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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 MOVES® SLC™ is a portable computer controlled electrically powered emergency transport ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation.

MOVES® SLC™ is intended to deliver high inspired oxygen concentrations to spontaneously breathing patients who require elevated inspired oxygen.

MOVES® SLC™ is intended to be used in a transport or emergency setting on adult patients who weigh between 40kg and 120kg.

MOVES® SLC™ provides the following supplemental functions for patients that it is ventilating or supplying with supplemental oxygen:

• Suction a.
  The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.

• Supplementary Oxygen b.
  The MOVES® SLCTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.

• c. Patient Monitoring
  The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® device (K093261), a portable multifunction patient support and monitoring system with the following capabilities:

• . Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
• Delivery of oxygen-enriched air that may be supplied from an external oxygen . source or generated internal to the system with the on-board oxygen concentrator.
• Patient monitoring functions including the following patient parameters: Pulse . Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.
• Suction/aspirator pump for medical suction procedures where secretions, blood . and other body fluids must be removed through the application of continuous negative pressure.
  The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.

The provided text is a 510(k) summary for the Thornhill Research Inc. MOVES® SLC™ medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and study designs (like sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies) that would be present in a submission establishing de novo safety and effectiveness for a novel device or AI algorithm.

The document mainly describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to predicate devices and compliance with relevant standards.

Here's a breakdown of the information available in the document regarding acceptance criteria and performance, as much as can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The "Summary of Performance Testing" section states:

"The results of performance testing demonstrate that the characteristics SLC are substantially equivalent to the identified predicates in terms of ventilator characteristics, patient monitoring performance, ability to delivery supplemental oxygen, and provide airway suction."

And the "Determination of Substantial Equivalence" section reiterates:

"Where differences in performance or technology exist, it has been demonstrated that they do not adversely impact safety or effectiveness. In addition, SLC has been tested to comply with relevant recognized consensus safety and performance standards as well as voluntary standards (detailed above)."

The acceptance criteria, implicitly, are that the device's performance characteristics for ventilation, patient monitoring, oxygen delivery, and suction must be substantially equivalent to those of its predicate devices and comply with all referenced standards and regulations.

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

This information is not provided in the 510(k) summary. The testing mentioned is "performance testing" and likely refers to engineering, bench, and potentially animal testing, rather than human clinical trials with specific patient sample sizes. The provenance of any data (country, retrospective/prospective) is also not mentioned.

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

This information is not applicable/provided. The document describes a medical device (ventilator, monitor, concentrator, suction pump), not an AI algorithm requiring expert-established ground truth on a test set (e.g., for image classification or diagnosis).

4. Adjudication Method for the Test Set

This information is not applicable/provided for the reasons stated above.

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

No, a MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically performed for AI-powered diagnostic aids where the impact on human reader performance is being evaluated.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The MOVES® SLC™ is a hardware medical device with integrated software/control. It is not an "algorithm only" device in the sense of a standalone AI diagnostic tool. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable in this context. The performance testing refers to the overall device's functionality.

7. The Type of Ground Truth Used

Given that this is a hardware device primarily demonstrating substantial equivalence and compliance with standards, the "ground truth" would be established through a combination of:

• Engineering specifications and measurements: Comparing output parameters (e.g., ventilator pressures, flow rates, oxygen concentration, monitoring accuracy) against known physical standards or the specifications of predicate devices.
• Performance against predicate device specifications: Ensuring that the MOVES® SLC™ meets or exceeds the demonstrated performance of its predicate devices for the various functions.
• Compliance with recognized consensus standards: Meeting the benchmarks set by standards like IEC 60601 series, EN-794-3, ISO 8359, and ASTM E1112-00.

There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" in the context of this 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable/provided. The MOVES® SLC™ is not described as a device that uses machine learning or an AI algorithm that requires a "training set" of data. Its control system and functionalities are based on established engineering principles and algorithms, not data-driven machine learning models that are "trained."

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

This information is not applicable/provided as there is no mention of a training set for an AI algorithm.

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