptance criteria and the study that proves the device meets them, especially in the context of AI/ML-based medical devices or diagnostic tools.

The device described (an oxygen conserving regulator) is a mechanical device, not an AI/ML-driven diagnostic or treatment device. Therefore, many of the typical requirements for AI/ML device studies (such as MRMC, expert consensus for ground truth, training set details, and specific performance metrics like sensitivity/specificity/AUC) are not applicable here.

The document primarily focuses on bench testing and biocompatibility to demonstrate substantial equivalence to a predicate mechanical device.

Here's an analysis based on the provided document, highlighting what is and is not present concerning "acceptance criteria" and "study proof":

Analysis of Acceptance Criteria and Study Proof for Respond OC Conserving Regulator (K250322)

Based on the provided FDA 510(k) Summary, the device is a mechanical oxygen conserving regulator. The "acceptance criteria" and "study proof" are framed in the context of demonstrating substantial equivalence to a predicate mechanical device through non-clinical (bench) testing and biocompatibility assessments, rather than clinical efficacy studies or AI/ML performance evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the types of tests conducted and states that the device "met its acceptance criteria" and "performs similarly to the predicate device." However, it does not explicitly list the specific quantitative acceptance criteria for each test (e.g., a specific tolerance for oxygen flow, a defined pass/fail for impact resistance) nor does it present the raw, quantitative reported performance results against these criteria. Instead, it provides qualitative statements of compliance.

2. Sample Size for the Test Set and Data Provenance

Given this is a physical device, the "test set" refers to the manufactured units subjected to bench testing. The document does not specify the sample size (number of devices) used for each of the non-clinical tests (e.g., how many units were subjected to accelerated aging, or impact testing).

Data Provenance: The data provenance is from non-clinical bench testing conducted by the manufacturer, Responsive Respiratory, Inc. It's not clinical data or retrospective/prospective human data. The country of origin for the testing itself is not explicitly stated but would typically be where the manufacturer's testing facilities are located.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable as the device is a mechanical oxygen regulator, not an AI/ML-driven diagnostic or classification device requiring expert-established ground truth from medical images or patient data. Ground truth for its performance would be established through calibrated laboratory equipment measuring physical parameters (flow, pressure, timing, etc.) against engineering specifications.

4. Adjudication Method for the Test Set

This question is not applicable for a mechanical device undergoing bench testing. Adjudication typically refers to resolving discrepancies between human readers or between AI and human readings. Test results for mechanical parameters are either within specification or not, based on objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI/ML) where human readers (e.g., radiologists) interpret cases, and the effectiveness of AI assistance on their performance is evaluated. The Respond OC Conserving Regulator is a therapeutic/delivery device, not a diagnostic one.

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

This question is not applicable in the typical sense for this device. There is no "algorithm" in the way an AI/ML device would have one. The device's "performance" is its mechanical function. The "bench testing" described in the summary is the standalone performance assessment of the device's mechanical and pneumatic operation (e.g., flow rates, bolus timing, pressure regulation) without human intervention beyond setting the controls for the test.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would be physical measurements against engineering specifications and industry standards. For example:

• Flow rates: Measured by calibrated flow meters against specified LPM settings.
• Pressure: Measured by calibrated pressure gauges against specified PSI output.
• Timing of bolus delivery: Measured by sensors and timers to confirm delivery within the specified inspiratory cycle.
• Biocompatibility: Confirmed by laboratory analysis against ISO standards.
• Ignition Sensitivity: Confirmed by testing against ASTM standards.

It is not expert consensus, pathology, or outcomes data, as these are related to clinical diagnosis or patient outcomes, not the performance of a mechanical oxygen delivery device.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is not an AI/ML device that requires data for model training.

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

This question is not applicable for the same reason as point 8.

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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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