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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 GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position. The GEN 3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.

The GEN 2 mechanical wheelchair is a highly adaptable allpurpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.

The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.

This document is a 510(k) premarket notification for mechanical wheelchairs (GEN 2 and GEN 3 models). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a study on an AI/ML powered device.

Therefore, many of the requested elements (acceptance criteria, sample size for test/training sets, ground truth establishment, expert qualifications, MRMC comparative effectiveness, standalone performance, etc.) are not applicable or not provided in this document.

However, I can extract information related to the performance testing conducted for these mechanical wheelchairs.

Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing performed to establish the safety and effectiveness of the modified GEN 2 and GEN 3 mechanical wheelchairs. The specific acceptance criteria are implied by adherence to the ISO 7176-1:2014 standard for static stability.

Note: The document explicitly states "The information provided supports a substantial equivalence decision based on the repeat pre-clinical testing of the forward, rearward and lateral static stability tests performed in accordance with ISO 7176-1:2014." This implies that the devices met the requirements of this standard.

The other questions are not relevant to this document as it pertains to physical medical devices (mechanical wheelchairs) and not an AI/ML powered device.

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

The SUNCO Mechanical Wheelchair, model SKW-9003 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, and the upholstery fabric meets the EN 1021-1:2006 Furniture --Assessment of ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette & EN 1021-2:2006 Furniture -- Assessment of ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. The back upholstery material is resistance-ignitability fabric. The removable desk-length armrest and swing-away detachable footrest.

This document is a 510(k) Premarket Notification from the FDA regarding the SUNCO Mechanical Wheelchair, model SKW-9003. This type of document is a regulatory approval, not a clinical study report. Therefore, it does not describe an AI/ML device or its performance criteria in the way envisioned by the posed questions.

The device in question is a mechanical wheelchair, which is a physical medical device, not a software or AI/ML-driven diagnostic or therapeutic device. The document focuses on demonstrating substantial equivalence to a predicate mechanical wheelchair based on design, materials, and performance against established safety standards.

Consequently, most of the requested information regarding acceptance criteria and a study proving an AI/ML device meets them cannot be extracted from this document. Specifically:

• No AI/ML device: The document pertains to a mechanical wheelchair, not an AI/ML device.
• No performance criteria for AI/ML: The acceptance criteria and performance data are related to the physical and mechanical aspects of the wheelchair (e.g., static stability, brake effectiveness, material ignitability), not AI/ML metrics like sensitivity, specificity, AUC, etc.
• No clinical study for AI/ML effectiveness: The "performance data" refers to non-clinical bench testing against ISO standards for biocompatibility and safety of the wheelchair, not a clinical study involving human readers or AI assistance.

Therefore, I will provide the information that is present in the document related to the wheelchair's acceptance criteria and testing, and explicitly state when the requested AI/ML specific information is not available.

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

The document does not present acceptance criteria in a quantitative table with specific target values and achievement against those targets. Instead, it states that the device was tested against recognized ISO standards and "complied with" them, which implies meeting the requirements of each standard. The predicate device's characteristics are used for comparison to establish substantial equivalence.

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 in the context of an AI/ML device or a clinical study. The performance data presented refers to bench testing of the physical wheelchair and its components. Specific sample sizes for these engineering tests (e.g., how many wheelchairs were tested for static stability) are not detailed, but the testing was done by the manufacturer (Danyang Sunco Machinery Co., Ltd.) in China. This is not a human subject-based test set.

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 as the device is a mechanical wheelchair and no ground truth by human experts interpreting data (as in AI/ML performance evaluation) was established. The "ground truth" for the wheelchair's safety and performance is defined by the technical specifications and test methods within the cited ISO standards.

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

Not applicable. There was no human interpretation or adjudication involved in evaluating the performance of this mechanical device against standard engineering tests.

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 therapeutic device. No MRMC study was conducted.

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

Not applicable. This is a mechanical wheelchair, not an AI algorithm.

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

For the mechanical wheelchair, the "ground truth" or reference for evaluating its performance is based on predefined engineering and safety standards (ISO standards) and the characteristics of a legally marketed predicate device. There is no "ground truth" in the sense of clinical pathology, expert consensus, or outcomes data as would be used for an AI/ML device.

8. The sample size for the training set

Not applicable. This device is a mechanical wheelchair and does not involve AI/ML models that require a training set.

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

Not applicable. This device is a mechanical wheelchair and does not involve AI/ML models that require a training set or ground truth for such a set.

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

The SUNTEC Mechanical Wheelchair, model ST-WL-1000 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, and the upholstery fabric meets the Requirements of Section E, Part I for Upholstery Fabrics of California Technical Bulletin CAL 117: 2000 standard for flame retardance.

