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The Altimate Medical EasyStand Bantam is intended to assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing between 50 - 100 lbs., including pediatrics.

The EasyStand Bantam is a standing frame for indov use that allows users with various degrees of pirysical disability to ob supported in a suitioning, weight-bearing position. The optional Shadow Tray device is a sit-io stands standing and can be used as a desk/workstation in the seated and/or standing position. The device comes in two il (accommodating individuals ranging in height from 28" – 40" (71cm – 102 cm) and so books (23kg) and small (accommodating individuals ranging in height from 20" – 10 – 10 – 10 – 137 cm - 137 cm) and up to 100lbs (23kg).

The provided document is a 510(k) summary for the EasyStand Bantam, an electric lift chair. It primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about acceptance criteria, device performance metrics, or a study design to measure such performance, as would be typical for a clinical or performance study of an AI/ML device.

Therefore, I cannot provide the requested information in the format specified. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance (country, retrospective/prospective).
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or human reader improvement.
6. Standalone algorithm performance.
7. Type of ground truth used (pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document focuses on:

• Device identification: Trade name, common name, classification, manufacturer.
• Intended Use: To assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing between 50 - 100 lbs., including pediatrics.
• Substantial Equivalence: Comparing the EasyStand Bantam to a legally marketed predicate device (Altimate Medical EasyStand Evolv; K062402) based on intended use, construction, and functionality. Key differences noted are user population (pediatric vs. larger persons) and additional features like a gas cylinder for seat elevation and a supine position option.
• Regulatory Status: 510(k) clearance by the FDA (K091242) for marketing the device.
• Performance Standards: States that "Although no performance standards or special controls have been developed to test positioning chairs, Altimate Medical has chosen to test the EasyStand Bantam against the standards as referenced in this submission." (The specific standards referenced are not detailed in the provided pages).

This document serves as regulatory submission for device marketing authorization, not a clinical or performance study with the detailed metrics you've requested for an AI/ML device.

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