(32 days)
The Convertible® I-1000 I-Series Positioning and Transfer Chair is an electric positioning chair with motorized positioning control that can be adjusted to various positions. The device is used to alter postural positions and to provide a means of transferring a patient horizontally from a height adjustable bed or trolley, to the chair and vice versa. The chair can then be transformed from a supine position into the sitting position without ever lifting the patient.
This device may be used on a wide range of patients, including adults and children up to 1000 pounds.
The Convertible® Positioning and Transfer Chair construction is made of steel tubular components, on to which is fitted foam filled upholstery. The mechanism allows the Convertible® Positioning and Transfor Chair to transform from the horizontal supine position into a chair, which can then be tilted. This is accomplished through the hand-held controller, which in turn operates two DC linear actuators. The first DC actuator allows the Chair and patient profile to change from a sitting position to a horizontal or supine position suitable for transferring. The second DC linear actuator allows the I-1000 to be independently inclined to the rear (Tilt-in-Space). A hand-held push button controller is used to engage actuator motion and vary the I-1000's position. The electric system is composed of a 24-volt rechargeable battery, an external battery charger, and a control unit. Recharging of the battery is accomplished via the external battery charger.
The Convertible® Positioning & Transfer Chair is ideal for moving those patients who are unable to move themselves. The Convertible® Positioning and Transfer Chair have been specifically designed to provide a means of transferring a patient horizontally from a height adjustable bed or trolley, to the chair and vice versa. The patient will always be supported either on the bed and/or the chair and is never suspended. To achieve this, The Barton® Positioning and Transfer System (PTS®) must be used.
The provided text is a 510(k) Summary for a medical device called the "Convertible® I-1000 Positioning and Transfer Chair." This summary focuses on demonstrating substantial equivalence to predicate devices and adherence to general safety standards, rather than defining specific performance acceptance criteria for a diagnostic or AI-based device.
Therefore, many of the requested elements for acceptance criteria and a study proving device performance (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth) are not applicable or not present in this type of submission.
The document describes performance in terms of mechanical and electrical safety and materials biocompatibility.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Mechanical/Structural | Self-imposed load and repeatability test requirements. (No specific numerical values provided in the summary, e.g., maximum load, number of cycles) | Representative sample underwent load and repeatability testing to verify functional and performance characteristics. (Passed, details not specified) |
| Biocompatibility | Evaluation for primary skin irritation in accordance with ISO 10993: Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization. | Under the conditions of the study, no erythema and no edema were observed. The response of the test article was categorized as negligible. |
| Electrical Safety | Applicable requirements of IEC 60601-1 General Safety (IEC 60601-1:1998) | The Convertible® I-1000 I-Series Positioning and Transfer Chair met the applicable requirements of IEC 60601-1. |
| Electromagnetic Compatibility | Applicable requirements of IEC 60601-1-2 EMC (IEC 60601-1-2:2001) | The Convertible® I-1000 I-Series Positioning and Transfer Chair met the applicable requirements of IEC 60601-1-2. |
| Wheel/Castor Robustness | EN 12531-12:1999 Castors and wheels. Hospital bed castors. – Test condition 12: Test of castors for hospital beds (The document states "relevant portions of applicable guidance and standards," implying compliance with this standard for castors). | The device conforms to relevant portions of EN 12531-12:1999. (Passed, details not specified) |
| Adhesive Strength | JIS Z0237:2000 Adhesive Strength Measurement Conditions (The document states "relevant portions of applicable guidance and standards," implying compliance with this standard if adhesives are used in a critical way). | The device conforms to relevant portions of JIS Z0237:2000. (Passed, details not specified) |
| Intended Use / Patient Capacity | Capable of supporting adults and children up to 1000 pounds. | The device is described as being used on a wide range of patients, including adults and children up to 1000 pounds, indicating it meets this capacity. (Implied by description and intended use, not a specific test result). |
2. Sample size used for the test set and the data provenance:
- Sample Size: "Representative sample for the device" was used for load and repeatability testing. No specific number is provided.
- Data Provenance: The tests appear to have been conducted by Barton Medical Corporation or its contracted lab (Intertek Testing Services NA, Inc.) as part of the submission process, likely in the US (where the submitter is based) or Japan (where the manufacturer is located). This is a prospective engineering/device testing approach, not a retrospective analysis of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a mechanical positioning and transfer chair, not a diagnostic device or AI system requiring expert-established ground truth for its functional performance. The "ground truth" for its performance is determined by adherence to engineering standards and safety tests.
4. Adjudication method for the test set:
- Not applicable. See point 3. Testing involves objective measurements against engineering 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. This is not a diagnostic device or an AI-assisted system. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used:
- Engineering Standards and Objective Measurements: The "ground truth" for the device's performance is established by its compliance with specified international and national engineering safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993-10, EN 12531-12, JIS T9201, JIS Z0237) and internal load/repeatability requirements. Biocompatibility was assessed via laboratory testing (skin irritation evaluation).
8. The sample size for the training set:
- Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.