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The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation.

The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive.

The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor. the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring.

Sentec's Digital Monitoring System is intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PC2), oxygen saturation (SpO2) and pulse rate (PR) in adult and pediatric patients as well as for PCO2 and PO2 monitoring in neonatal patients.

The tCOM+ (REF 103164) is a portable, lightweight, stand-alone monitor with a convenient carrying handle and with an integrated calibration and storage facility for the V-Sign™ Sensor 2 or OxiVenT™ Sensor, respectively. It provides continuous and noninvasive PCO2, SpO2 and PR monitoring if used with a V-Sign™ Sensor 2 or PCO2, PO2, SpO2 and PR monitoring if used with a OxiVenT™ Sensor.

Acceptance Criteria and Study for Sentec Digital Monitoring System (SDMS) tCOM+

The Sentec Digital Monitoring System (SDMS) tCOM+ is a transcutaneous blood gas monitoring system intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PO2), oxygen saturation (SpO2), and pulse rate (PR). The tCOM+ is an updated version of the previously cleared Sentec Digital Monitor (SDM), with technological upgrades such as a touchscreen user interface and wireless communication capabilities.

The submission focuses on demonstrating substantial equivalence to its predicate device, the SDM, and updated disposables. The core performance of the device, particularly its measurement modalities, is considered unchanged from the predicate. Therefore, the acceptance criteria and supporting studies primarily revolve around verifying the safety and effectiveness of the new monitor features and updated accessories, and demonstrating that the clinical performance remains consistent with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not specify sample sizes for test sets in the context of clinical performance data. The submission explicitly states:

• "No clinical performance data were generated on the tCOM+, because compared to its predicate device, the Sentec Digital Monitor (SDM), it uses the same sensors without software changes impacting algorithm or clinical performance."
• "The introduction of the updated disposables...do not affect the clinical functionality or performance of Sentec's Digital Monitoring System. No further clinical data was required to support safety and performance."

Therefore, there isn't a "test set" of patient data for clinical performance in the context of the tCOM+ submission. The testing done involved non-clinical performance (bench testing, biocompatibility, risk management, software validation, human factors) and compliance with various recognized standards.

For the Human Factors Evaluation testing, while a sample size for participants is typically part of such studies, the document does not disclose this information or the data provenance.

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

Given that "no clinical performance data were generated" for the tCOM+ as the clinical functionality and performance are considered unchanged from the predicate, no experts were used to establish ground truth for a new clinical test set for this submission. The ground truth for the predicate device's performance would have been established during its initial clearance, but that information is not part of this 510(k) summary.

4. Adjudication Method for the Test Set

Since no new clinical test set was generated for the tCOM+, there was no adjudication method employed for clinical data.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that no clinical performance data were generated for the tCOM+, as the device's core measurement technology and algorithms are identical to its predicate. Therefore, there is no effect size reported for human readers with or without AI assistance, as AI assistance is not described as a new feature requiring such a study.

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

The submission does not specifically describe a standalone (algorithm only) performance study in the context of new clinical data. The device is a monitoring system that interacts with a human user (professional medical personnel or trained lay operators). The core measurement algorithms for PCO2, PO2, SpO2, and PR are stated to be "unchanged" and "identical" to the predicate. The software development and testing focused on verification to requirements and validation to meet specified intended uses, implying the algorithm's performance inherited from the predicate was considered sufficient.

7. The Type of Ground Truth Used

For the non-clinical aspects:

• Mechanical, Electrical, EMC, Safety Standards: Compliance with industry-recognized standards (e.g., IEC 60601 series, ISO 80601-2-61). The "ground truth" here is adherence to the technical specifications and test methodologies defined by these standards.
• Biocompatibility: Compliance with ISO 10993-1:2018. The "ground truth" is established by laboratory testing results against the criteria within this standard.
• Risk Management: Identification and mitigation of hazards, with acceptable residual risks. The "ground truth" is the thoroughness of the risk analysis and the documented resolution of identified risks.
• Software Development: Verification to requirements and validation to intended use. The "ground truth" is the functional correctness and reliability of the software against its specifications.
• Human Factors: Conformance to usability engineering principles as per FDA guidance. The "ground truth" is successful completion of human factors testing.