The document provided is a 510(k) premarket notification for a mechanical wheelchair, the SUNTEC Mechanical Wheelchair, model ST-WL-1000. For medical devices like this, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrated through performance testing against recognized national or international standards, and a comparison to a legally marketed predicate device.

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

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

The acceptance criteria are generally established by the performance standards (ISO standards in this case), and the device performance is reported implicitly by the statement that the device "completed the performance tests in accordance with ISO 7176 series standards" and "function safely and effectively" and "performs as well as the legally marketed device." The comparison table directly addresses the performance relative to the predicate by noting "Same" or explaining why differences do not affect safety or effectiveness.

Acceptance Criteria (ISO Standards) and Reported Device Performance (as summarized by the manufacturer):

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 describes performance testing against ISO standards for the device itself. These are typically engineering tests performed on a sample of the manufactured device. The document does not specify a "sample size" in terms of subject count or a specific number of devices tested for each standard. It only states that the "subject devices completed the performance tests." There is no mention of data provenance (e.g., country of origin, retrospective/prospective). This type of submission relies on engineering test reports rather than clinical trial data.

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 a submission for a mechanical wheelchair based on performance standards. "Ground truth" in this context would be the objective measurements and outcomes of the engineering tests according to the ISO standards. There are no human "experts" establishing conventional ground truth as one might find in an imaging or diagnostic AI study. The "experts" would be the engineers and technicians performing the standardized tests.

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

Not applicable. This is an engineering performance test, not a subjective evaluation requiring an adjudication method. Test results are objective measurements against defined criteria within the ISO 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 device is a mechanical wheelchair and does not involve AI or human "readers" or multi-reader multi-case studies.

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

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

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

The "ground truth" for this device's performance is established by the objective measurements and pass/fail criteria defined within the referenced ISO performance standards. For example, static stability is measured against a specific angle without tipping, and brake effectiveness is measured by the stopping distance.

8. The sample size for the training set

Not applicable. This document is for a mechanical wheelchair, not an AI/ML algorithm that requires a training set.

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

Not applicable. This document is for a mechanical wheelchair, not an AI/ML algorithm that requires a training set.

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

The Shanghai Phoenix Mechanical Wheelchair 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 resistant to ignition source smouldering cigarette. and match flame equivalent.

The provided document K130848 describes the Shanghai Phoenix Mechanical Wheelchair and its substantial equivalence to a predicate device, as well as the performance tests conducted to meet relevant international standards.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Shanghai Phoenix Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series relevant standards. This means the acceptance criteria are defined by these standards. The device's reported performance is its successful compliance with these standards.

Note: The document states "Shanghai Phoenix Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series relevant standards". This implies that the device successfully passed all tests outlined in these standards, thus demonstrating compliance. Specific numerical results for each test were not provided in this summary.

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

The document does not specify the exact sample size (number of wheelchairs) used for the performance testing.
The testing is described as "Literature for Performance Testing," which typically refers to laboratory testing of physical samples, not clinical data.
Data Provenance: The tests relate to international and European standards (ISO and EN). The manufacturer is based in Shanghai, China, suggesting the testing was likely conducted in accordance with these international standards, potentially in specialized testing facilities in China or elsewhere. It is a prospective evaluation of the manufactured device.

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

For engineering performance standards like those referenced (ISO 7176, EN 12183), "ground truth" is typically established by the standard itself and verified by accredited testing laboratories and their qualified engineers/technicians. These tests are objective measurements (e.g., static stability, brake effectiveness, dimensions, strength, flammability) against predefined criteria, rather than subjective expert consensus on medical images or diagnoses. Therefore, the concept of "experts establishing ground truth" in the clinical sense doesn't directly apply here. The "experts" would be the personnel at the testing lab who execute and interpret the standard tests.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are characteristic of clinical studies involving subjective assessments (e.g., radiologists reviewing images). For objective engineering performance tests against international standards, there is no "adjudication method" in this sense. The test results are either within the acceptable range specified by the standard or they are not. If a deviation occurs, the device fails the test for that criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in tasks like image interpretation, which is not applicable to the performance testing of a mechanical wheelchair.

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

No, a standalone (algorithm-only) performance study was not done. This concept applies to AI algorithms, and this document pertains to a mechanical medical device, not an AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is the objective, quantifiable criteria defined by the referenced international and European engineering standards (ISO 7176 series, EN 12183, EN 1021-1/-2). These standards specify test methods, measurement procedures, and acceptable ranges or thresholds for various performance aspects (e.g., static stability angles, brake force, material ignition resistance, strength under load).

8. The Sample Size for the Training Set

This document describes the performance testing of a physical medical device (mechanical wheelchair). The concept of a "training set" is relevant for machine learning algorithms. Therefore, a training set sample size is not applicable in this context.

