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The Bowhead ERA Wheelchairs are manually operated wheelchairs intended to be used as a means of mobility for individuals restricted to a sitting position.

The Bowhead ERA Wheelchairs are composite based mechanical, manually operated, wheelchairs intended to be used as a means of mobility for adults restricted to a sitting position. Using the push ring on the rear wheels, users can self-propel themselves forward or backwards. The chairs are designed for riding over various indoor and outdoor surfaces. The Bowhead ERA Wheelchairs include four (4) mechanical wheelchair models with each model containing slightly different design features. Each wheelchair is provided assembled with a sling backrest, seat, seat post, brakes, frame, rear wheels, and casters. The overall length, width and height, backrest angle, COG, wheelbase, and seat width and height are adjustable ensuring comfort for the patient.

The provided text is a 510(k) summary for the Bowhead ERA Wheelchairs. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, the information you've requested regarding acceptance criteria, a study proving the device meets them, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment is not available in this document.

The document details a comparison of technological characteristics between the Bowhead ERA Wheelchairs and two predicate devices (APEX Manual Wheelchair and Panthera X) and lists non-clinical tests performed to support substantial equivalence. These non-clinical tests are against established standards for wheelchairs, not against a specific set of acceptance criteria derived from a clinical study for this particular device.

Here's a breakdown of what is available in the document related to performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria for the device's performance in the sense of clinical accuracy or diagnostic capabilities. Instead, it lists the non-clinical tests performed and concludes that the device is "as safe and effective as the predicate devices" based on these tests.

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

• Sample Size: Not applicable. The "tests" mentioned are non-clinical engineering and performance tests on the device itself, not clinical trials with human subjects.
• Data Provenance: Not applicable. The data comes from physical testing of the device, not from human data.

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

• Not applicable, as this is related to clinical evaluation and ground truth for diagnostic accuracy, which is not the subject of this 510(k) summary. The "tests" are against engineering standards.

4. Adjudication Method for the Test Set:

• Not applicable for the same reasons as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. MRMC studies are typically for medical imaging or diagnostic devices where human interpretation is involved. This device is a mechanical wheelchair.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device does not involve algorithms or AI.

7. The Type of Ground Truth Used:

• Not applicable in the context of clinical ground truth. The "ground truth" for the non-clinical tests is adherence to the specified RESNA WC-1:2019 standards and flammability requirements.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI or machine learning model being trained for this device.

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

• Not applicable.

In summary, the provided document is for a mechanical wheelchair, which falls under a different regulatory pathway (510(k) for substantial equivalence to a predicate device) than, for example, an AI/ML-driven diagnostic tool. Therefore, the types of clinical and performance studies you're asking about are not relevant to this specific device submission. The "study" proving the device meets criteria is a series of non-clinical, engineering-based performance tests against recognized standards.

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