For clinical performance, the ground truth is assumed to be equivalent to the predicate device's established clinical ground truth, as the core measurement technology, sensors, and algorithms remain unchanged. The original predicate device's clearance would have relied on appropriate clinical data (e.g., comparison to arterial blood gas measurements for PCO2/PO2, or co-oximetry for SpO2), but this is not detailed in the current submission.

8. The Sample Size for the Training Set

The submission does not mention a training set in the context of new algorithm development or machine learning. Since the software changes primarily relate to the user interface and connectivity, and the measurement algorithms are "identical to the configuration listed under K151329" (the predicate), there was no new training required for clinical algorithms.

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

As no new training set for algorithms was used in this submission, this question is not applicable.

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The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for all other medical applications, the device is Rx only.

The Intelli-OX portable oxygen delivery system that supplies Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical 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 standard high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation. 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 content gauge, indexed flow meter, and integrated valve-regulator. 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. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla.

The provided text describes the 510(k) submission for the Intelli-OX, an integrated portable oxygen delivery system, specifically focusing on its MR Conditional status. However, the document does NOT contain information related to a study proving the device meets acceptance criteria for an AI/ML-driven medical device, nor does it involve human readers, ground truth establishment by experts, or training sets.

The information provided pertains to the regulatory submission of a physical medical device (oxygen delivery system) to the FDA, and its testing for MR compatibility.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for a test set or data provenance for an AI/ML device.
• Number of experts or their qualifications for establishing ground truth for an AI/ML device.
• Adjudication method for a test set for an AI/ML device.
• MRMC comparative effectiveness study or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• Sample size for the training set.
• How ground truth for the training set was established.

The document does mention "MRI performance testing" which was completed to support the substantial equivalence determination for its MR Conditional status. The acceptance criteria for this specific aspect are listed as compliance with:

• ASTM F2052-15: "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
• ISO TIR 10974, 2012, Clause 21: "Assessment of the Safety Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device"

This is a physical performance test for MR compatibility, not a study of an AI/ML device's diagnostic or predictive performance.

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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 Walk-O2-Bout® is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and 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 intended for use during MR imaging for static magnetic fields of 3.0 T or less. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

The Walk-O2-Bout® regulator is designed to be installed on a medical grade aluminum cylinder having 0.750-16 UNF-2B threads; regulate high pressure oxygen from 300-2000 psig nominal; deliver a prescribed amount of oxygen; and be ignition fault resistant. The device consists of: A threaded fill fitting per CGA 540. It shall allow the regulator installed on a cylinder to be refilled to its service pressure. It also allows for the pulling of a vacuum on the system. A pressure regulator section to reduce the pressure from 300-2000 psig to 50 psig nominal. Options of flow selector valves to control the flow between 0 and 25 L/min, at the regulated pressure. A vinyl dipped handle for ease of carrying. A DISS 1240 check valve to deliver 50 psig of oxygen high flow rates of oxygen to ventilators. There are several models offered. In all cases the basic pressure regulator is identical for all models. The models are offered with the following options: Flow rate range of 0 4 L/min (Pediatric), 0 15 L/min and 0 25 L/min (adult) Check Valve Swivel or Fixed Barb Fitting Handle style MR Conditional.

The provided text describes the 510(k) premarket notification for the Walk-O2-Bout®, a portable oxygen delivery system. However, it does not contain the detailed acceptance criteria and study results in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device (K101792 – Linde – LIV Portable Oxygen System) rather than providing specifics of direct performance against pre-defined acceptance criteria with empirical data.

The "Acceptance Test Procedure" mentioned under "Non-clinical Testing Summary" suggests that such tests were performed, but the results and specific criteria are not detailed. Similarly, while "Flow accuracy: +/- 10%" is listed as a specification, the study proving the device meets this accuracy is not described.

Therefore, I cannot fulfill all parts of your request with the provided input. However, I can extract the available information as much as possible.

Here's a breakdown of what can be extracted and what information is missing from the provided document:

1. A table of acceptance criteria and the reported device performance

Based on the document, the acceptance criteria are generally implied by the specifications and compliance with standards. The specific reported device performance values against these criteria are not explicitly provided in a quantitative table within this document.

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

The document does not explicitly state the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "a number of tests appropriate for the proposed device" were performed.

