(39 days)
The Merits Model E Series Lift Chairs are intended to assist elderly and/or physically challenged persons, who have difficulty rising from a seated position to a standing position.
The Merits Pioneer Model E Series Lift Chair operates using standard AC Power from a wall outlet. All models consist basically of an upholstered chair assembly, which is constructed of fabric, and fastened to a lower frame, lifting assembly, which is constructed of welded steel. Additionally, all include one/or two motorized linear actuators which are used to position the chair assembly, and a hand held, push button type pendant control, which is used to engage actuator motion and vary the chair's position.
The provided documentation pertains to a 510(k) premarket notification for the "Merits Model E Series Lift Chair," a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the manner typically seen for complex diagnostic or AI-driven devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is largely not applicable or not provided in this type of regulatory submission.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Safety: Device operates without causing harm. | "The results of the testing confirm that the device meets specifications." |
| Functionality: Assists users in rising from a seated to a standing position. | "Merits Model E Series Lift Chairs are equivalent in functions to the legally marketed predicate device." |
| Technological Equivalence: Uses similar technological characteristics as the predicate. | "The devices both use motorized linear actuator which is used to position the chair assembly, and a hand held, push button type pendant control... There are no major technological differences." |
| Substantial Equivalence: Overall similarity to the predicate device, demonstrating equivalent safety and effectiveness. | "The Merits Model E Series Lift Chairs are substantially equivalent to the currently marketed device, GOLDEN POWER LIFT CHAIR Model PR355M (K880800)." |
Explanation: In a 510(k) submission for a device like a lift chair, the "acceptance criteria" are implicitly tied to demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" primarily refers to the internal testing and comparison against the predicate rather than a clinical study with quantitative metrics.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document references "testing" but does not detail a sample size or a formal "test set" in the context of clinical performance or algorithm evaluation.
- Data Provenance: Not specified. Given the nature of a lift chair, the "testing" would likely involve engineering verification and validation of motors, controls, and structural integrity, rather than data collected from users in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. This type of device does not involve expert-established "ground truth" for performance.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. There is no mention of an adjudication process for a test set, as this is not a diagnostic device requiring interpretational agreement.
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
- MRMC Study: Not applicable. This is not an AI-powered diagnostic device, so an MRMC study is irrelevant.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. There is no algorithm or AI component in this device. "Performance" refers to the mechanical and electrical functionality of the lift chair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the traditional sense. The "ground truth" for a lift chair's performance would be its ability to physically lift and lower as intended, meet safety standards (e.g., weight capacity, stability), and operate reliably according to engineering specifications. This is established through engineering and performance testing.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no AI model or "training set" involved.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. There is no AI model or "training set" involved.
Summary of Device and Approval Context:
The Merits Model E Series Lift Chair is a mechanical and electrical device designed to assist individuals with mobility challenges. Its 510(k) clearance is based on demonstrating substantial equivalence to an existing legally marketed device (GOLDEN POWER LIFT CHAIR Model PR355M), meaning it is as safe and effective. The "Performance Data" section briefly states that "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." This indicates that the company performed internal verification and validation tests to ensure the device performs its intended function safely and reliably, aligning with the predicate device's capabilities, rather than a clinical study with human subjects or an AI algorithm performance study.
§ 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.