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The YJ-K1/K2 Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The YJ- K1,K2 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

The provided document pertains to a 510(k) premarket notification for a manual wheelchair (YJ-K1/K2 Wheelchair) and does not describe acceptance criteria or a study related to an AI/ML-driven device. The document primarily focuses on demonstrating substantial equivalence to a predicate manual wheelchair through non-clinical performance testing and biocompatibility testing.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is not available within this document.

The document states:

• "No clinical study is included in this submission." (Page 8)
• The tests conducted are non-clinical, focusing on mechanical performance and biocompatibility to standards like ISO 7176 series and ISO 10993 series. (Page 8)
• The device is a "mechanical wheelchair" (Page 5).

Since the request is specifically for a device that would require such studies (e.g., an AI/ML diagnostic device), and this document describes a manual wheelchair, it is not possible to extract the requested information.

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The YJ-010B Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The YJ-010B series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footplates and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

The provided document is a 510(k) premarket notification for a Bariatric Heavy Duty Wheelchair. It does not describe an AI medical device or a study involving AI assistance or human readers. Therefore, I cannot extract information related to acceptance criteria and study proving a device meets those criteria for an AI-powered device, as the document pertains to a mechanical wheelchair.

The document discusses:

• Acceptance criteria (implicitly): The device (a manual wheelchair) needs to demonstrate substantial equivalence to a predicate device, primarily through non-clinical performance testing and biocompatibility assessments, adhering to various ISO standards.
• Device performance: The document lists various specifications of the proposed wheelchair (e.g., dimensions, weight capacity, stability angles, brake effectiveness) and states that these comply with relevant ISO standards.
• Ground Truth: For a mechanical device like a wheelchair, "ground truth" would relate to its physical properties and performance metrics as measured according to established engineering and safety standards (e.g., ISO 7176 series).
• Sample Size: Not applicable in the context of an AI test set. This refers to physical samples of the wheelchair models being tested.
• Experts/Adjudication/MRMC/Standalone: These concepts are not applicable to the evaluation of a mechanical wheelchair. There is no AI algorithm being evaluated.
• There is no clinical study included in this submission.

To answer your request, here's a blank template for an AI medical device study, illustrating the elements you've asked for, as this document does not contain the necessary information.

Acceptance Criteria and Study for an AI Medical Device

Study Description:
(This section would be filled if the document were about an AI device. As it is not, this remains a template.)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The above table is a placeholder for a hypothetical AI device study and cannot be populated from the provided document, which describes a mechanical wheelchair.

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

• Test Set Sample Size: [Number of cases/patients/images]
• Data Provenance: [e.g., Retrospective or Prospective; Country of origin (e.g., Multi-site from US, Europe, Asia)]

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

• Number of Experts: [ e.g., 3]
• Qualifications of Experts: [e.g., Board-certified Radiologists with >10 years of experience in [specific domain, e.g., chest imaging, mammography]; Certified Pathologists with >5 years of experience]

4. Adjudication Method for the Test Set

• Adjudication Method: [e.g., 2+1 (two initial readers, third independent reader for discordance); 3+1 (three initial readers, fourth independent reader for discordance if majority not reached); Consensus meeting; None (if single reader ground truth)]

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

• MRMC Study Conducted?: [Yes/No]
• Effect Size (e.g., improvement in AUC or F-measure for human readers with AI assistance vs. without AI): [e.g., Human readers' AUC improved from X to Y (an absolute increase of Z); F-measure increased by Z%]

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

• Standalone Performance Study Conducted?: [Yes/No]
• Key Performance Metrics (if Yes): [e.g., Sensitivity: X%, Specificity: Y%, AUC: Z]

7. The Type of Ground Truth Used

• Type of Ground Truth: [e.g., Expert consensus (radiologist readings); Pathological diagnosis (biopsy/histology); Clinical outcomes data (e.g., hospital discharge codes, follow-up imaging); Longitudinal follow-up data]

8. The Sample Size for the Training Set

• Training Set Sample Size: [Number of cases/patients/images]

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

• Ground Truth Establishment for Training Set: [e.g., Clinical reports by attending physicians; Single expert review; Automated label extraction; A subset might be expert-reviewed, while the majority are from routine clinical practice.]

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The YJ-011S Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The YJ-011S series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

The provided text describes a 510(k) premarket notification for a reclining wheelchair, which is a Class I device. As such, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than a clinical study or AI/software validation. Therefore, many of the requested elements regarding acceptance criteria for AI performance, clinical study details, expert review, effect size, and training/test set specifics are not applicable or not present in this type of regulatory submission.

Applicable Information from the Submission:

This submission for the Zhenjiang Assure Medical Equipment Co., Ltd. Reclining Wheelchair (K232198) primarily relies on demonstrating compliance with recognized performance standards for mechanical wheelchairs and biocompatibility testing. The "acceptance criteria" are implied by the successful execution and results of these tests, showing the device meets the safety and performance benchmarks established by the standards and is comparable to the predicate device.

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

The submission does not present a formal "acceptance criteria" table with specific quantitative thresholds that would be typical for an AI/software device. Instead, acceptance is demonstrated by compliance with international standards for wheelchairs and biocompatibility. The "reported device performance" is that the device complied with these standards.