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

This information is not applicable and not provided. The testing appears to be primarily engineering and bench testing, not involving expert interpretation or "ground truth" in the clinical sense.

4. Adjudication method for the test set

This information is not applicable and not provided. The testing appears to be primarily engineering and bench testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical gas pressure regulator, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

The concept of "ground truth" as it applies to clinical diagnoses (e.g., pathology, outcomes data) is not relevant here. The ground truth for this device's performance would be established by physical measurement against engineering standards and specifications.

8. The sample size for the training set

This is not applicable as the device is a physical product and not an AI/machine learning algorithm that requires a training set.

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

This is not applicable.

Summary of Study (Based on Provided Text):

The "study" described in this document is a series of non-clinical, bench-testing evaluations to demonstrate the physical and functional performance of the Walk-O2-Bout® device. The primary goal was to show substantial equivalence to a legally marketed predicate device (Linde – LIV Portable Oxygen System, K101792) and compliance with relevant industry standards (ISO, ASTM, CGA).

• Type of Study: Non-clinical bench testing.
• Purpose: To demonstrate the device's physical performance, safety (ignition, MR compatibility), and biocompatibility, and to support a claim of substantial equivalence to a predicate device.
• Key Tests Mentioned: Acceptance Test Procedure, Low/High temperature, Gas tightness, Flow regulation (Flow capacity), Outlet Flow vs. inlet pressure, Pressure regulation, Static increment, Pressure relief, Mechanical resistance, Endurance Inlet, Fill fitting endurance, Safety, Drop, Vibration and Shock, Proof pressure, Burst pressure, Ignition (ASTM G175), MR Conditional Testing (ASTM F2052-15, tested per ASTM F2052-06), Biocompatibility.
• Clinical Testing: "There was no clinical testing."

In conclusion, while the document confirms that various tests were performed to assess the device's performance against established standards and specifications, it does not provide the quantitative results or detailed acceptance criteria for each test in a manner that would fully answer your request. It mainly serves as a summary for a 510(k) submission, confirming adherence to regulatory requirements and substantial equivalence.

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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 LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. 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 rah Uized or otherwise secured to prevent falling and rolling.

The Linde Integrated Valve™ ("LIV") is a portable oxyqen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of user-selectable flow settings is available, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50psig oxygen delivery, while an optional bed hanger allows the LIV to be readily attached to a bed. The LIV is suitable for use in all healthcare settings, including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.

The Linde Integrated Valve (LIV) is a portable oxygen delivery system. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might for a novel AI/software device.

Here's the breakdown based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the LIV primarily relies on demonstrating substantial equivalence to a predicate device (MEDICYL-E-Lite K033897) rather than setting specific quantitative acceptance criteria for novel performance, as one would for an AI/software device. The "acceptance criteria" here are implicitly met by showing the device's technical characteristics are substantially similar and that it conforms to relevant standards.

• Flowrate Selector and Flow Outlet (yes)
• Cylinder On/Off (yes)
• Filling Port (active; w/ non-return valve)
• Excess Flow Device (yes)
• Residual Pressure Valve (yes)
• Burst Disk (yes)
• Single stage piston style (yes)
• Guard (2 grip, Access Ports, green color)
• Cylinder Sizes (D, E)
• Materials/construction (Aluminum)
• MRI Compatibility (yes; tested up to 3.0T) |
  | Compliance with 21CFR49 § 178.46 | Aluminum cylinders conform to the requirements of 21CFR49 § 178.46, Specification SAL seamless aluminum cylinders. |
  | MRI Compatibility (ASTM standard 2503-05 and CDRH document) | Evaluated in accordance with the draft CDRH Magnetic Resonance Working Group document, "A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems," dated February 7, 1997.
  MR-conditional (per ASTM standard 2503-05). Intended for use during MR imaging for MRI systems up to 3.0T. |
  | Safety and Effectiveness (Implicit) | The manufacturer believes that the LIV is substantially equivalent to the predicate device and "does not raise any new questions of safety or effectiveness" based on safety and performance testing and compliance with voluntary standards. |
  | Intended Use Alignment with Predicate | Both devices are portable oxygen delivery systems. The LIV's indications for use: "integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only." |
  | Additional Features (no new safety/effectiveness concerns) | The LIV includes features not in the predicate: Pressure Outlet (yes) and Contents Gauge (active), which are implicitly deemed not to raise new safety or effectiveness concerns. |

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

This is not applicable in the context of this 510(k) summary. This document does not describe a "test set" or data provenance in the way one would for a clinical study comparing AI performance against ground truth. The evaluation is primarily based on engineering design, materials, and compliance with standards, along with a comparison of technological characteristics to a predicate device.

