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The intended use of this device (growable, manual, rigid wheelchair) is the same as the predicate device, the Zippie® (growable, manual, rigid wheelchair) manufactured by Sunrise Medical Inc. The intended use for the growable, manual, rigid wheelchair is to provide mobility to physically impaired children. The manual wheelchair is intended for ongoing daily use and is designed so that the wheelchair can be adjusted as the user grows.

This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions:

• Amputee;

• Arthritis:

• Arthrogriposis;

• Cerebral Palsy;

• geriatric conditions;

• head injury or trauma;

• hemiplegic;

• Multiple Sclerosis;

• Muscular Dystrophy;

• paraplegic;

• Polio:

• quadraplegic;

• Spina Bifida;

• Stoke/CVA;

• tetraplegic; and

• other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis

The TiLite YG and YGS model wheelchairs are rigid manual titanium wheelchairs.

The provided text describes the TiLite YG and YGS growable, manual, rigid wheelchairs. It details their intended use, target population, and comparison to a predicate device. The information supplied focuses on the physical and functional characteristics of the wheelchair and its equivalence to a predicate device based on meeting specific standards.

However, the input document does not contain information about a study involving software or AI performance, acceptance criteria in terms of metrics like sensitivity, specificity, or AUC, or details about ground truth establishment, expert adjudication, or reader studies in the context of AI/software.

Given the nature of the device (a mechanical wheelchair) and the provided 510(k) summary, the "acceptance criteria" and "study" refer to engineering and safety standards, not an AI or software performance study as implied by the user's request.

Therefore, I can only provide information based on the document's content, which describes compliance with ISO standards for the physical product.

Here’s the information based on the provided text, interpreted for a mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the device "Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7, and 8." This acts as both the acceptance criteria and the reported performance.

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

The document does not specify a "test set" in the context of data or images. For a mechanical device, testing usually involves prototypes or production units. The document does not provide details on the sample size of wheelchairs tested or data provenance (country of origin, retrospective/prospective).

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

This information is not applicable to the provided document, which describes a physical medical device (a wheelchair) and its compliance with engineering standards. The phrase "ground truth" typically refers to verified diagnoses or labels in AI/software performance studies. The testing mentioned (ISO 7176) involves standardized mechanical and safety tests.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies or expert labeling for AI ground truth, not for the testing of a mechanical wheelchair against ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which doesn't fit the context of this wheelchair submission.

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

This information is not applicable. The device is a physical, mechanical wheelchair, not an algorithm.

7. The type of Ground Truth Used

This information is not applicable. The "ground truth" for the wheelchair is its physical properties and performance against established engineering and safety standards (ISO 7176), not expert consensus, pathology, or outcomes data in a diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable to the provided document. There is no mention of a "training set" as this is for a physical device, not an AI model.

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

This information is not applicable.

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Wheelchair mobility, either self-propelled or propelled by an attendant, for the physically impaired.

The wheelchair is a standard lightweight manual folding chair that provides mobility based on an individual user's needs and capabilities. Since it has the same intended use as typical wheelchairs, its features are also comparable. A sling seat and backrest are affixed to a sturdy frame that is supported by two large rear wheels and two forward swivel caster wheels. The two side frames are connected by a horizontal cross brace, rather than a vertical cross brace, that can assume a folded configuration. The wheelchair accommodates removable armrests, detachable footrests, rear anti-tippers, push handles, and wheel locks.

The ActivX Wheelchair is a standard lightweight manual folding chair. The manufacturer, Adorno/Rogers Technology, Inc. (A/RT), claims that its device is substantially equivalent to the Quickie2 (K890050) wheelchair. The primary difference is the ActivX's horizontal cross brace, which allows for a different folding mechanism.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly mentions "subject evaluations" but does not specify the sample size of these subjects. It also doesn't indicate the country of origin for this data or whether it was retrospective or prospective.

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

The document does not provide details on the number or qualifications of experts used for the "subject evaluations."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the subject evaluations.

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

No MRMC comparative effectiveness study was mentioned. The study focused on the ActivX's performance against a standard, not on comparing human readers' improvement with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone study was performed. The "Design Validation/Verification" included the ANSI/RESNA two-drum test and subject evaluations, which assessed the device's performance independently.

7. Type of Ground Truth Used

The ground truth appears to be a combination of:

• Performance Standards: The ANSI/RESNA two-drum test provides an objective, standardized measure of mechanical durability.
• User Feedback/Subjective Evaluation: "Subject evaluations" indicate that users tested the device and their feedback was part of the assessment.

8. Sample Size for the Training Set

The document does not mention any training set or related sample size. This is a medical device, not an AI/ML product, so a training set in the typical AI sense would not apply.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set, the establishment of ground truth for such a set is not applicable.

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