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The intended use of the X8 power wheelchair is to provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair.

The Extreme 4x4- X8 is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a four-wheel drive format wheelchair as its basic configuration with direct drive motors on all four wheels. The wheelchair frame is a non-folding type. The frame of the unit is of welded steel construction. The wheelchair consists of the following basic components: frame w/four motors, joystick, seat, armrests, and footrests.

The provided text is a 510(k) summary for a power wheelchair (Extreme 4x4-X8). This document primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison table and general declarations, rather than presenting a detailed study with acceptance criteria and performance data in the typical sense of a clinical or performance study for an AI/software medical device.

Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance) are not applicable to this type of submission. The device is a physical power wheelchair, not an AI/software device.

However, I can extract the closest information available from the text regarding "acceptance criteria" (interpreted as performance specifications for the device) and "device performance" (as reported in the comparison to the predicate).

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical power wheelchair, "acceptance criteria" are implied by the performance characteristics of the predicate device (K000796, Extreme 4x4-X4) which the new device (Extreme 4x4-X8) aims to meet or exceed. The "reported device performance" refers to the specifications of the Extreme 4x4-X8.

Study Proving Device Meets Acceptance Criteria:

The document describes the submission as a "510(k) Premarket Notification" for the Extreme 4x4-X8 power wheelchair. The "study" proving the device meets the acceptance criteria is implicitly the comparison to the legally marketed predicate device (Extreme 4x4-X4, K000796), as presented in the "Device Comparison Table" and the "Substantial Equivalence" section. The claim is that the X8 has the "same intended function and use as the X4" with "minor modifications" that improve performance (e.g., articulated frame, higher speed/torque motors, latest electronic software/hardware). The FDA's letter states they "determined the device is substantially equivalent...to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" in the context of a 510(k) pathway for this type of device.

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

• Not applicable. This submission is for a physical medical device (power wheelchair), and the provided document does not detail a clinical "test set" or data provenance in the way one would for an AI/software device. The comparison is based on engineering specifications and design features.

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 "ground truth" derived from expert consensus mentioned for a test set in this document.

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

• Not applicable. There is no adjudication method mentioned.

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/software device, and no MRMC study was performed or is relevant.

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

• Not applicable. This is not an AI/software device.

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

• Not applicable. The "ground truth" equivalent in this context is the safety and effectiveness profile of the predicate device, established through its prior marketing clearance and compliance with performance standards typical for power wheelchairs. The new device demonstrates substantial equivalency to this established baseline.

8. The sample size for the training set

• Not applicable. This is not an AI/software device, and there is no concept of a "training set" in the provided documentation.

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

• Not applicable. (See point 8).

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The indended use of the Frontier Power wheelchair is to provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair

The Frontier Power Wheelchair is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a mid wheel drive format wheelchair as it's basic configuration with direct drive motors and four swivel castors. The wheelchair frame is of a non-folding type with a mid mounted drive wheels on individual, front pivoting extension arms ending in front mounted swivel castors. The rear of the main frame ends with a lateral pivoting beam arm with swivel castors mounted on each side. This frame design allows for all 6 wheels to contact the ground over uneven terrain.

The frame consists of a combination of 2" diameter round steel tube. 1 ¼" diameter round steel tube and 1 ¼" square tube. The wheelchair consists of the following basic components: frame with articulated drive wheels and casters, seat, armrests, and footrests.

The provided document, K030783, describes a 510(k) premarket notification for the "Frontier Power Wheelchair." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for an AI/ML powered medical device. Therefore, much of the requested information (like sample sizes for test/training sets, expert qualifications, and MRMC studies) is not applicable to this type of submission.

However, I can extract information related to the performance testing conducted and how it relates to general acceptance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable as the document describes physical performance testing of a wheelchair, not an AI/ML algorithm requiring a test set of data.

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

This information is not applicable as the document describes physical performance testing of a wheelchair, not an AI/ML algorithm requiring expert-established ground truth. The "ground truth" here would be the physical measurements and observations during the standardized tests.

4. Adjudication Method for the Test Set

This information is not applicable. The performance testing was conducted according to established international and national standards (ISO/CD 7176-21 and ANSI/RESNA Vol.2 Section 21 Amendments). These standards define specific test procedures and criteria, eliminating the need for an adjudication method in the context of expert review.

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 human reader performance with and without AI assistance, which is not applicable to a power wheelchair.

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

No, a standalone algorithm performance study was not done. This device is a power wheelchair, a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing was established by objective measurements and observations according to the detailed methodologies outlined in the referenced international and national standards: ISO/CD 7176-21 and ANSI/RESNA Vol.2 Section 21 Amendments for powered wheelchairs and motorized scooters.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of a physical power wheelchair being tested for performance against established standards.

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

This information is not applicable for the reasons stated in point 8.

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THE INTENDED USE OF THE KARMA 800 SERIES MANUAL WHEELCHAIR IS TO PROVIDE MOBILITY TO PERSONS LIMITED TO A SITTING POSITION.

The Karma 800 Series Manual Wheelchair is a user propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons limited to a sitting position.

