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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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