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The Access Point, LLC Deluxe Nebulizer is intended to provide a source of compressed air for medical purposes for use in home health care. The Deluxe Nebulizer is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.

The Deluxe Nebulizer, consist of four components. The nebulizer main unit, air compressor, air filters and nebulizer kit (hand held nebulizer with mouthpiece). The Nebulizer atomizes medicinal liquid into tiny fog droplets by compressing air. Patients inhale the compressed air for optimal internal medicinal delivery.

This 510(k) summary for the Deluxe Nebulizer does not contain the acceptance criteria or results from a study proving it meets specific performance criteria designed for a diagnostic or AI-driven device.

This submission is for a medical device that provides compressed air for nebulizer therapy. Its performance is evaluated against recognized consensus standards for safety and electrical compatibility, rather than through clinical or diagnostic accuracy studies.

Here's why the requested information for an AI/diagnostic device is not present in this document:

• Device Type: The Deluxe Nebulizer is a compressor for a nebulizer. It's a mechanical device, not an AI, diagnostic, or imaging device designed to provide a specific output value, classification, or prediction.
• Performance Metrics: The "performance" of this device is related to its ability to safely and reliably produce compressed air according to engineering and safety standards, not to its diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Therefore, I cannot populate the table or answer many of the questions as they pertain to clinical performance studies for AI/diagnostic devices.

However, I can extract the available information related to the device's conformance to standards based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI or diagnostic device that uses a "test set" of data for performance evaluation in the way a diagnostic algorithm would. Testing would involve engineering verification and validation against the specified standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for this type of device. Conformance to engineering and safety standards is verified.

4. Adjudication method for the test set: Not applicable.

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 not an AI-assisted diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "truth" here is compliance with established engineering and safety standards.

8. The sample size for the training set: Not applicable. This is not an AI device that requires a "training set."

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

Summary of Device Performance as Stated:

The document explicitly states: "The Deluxe Nebulizer was designed to conform to the applicable sections of the following recognized consensus standards. The testing included verifying conformance to these standards and the published specifications."

The Conclusion reinforces this by stating: "The Deluxe Nebulizer is as safe and effective as the predicate devices when used according to the instructions in the directions for use supplied with the devices." This implies that the testing performed demonstrated compliance with these standards, establishing its safety and effectiveness. The "study" for this device revolves around engineering and safety verification and validation, rather than clinical efficacy trials or diagnostic accuracy trials.

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AXS-1 Lite Wheelchairs are indicated for providing mobility to persons limited to a sitting position

The Access Point Medical Explorer Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical. steel frame and leatherette or nylon upholstery that meets FN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors, over smooth Transport Series. Transport Chair is and China C standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.

This document is a 510(k) premarket notification for the AXS-1 Lite Wheelchair (originally submitted as Explorer Wheelchair). It primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and results.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide what is available and indicate when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a clinical study or a specific test set with a sample size for evaluating device performance in humans. The device's substantial equivalence is established through conformance to recognized standards, which typically involve laboratory testing, not human subject testing in the context of this 510(k). The "data provenance" in terms of country of origin or retrospective/prospective is not applicable here as it's not 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 document does not describe a study involving expert assessment or ground truth establishment in a clinical context.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication is 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

Not applicable. This device is a mechanical wheelchair, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance in a clinical read.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

For the safety and performance claims, the "ground truth" is defined by the compliance with the listed international and national standards (ISO, EN, and 21 CFR regulations). These standards outline specific test methods and criteria that, when met, are considered evidence of safety and effectiveness for a device of this class.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a training set.

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

Not applicable. As above, there is no training set for this mechanical device.

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AXS-1 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.

The Access Point Medical AXS-1 Basic Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and leatherette or nylon upholstery that meets EN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.

This document is a 510(k) premarket notification for the AXS-1 Basic Wheelchair. It describes the device, its intended use, and compares it to a predicate device. The primary method used to demonstrate substantial equivalence is through compliance with recognized international standards for wheelchairs.