The product is designed to be a lightweight, everyday wheelchair for both indoor use. It is a folding, or non-rigid type of wheelchair. The product consist primarily of an aluminum allov frame with cross braces, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning.

The frame is constructed of round, aluminum alloy tubing that is welded. The seat-to-floor heights are adjustable via dual rear axle positions. The slung fabric seat and back meets the requirements of California 117 specifications for flame retardancy. Swing back armrest and swing away footrest are standard features.

Here's an analysis of the provided documents regarding the Karma 800 Series Manual Wheelchair, focusing on the requested information:

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for a manual wheelchair, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria.

Therefore, for most of your questions, the answer will be "Not applicable" or "No information provided" based on the given text.

Here's the breakdown of the information that is available or explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The 510(k) summary explicitly states "Performance Data: NA" (Not Applicable). This is common for Class I medical devices like manual wheelchairs, where substantial equivalence to a predicate device is often demonstrated through technological equivalence and adherence to general controls, rather than extensive new performance testing against specific quantitative criteria.

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

• Sample Size for Test Set: No information provided.
• Data Provenance (country of origin, retrospective/prospective): No information provided.

Explanation: Since no performance study is described, there is no test set or associated data provenance mentioned.

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

• Number of Experts: No information provided.
• Qualifications of Experts: No information provided.

Explanation: This is relevant for studies involving human interpretation or subjective assessment, which is not described here.

4. Adjudication Method for the Test Set

• Adjudication Method: No information provided.

Explanation: As no study or ground truth establishment process is detailed, no adjudication method is mentioned.

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

• Was an MRMC study done? No.
• Effect size of human readers with AI vs. without AI assistance: Not applicable (no AI involved).

Explanation: This device is a manual wheelchair, a mechanical device. It does not involve AI, and thus no MRMC study or AI-assisted performance evaluation would be applicable.

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

• Was a standalone performance study done? No.

Explanation: This question pertains to AI/algorithmic performance, which is not relevant for a manual wheelchair. The "Performance Data: NA" indicates no specific performance study was conducted.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable.

Explanation: Ground truth is typically established in studies where an algorithm or human interpretation is being evaluated against a known standard (e.g., pathology for a cancer diagnosis AI). For a manual wheelchair, the "ground truth" of its function is its ability to provide mobility, which is generally established through design specifications, manufacturing quality control, and adherence to established standards rather than a clinical study with a "ground truth" diagnosis.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable.

Explanation: This device does not involve a machine learning model, so there is no "training set."

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

• Method for Establishing Ground Truth: Not applicable.

Explanation: As there is no training set, this question is not relevant.

Summary of what the documents do provide:

• Intended Use: To provide mobility to persons limited to a sitting position.
• Technological Description: User-propelled mechanical wheelchair, lightweight, folding, aluminum alloy frame, cross braces, large rear wheels with hand rims, front pivoting casters, adjustable seat-to-floor heights, flame-retardant fabric seat/back, swing-back armrest, swing-away footrest.
• Predicate Device: Karma Manual Folding Wheelchair (K950195).
• Substantial Equivalence: Based on similar intended function, use, and basic mechanical components (aluminum alloy folding frame, wheels, casters).
• Regulatory Class: I
• Product Code: IOR
• Manufacturer: Karma Medical Products, Co., LTD.
• Submitter/Correspondent: Vestil Manufacturing Corporation
• Date of FDA Review: June 14, 2002.
• FDA Decision: Found substantially equivalent to the predicate device.

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The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.

The Discovery power wheelchair is a battery powered, motorized mobility vehicle. The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.

The Discovery is designed to be durable, dependable, sporty and aesthetically appealing while being economically priced.

Here's an analysis of the provided information regarding the Karma Discovery Series Power Wheelchair, framed by your requested categories:

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 the sample size of devices used for testing. The data provenance is also not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. The standards (ISO/CD 7176-21 and ANSI/RESNA Vol.2 Section 21 Amendments) are primarily engineering and performance standards, not typically relying on expert interpretation for "ground truth" in the way a medical diagnostic device would.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of performance testing against engineering standards, an adjudication method in the sense of reconciling divergent expert opinions is unlikely to have been relevant. The tests likely have objective pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or assistive devices where human interpretation or interaction is a critical component influencing effectiveness, and the document describes a power wheelchair, a mechanical mobility device.

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

Yes, the performance testing described effectively represents "standalone" performance in the context of this device. The tests were performed on the power wheelchair itself to ensure it met specific engineering and safety standards, without necessarily involving a human user in a "human-in-the-loop" performance evaluation (beyond what's necessary to operate the device for testing purposes). The focus is on the device's inherent mechanical and electrical capabilities.

7. The Type of Ground Truth Used

The ground truth used was compliance with established engineering and safety standards. Specifically, the device's performance was compared against the requirements laid out in:

• ISO/CD 7176-21
• ANSI/RESNA Vol.2 Section 21 Amendments

These standards define objective performance criteria for power wheelchairs.

8. The Sample Size for the Training Set

This information is not provided in the document. The concept of a "training set" is typically associated with machine learning or artificial intelligence algorithms, which are not relevant to the described testing of a power wheelchair against engineering standards.

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

This information is not applicable as there is no "training set" in the context of the performance testing described.

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