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The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen.

The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.

The Portable Oxygen Concentrator P2-TOC is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user.

The Portable Oxygen Concentrator P2-TOC has two oxygen supply modes, namely continuous oxygen supply mode and pulse oxygen supply mode. Hereinafter referred to as "continuous mode" and "pulse mode" .

In the continuous mode, the Portable Oxygen Concentrator P2-TOC can continuously deliver oxygen at a fixed flow rate. In the pulse mode, the Portable Oxygen Concentrator P2-TOC is able to deliver oxygen only when the user inhales by detecting the human respiratory rate.

The provided text describes a 510(k) premarket notification for a Portable Oxygen Concentrator (P2-TOC). It details the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence. However, the document does not contain information related to an AI/ML-enabled device or a study involving human experts, ground truth establishment, or comparative effectiveness with AI assistance.

Therefore, I cannot fulfill most of the requested points as the provided document is for a physical medical device (portable oxygen concentrator) and not an AI/ML diagnostic or therapeutic device.

The document primarily focuses on:

• Device Description and Indications for Use: What the portable oxygen concentrator does.
• Principle of Operation: How it separates oxygen from air.
• Comparison with Predicate Devices: Demonstrating similarity in function and safety to already-marketed oxygen concentrators.
• Non-Clinical Tests Performed: This section lists various engineering and safety standards (electrical safety, EMC, software verification, biocompatibility) that the device complies with. These are standard tests for medical devices to ensure quality and safety, not AI model performance.
• Absence of Clinical Accuracy Testing: Explicitly states "There was no clinical testing performed." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means.

Here's what I can extract from the provided text regarding acceptance criteria and performance, focusing on what is relevant for a physical medical device:

The "acceptance criteria" for a physical device like a Portable Oxygen Concentrator are typically defined by compliance with recognized consensus standards and performance specifications. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to show compliance with these standards and performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance (Based on "Comparison with predicate device" and "Non-Clinical Tests Performed"):

Regarding the points specific to AI/ML devices, I must state that the document does not provide the requested information for the following reasons:

2. Sample size used for the test set and the data provenance: Not applicable. This document describes testing for a physical device's compliance with engineering standards, not an AI model trained on data. There is no concept of a "test set" from a data perspective. The "testing" refers to bench testing of the physical hardware and embedded software. Data provenance would not be a relevant concept as it pertains to clinical data for AI model training/testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth established by experts is mentioned. The ground truth for device performance is based on physical measurements against established engineering and medical device standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring expert adjudication.

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 physical oxygen concentrator, not an AI-assisted diagnostic or therapeutic device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to a physical device, not a standalone AI algorithm. While it has embedded software, its "performance" is measured by its physical output (oxygen concentration, flow rate) and adherence to safety standards, not by an algorithm's classification or detection accuracy.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is determined by direct measurement of physical parameters (e.g., oxygen purity, flow volume, noise levels) and compliance with specified engineering and safety standards, as detailed in the "Non-Clinical Tests Performed" section.

8. The sample size for the training set: Not applicable. This is for an AI/ML model, not a physical medical device. The device itself is manufactured; it doesn't "learn" from a training set in the AI sense.

9. How the ground truth for the training set was established: Not applicable. See point 8.

In summary, the provided document is a regulatory submission for a physical Portable Oxygen Concentrator, and therefore, the information requested, which pertains to AI/ML device performance and validation studies, is not present. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this device are based on demonstrating compliance with a comprehensive set of recognized consensus engineering and safety standards through non-clinical bench testing.

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The Portable Oxygen Concentrator (Model: P2-K4.P2-S4. P2-S3) is intended to provide supplemental oxygen in a home, institutional, or travel environment. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator(Model:P2-K4,P2-K3,P2-S4,P2-S3) is small, portable and may be used in home, institution and various mobile environments. However, there is not any type of humidifier that is suitable for use with this device because of its pulse dose delivery mode.

Portable Oxygen Concentrator (Model:P2-K4,P2-K3,P2-S4,P2-S3) is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.

This document describes acceptance criteria and testing for a Portable Oxygen Concentrator (Models: P2-K4, P2-K3, P2-S4, P2-S3).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with various international and national standards for medical electrical equipment, biocompatibility, and specific oxygen concentrator requirements. The reported device performance is demonstrated by the successful completion of tests against these standards.

Differences Noted in Comparison to Predicate Device and their Mitigation:

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

The document does not specify a "test set" in the context of clinical trials or AI model validation with a specific number of cases. Instead, it refers to conformity testing against established standards. For such conformity testing, the "sample size" typically refers to the number of devices or components tested to ensure consistent performance across the production. This information (specific number of devices tested for each standard) is not provided in this summary.

Data provenance: The testing appears to be primarily non-clinical bench testing and verification, likely conducted at the manufacturer's facility or by a certified testing laboratory. There is no mention of country of origin of data for a "test set" as understood in a clinical study.

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

Not applicable. This is not an AI/ML-driven diagnostic device that requires expert-established ground truth on a test set of medical images or patient data. The device's performance is validated against engineering and medical device standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a diagnostic device requiring adjudication of expert interpretations 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

No. This is a medical device for oxygen delivery, not a diagnostic AI system, therefore, an MRMC comparative effectiveness study is not relevant or mentioned.

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

Not applicable. This device is a hardware-based oxygen concentrator with embedded software; it is not a standalone AI algorithm.

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

The "ground truth" for this device's performance is defined by compliance with a comprehensive set of international and national standards for medical devices, electrical safety, EMC, biocompatibility, and specific oxygen concentrator requirements (e.g., ISO 80601-2-69, ISO 80601-2-67). This is a technical and performance-based "ground truth" rather than clinical diagnostic ground truth.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device trained on data, there is no "training set."