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

As mentioned above, the concept of a "training set" is not applicable to the performance testing of this mechanical device. Ground truth for the performance of the wheelchair is established by the engineering standards themselves and their specified test methodologies.

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Profhand pedal wheelchair is manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.

Profhand pedal wheelchair is manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both indoor and outdoor environments, and to transport one (1) person at a time. The Chassis and pedaling mechanism are made form a aluminum alloy. Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design. The seat cushion and back are made from flame retardant Nylon and/or Polyester fabric. The main operation of Profhand pedal wheelchair is as the following description (Note: This main operation can only be done under the instruction and permission of physician, so it is classified as a prescription device): Put a suitable seat cushion on the wheelchair seat. Put your foot into the pedal and attach the foot strap to stabilize foot. When riding use both legs to pedal for forward movement. To stop use the brake mounted in the control lever. For parking or getting on/off the wheelchair lock the brakes. In addition to the main operation as above mentioned, the Profhand pedal wheelchair also provide the handle bars in rear side of the chair to let healthcare person help moving the person who is seated on the wheelchair as the other general mechanical wheelchair.

The provided document is a 510(k) summary for the Profhand Pedal Wheelchair Model HM-10. It describes the device's technical specifications, intended use, and claims substantial equivalence to a predicate device. However, it does not include acceptance criteria or a study that evaluates the device's performance against specific clinical metrics as typically seen for AI/ML-driven devices.

Instead, the document focuses on compliance with established international standards and FDA guidance documents for mechanical wheelchairs. This type of submission relies on demonstrating adherence to safety and performance benchmarks already defined for similar mechanical devices, rather than novel clinical performance metrics.

Therefore, many of the typical AI/ML-related questions cannot be answered from this document. I will answer what is available and clarify what information is not present.

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

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. The testing described refers to compliance with ISO standards for mechanical wheelchairs, which typically involves physical testing of the device itself and its components, rather than a clinical "test set" of patient data as might be relevant for AI/ML devices.

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 this type of mechanical device is compliance with engineering and safety standards, which is determined through laboratory testing and verification against the specific requirements outlined in the ISO standards, not by expert medical review of patient data.

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

This information is not applicable and therefore not provided. Adjudication methods are relevant for subjective interpretations of data (e.g., medical image reads) to establish ground truth. For mechanical device testing against ISO standards, the results are typically objective measurements and observations, not requiring adjudication in the clinical sense.

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. MRMC studies are designed to evaluate the performance of AI/ML systems in a clinical context, often with human readers. The Profhand Pedal Wheelchair is a mechanical device, not an AI/ML system, and therefore such a study would not be relevant.

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 an algorithm.

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

The "ground truth" for this device's safety and effectiveness is established through its conformance to recognized international standards (ISO standards) and FDA guidance documents for mechanical wheelchairs. This involves objective testing against predefined parameters for stability, braking, dimensions, material properties (e.g., flammability, biocompatibility), etc. It is not based on expert consensus, pathology, or outcomes data related to disease diagnosis or patient treatment in a clinical sense.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a mechanical wheelchair and does not involve an AI/ML model 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 there is no AI/ML model or training set, there is no ground truth to establish for such a set.

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The Oceanic is a manual attendant-operated wheelchair intended to provide mobility to people with reduced-mobility problems.

The Oceanic Wheelchair is a wheelchair suitable for use on different terrains and also in water. It can be used on surfaces like sand, snow, gravel, grass and in water. The user must be accompanied at all times, since it can not be driven by the person sat on it. This is a very long life product with the following components: Wheelchair, Foldable armrests, Foldable footrest, Starring/traction bar. The Oceanic is available in large (Oceanic) and small (Oceanic Baby) configurations which vary in length and also in the width and height of the Seat. The Oceanic Baby and Oceanic intended use is the same, but the Oceanic Baby has a maximum weight load of 50kg while the maximum weight load for the Oceanic is 100kg. All parts on our wheelchair are fabricated from aluminium and selected materials suitable for use in an aquatic environment. The chair can be submersed in water without any harmful effects. Users manual provides information on warnings, cautions, maintenance and operation instructions.

The provided text describes a 510(k) premarket notification for a medical device, the Novaf Oceanic Wheelchair. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive clinical studies to prove effectiveness with specific acceptance criteria in the same way a new drug or high-risk medical device might. The "performance testing" mentioned is primarily for safety and mechanical aspects to support this substantial equivalence.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance with metrics like sensitivity/specificity, and training set details) are not applicable to this type of regulatory submission and are not present in the provided document.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document states "Testing has been performed to evaluate the overall stability, dimensions and mechanics of the Oceanic. The testing showed that the Oceanic is safe and effective for its intended use." However, it does not provide a detailed table of specific acceptance criteria (e.g., maximum deflection under load, specific stability angles, etc.) or quantitative results against those criteria. It only offers a high-level statement of successful testing.