Here's a breakdown of the requested information based on the provided text:

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 specify a sample size for a test set in the traditional sense of a clinical or performance study with human subjects or a dataset. The demonstration of compliance is based on the design and manufacturing adherence to recognized international standards. This is typical for Class I medical devices like a basic wheelchair, where safety and effectiveness are primarily established through engineering design, material specifications, and testing to recognized standards, rather than large-scale clinical trials. The data provenance is implied to be from the manufacturer's internal testing and quality control processes to ensure compliance with the stated standards.

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 the context of device performance testing through standard compliance, refers to whether the device physically performs according to the standard's specifications. This is determined by engineering tests and measurements, not expert consensus on a dataset.

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

Not applicable. As described above, the compliance is based on engineering tests against standards, not on expert adjudication of a test set.

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 device is a basic mechanical wheelchair and does not involve AI or human "readers" in its function or evaluation.

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

Not applicable. This device is a basic mechanical wheelchair and does not involve algorithms or human-in-the-loop performance.

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

The "ground truth" for this submission is compliance with recognized international performance and safety standards (ISO and EN standards listed in Section P). This means the device was designed and tested to meet the objective, measurable requirements set forth in those standards.

8. The sample size for the training set

Not applicable. The AXS-1 Basic Wheelchair is a mechanical device, and the submission does not involve machine learning or AI models that would require a "training set."

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

Not applicable, as there is no training set for this mechanical device.

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AXS Transport Chairs are indicated for providing mobility to persons limited to a sitting position

The Access Point Medical AXS Transport Chair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of a rigid mechanical Aluminum Alloy or steel frame and nylon upholstery that meets EN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 8x1" solid rubber rear wheels and two 8x1" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.

This document describes a 510(k) premarket notification for the "AXS Transport Chair" (K050281). This is a submission for a mechanical wheelchair, which is a Class I device. Class I devices are generally considered low risk and often establish substantial equivalence through a comparison to a predicate device, rather than extensive clinical studies with acceptance criteria for device performance.

Therefore, the typical structure for reporting acceptance criteria and a study proving device performance as seen in submissions for higher-risk devices with new technology or significant performance claims, is not applicable here. This submission relies on demonstrating the AXS Transport Chair is substantially equivalent to a legally marketed predicate device by showing identical technological characteristics and adherence to relevant consensus standards.

Here's how the information requested maps to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission does not describe a test set in the sense of a clinical trial or performance study involving human subjects or specific data samples. The "test" in this context refers to the manufacturer's internal verification and validation processes to ensure the product meets the cited consensus standards. These tests would involve physical testing of the wheelchair's components and assembled unit according to the methodologies outlined in each ISO and EN standard.

• Sample Size: Not explicitly stated as it's not a dataset-driven study. The sample size would be determined by the requirements of each specific ISO/EN standard for verifying compliance (e.g., number of units tested for static stability, brake efficiency, impact/fatigue strength).
• Data Provenance: The data would be from the manufacturer's own internal testing and quality control processes. The country of origin of the data would be where the manufacturing and testing occur, which is implied to be by the same manufacturer as the predicate device (Jiangsu Intco Medical Equipment & Supply Co., Ltd. - China). The testing is prospective in the sense that it's performed on the manufactured product to verify compliance.

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 the context of a clinical or diagnostic study, refers to a definitive diagnosis or outcome. For a Class I mechanical device like a wheelchair, "ground truth" is defined by adherence to established engineering and safety standards (e.g., ISO, EN). The "experts" involved are the engineers, quality control personnel, and certification bodies responsible for conducting and verifying these tests. Their qualifications would be in engineering, product testing, and quality assurance relevant to medical devices and assistive technology.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of resolving discrepancies in expert interpretations, as there are no expert interpretations of clinical data in this submission. Compliance with standards is typically binary (pass/fail) based on objective measurements and test procedures.

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

No, an MRMC comparative effectiveness study was not done. Such studies are relevant for diagnostic devices or those requiring human interpretation of results, where the impact of AI assistance on human performance (e.g., radiologists, pathologists) is assessed. This device is a mechanical wheelchair.

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

Not applicable. This device does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is objective compliance with established international and national consensus standards (ISO 7176 series, EN 1021-1, and 21 CFR regulations) for mechanical wheelchairs. This is verified through physical and material testing according to the specified methodologies within those standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this device does not involve machine learning or AI that would require data for training an algorithm.

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

Not applicable, as there is no training set.

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