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

This information is not applicable. The evaluations were non-clinical performance and biocompatibility tests of the physical device, not an assessment of software or AI performance on a data set. Therefore, there is no "test set" in the context of data or images, nor data provenance.

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. There was no test set requiring expert ground truth establishment for this type of medical device submission.

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

This information is not applicable. There was no test set requiring adjudication in this type of submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This device is a mechanical wheelchair, not an AI-assisted diagnostic or interpretative device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This information is not applicable. This device is a mechanical wheelchair and does not involve an algorithm.

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

This information is not applicable in the context of "ground truth" for AI/software. The "ground truth" for this device's performance is defined by the established criteria and methods within the referenced ISO standards for mechanical wheelchairs and biocompatibility.

8. The sample size for the training set

This information is not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that would require a training set.

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

This information is not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that would require a training set or its associated ground truth establishment.

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The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

The Zhenjiang Assure Mechanical Wheelchair,model:K1 is indoor/outdoor wheelchair that has a base with four-wheeled with a seat.The device can be disassembled for transport and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, the upholstery fabric meets the flame retardant test.

The provided text is a 510(k) summary for the Zhenjiang Assure Mechanical Wheelchair, Model:K1. This document focuses on demonstrating substantial equivalence to a predicate device and does not involve AI/ML technology or associated performance metrics like sensitivity, specificity, or AUC. Therefore, a table of acceptance criteria and reported device performance related to those metrics, along with details about studies involving test sets, ground truth establishment, expert adjudication, or MRMC studies, cannot be extracted from this text.

The document describes non-clinical performance testing against established ISO standards for wheelchairs to demonstrate safety and effectiveness.

Here's a breakdown of the available information based on your request:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of AI/ML metrics (e.g., sensitivity, specificity, AUC). Instead, it lists the international standards to which the device conforms for non-clinical performance. The "reported device performance" is essentially that the device is "compatible as requirement of" these ISO standards.

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

This information is not applicable and therefore not provided, as the studies are physical performance tests for a mechanical wheelchair, not data-driven AI/ML studies. The testing is based on risk assessment utilizing Failure Mode Effect Analysis (FMEA).

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 therefore not provided. The "ground truth" for a mechanical wheelchair's performance is determined by its adherence to specified engineering and safety standards (e.g., ISO 7176 series), which are validated through physical testing.

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

This information is not applicable and therefore not provided, as there is no expert adjudication of subjective assessments. The methods for verifying compliance with ISO standards are typically standardized testing procedures.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and therefore not provided. The submission is for a mechanical wheelchair, which does not involve human readers or AI assistance in its function or evaluation.

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

This information is not applicable and therefore not provided. The device is a mechanical wheelchair and does not involve algorithms or AI.

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

The "ground truth" for the device's performance is compliance with the technical specifications and safety requirements outlined in the referenced ISO 7176 series standards. These are empirically verifiable through physical testing.

8. The sample size for the training set

This information is not applicable and therefore not provided, as this is not an AI/ML device that requires a training set.

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

This information is not applicable and therefore not provided, as this is not an AI/ML device that requires a training set.

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The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

The Zhenjiang Assure Mechanical Wheelchair, model:A227 is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device can be disassembled for transport and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, the upholstery fabric meets the flame retardant test. The maximum weight bearing capacity of the device is 250 1bs/113.5 kgs.

This submission describes the Zhenjiang Assure Mechanical Wheelchair, model: A227, a Class 1 device intended to provide mobility to persons restricted to a sitting position. Since this is a mechanical wheelchair, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to compliance with recognized performance standards rather than typical AI/algorithm performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

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

This submission does not involve a software algorithm or AI, so there is no "test set" in the traditional sense of a dataset. The performance testing involves physical testing of the wheelchair device against established international standards. The sample size would refer to the number of physical units of the Zhenjiang Assure Mechanical Wheelchair (model: A227) that were subjected to these tests. The document does not specify the exact number of units tested.

The data provenance is from physical performance testing conducted on the device, specifically mentioned as being performed by the manufacturer, Zhenjiang Assure Medical Equipment Co., Ltd., to comply with ISO and ANSI/RESNA standards. The location of the company is Zhenjiang, China. The testing would be prospective in nature, as it's directly assessing the performance of the manufactured wheelchair model against specified criteria.

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

Not applicable. For a mechanical device like a wheelchair, "ground truth" is established by adherence to universally accepted engineering and safety standards (e.g., ISO, ANSI/RESNA). There are no human experts establishing a subjective ground truth for a test set in the way there would be for an AI diagnostic algorithm. Compliance is determined by objective measurements and tests. The experts involved would be engineers and technicians specialized in medical device testing and quality assurance, trained in applying these specific standards.

4. Adjudication Method for the Test Set:

Not applicable. Compliance with mechanical standards is typically determined by objective measurements and passing/failing predefined test protocols, not by 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 mechanical wheelchair, not an AI-powered diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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:

The "ground truth" for this mechanical device is defined by international consensus standards for wheelchair performance and safety, specifically the ISO 7176 series and ANSI/RESNA WC Vol. 1 standards. These standards prescribe specific test methods and acceptable limits for various performance parameters (e.g., static stability, brake effectiveness, ignition resistance).

8. The Sample Size for the Training Set:

Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for a mechanical device, there is no ground truth to be established for it.

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