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

• Sample Size for Test Set: Not specified. The document only mentions "Testing has been performed" without detailing the number of wheelchairs or components tested.
• Data Provenance: Not specified, but implied to be from internal testing conducted by the manufacturer, Novaf Andalucia 2007, S.L., likely in Spain (country of origin for the sponsor). The testing is retrospective in the context of the 510(k) submission, meaning it was performed before filing the notification.

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

• Not Applicable. This type of device (manual wheelchair) does not typically involve expert review for "ground truth" establishment in the sense of diagnostic accuracy or interpretation. The performance testing would be against engineering standards and specifications.

4. Adjudication method for the test set

• Not Applicable. As there's no expert interpretation or "ground truth" adjudication in the diagnostic sense, no adjudication method would be used. The testing would involve objective measurements and comparisons to predetermined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This device is a manual wheelchair, and its safety and effectiveness are determined by mechanical and functional performance, not diagnostic interpretation.

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 or AI system. Therefore, standalone performance in this context is irrelevant. The "standalone" performance refers to the device itself (the wheelchair) performing its function as intended.

7. The type of ground truth used

• The "ground truth" for this device would be established by engineering specifications, regulatory standards (e.g., ISO standards for wheelchairs if referenced, though not explicitly stated here), and internal design requirements. For example, the "ground truth" for stability would be a specific angle or load threshold it must withstand. For weight capacity, it would be a specific weight it must support without failure. The document implies these standards were met, but doesn't list the exact standards or specifications.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI/ML algorithm. There is no concept of a "training set" for this product.

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

• Not Applicable. As there is no training set.

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The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.

The GEN 2 mechanical wheelchair is a highly adaptable all-purpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.

This is a 510(k) premarket notification for a mechanical wheelchair, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details relevant to AI/ML device performance (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or present in the provided text.

The document discusses the substantial equivalence of the GEN 2 Mechanical Wheelchair to a predicate device based on design, materials, intended use, and non-clinical performance data against international standards for mechanical wheelchairs.

Here's the relevant information that can be extracted:

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

The document doesn't present a table of "acceptance criteria" in the typical sense for a pass/fail study like an AI/ML device. Instead, it compares the technological characteristics of the GEN 2 wheelchair to a predicate device (Ki Mobility Catalyst Wheelchair) to establish substantial equivalence.

The reported device performance for the GEN 2 Mechanical Wheelchair is that it underwent non-clinical testing to international standards, as listed below. The conclusion is that "The non-clinical test results demonstrate the GEN 2 Mechanical Wheelchair does not raise any issues regarding safety and effectiveness" and "supports a determination of substantial equivalence to mechanical wheelchairs previously cleared by FDA."

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 to this type of device submission. The testing performed is non-clinical, focusing on mechanical properties and compliance with safety standards, rather than evaluating performance on a test set of data with human subjects or a dataset similar to AI/ML evaluations. There's no "test set" in the context of data used for algorithm evaluation.

The provenance of the data is that it comes from non-clinical testing against specified ISO standards.

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)

Not applicable. There is no test set with ground truth established by experts as would be the case for an AI/ML diagnostic device. The evaluation is based on engineering and materials testing against international standards for wheelchair safety and performance.

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

Not applicable. No adjudication method is described because there isn't a test set with expert-established ground truth.

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 device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" in this context refers to the international standards for mechanical wheelchairs (e.g., ISO 7176 series and their specified test methods, ASTM, JIS standards). The device's performance is compared against these engineering standards to ensure safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires 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: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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The Mechanical Wheelchair is intended to provide mobility to persons restricted to a sitting position.

Not Found

This document is an FDA 510(k) clearance letter for a Mechanical Wheelchair. It does not contain information about acceptance criteria or a study proving device performance in the context of AI or machine learning. The letter confirms substantial equivalence to a predicate device, which is a regulatory pathway for Class I and II medical devices that typically relies on the device meeting established performance standards rather than requiring extensive clinical trials or AI-specific performance metrics.

Therefore, I cannot provide the requested information from the provided text, as it describes a traditional mechanical medical device and not an AI-enabled one.

Here's why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not available. This is a clearance letter, not a performance report for an AI device.
2. Sample size used for the test set and the data provenance: Not applicable. There's no AI test set mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no AI ground truth establishment described.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 for a mechanical wheelchair, not an AI-assisted device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses regulatory clearance for a physical product (a mechanical wheelchair) and does not involve AI/ML performance evaluation.

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