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The POGS 65/130 is intended to generate and deliver USP 93% supplemental oxygen. This device is intended to be used only by trained personnel in disaster relief and emergency preparedness situations, military settings or where bottled oxygen is not readily available.

The Portable Oxygen Generation System 65/130 (POGS 65) has been designed to accommodate medical personnel that require a portable, reliable source of supplemental oxygen in a setting where liquid oxygen may be unavailable. This system is based on the Pressure Swing Absorption principle and uses a molecular sieve to separate gasses from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through the oxygen boost and distribution system. The POGS 65/130 is a system that generates USP 93% oxygen at a flow rate of up to 65 LPM at a pressure of 50-60 PSI. Included with the generator are medical-grade oxygen hose for both low and high pressure, spare parts and tools that are required, but may be not be easily accessible to the user. The POGS 65/130 is compatible with commercial oxygen consuming equipment and accessories, including D. E, H, K, and M cylinder filling accessories, ventilators, nasal cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators. It also connects with the high pressure Hospital Oxygen Backup System and the low-pressure Patient Oxygen Distribution System. A complete POGS 65/130 system consists of two (2) feed air compressors, two (2) oxygen generators, one (1) boost and distribution center, and one (1) oxygen back-up system. Each feed air compressor and oxygen generator pair is designed to provide up to 65 LPM independently or can operate in parallel to achieve up to 130 LPM to provide the user flexibility in the deployment of their resources. The approach is modular and enables the user to add or subtract systems to meet the requirements of the situation. Each POGS 65 pair responds to the oxygen demand that is being used and when operated in parallel, will load share between the pair. The boost and distribution system receives the oxygen from up to two oxygen generators. The boost and distribution system can feed the oxygen to 1) the hospital distribution system, 2) fill the back-up system, 3) fill cylinders or 4) fill the hospital back-up system depending upon the requirements of the situation. To ensure patient care, the hospital distribution system has priority over all other options. One or more type of cylinder or back-up system may be filled in conjunction with supplying the hospital distribution system. The System includes the capability to evacuate high pressure oxygen cylinders to 25 inches Hg vacuum prior to filling.

The provided text describes the POGS 65/130 Portable Oxygen Generation System and its 510(k) summary. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a study proving those criteria.

The document primarily focuses on:

• The device's description, operation, and indications for use.
• Comparisons with a predicate device (POGS 33C) and improvements.
• The fact that non-clinical bench testing was performed.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Study for POGS 65/130 Portable Oxygen Generation System

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information Regarding Acceptance Criteria:
The document states that "Requirements are based on the deployment oxygen system- medium (DOGS-M), operational requirements documents that have been issued by the United States Air Force and the United States Army." However, the exact quantitative acceptance criteria (e.g., specific thresholds for purity, flow rate stability, pressure consistency over time, or specific compatibility tests and their pass/fail criteria) from these military documents or the ASTM standard are not detailed in the provided text. The table above largely infers acceptance criteria from the reported performance claims.

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

• Sample Size for Test Set: Not specified. The document only mentions "Non-clinical bench testing." The number of devices or test runs is not provided.
• Data Provenance: The testing was "conducted by On-Site Gas Systems, Inc." The country of origin of the data is implicitly the USA, where On-Site Gas Systems, Inc. is located. It is a non-clinical bench test, not data from human subjects, so retrospective or prospective doesn't directly apply in the usual clinical sense.

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

• Number of Experts: Not applicable. This was non-clinical bench testing of a device's physical output (oxygen purity, flow, pressure). There is no "ground truth" established by human experts in the context of diagnostic performance. The ground truth would be the direct measurement of the device's output parameters.
• Qualifications of Experts: Not applicable for the reasons above.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. This was non-clinical bench testing. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of data where consensus is needed for ground truth.

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

• MRMC Study: No. This device is an oxygen generator, not an AI-assisted diagnostic tool.

