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

The AVANTICARE Mechanical Wheelchair, MR-9000 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 text is a 510(k) summary for the LERADO AVANTICARE Mechanical Wheelchair, MR-9000. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

Here's an analysis based on the information provided, and what is missing:

Information Provided:

• Acceptance Criteria: The document states, "Mechanical Wheelchair, MR-9000 meets the applicable AVANTICARE performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." These standards contain detailed performance and safety requirements, which serve as the acceptance criteria. However, the specific individual criteria (e.g., maximum weight capacity, braking effectiveness, durability cycles) from these standards are not listed in the provided text, nor are the specific results for each criterion.
• Study That Proves the Device Meets Acceptance Criteria: The document simply states that the device "meets the applicable performance requirements." It does not provide details of the study conducted to demonstrate this. There is no mention of a testing report, the methodology, or the results against each specific requirement.
• Device Performance: No specific performance metrics (e.g., weight capacity, speed, range) are reported, beyond the general statement of meeting the standards.
• Sample Size: Not mentioned.
• Data Provenance: Not mentioned (country of origin, retrospective/prospective).
• Number of Experts/Qualifications: Not applicable for this type of mechanical device testing.
• Adjudication Method: Not applicable.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating diagnostic or screening systems where human readers are involved.
• Standalone Performance: The core assertion is that the device (algorithm equivalent) meets the standards, but the details of the standalone testing are not provided.
• Type of Ground Truth: For mechanical devices, "ground truth" often refers to objective measurements against established technical standards. The ground truth here would be the specified requirements within ANSI/RESNA WC vol. 1 and ISO 7176.
• Sample Size for Training Set: Not applicable for a mechanical device.
• How Ground Truth for Training Set was Established: Not applicable.

Based on the provided text, I cannot complete the requested tables and sections with specific values and details. The document only offers a high-level statement that the device meets relevant standards.

Here's how I would present the information, highlighting what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text indicates that the device meets the California Technical Bulletin CAL 117 standard for flame retardant upholstery, and the general performance requirements of ANSI/RESNA WC vol. 1 and ISO 7176. However, it does not enumerate the specific criteria from these standards nor the quantitative results of the device against each criterion.

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified, but generally, testing for such devices would occur at a certified testing facility, likely in Taiwan (where the manufacturer is located) or a recognized international lab. The document does not specify if the tests were performed retrospectively or prospectively relative to the filing date, but regulatory testing is typically conducted prior to submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable to the performance testing of a mechanical wheelchair. Ground truth for such devices is established by objective measurements and tests against industry standards by qualified technicians/engineers at testing facilities, not by medical experts forming a consensus on an image or medical condition.

4. Adjudication method for the test set

• Not applicable for the performance testing of a mechanical wheelchair.

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-assisted diagnostic or screening tool.

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

• Yes, the performance testing described ("Mechanical Wheelchair, MR-9000 meets the applicable AVANTICARE performance requirements...") implicitly refers to standalone testing of the device itself, against various physical stress, durability, and safety parameters stipulated in the ANSI/RESNA and ISO standards. The results of these tests, while not detailed, are the basis for the claim of meeting the standards.

7. The type of ground truth used

• The ground truth for this mechanical device testing would be the objective, predefined technical specifications and performance limits outlined in the ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards, as well as the California Technical Bulletin CAL 117 standard. Test equipment and methodologies are designed to objectively measure if the device's performance meets these numerical and qualitative criteria.

8. The sample size for the training set

• Not applicable. Mechanical device design and testing do not typically involve a "training set" in the context of machine learning or AI.

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

• Not applicable.

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

The AVANTICARE Transport Wheelchair, MT-3000 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 text is a 510(k) Summary for the LERADO AVANTICARE Transport Wheelchair, MT-3000. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study proving that the device meets those criteria in the way typically expected for an AI-powered diagnostic device.

The "Performance Testing" section states: "AVANTICARE Transport Wheelchair, MT-3000 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards."

This indicates that compliance with these established industry standards serves as the "acceptance criteria" and the "study" is the testing performed against these standards. Unfortunately, the document does not provide the specific numerical acceptance criteria, the detailed results, or the methodology of this performance testing.

Therefore, I cannot fully complete the requested table and answer all questions in the requested format for an AI/diagnostic device, as the provided content pertains to a mechanical wheelchair and not a software or AI-based medical device.

However, I can extract what is provided related to performance and create a table based on the type of information that would be in an acceptance criteria table, even if specific numerical values are not given in this document.

Here's an attempt to answer based only on the provided text, acknowledging its limitations for an AI/diagnostic context:

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)

• Sample Size: Not specified in the document. It refers to the testing of "the device" (singular), implying a representative unit or units.
• Data Provenance: Not specified. The device manufacturer is in Taiwan, ROC, so testing would likely have occurred there or with a certified lab. The study type (e.g., retrospective or prospective) is not applicable or specified for this type of mechanical device testing.

