(183 days)
The Intended Use of the Pride Mobility T3 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
The Pride Mobility T3 Lift Chair is an upholstered chair having welded steel frame construction. The chair upholstery (foam and fabric) are compliant to Cal 117 and BS5852 Flammability requirements. The upholstered chair is assembled to a weldedsteel lifting frame mechanism, and a Hand Control Switch Device engages motor / actuators to position the chair to recline, sitting, or standing positions. The system is a low voltage DC motor system that reduces the standard household alternating current of 110V AC / 240V AC to direct current (24 / 39V DC). The electrical components include the external transformer with battery backup, two motor / actuators, and the Hand Control.
The provided text describes a 510(k) submission for the Pride Mobility T3 Lift Chair. This is a medical device that assists individuals with mobility challenges in transitioning from a seated to a standing position.
Here's an analysis of the provided information, specifically addressing the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
For the Pride Mobility T3 Lift Chair, the "acceptance criteria" are based on its compliance with specific safety and flammability standards, and its substantial equivalence to a predicate device. The device's performance is demonstrated by passing tests related to these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance Status) |
|---|---|
| Flammability Testing: | |
| CAL 117 Sections A, D, & E | Compliant |
| BS5852 | Compliant |
| Electromagnetic Compatibility: | |
| EN 61000-6-3 (Emissions) | Compliant |
| EN 61000-6-1 (Immunity) | Compliant |
| Medical Electrical Equipment Safety: | |
| EN60601-1 / A2: 1995 | Compliant |
| Mechanical Integrity/Durability: | |
| Fatigue Testing - Cycle Tests | Passed |
| Fatigue Testing - Impact Tests | Passed |
| Fatigue Testing - Downward Force Tests | Passed |
| Substantial Equivalence: | |
| Comparison to Pride Mobility C5 (K070950) | Deemed Substantially Equivalent (same intended use, similar technological characteristics, differences do not raise new safety/effectiveness questions) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a "test set" in the context of clinical data. The testing performed was non-clinical testing of the device itself (flammability, electrical safety, mechanical fatigue). Therefore, "data provenance" in terms of subject data is not applicable. The tests were likely conducted in a controlled laboratory environment.
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)
This is not applicable to this device. The "ground truth" for the non-clinical tests (flammability, electrical, mechanical) is typically the standard itself (e.g., "does the material ignite within X seconds under Y conditions?"). Expert consensus in the medical or diagnostic sense is not relevant for these types of engineering and safety tests. The reports from the testing labs would serve as the attestations to compliance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as there was no clinical test set requiring adjudication of findings. The tests were objective assessments against established engineering and safety standards.
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. This type of study is relevant for diagnostic devices (e.g., AI in radiology), not for a mechanical lift chair. The device's function is to directly provide lift assistance, not to assist humans in making a diagnostic interpretation.
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 chair, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was the objective pass/fail criteria defined by the respective safety and performance standards. For example, for flammability, the ground truth is whether the material meets the specified burn rates or self-extinguishing properties outlined in CAL 117 or BS5852. For fatigue testing, the ground truth is whether the components withstand the prescribed number of cycles or impact forces without failure. For substantial equivalence, the "ground truth" is whether the technical characteristics and intended use align sufficiently with the predicate device.
8. The sample size for the training set
This is not applicable as there is no "training set" in the context of an algorithm or AI model for this mechanical device.
9. How the ground truth for the training set was established
This 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.