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

• Standalone Performance: The non-clinical bench testing mentioned ("Performance Standard ASTM F-1464-93 was used," "Non-clinical bench testing conducted by On-Site Gas Systems, Inc. is sufficient in establishing substantial equivalence on the POGS 33C to the predicate device on which substantial equivalence is claimed, including oxygen purity evaluations.") could be considered "standalone" in the sense that they evaluated the device's inherent performance characteristics (oxygen output, purity, flow, pressure) without human intervention in the generation process itself. It's a test of the machine's output, not an algorithm's diagnostic performance.

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

• Type of Ground Truth: The ground truth for this device's performance would be the direct, objective measurement of the oxygen's physical properties (purity, flow rate, pressure) using calibrated laboratory equipment and standard measurement techniques.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a physical oxygen generator, not an AI/machine learning algorithm that requires a "training set" in the computational sense.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

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The POGS 33C is intended to generate and deliver USP 93% supplemental oxygen and medical grade air. This device is intended to be used only by trained personnel in disaster relief and emergency preparedness situations, or military settings where bottled oxygen is not readily available.

The Portable Oxygen Generation System 33 (POGS 33C) has been designed to accommodate medical personnel with a source of supplemental oxygen in a setting where liquid oxygen may be unavailable, and of medical air to drive respiratory equipment. Aero-medical evacuation and ground based medical missions require medical support systems capable of providing therapeutic oxygen. Requirements are based on the mobile, deployment oxygen system, operational requirements document that has been issued by the United States Air Force. This system is based on the Pressure Swing Absorption principle and uses a molecular sieve to separate gasses from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of four ports with a total maximum flow of 33 liters-per-minute at 50 PSIG. The oxygen concentration purity level is at 90% +/- 3%. Included with the generator is a secured accessory kit including medical-grade oxygen hose and flow regulators for the outlets. The POCS 33C is compatible with commercial oxygen consuming equipment and accessories, including D, E, H, and K cylinder filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators. Medical air output of up to a total of 30 liters-per-minute at 50 PSIG is also provided.

The provided document is a 510(k) summary for the POGS 33C Portable Oxygen Generation System. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific clinical studies against predefined acceptance criteria for novel device performance. Therefore, much of the requested information, particularly regarding typical AI/software device evaluation, is not applicable or available in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria or a detailed quantitative performance table as would be found for a novel device undergoing extensive clinical trials. Instead, it relies on substantial equivalence to a predicate device.

The key performance claims are related to the device's capability and purity:

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

Not applicable. The evaluation performed was "Non-clinical bench testing," not a clinical study on a test set of data.

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

Not applicable. This was a non-clinical bench test of a physical device, not an evaluation requiring expert-established ground truth on a dataset.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical bench test.

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

No, a MRMC comparative effectiveness study was not done. The document describes a physical oxygen generation system, not an AI or imaging device that would typically undergo such a study.

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

No, a standalone algorithm performance study was not done. This device is hardware for generating oxygen and medical air, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the device's performance (specifically oxygen purity) was established through non-clinical bench testing conducted by On-Site Gas Systems, Inc. This means the device's output was measured and verified against specifications using laboratory equipment rather than expert consensus or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its performance claims and is substantially equivalent to its predicate device is described as "Non-clinical bench testing conducted by On-Site Gas Systems, Inc." This testing was sufficient to establish substantial equivalence for the POGS 33C to the predicate device (POGS 33, K041664), including oxygen purity evaluations. The specific standard used for performance evaluation was ASTM F-1464-93.

The improvements made to the device (stainless steel fittings, aluminum sieve beds, Microboost reliability, feed air compression packaging, improved connectors, manuals, and labeling) were also part of this non-clinical evaluation to ensure they did not negatively impact the safety or effectiveness of the device compared to the predicate. The expanded indications for use did not change the function or therapeutic value of the device, implying that the non-clinical performance remained consistent with the predicate device for these broader uses.

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The POGS 33C is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. The POGS 33C is compatible with commercial oxygen-consuming equipment and accessories, including D, E, H, and K cylinder-filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators.