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 is not applicable to the performance testing of a mechanical wheelchair against engineering standards. "Ground truth" in this context would be the objective measurements and adherence to the specified technical parameters of the standards, not expert interpretations.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert opinions related to diagnostic interpretation. The wheelchair testing would involve objective measurements and pass/fail criteria based on engineering specifications.

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 for AI-assisted diagnostic devices, not mechanical wheelchairs.

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

Not applicable. This is for AI algorithms, not mechanical wheelchairs.

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

The "ground truth" for the performance testing of the wheelchair would be the objective measurements of the device's characteristics and performance parameters (e.g., strength, stability, dimensions, durability, flame retardancy of materials) as defined and evaluated against the specific, quantifiable criteria within the ANSI/RESNA WC vol. 1 and ISO 7176 standards, and California Technical Bulletin CAL 117.

8. The sample size for the training set

Not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that requires a training set.

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

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

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

The AVANTICARE Mechanical Wheelchair, MS-8000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The dcvice can bc disassembled for transport and it is foldable easily. The device uses a standard sling type back and scat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

The provided document is a 510(k) premarket notification for a mechanical wheelchair (LERADO, AVANTICARE Mechanical Wheelchair, MS-8000). The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information, based solely on the provided text:

Acceptance Criteria and Device Performance (LERADO, AVANTICARE Mechanical Wheelchair, MS-8000)

Study Information:

1. Sample size used for the test set and the data provenance:
   The document does not specify a separate "test set" in the context of an AI/algorithm-based device. The performance testing refers to meeting established industry standards (ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards) rather than a study on a specific dataset of patient outcomes or expert interpretations. The device itself is a physical product (mechanical wheelchair). Therefore, data provenance is not applicable in the typical sense of medical imaging or diagnostic algorithms.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. This is a mechanical device, not a diagnostic or prognostic algorithm that requires expert ground truth establishment for a test set. Acceptance criteria are based on engineering standards and design comparisons.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as there is no test set requiring expert adjudication for ground truth.

4. 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. The device is a mechanical wheelchair and does not involve AI assistance or human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is a mechanical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For a mechanical wheelchair, the "ground truth" for performance is established by adherence to recognized engineering and safety standards (ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards) and by direct comparison of physical and functional attributes to a legally marketed predicate device. The information provided about "Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant" is also a type of regulatory-defined ground truth for a specific material property.

7. The sample size for the training set:
   Not applicable. This is a mechanical device, not an algorithm that requires a training set.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set.

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

The LERADO, AVANTICARE Power Wheelchair, PW-1800 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

This document describes the 510(k) submission for the LERADO, AVANTICARE Power Wheelchair, PW-1800. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the SINON Power Wheelchair, SN-W401.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from demonstrating substantial equivalence to the predicate device. The performance of the subject device (PW-1800) is considered to meet these criteria by being "SAME" as the predicate device (SN-W401) across various parameters, or having minor differences that are argued not to lead to performance differences.

Note regarding Battery Type: The subject device uses 34Ah batteries while the predicate uses 38Ah. The submission states that "The two type batteries are from the same supplier, and also certified by UL. The differences for the two devices do not lead to any performance differences, thus they are substantially equivalent." This is the only explicit "difference" acknowledged and justified.

Performance Testing:
The submission mentions "Performance Testing:" EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods). This indicates that the device was tested against these industry standards. However, specific results from these tests are not provided in this excerpt, but rather the implication is that the device passed these tests to demonstrate safety and performance.

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

This is a 510(k) submission for a power wheelchair, a medical device, not a diagnostic AI/ML system. Therefore, the concept of "test set" in the context of a dataset for an algorithm does not directly apply. The "test set" for this device would refer to the physical units produced for compliance testing. The document doesn't specify the number of individual devices tested, but rather the standards against which a device (or representative samples) were tested.

• Sample Size: Not explicitly stated for specific tests, but generally refers to physical prototypes or production samples.
• Data Provenance: Not applicable in the context of a data-driven system. The "provenance" here refers to the manufacturing location (Taiwan, ROC) and the standards applied.

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

This is not applicable as this is a physical medical device (power wheelchair), not an AI/ML diagnostic system requiring expert annotated ground truth on a dataset. The "ground truth" for a power wheelchair is its physical performance and safety characteristics as measured against established engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable for a physical device. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth. For this device, compliance is determined by testing against predefined engineering and safety standards.

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/ML diagnostic device that would involve human "readers" or an "AI assistance" component to improve their performance.

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

Not applicable. This is a standalone physical power wheelchair, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance and safety is established through:

• Engineering Specifications: The design parameters and declared specifications of the device (e.g., weight limit, maximum speed, dimensions).
• Safety Standards: Compliance with recognized international and national standards such as ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 for EMC and other wheelchair-specific requirements.
• UL Certification: Mentioned for the charger and batteries, indicating adherence to UL safety standards.
• Ignition Resistance Test: For back upholstery, performed by SGS.

These standards and certifications serve as the objective benchmarks against which the device's performance and safety are assessed.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system requiring a "training set."

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

Not applicable. See point 8.

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