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

Not applicable. This is a medical device (hardware) submission, not an AI/software device submission requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as above.

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. The LIV is a hardware device for oxygen delivery, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for this type of device submission revolves around engineering specifications, material properties, and functionality meeting established standards and being comparable to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. No AI/machine learning training set is involved.

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

Not applicable. No AI/machine learning training set is involved.

In summary:

The provided document is a 510(k) summary for a physical medical device (an oxygen delivery system). It demonstrates the device's safety and effectiveness by establishing substantial equivalence to an already legally marketed predicate device, rather than through a standalone performance study with clinical endpoints or AI-specific validation metrics. The "study" implicitly referenced is the "safety and performance testing and compliance with voluntary standards" conducted by the manufacturer, which is deemed sufficient to demonstrate this equivalence. The "acceptance criteria" are met by matching or exceeding the predicate's characteristics and complying with relevant engineering and safety standards.

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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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The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRIcompatible, and intended for use during MR imaging for MRI systems up to 3.0T.

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 MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR imaging for MRI systems up to 3.0T. 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 intearated system includes an aluminum cylinder, valve, requlator and flow meter. The device offers low flow settings that may be clinically appropriate for certain classes of patients.

This document describes a 510(k) submission for the AGA Linde Healthcare MEDICYL-E-Lite Portable Oxygen Delivery System. This is a medical device, and the information provided is for regulatory clearance based on substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria in the way an AI/ML device would be assessed.

Therefore, many of the requested categories for AI/ML device performance studies are not directly applicable to this document. I will extract the information that is present and explain why other sections are not covered.

1. Table of acceptance criteria and the reported device performance

For a medical device like the MEDICYL-E-Lite, "acceptance criteria" are typically related to meeting regulatory standards, safety requirements, and functional specifications, often demonstrated through testing and comparison to predicate devices. The document focuses on showing substantial equivalence and compliance with relevant regulations.

The primary "acceptance criteria" here is substantial similarity to the predicate devices, with the added functionality of MRI compatibility for the "MEDICYL-E-Lite (MRI)" version. The document explicitly states: "The manufacturer believes that the technological characteristics of the MEDICYL-E-Lite portable oxygen system is substantially similar to those of the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. For a device like an oxygen delivery system, "test set" would typically refer to the units tested for physical performance and safety. The document mentions "safety and performance testing" and compliance with "voluntary standards" and "21 CFR49 § 178.46, Specification SAL seamless aluminum cylinders." It also states the MRI compatibility was "tested up to 3.0T" and evaluated "in accordance with the draft CDRH Magnetic Resonance Working Group document, A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems, dated February 7, 1997." However, the sample size of devices tested or the specific provenance of that test data is not detailed.

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)

This is not applicable as this is a mechanical device, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar. The "truth" here relates to physical specifications and safety standards.

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

This is not applicable for this type of device submission. Adjudication methods are typically used in clinical trials or studies for diagnostic devices where subjective interpretations might differ.

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. This is a physical medical device, not an AI/ML system, and therefore no MRMC study was performed.

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

This is not applicable as this is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for this device is based on engineering specifications, regulatory compliance, performance testing results against predefined standards, and demonstration of substantial equivalence to legally marketed predicate devices. For example:

• Physical dimensions and materials: Measured against design specifications.
• Pressure design: Tested to meet the stated psi.
• Flow settings: Verified to operate as specified.
• MRI compatibility: Tested against established protocols outlined in the CDRH Magnetic Resonance Working Group document.
• Cylinder specifications: Conformity to "21 CFR49 § 178.46, Specification SAL seamless aluminum cylinders."

8. The sample size for the training set

This is not applicable. There is no AI/ML model for which a "training set" would be used for this device.

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

This is not applicable as there is no AI/ML model and therefore no "training set."

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