The Portable Oxygen Generation System 33 (POGS 33C) has been designed to The Fortable Oxygen Ocheration of Supplemental oxygen in a setting where liquid oxygen may be unavailable, and of medical air to drive respiratory equipment. liquid oxygen may be unavaliable, and sed medical missions require medical support systems Aeromedical evacuation and ground ban. The gaseous oxygen generator will also be required Capable of providing therapoule oxygen. The gassessing and the oxygendriven equipment included in the AFMS deployable medical assemblages. Requirements are differi equipment included in the uspicy and mational requirements document that has been issued by the United States Air Force. This system is based on the Pressure Swing Adsorption principle and uses a molecular sieve to separate gases from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of four ports with a total maximum flow of 33 liters-per-minute at 50 psig. The oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%. Included with the generator is a secured accessory kit including medicalgrade oxygen hose and flow regulators for the outlets. Medical air output of up to a total of 30 liters per minute at 50 PSIG is also provided.

Acceptance Criteria and Study for Portable Oxygen Generator System: POGS 33C

This document describes the acceptance criteria and the study that demonstrates the Portable Oxygen Generator System: POGS 33C meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary explicitly states that "Non-clinical bench testing" was conducted.

• Test Set Sample Size: The document does not specify the sample size used for the bench testing. It's implied that typical engineering validation and verification protocols would be followed, but no specific numbers are provided.
• Data Provenance: The testing was conducted by On Site Gas Systems, Inc. This indicates the data is prospective as it was generated specifically for the 510(k) submission. The country of origin for the data is implicitly the United States, where On Site Gas Systems, Inc. is located.

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

• Number of Experts: Not applicable/not mentioned. This was non-clinical bench testing, not a study involving expert interpretation of medical data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for the performance parameters (flow, pressure, purity) would be established by calibrated measurement instruments rather than human adjudication.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an oxygen generator, and its performance is evaluated through objective physical measurements rather than human interpretation of medical cases.

6. Standalone Performance Study

• Standalone Study: Yes, a standalone performance evaluation was conducted. The "non-clinical bench testing" described evaluates the algorithm (or the device's functional components) directly on its ability to produce oxygen and medical air according to specifications, without human intervention as part of the primary performance assessment.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance is based on objective physical measurements obtained from calibrated instrumentation. This includes measurements of oxygen purity, flow rate, and pressure. These are quantifiable, verifiable physical properties.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical medical device (an oxygen generator), not an algorithm or AI model that requires a training set in the conventional sense. The "training" for such a system would involve engineering design, prototyping, and iterative testing, but not a distinct "training set" of data.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable. As this is a physical device, a "training set" with established ground truth is not relevant to its development in the context of typical AI/algorithm studies. The device's design and engineering parameters are based on scientific principles and industry standards for oxygen generation, which are validated through rigorous bench testing.

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The POGS is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. POGS is compatible with commercial oxygen-consuming equipment and accessories, including D,E,H, K cylinder-filling accessories, ventilators, cannulas, and Draeger Narkomed Anesthesia Machine.

The FDA-cleared On Site Gas Systems' Portable Oxygen Generation System 33, "POGS 33", (K020362) is being modified to include medical air, and compatibility with the Draegar Narkomed Anesthesia Machine. The system uses PSA technology, and supplies medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in battlefield/ hospital settings in military facilities only.

The POGS 33 utilizes the same Draegar Narkomed Anesthesia Machine as the predicate, PVOCS. The POGS 33 utilizes the same oilless scroll feed compressor in the production of medical air as does the predicate, PVOCS.

The variations of the POGS device to the predicate are greater oxygen total flow, to accommodate more cannulas per device. The variations are designed and tested for the same indication of use, safety and effectiveness. Variations are substantially equivalent to the predicate device.

This document, K030920, describes the Portable Oxygen Generation System with Medical Air (POGS 33) manufactured by On Site Gas Systems, Inc. It's a 510(k) summary seeking substantial equivalence to existing legally marketed devices.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the POGS 33 are based on recognized FDA standards for oxygen concentrators and medical air.

