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The Able-X is indicated for use by stroke patients undergoing upper limb rehabilitation to facilitate: :

• Stroke rehabilitation by muscle re-education
• Maintaining or increasing range of motion

The Able-X is an exercise system that uses virtual reality to promote therapeutic bilateral movement exercises through use of a wireless hand held game controller and computer games. The Able-X is comprised of a lightweight polymer handlebar with a wireless game controller mounted at one end and a fixed hand vertical hand grip at the other end of the bar. The wireless controller communicates via a USB receiver dongle to a computer installed with therapeutic exercise games. Game play of the therapeutic exercises is controlled through the game controller and displayed in real-time on the computer screen. The Able-X therapeutic exercise games are provide on a CD or can be downloaded directly through the internet. The Able-X does not include a separate console and is intended to be operated directly through a user supplied computer that meets minimum processing and operating system requirements.

The provided text states, "Testing confirms that the Able-X can be used according to its intended use and in an equivalent manner to the predicate devices." However, it does not provide specific acceptance criteria or detailed study results with quantitative performance data. The device is cleared based on substantial equivalence to predicate devices, rather than meeting specific performance metrics from a dedicated study.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the Able-X device itself. The basis for clearance is "substantial equivalence" to predicate devices.
• Reported Device Performance: The text generally states: "Testing confirms that the Able-X can be used according to its intended use and in an equivalent manner to the predicate devices." No specific metrics (e.g., accuracy, sensitivity, range of motion improvement percentage) are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified.

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 as no specific test set requiring expert ground truth is described.

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

• Not applicable as no specific test set requiring adjudication is described.

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, an MRMC study is not mentioned. This device is not an AI-assisted diagnostic tool for human readers.

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

• This device is an exercise system; the concept of "standalone performance" as typically applied to algorithms is not directly relevant here. Its performance is inherent in its function as an exercise aid.

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

• Not applicable, as no specific ground truth for performance metrics is described. The clearance is based on substantial equivalence, implying that its functional characteristics were deemed sufficiently similar to existing devices.

8. The sample size for the training set

• Not applicable. This device is an exercise hardware/software system, not a machine learning algorithm that requires a training set in the typical sense.

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

• Not applicable for the same reason as above.

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To assist persons who have difficulty rising from a seated position to a standing position.

The EasyStand Evolv is a modular standing frame for indoor use that allows users with various degrees of physical disability to be supported in a standing, weight-bearing position. The device is modular and is configured around a centralized seat. It incorporates pivot points that allow a user to rise from a fully seated to a fully standing position. Pivot action is such that shear the user, seat and seat back is minimized. Device is modular in that multiple uses of the device can be accommodated depending on the overall configuration of the device. Current modules allow for passive standing (Basic), workstation use at an elevated or seated position (Shadow Support Tray) and standing with leg exercise (Glider). Elevation action is provided by one of two means. The standard device utilizes a user controlled hydraulic pump. The optional electrical version uses a low voltage motor-driven linear actuator that is powered by two 12-Volt batteries and actuated by a hand held control pendant. On the electrical version, the patient or a care provider activates the hand held control pendant to change the position of the seat. The electric version also provides an emergency release. Recharge of batteries is accomplished by connection of an external battery charger to the control pendant. The EasyStand Evolv is designed for indoor use and will accommodate individuals ranging in height from 5' to 6'2" (152cm - 188 cm) and up to 280lbs (127kg)

The provided text describes a 510(k) summary for the EasyStand Evolv, an electric positioning chair. It details the device's functionality, intended use, and its substantial equivalence to predicate devices, in addition to performance standards it was tested against. However, the document does not contain information about a study proving the device meets specific acceptance criteria in the way typically associated with AI/ML medical devices (e.g., performance metrics based on sensitivity, specificity, accuracy, or comparative effectiveness studies with human readers).

Instead, the "acceptance criteria" here refer to compliance with established safety and electrical standards for medical devices and demonstrating substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent or not applicable in this context:

Acceptance Criteria and Device Performance (Based on Regulatory Compliance)

• BS EN 12182:1999 Part 1
• IEC/EN 60601-1: 1998; A1:1991; A2:1995 Part 1
• UL 60601-1:2003 First Edition
• CAN/CSA 22.2 No. 601.1-M90 | The manufacturer "has chosen to test the EasyStand Evolv against these standards." The FDA's 510(k) clearance implies successful adherence to these standards for safety. |
  | Substantial Equivalence to Predicate Devices:
• Altimate Medical StandEX (K885343)
• Invacare Lift Chair (K002171) | The FDA determined the device is "substantially equivalent" to the predicate devices for its intended use, construction, and functionality, particularly regarding the power lift feature and supporting a person in a standing position. Key differences (e.g., battery vs. AC power, seat material, exercise functionality) were acknowledged but did not preclude substantial equivalence. |
  | Intended Use: To assist persons who have difficulty rising from a seated position to a standing position. | Functionality description supports this intended use, allowing users to rise from seated to standing with minimal shear. |
  | Weight Capacity: 280 lbs. (127kg) | Device is designed to accommodate individuals up to 280 lbs. |
  | Height Accommodation: 5' to 6'2" (152cm - 188 cm) | Device is designed to accommodate individuals within this height range. |

Study Details (Information Not Provided for AI/ML-style studies)

The provided text describes a regulatory submission for a physical medical device (an electric positioning chair), not an AI/ML algorithm or software as a medical device. Therefore, many of the requested details about statistical studies (sample size for test/training, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable or not present in this type of document.

1. Sample size used for the test set and the data provenance: This information is not provided. The "testing" referred to is against safety and electrical standards, not performance against a diagnostic or predictive ground truth using a clinical test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of "ground truth" establishment in a clinical evaluation sense for this device.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 is not an AI/ML device affecting human reader performance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device with direct user interaction.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic/predictive performance. The "ground truth" for this device would be its ability to physically perform its described functions safely and effectively (e.g., lift a person of a certain weight, meet electrical safety standards), which is assessed through engineering and compliance testing rather than clinical data comparison to a true diagnosis.
7. The sample size for the training set: Not applicable. There is no "training set" for this type of physical device.
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary focuses on demonstrating the EasyStand Evolv's safety and effectiveness through compliance with recognized standards and substantial equivalence to existing predicate devices. It is not an AI/ML device, and thus, typical performance study metrics and methodologies for AI are not found in this document.

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