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

Not applicable. There is no "training set" or associated ground truth for this device.

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The Portable Oxygen Concentrator (Model: P2-E7, P2-E) is intended to provide supplemental oxygen in a home, institutional, or travel environment.

Portable Oxygen Concentrator (Model: P2-E7, P2-E) is a portable oxygen generator that is intended to release oxygen for respiratory by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment.

The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.

Model difference: The only different between model P2-E7 and P2-E is that P2-E7 has biggest output oxygen flow of 1.4L/min (at 7 gears) and P2-E has biggest output oxygen flow of 1.0L/min (at 5 gears).

The provided document is a 510(k) Summary for a Portable Oxygen Concentrator. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence for regulatory clearance. It does not present information about a study that assesses the device's performance against clinical acceptance criteria using human subjects or an AI algorithm.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (in a clinical context).
• Sample size used for a test set or data provenance related to clinical performance.
• Number of experts or their qualifications for establishing ground truth for a clinical test set.
• Adjudication method for a clinical test set.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical evaluation.
• Sample size for a training set (as no AI algorithm requiring a training set is discussed).
• How ground truth for a training set was established.

The document focuses on non-clinical testing and engineering standards to demonstrate safety and effectiveness, and substantial equivalence to a predicate device, not clinical performance against acceptance criteria in a human study, nor does it involve an AI component.

The relevant information from the document related to testing and "acceptance" is as follows:

Acceptance Criteria (Implied by Standards and Comparison to Predicate):

While not explicitly stated as "acceptance criteria" in a clinical performance sense, the document demonstrates the device meets various safety, performance, and compatibility standards. The "reported device performance" in this context refers to the device's adherence to these standards and its characteristics in comparison to the predicate.

Study Proving Device Meets Criteria:

The "study" in this context refers to the non-clinical testing and validation performed to demonstrate substantial equivalence and adherence to recognized standards.

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

2. Sample sized used for the test set and the data provenance: Not applicable in the context of human clinical data for this submission. The "test sets" refer to the specific units of the device models (P2-E7, P2-E) subjected to various engineering and functional tests. The data provenance is from Qingdao Kingon Medical Science and Technology Co., Ltd. (China) through bench testing. The document refers to "non-clinical tests performed." The testing is retrospective in the sense that the results were submitted for regulatory review after completion.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, is established by adherence to internationally recognized engineering and medical device standards (e.g., ISO, IEC, AAMI ANSI) and direct measurement of device characteristics. The expertise would lie in the engineers and testing personnel who conducted these standard tests.

4. Adjudication method: Not applicable. Standard technical testing and comparison against predicate.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance, often with or without AI assistance, in diagnostic tasks. This device is a portable oxygen concentrator, not an imaging or diagnostic AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "software" in this device controls hardware functions (e.g., alarms, breath detection, display) and is deeply embedded, not a standalone AI algorithm for interpretation or diagnosis.

7. The type of ground truth used: For hardware performance, the ground truth is defined by the specifications in the relevant industry standards (e.g., oxygen concentration, pressure, noise levels) and the functional requirements of the device. For software, the "ground truth" is adherence to software development life cycle processes (IEC 62304) and correct execution of defined functions without critical errors.

8. The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a training set in the typical machine learning sense. The software is embedded control software.

9. How the ground truth for the training set was established: Not applicable. See point 8.

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The Portable Oxygen Concentrator, model: P2-E6 is intended to provide supplemental oxygen in a home, institutional, or travel environment.

Portable Oxygen Concentrator, model: P2-E6 is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The P2-E6 is small, portable and may be used in home, institutional, or travel environment.

The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.

This document is a 510(k) Summary for a Portable Oxygen Concentrator, model: P2-E6. It seeks to demonstrate substantial equivalence to a predicate device (GCE Zen-O™ Portable Oxygen Concentrator, Model: RS-00500, K162433).

The information provided does not describe an AI medical device or a study involving human readers and AI assistance. Instead, it focuses on the engineering and performance characteristics of a physical medical device (an oxygen concentrator) and its compliance with various medical device standards. There is no mention of an algorithm or AI in the context of diagnostic or interpretive tasks for which acceptance criteria typically involve clinical performance metrics like sensitivity, specificity, or AUC based on expert reads.

Therefore, I cannot fulfill the request to discuss the acceptance criteria and study proving a device meets acceptance criteria in the context of AI assistance or diagnostic performance, as the provided text pertains to a different type of medical device clearance.

The 510(k) summary focuses on demonstrating that the new oxygen concentrator is substantially equivalent to a previously cleared predicate device by comparing:

• Intended Use and Indications for Use: Stating they are the same (supplemental oxygen in home, institutional, or travel environment).
• Technological Characteristics: Comparing design, principle of operation, oxygen concentration, settings, alerts, etc.
• Performance Testing: Referring to compliance with established consensus standards (e.g., ISO, IEC) for electrical safety, electromagnetic compatibility, biocompatibility, and specific oxygen concentrator performance (e.g., oxygen concentration, discharge pressure, breath rate, bolus size).
• Software Verification and Validation: Describing the software's level of concern, programming language, hardware platform, and testing to ensure it performs as intended.

Key takeaway from the document: The manufacturer is demonstrating the safety and effectiveness of their new oxygen concentrator by showing it meets recognized engineering and performance standards, and that any differences from the predicate device do not raise new questions of safety or effectiveness. There is no AI component or clinical reader study described.

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