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

The document does not specify a sample size for a test set in the context of clinical studies with patients. The performance data presented refers to the device meeting established quality and performance standards rather than results from a pre-market clinical trial involving human subjects or real-world data.

The data provenance is from non-clinical tests conducted by the manufacturer to demonstrate compliance with recognized standards. This is not retrospective or prospective clinical data.

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

Given that this is a 510(k) submission based on non-clinical performance data against established standards, the concept of "ground truth established by experts" as it would apply to a diagnostic or clinical AI device is not applicable in this context. The "ground truth" here is the set of criteria defined by the recognized standards (ASTM F 1464-93 and USP Standards). The expertise lies in the development and validation of these standards themselves, not in a specific set of experts adjudicating results for this particular device's performance test.

4. Adjudication Method for the Test Set

Again, an adjudication method for a "test set" in the sense of expert review of clinical cases is not applicable here. The device's performance is measured against objective, verifiable parameters defined by the ASTM and USP standards. Passing these tests constitutes meeting the "acceptance criteria."

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

No MRMC study was done, as this is a device for generating oxygen and medical air, not a diagnostic imaging device or an AI application intended to assist human readers in interpretation. Therefore, there is no effect size related to human reader improvement with or without AI assistance.

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

The device is a machine that generates gases. Its performance is inherently "standalone" in that it produces oxygen and medical air autonomously based on its design and manufacturing. There is no "algorithm only" performance separate from the physical device's operation. Its performance is evaluated independently against physical/chemical standards.

7. The Type of Ground Truth Used

The "ground truth" used for this device is based on established industry and regulatory standards:

• ASTM F 1464-93 for oxygen concentrators.
• USP Standard for oxygen.
• USP Standard for Medical Air.

These standards define the acceptable purity, concentration, and other performance characteristics for medical-grade oxygen and air.

8. The Sample Size for the Training Set

This device does not utilize a "training set" in the context of machine learning or artificial intelligence. It's a mechanical and chemical system. Therefore, the concept of a training set sample size is not applicable.

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

Since there is no training set for this type of device, the question of how its ground truth was established is not applicable. The "ground truth" relevant to this device's approval are the performance specifications mandated by the recognized standards it claims to meet.

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Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.

Hemosorb is a bulk granular hemostatic agent, which is placed on or into a wound to effect adsorption, and coagulation of same. The effect of Hemosorb is purely physical, not chemical in nature. Hemosorb has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting.

The provided document is a 510(k) summary for the device Hemosorb, a topical dressing for managing bleeding wounds. It addresses the device's substantial equivalence to a predicate device, Sorbastace.

Here's an analysis of the acceptance criteria and the study descriptions, organized by your requested information:

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

The document does not explicitly state formal "acceptance criteria" in a quantitative manner as might be seen for a new, de novo device. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device, Sorbastace. The performance is reported in terms of efficacy in stopping bleeding and biocompatibility.

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

The document provides details of several tests, but specific sample sizes for each animal study are often not explicitly stated.

• In vitro and In vivo (rats, rabbits, larger mammals) at the University of Connecticut: "In Invitro and Invivo testing on rats, rabbits and larger mammals at the University of Connecticut." No specific numbers mentioned, but indicates multiple types of animals.
• VAMC (rats and pigs): "Tests by the Chief of Surgery at VAMC. Newington, CT, conducted at Hartford Hospital on rats and pigs' livers and skin." No specific numbers mentioned.
• USUHS and Office of Naval Research (large mammals): This study clearly states a mortality rate for "No Dressing," "Standard Dressing," and "Standard Dressing with Hemosorb," implying a cohort for each. However, the exact sample size (number of large mammals) in each group is not provided.
• Biocompatibility testing (MicroTest Laboratories, Inc.): These are laboratory tests on samples of the device material, not on a "test set" of patient data.

