(35 days)
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)
| Acceptance Criteria | Reported Device Performance (Compliance) |
|---|---|
| Safety Standards 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.
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 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.
- 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.
- The sample size for the training set: Not applicable. There is no "training set" for this type of physical device.
- 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.
§ 890.3110 Electric positioning chair.
(a)
Identification. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.(b)
Classification. Class II. The electric positioning chair is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable;
(9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and
(10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.