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The HandiNor HandiVipp is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Handivipp is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.

The HandiNor HandiVipp is indicated for individuals with postural challenges e.g. Individuals with Scoliosis, Kyphosis, Cerebral Palsy, Muscular Dystrophy, Multiple Sclerosis, CVA, Spinal Chord injury, Spina Bifida, ALS and similar Neuromuscular and Musculoskeletal pathologies.

The HandiVipp comfort wheelchair, "HandiVipp", is a manually operated, self propelled or attendant propelled mechanical wheelchair. The HandiVipp 's intended use is to provide mobility to persons who may require specialized postural support and tilting features to assist in feeding and pressure relief. It is designed to meet the mobility and positioning needs of individuals with postural challenges e.g. Individuals with Scoliosis, Kyphosis. Cerebral Palsy. Muscular Dystrophy, Multiple Sclerosis and the like.

The HandiVipp frame is constructed from both 22 mm and 18 mm outside diameter (OD) round, mechanical, steel tubing. The side frames are of welded construction and are secured to the remaining frame members using screws and bolts. This device is a rigid wheelchair that incorporates a solid seating surface. The back frame can be folded by releasing a bolt. The seating plate (plain seat) has different hooks and different height levels on the hooks (short (standard), long and plain). This type of seat makes the chair easily adaptable to the various types of wheelchair cushions and seating systems.

Here's the analysis of the provided 510(k) summary for the HandiNor HandiVipp manual wheelchair, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a mechanical wheelchair. Medical devices like wheelchairs are typically cleared based on demonstrating substantial equivalence to a predicate device, often through engineering performance testing against recognized standards, rather than clinical trials or AI-specific performance metrics (like sensitivity, specificity, or reader studies). Therefore, many of the requested AI-centric points (like multi-reader multi-case studies, ground truth establishment for training data, etc.) are not applicable to this type of device and submission.

Acceptance Criteria and Device Performance for HandiNor HandiVipp Wheelchair

The HandiNor HandiVipp wheelchair demonstrated compliance with recognized international standards for wheelchairs.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on the Standards:

• ISO 7176-1: "Wheelchairs – Part 1: Determination of static stability" – Assesses the wheelchair's stability against tipping.
• ISO 7176-3: "Wheelchairs – Part 3: Determination of effectiveness of brakes" – Evaluates the braking system's ability to hold the wheelchair.
• ISO 7176-5: "Wheelchairs – Part 5: Determination of dimensions, mass and manoeuvring space" – Specifies methods for measuring various dimensions, mass, and the space required for maneuvering.
• ISO 7176-7: "Wheelchairs – Part 7: Measurement of seating and wheel dimensions" – Focuses on measuring specific dimensions related to seating and wheels.
• ISO 7176-8: "Wheelchairs – Part 8: Requirements and test methods for static, impact and fatigue strengths" – Assesses the structural integrity, durability, and resistance to impact and fatigue.

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. For mechanical device testing against ISO standards, usually, a defined number of production units or prototypes are subjected to the tests. The document doesn't specify this number.
• Data Provenance: The testing was conducted to prove compliance with international ISO standards. The country of origin for the testing itself is not stated, but the submitter (HandiNor as) is from Norway. This is engineering performance data, not patient data, so "retrospective or prospective" is not applicable in the clinical sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: For this mechanical device, "ground truth" in the clinical AI sense (e.g., expert consensus on medical images) is not relevant. The "ground truth" or standard for comparison is the performance specified by the ISO standards and the predicate device. Compliance with these standards is typically assessed by engineers or testing agencies.

4. Adjudication Method for the Test Set

• Not Applicable: As there are no human-interpreted "test cases" requiring adjudication in the AI sense, this is not relevant. Device performance is determined by passing objective engineering tests.

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

• No: This is a mechanical wheelchair, not an AI or imaging device. Therefore, no MRMC study was performed or is relevant.

6. Standalone (Algorithm Only) Performance Study

• No: This is a mechanical wheelchair. "Algorithm only" performance is not applicable. The device's performance is its physical function and durability in accordance with the specified standards.

7. Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance: The "ground truth" or benchmark for this submission is established by the requirements outlined in the ISO 7176 series of standards (parts 1, 3, 5, 7, and 8) and the performance characteristics of the predicate device (Sunrise Medical Quickie TSR, K952641). The device is deemed safe and effective if it meets these established engineering and safety benchmarks, and is substantially equivalent to the predicate.

8. Sample Size for the Training Set

• Not Applicable: This is a mechanical device, not a machine learning model. There is no concept of a "training set."

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

• Not Applicable: As there is no training set, this question is not relevant.

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The intended use of the Model Action AT II Manual Wheelchair is to provide mobility to persons limited to a sitting position.
To provide mobility to persons limited to a sitting postion.

The Invacare Corporation Model Action AT II is a manually operated, self propelled, manual, mechanical wheelchair. It's intended function and use is to provide mobility to persons who may be restricted to a sitting position. This product may also be used as an attendant propelled patient transport device in a health care environment such as a hospital, nursing home or extended care facility.
The product consists basically of the wheelchair frame, larger rear wheels with handrims for propelling the chair, and smaller front pivoting casters for steering and turning.
The wheelchair frame is constructed from both 1/4" and 1" outside diameter (OD) round, mechanical, steel tubing. The side frames are of welded construction and are secured to the remaining frame members using screws and bolts. This device is a rigid, "non folding" type wheel chair that incorporates a solid seating surface. This type of seat makes the chair easily adaptable to the various types of wheelchair cushions and seating systems currently available in the market.
The Action AT II also includes a "Tilt in Space" feature which allows the seat and back of the wheelchair to be tilted. This feature is used for those patients who require a tilt feature for stability, comfort or head control. It also serves as an attendant aid in those situations where a patient need to be tilted to be fed, or attended to in some fashion. The attendant version of the chair also is available with a stroller type push handle for ease of attendant pushing.
The "Tilt in Space" feature is manually operated and is activated by two release levers located at the rear of the wheelchair. Adjusting the tilt is achieved by squeezing the two release lever handles inward simultaneously. When the levers are squeezed, flexible cables attached to each release lever diseneage gear rack segments from independent actuator rods which are notched to match the teeth of the gear segments. Once the desired tilt angle has been obtained, the handles are released and the chair will remain at the angle chosen. The chair has a tilt angle range of 55 degrees.

The provided text is a 510(k) summary for the Invacare Model Action AT II Manual Wheelchair. It focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards rather than clinical study results involving human readers and AI. Therefore, much of the requested information regarding AI performance, human expert involvement, and specific clinical study designs is not available in this document.

However, I can extract the information related to acceptance criteria and the study that proves the device meets those criteria based on the provided text.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document refers to the device meeting performance requirements and test methods of established standards (RESNA and ISO). It does not describe a clinical test set in the traditional sense of patient data. Instead, it indicates that the device was subjected to engineering and materials testing as outlined by these standards. Therefore:

• Sample Size: Not applicable in the context of patient data. The "sample" would refer to the physical wheelchair unit(s) subjected to the engineering tests. The specific number of units tested is not stated.
• Data Provenance: Not applicable in the context of patient data. The "tests" are engineering performance tests, not clinical data from patients.

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

Not applicable. The ground truth for performance is established by the specifications and test methodologies defined in the RESNA and ISO standards, which are engineering and material science standards, not medical expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. This concept applies to human expert review of clinical data, not engineering performance testing against established 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 a manual wheelchair, not an AI-powered diagnostic or assistive device where human reader performance would be a factor.

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

Not applicable. This is a manual wheelchair, and there is no algorithm or AI component involved.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is established by the engineering and performance requirements specified in the RESNA and ISO standards. These standards define the acceptable limits for static, impact, and fatigue strengths, as well as general wheelchair functionality.

8. The Sample Size for the Training Set:

Not applicable. This document describes a medical device (manual wheelchair) which is evaluated against engineering performance standards. There is no AI or machine learning component, and thus, no training set for an algorithm.

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

Not applicable, as there is no training set for an algorithm.

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