Data Provenance: The studies were conducted in the USA (University of Connecticut, Hartford Hospital, VAMC Newington CT, USUHS, MicroTest Laboratories, Inc. of Agawam, Mass.). All studies appear to be retrospective data collected for regulatory submission.

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

The document does not detail the use of "experts" to establish a ground truth for a test set in the way a clinical study for diagnostic devices might. Instead, the "ground truth" for efficacy was based on measurable physiological outcomes (coagulation rate, bleeding time, blood loss, mortality) observed in animal models. Toxicity was assessed through histopathology and standard biocompatibility tests.

The studies were conducted by:

• University of Connecticut researchers
• UConn Chemistry Department
• Chief of Surgery at VAMC, Newington, CT (conducted at Hartford Hospital)
• USUHS (Uniformed Services University of the Health Sciences) and Office of Naval Research
• ISO 17025 Certified MicroTest Laboratories, Inc.

The qualifications mentioned are "Chief of Surgery" and "UConn Chemistry Department," which imply relevant expertise but specific years of experience or board certifications are not provided.

4. Adjudication method for the test set

Not applicable. The studies described are preclinical animal studies and laboratory tests, not clinical trials involving human readers or subjective assessments that would require an adjudication method. The outcomes measured are objective (e.g., mortality, blood loss, lab test results).

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 a medical device for local management of bleeding, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison was performed.

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

Not applicable. The device is a physical hemostatic agent, not an algorithm. Therefore, no standalone algorithm performance was evaluated.

7. The type of ground truth used

The ground truth used was based on objective physiological measurements and standardized laboratory results:

• Efficacy: Coagulation rate, bleeding time, reduction in blood loss, and survival/mortality rates in various animal models (rats, rabbits, pigs, large mammals).
• Toxicity/Biocompatibility: Histopathology scores in rats and results from standard ISO biocompatibility tests (cytotoxicity, sensitization, irritation, implant reactions).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set" in that context. The development of the device would have involved iterative testing and refinement, but not in the sense of a data-driven training set for an algorithm.

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

Not applicable, as there is no training set for an algorithm.

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QuikClot is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

QuikClot is a bulk granular hemostatic agent, which is placed on or into a moderate to severe wound to effect adsorption, and coagulation of same.

QuikClot is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.

The effect of QuikClot is purely physical, not chemical in nature. QuikClot has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting.

The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation.

Used in conjunction with a sterile bandage and pressurizing wrap, QuikClot will reduce blood loss dramatically, and significantly increase survivability of highvolume catastrophic wounds.

I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance, sample size for testing or training, expert involvement, adjudication methods, or MRMC studies.

The document is a 510(k) summary for a device called "QuikClot." It focuses on demonstrating substantial equivalence to a legally marketed predicate device (RDH Bandage) rather than detailing specific performance against acceptance criteria in the context of an AI/ML device.

Here's why the requested information cannot be extracted:

• Device Type: QuikClot is described as a "bulk granular hemostatic agent," which is a physical device, not an AI/ML device. The questions you've asked are highly specific to AI/ML device validation.
• Study Focus: The studies mentioned ("Invitro and Invivo testing on rats, rabbits and larger mammals," "biocompatibility testing") are geared towards demonstrating the hemostatic properties and safety of the physical product, not the performance of an algorithm.
• Regulatory Context: A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, meaning it's as safe and effective as a device already on the market. It doesn't typically require the type of detailed performance criteria and AI-specific studies you've inquired about.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, AI performance, expert review, or data origins.

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The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.

The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of The feed air compressor creates a vacuum to draw air into a oxygen. holding talk. The air is then flushed through two tanks in series to provide continuous oxygen. The molecular sieve material adsorbs nitrogen, which comprises approximately 78% of the makeup of air. The resulting gas is approximately 93% oxygen.

The variations of the device are to allow for less total flow, to accommodate fewer cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Portable Oxygen Generator:

This submission is a 510(k) premarket notification for a Class II medical device (Portable Oxygen Generator). The document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a novel clinical study with detailed performance metrics against specific acceptance criteria.

