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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The JAN MAO Wheelchair、JMC612-FL318EPP(& JMC612-FL418EPP)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 uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

The acceptance criteria pertain to the JAN MAO Wheelchair models JMC612-FL318EPP and JMC612-FL418EPP.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a specific "test set" sample size or data provenance in terms of country of origin or whether it was retrospective or prospective. It refers to general "Performance Testing" against standards. This suggests that the testing was likely done on physical samples of the manufactured wheelchairs.

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

Not applicable. The "ground truth" for a medical device like a wheelchair is established by its adherence to recognized engineering and safety standards (ANSI/RESNA WC Vol. 1, ISO 7176, CAL 117), not by expert consensus on clinical presentation or pathology.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation relies on standardized testing protocols outlined in the referenced standards, not an adjudication process involving human reviewers for clinical data.

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

Not applicable. This is not a diagnostic device where human reader performance would be enhanced by AI. The device is a mechanical wheelchair.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a mechanical wheelchair, not an algorithm. Performance testing is purely standalone, meaning the device itself is tested against established engineering and safety benchmarks.

7. Type of Ground Truth Used:

The ground truth used for performance evaluation is based on recognized engineering and safety standards. Specifically:

• ANSI/RESNA WC Vol. 1 (Wheelchair standards for performance requirements)
• ISO 7176 Wheelchair Standards (International standards for wheelchairs)
• California Technical Bulletin CAL 117 (Standard for flame retardancy of upholstery fabric)

8. Sample Size for the Training Set:

Not applicable. The JAN MAO Wheelchair is a mechanical device, not an AI/ML algorithm or software that requires a training set.

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

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

Study Proving Device Meets Acceptance Criteria:

The document states that "JAN MAO Wheelchair, JMC612-FL318EPP ( & JMC612-FL418EPP ) meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." Additionally, the upholstery fabric "meets the California Technical Bulletin CAL 117 standard for flame retardant."

This indicates that internal performance testing, likely conducted by the manufacturer or a third-party testing facility, was performed to verify compliance with these established standards. While the specific test reports are not included in this summary, the statement serves as the manufacturer's claim of compliance based on such studies. The FDA's 510(k) clearance implies that the FDA found sufficient evidence in the submission to support these claims, allowing the device to be marketed as substantially equivalent to a predicate device that also meets these standards.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The JAN MAO Wheelchair, JMC611-F18EPP is an 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 uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

Here's a breakdown of the acceptance criteria and study information for the JAN MAO Wheelchair, JMC611-F18EPP, 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 document does not specify a separate "test set" in the context of clinical data or patient-specific evaluation. The "testing" refers to performance testing of the device itself against established engineering and safety standards.

• No "sample size" of patients or users is mentioned for the performance testing. The wheelchair as a product is tested.
• Data Provenance: The testing was conducted by JAN MAO INDUSTRIES CO., LTD. in Taiwan. The summary does not provide details on specific labs or whether external, independent testing was performed, only that the company states the device "meets the applicable performance requirements."

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

N/A. This type of information is not applicable to the performance testing of a mechanical wheelchair against engineering standards. "Ground truth" in this context refers to the defined specifications within the ANSI/RESNA WC vol. 1 and ISO 7176 standards, and the flame retardancy criteria of CAL 117. These standards are established by technical committees and regulatory bodies, not by individual experts assessing a specific test set.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess a case to establish a consensus ground truth. For equipment performance testing against explicit standards, the results are objectively measured and compared to the standard's specifications.

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

No. An MRMC study is a type of clinical trial involving human readers evaluating medical images or data. This is not relevant to the regulatory submission for a mechanical wheelchair, which focuses on device safety and performance according to engineering standards.

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

N/A. "Standalone" performance generally refers to the performance of an AI algorithm without human interaction. This concept is not applicable to a mechanical wheelchair.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is based on:

• Established Industry Standards: ANSI/RESNA WC vol. 1 and ISO 7176 are internationally recognized standards for wheelchair performance and safety.
• Regulatory/Technical Standards: California Technical Bulletin CAL 117 is a specific standard for flame retardancy of materials.

The device's performance is measured against the specifications, test methods, and acceptance criteria defined within these published standards.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" applies to machine learning algorithms. This device is a mechanical wheelchair and does not utilize a training set in this context.

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

N/A. As there is no training set for a mechanical wheelchair, there is no ground truth established for it in this manner. The "ground truth" for verifying the product is the adherence to the published performance and safety standards.

Ask a specific question about this device

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The JAN MAO Wheelchair, JMC612-F18EPP is an 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 uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

The provided submission describes a medical device, the JAN MAO Wheelchair, JMC612-F18EPP, and its substantial equivalence to a predicate device. However, it does not include information about AI algorithms or advanced performance studies typically associated with "acceptance criteria" and "device performance" in the context of AI/ML devices.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text as they relate to AI/ML device studies. The information available pertains to traditional medical device regulatory submissions.

Here's an analysis based on the provided text, focusing on the available information:

Analysis of the Provided Text:

The document describes a 510(k) premarket notification for a mechanical wheelchair. The primary method for demonstrating "device performance" and meeting "acceptance criteria" in this context is through compliance with recognized standards and comparison to a legally marketed predicate device.

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

Note: The specific numerical acceptance limits or detailed test results for ANSI/RESNA or ISO 7176 are not provided in this summary. The submission simply states that the device "meets the applicable performance requirements."

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 provided in the document. For a mechanical device like a wheelchair, "test set" typically refers to the units produced for testing against engineering standards. The sample size and data provenance are not specified.

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. "Ground truth" and "expert consensus" are terms primarily used in the context of AI/ML or diagnostic device studies. For a mechanical wheelchair, compliance with standards is typically verified through engineering tests, not expert consensus on ground truth.

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

This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, not for objective engineering tests of a mechanical device.

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 not provided. MRMC studies and the concept of "human readers improving with AI" are specific to AI-assisted diagnostic or interpretive devices. This is a mechanical wheelchair.

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

This information is not applicable and not provided. There is no algorithm mentioned in the context of this mechanical wheelchair.

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

This information is not applicable and not provided. As mentioned previously, "ground truth" is not a concept typically applied to the performance assessment of a mechanical device like a wheelchair in a regulatory submission like this. Performance is largely determined by adherence to engineering specifications and safety standards.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable and not provided. There is no "training set" nor "ground truth" in the AI/ML sense for this device.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is performance testing against recognized national and international wheelchair standards.

• Study Name (Implied): Performance Testing of JAN MAO Wheelchair, JMC612-F18EPP
• Standards Used: ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. The upholstery fabric also met the California Technical Bulletin CAL 117 standard for flame retardant.
• Result: The device "meets the applicable performance requirements as specified" in these standards.
• Methodology (Implied): This type of testing typically involves a series of physical and mechanical tests specified by the standards, such as fatigue testing, static stability, braking efficacy, dimensional checks, and material flammability tests. The specifics of these tests are not detailed in the summary.
• Substantial Equivalence Comparison: The submission also relies on comparison to a legally marketed predicate device, the AVANTICARE Mechanical Wheelchair, MR-9000 (K050708), to demonstrate substantial equivalence. Key attributes compared include intended use, foldability, overall dimensions, weight capacity, and upholstery material. The differences (removable armrest and swing-away footrest) were deemed not to impact safety.

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