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The XFGW30-107 and XFGW25-203 Powered Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. This product is suitable for disabled people with mobility difficulties and elderly people.

The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The XFGW30-107 and XFGW25-203 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.

The provided text is a 510(k) summary for a Powered Wheelchair (K212854). It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence. However, this document does not describe the specific type of study, data, or adjudication methods typically used to prove that an AI/algorithm-based medical device meets acceptance criteria.

The document discusses the regulatory clearance for a physical medical device (a powered wheelchair), not a software or AI-driven diagnostic/therapeutic tool. Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, MRMC studies, training/test sets, and adjudication methods are not applicable to this document.

The "acceptance criteria" discussed in this document relate to the physical and functional performance of the wheelchair as measured against established ISO standards and comparison to a legally marketed predicate device.

To answer your request based on the provided document, I will reinterpret "acceptance criteria" and "study" in the context of a powered wheelchair's regulatory submission.

Reinterpretation for a Powered Wheelchair:

• Acceptance Criteria: These are the performance and safety requirements that the powered wheelchair must meet, often defined by international standards (e.g., ISO 7176 series) and demonstrated through non-clinical testing.
• Study Proving Acceptance: This refers to the non-clinical testing conducted to show compliance with the standards and substantial equivalence to the predicate device.

Here's the information extracted and reinterpreted where appropriate based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to the listed international standards (ISO 7176 series, IEC standards, EN 12184, ISO 10993 series). The reported device performance is presented in various sections, particularly in the "Performance Comparison" table (Table 2).

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

• Sample Size: The document does not specify a "sample size" in the context of a test set for an algorithm, as this is a physical device. For non-clinical performance and safety testing, typically a certain number of units of the device would be tested to demonstrate compliance with standards. The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications..." but doesn't quantify the number of devices or test repetitions.
• Data Provenance: Not applicable in the sense of patient data for AI. The "data" here comes from a physical product's performance and safety testing.
  • Country of Origin: The manufacturer is Zhejiang Qianxi Vehicle Co., Ltd. (China). Testing would presumably be conducted by the manufacturer or accredited labs.
  • Retrospective or Prospective: Not applicable in the context of an AI study. This is product-specific testing.

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. "Ground truth" in this context is established by objective measurements and standardized test procedures defined in the ISO and IEC standards, not by human experts interpreting data.

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

• Not applicable. This is for product performance testing against standards, not for human interpretation of data for an AI algorithm.

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 powered wheelchair, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for the device's performance is established by the specifications and test methods outlined in objective, internationally recognized standards (e.g., ISO 7176 series for wheelchair performance, ISO 10993 for biocompatibility). The measurements obtained from testing the physical device against these standards serve as the "truth."

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" for the device itself in this submission.

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

• Not applicable. As above, there is no "training set" for an AI algorithm.

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