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

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

The document does not explicitly state a sample size for a test set or data provenance in the context of a clinical study. The performance data section refers to compliance with an industry standard and substantial equivalence to predicate devices, implying that testing was conducted to demonstrate these points, but the details of such testing (e.g., number of devices tested, duration of testing) are not provided.

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 information is not applicable and not provided in the document. This submission does not describe a study involving expert review or ground truth establishment in the way typically seen for diagnostic AI/imaging devices.

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

This information is not applicable and not provided. No adjudication method is mentioned as there's no clinical trial with expert review described.

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

No MRMC comparative effectiveness study was done or described. This device is an oxygen generator, not a diagnostic imaging device with AI assistance for human readers.

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

This information is not applicable and not provided. The device is an oxygen generator, not an algorithm. Its "performance" refers to its ability to mechanically produce oxygen meeting specified purity and flow, not algorithmic performance.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable here. The performance is assessed against engineering and performance specifications outlined in the ASTM F 1464-93 standard and by comparison to the functionality of predicate devices. The "truth" is whether the device consistently produces oxygen of a certain purity and flow rate under various conditions as required by the standard.

8. The sample size for the training set

This information is not applicable and not provided. This is not a machine learning or AI device, so there is no "training set."

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

This information is not applicable and not provided. As there is no training set, there is no need to establish ground truth for one.

Summary of the Study and Device Proof:

The "study" or proof for this device meeting its acceptance criteria is based entirely on its compliance with the FDA recognized standard ASTM F 1464-93 and demonstrating substantial equivalence to two legally marketed predicate devices (K 020362 and K 014078). The manufacturer states that the device "meets the requirements" of this standard. This implies that engineering tests, design verification, and validation activities were performed against the specifications within that standard. The effectiveness is also tied to the fact that "variations are designed and tested for same indication of use, safety and effectiveness" as the predicate devices. The core technology, molecular sieve material for oxygen concentration, is stated to be "well established" and used in the predicate devices.

This 510(k) submission is a declaration of compliance and equivalence, rather than a detailed report of a clinical efficacy trial. Specific data points from tests demonstrating compliance to ASTM F 1464-93, such as oxygen concentration levels over time, flow rates, alarm functionality, and environmental tolerances, would have been submitted to the FDA, but they are not detailed in this summary document.

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The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.

The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of The feed air compressor creates a vacuum to draw air into a oxvaen. holding talk. The air is then flushed through two tanks in series to provide continuous oxygen. The molecular sieve material adsorbs nitrogen, which comprises approximately 78% of the makeup of air. The resulting gas is approximately 93% oxygen.

The variations of the device are to allow for greater total flow, to accommodate more cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.

The provided text describes a Portable Oxygen Generator (P.O.G.S. - 3.3) by On Site Gas Systems. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to previously marketed devices.

Here's an analysis of the acceptance criteria and the study that indicates the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document refers to "non-clinical tests" and states the device "meets the requirements" of the standard. However, it does not provide any specific sample size for the test set or information regarding data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be centered on compliance with a technical standard rather than a clinical study with patients.

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

The document makes no mention of experts being used to establish ground truth for testing. The evaluation of the device's performance is against the technical requirements of ASTM F 1464-93.

4. Adjudication Method for the Test Set:

There is no mention of an adjudication method in the context of the testing described. The assessment is against the parameters of the ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document is for a Portable Oxygen Generator, which is a physical device, and not a diagnostic or imaging algorithm that would typically involve human readers.

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

This question is not applicable as the device is a Portable Oxygen Generator, not an algorithm. The assessment is of the device's physical performance.

7. The Type of Ground Truth Used:

The "ground truth" used for this device's acceptance is compliance with the technical specifications and performance requirements outlined in the FDA recognized standard ASTM F 1464-93 for Oxygen Concentrators. This standard defines objective, measurable parameters for oxygen concentration, flow rate, and other safety/performance aspects of such devices.

