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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

The Genemax Power Wheelchair, PW3 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided text describes the Genemax Power Wheelchair, PW3, and its substantial equivalence to a predicate device (TEH LIN Power Wheelchair, TL-320 (K022697)). However, it does not contain acceptance criteria for device performance or a detailed study description that proves the device meets specific performance criteria.

Instead, it focuses on demonstrating substantial equivalence based on shared design characteristics, components, and general safety considerations. The performance testing section only lists compliance with certain standards, but does not provide quantitative acceptance criteria or results from those tests.

Therefore, I cannot fulfill all parts of your request with the provided information. I will, however, extract the relevant information concerning performance testing and the nature of the comparison study.

Here's a breakdown of what can be inferred and what is missing:

Acceptance Criteria and Study Details (Based on provided text)

1. Table of Acceptance Criteria and Reported Device Performance:

• EMC Report ANSI / RESNA WC/Vol.2-1998 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)
• CISPR 11: 1990
• EN61000-3-2: 1995
• IEC61000-3-3: 1995 |
  | Weight Capability (Implicit) | New device (PW3) can bear more weight (264.6 pounds) than predicate (242.5 pounds), a difference of 22.1 pounds. Considered "substantially equivalent" as the new device is superior. |
  | Safety on Inclines (Implicit) | Safety levels are the same when operating on 12-degree inclines. Considered "substantially equivalent." |
  | Braking Time, Distance, and Dynamic Stability (Implicit for Higher Speed) | New device has a higher maximum speed (5 mph) than predicate (2.62 mph). This implies acceptance criteria for braking time, distance, and dynamic stability for the higher speed were met, as it's stated, "The different maximum speeds do not lead any safety considerations and they are substantially equivalent in this aspect." |

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document refers to "Performance Testing" based on standards, which typically involves testing a limited number of devices to ensure compliance. It does not mention a specific "test set" in terms of patient data or clinical samples.
• Data Provenance: The device manufacturer is "Genemax Medical Products Industry Corp." based in Taichung, Taiwan, R.O.C. The performance testing was done in relation to international standards (ANSI, RESNA, CISPR, EN, IEC). The location where these tests were physically performed is not explicitly stated, beyond the manufacturer's location. The study is not a clinical study involving human subjects or patient data, but rather engineering/device performance testing. Thus, it's not "retrospective or prospective" in the sense of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This type of information is typically relevant for studies involving subjective review (e.g., image interpretation by radiologists). The provided text describes engineering performance testing against established standards for a medical device (power wheelchair). The "ground truth" here is compliance with technical specifications and safety standards, not a diagnostic interpretation established by human experts.

4. Adjudication method for the test set:

• Not Applicable. As above, this applies to scenarios requiring expert consensus on subjective data (e.g., medical diagnoses). Here, performance is assessed against objective engineering 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:

• No. This is a power wheelchair, not an AI diagnostic or assistance device. Therefore, no MRMC study with human readers or AI assistance was performed or described.

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

• Yes, in spirit, but not in the context of an "algorithm." The performance testing described (EMC, ANSI/RESNA, CISPR, EN, IEC standards) evaluates the device itself (the power wheelchair) in a "standalone" manner against predefined technical and safety specifications, without human interaction being part of the evaluation method for the device's core performance in these tests. It is not an algorithm's performance being assessed.

7. The type of ground truth used:

• Engineering Standards and Specifications. The "ground truth" for the performance testing is adherence to the technical requirements and safety parameters defined within the listed standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) and the device's own design specifications (e.g., maximum weight capacity, speed, incline capability).

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning study. There is no concept of a "training set" for this type of device and performance testing.

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

• Not Applicable. As above, no training set is relevant here.

Summary of the "Study" described:

The document describes a substantial equivalence comparison study to a predicate device (TEH LIN Power Wheelchair, TL-320 (K022697)). The "study" involves comparing technical specifications and design features and performing general performance testing against established international standards. The primary goal is to demonstrate that despite minor differences (like appearance, dimensions, weight limit, and maximum speed), the new device (Genemax PW3) is as safe and effective as the predicate device. The performance testing focuses on compliance with electrical and general safety standards for powered wheelchairs.

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