(243 days)
The Altimate Medical EasyStand Bantam Medium is intended to assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing up to 200lbs.
The EasyStand Bantam Medium is a 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 a sitto-stand stander with the option of supine positioning. The optional Shadow Tray supports the user from sitting to standing and can be used as a desk/workstation in the seated and /or standing position. The device offers two options to raise the seat, the standard nanual hydraulic lift or the optional Pow'r Up lift. The Bantam Medium accommodates most individuals within the height range of 48"-66" and up to 200 lbs.
This document is a 510(k) summary for Altimate Medical's EasyStand Bantam Medium, a medical device. The document describes the device, its intended use, and its substantial equivalence to a predicate device. It also outlines the performance standards it meets.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 (3rd Edition) and CSA C22.2#60601-1 (3rd Edition) for basic safety and performance, including risk management | The EasyStand Bantam Medium meets these standards. |
| IEC 60601-1 (2nd Edition) to address medical electrical equipment general requirements for safety, including mechanical strength testing for claimed weight capacities | The EasyStand Bantam Medium and predicate devices all meet this standard, including mechanical strength testing for the claimed weight capacities. |
| IEC 60601-1-11 to address specific requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | The EasyStand Bantam Medium meets this standard. |
| IEC 60601-1-2 to address Class B emissions and immunity for non-life-supporting equipment | The EasyStand Bantam Medium meets this standard. |
| BS EN 12182:1999 to address safety requirements for medical electrical systems. (Included in this test report, load testing results support EasyStand Bantam Medium substantial equivalency.) | Load testing results supporting substantial equivalency were included in the test report against this standard. |
2. Sample size used for the test set and the data provenance:
The document does not specify a "test set" in the context of patient data or a clinical study. Instead, it refers to the device being tested against various international performance standards. The testing described is likely engineering and safety testing on the device itself, not a study involving human subjects or data from a specific population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The "ground truth" for the device's performance is established by its compliance with recognized international safety and performance standards for medical electrical equipment, not by expert consensus on clinical data. The experts would be the engineers and testing personnel who performed the evaluations against the standards.
4. Adjudication method for the test set:
This information is not applicable as the "test set" refers to compliance with engineering and safety standards, not a clinical trial requiring adjudication of patient outcomes or imaging data.
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 comparative effectiveness study was not done. The device is a physical medical device (standing frame), not an AI diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone (algorithm only) performance study was not done. This device is a mechanical and electrical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the device's acceptance is its compliance with recognized international performance standards (IEC 60601-1, CSA C22.2#60601-1, IEC 60601-1-11, IEC 60601-1-2, BS EN 12182:1999). This would involve engineering measurements, stress tests, electrical safety checks, and other objective evaluations against the quantitative and qualitative requirements of these standards.
8. The sample size for the training set:
This information is not applicable. The device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
§ 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.