8. The Sample Size for the Training Set:

This question is not applicable to a physical medical device like an oxygen generator. The concept of a "training set" is relevant for machine learning algorithms, not for the engineering design and testing of a hardware product.

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

This question is not applicable, as there is no "training set" for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a "Discussion of Non-clinical Test to Support Determination of Substantial Equivalency" specifically focused on "Performance Data."

The key statement is: "The device meets the requirements of the FDA recognized standard covering Oxygen Concentrators, ASTM F 1464-93, and is substantially equivalent to the predicate devices."

This indicates that:

• The device was subjected to non-clinical tests.
• These tests evaluated its performance against the technical specifications and requirements of ASTM F 1464-93.
• Successful completion of these tests, demonstrating compliance with the standard, served as the basis for the FDA's determination of substantial equivalence.

The document does not provide details of the granular test results, the specific number of units tested, the methodology of how "meeting" the standard was confirmed, or any clinical trial data with human subjects. The acceptance is based on adherence to an established engineering and performance standard.

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The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.

The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of The feed air compressor creates a vacuum to draw air into a oxvaen. holding talk. The air is then flushed through two tanks in series to provide continuous oxygen. The molecular sieve material adsorbs nitrogen, which comprises approximately 78% of the makeup of air. The resulting gas is approximately 93% oxygen.

This appears to be a 510(k) summary for a medical device, specifically an Oxygen Concentrator (Portable Oxygen Generator). The provided text focuses on the device's description, intended use, and substantial equivalence to predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics.

Therefore, it's not possible to fully answer all aspects of your request as the provided text does not contain information about a clinical study involving human readers, sample sizes for test/training sets, expert qualifications, adjudication methods, or specific device performance numbers beyond meeting a recognized standard.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that the resulting gas is "approximately 93% oxygen." This can be considered a key performance metric. The main "acceptance criterion" mentioned is compliance with the ASTM F 1464-93 standard for Oxygen Concentrators. The document explicitly states, "The device meets the requirements of the FDA recognized standard covering Oxygen Concentrators, ASTM F 1464-93, and is substantially equivalent to the predicate devices."

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

• Sample Size for Test Set: Not applicable. The document describes a non-clinical test to support substantial equivalence. It does not mention a "test set" in the context of diagnostic performance or human reader studies.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test" mentioned is compliance with a standard, not data from a clinical trial.

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

• Not applicable. There's no mention of experts establishing ground truth for a diagnostic test set in this 510(k) summary. The ground truth for the device's performance would be derived from the physical and chemical testing against the ASTM standard.

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

• Not applicable. No adjudication method is mentioned as there's no interpretation of diagnostic outputs by experts.

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:

• No. This is a 510(k) for an oxygen generator, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is mentioned.

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

• Not applicable. This device is not an algorithm. Its performance is inherent in its mechanical and chemical operation.

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

• The "ground truth" for this device's performance is objective measurement against the physical and chemical specifications outlined in the ASTM F 1464-93 standard for Oxygen Concentrators, and the measured oxygen concentration (approx. 93%).

8. The sample size for the training set:

• Not applicable. This device is not an AI model that requires a training set.

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

• Not applicable. No training set is involved.

Summary of what the document does provide regarding acceptance criteria and study:

The primary "study" referred to is a non-clinical test demonstrating compliance with a recognized industry standard: ASTM F 1464-93.

• Acceptance Criteria (implicit): Meeting the specifications set forth in ASTM F 1464-93 for Oxygen Concentrators, and achieving an oxygen concentration of approximately 93%.
• Study: A non-clinical test was performed to verify the device's adherence to the ASTM F 1464-93 standard. The nature of this test (e.g., how many units tested, specific methodologies) is not detailed in this summary, but the conclusion is that it met the requirements.
• Conclusion: The device was deemed "substantially equivalent" to predicate devices based on its design, performance specifications, and intended use, primarily due to its compliance with ASTM F 1464-93.

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