(25 days)
The Medical Treatment Chairs are intended for use in medical procedures such as the administration of renal dialysis to, and taking bloods from, patients in hospital departments or home use, under the supervision of trained medical staff. The Medical Treatment Chairs are also intended for use in day surgery and nursing homes. The chairs are designed so that the occupant is accommodated in a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.
The chairs are also used to position patients for easy access by healthcare professionals. The chairs are designed so that the occupant is accommodated in a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.
All models are intended to be used by patients with a weight not exceeding:
- 130kg (T100 and T200 series)
- 130kg (T300 and T400 series)
- 200kg (T500, T550, T600 and T650 series)
- 300kg (T500B, T600B)
The range of chairs, used to aid medical procedures such as renal dialysis, blood collection and chemotherapy, are called Medical Treatment Chairs and are made up of models T-100, 200, 300, 400, 550, 500B, 550, 600, 600B, 650:
The manually-operated range of treatment chairs (T100, 200, 300) typically have the following features:
- Manually-operated recliner
- Adjustable head/neck rest
- Upholstered arms
- Four locking braked castors
- Vinyl-covered
- The T100, T200 and T300 models offer optional CPR support posts, gas spring assisted back rest and accessories, whilst other models come standard with these features
- Fold-down trays
- Fold-out arms
The electric-powered range of treatment chairs (T400 through to T600 series) offer the above features in addition to:
- power-operated seat and leg rest and back rest reclines, with some models offering one-touch memorized positions
- battery back-up 24V rechargeable
- height-adjustable swing-out arm rests (except the T400)
The electric-powered chairs, depending on the model, may have different numbers of actuators, i.e:
- T400 2 actuators
- T500 2 actuators
- T500B 2 actuators, reinforced frame
- T550 3 actuators
- T600 3 actuators
- T600B 3 actuators, 2 motors, reinforced frame, extra lift levers
- T650 3 actuators
The device is classified as:
- Class I (FMR)
- Class II (FKS, INO) electric-powered version.
Specific ancillary devices and accessories are not listed here due to the wide variety of procedures in which the chair is used.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance
The document doesn't explicitly list "acceptance criteria" in a typical quantitative format (e.g., "Accuracy > 90%"). Instead, it describes compliance with various standards and self-imposed test requirements for functional and performance characteristics. The "reported device performance" is primarily stated as meeting these standards and requirements.
Table of Acceptance Criteria and Reported Device Performance
| Critical Area/Acceptance Criteria (Implied) | Standard Met/Reported Device Performance |
|---|---|
| Quality System | ISO 13485:2003 |
| Risk Analysis | ISO 14971:2000 |
| Design Control | (Not specified, but generally implied by QS) |
| Flame Retardancy | California 117 sD p2, AS/NZS4088.1:1996, AS 1530.3-1989 |
| Frame Loading | AS 4688.2:2000 (Specifically for stability) |
| Electrical Safety (Whole Chair) | IEC 60601-1 |
| Electrical Safety (Linak actuators) | EN 60601-1-2:2002 (EMC), EMC parts of EN 1970:200, EN 60601-2-38:1997, EN 60601-2-52:2007, IEC 60601-1:1988+A1:91+A2:95 |
| Electrical Safety (Dewert actuators) | EN 60601-1/A2:1995, EN 60601-2-38:1996, EN 60335-1/A2:2006, EN 60601-1-2:2001, EN 1970:2000, EN 60529/A2:2000 |
| Biocompatibility | ISO 10993-1:2003 (Evaluation and testing) |
| Castors and Brakes | EN 12526 - 12533 |
| Labeling | BS EN 1041:2008, BS EN 980:2003 |
| Clinical Investigation | AS ISO 14155-1:2004, AS ISO 14155-2:2004 |
| Self-imposed Load and Repeatability | "Representative samples for the device underwent load and repeatability testing to verify functional and performance characteristics." (Implied successful Verification) |
| Weight Capacity | - T100, T200, T300, T400 series: 130kg |
| - T500, T550, T600, T650 series: 200kg | |
| - T500B, T600B: 300kg | |
| Substantial Equivalence | Found substantially equivalent to the Convertible I-Series Positioning and Transfer Chair in intended use, basic construction, principles of operation, electrical and mechanical characteristics, and general safety and EMC compliance. |
Study Details
The document describes pre-market testing and adherence to various recognized standards rather than a typical "study" in the sense of an AI/software device performance evaluation. The "device" in question is a medical treatment chair, primarily a mechanical and electrical device, not an AI or diagnostic tool.
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: "Representative samples for the device" were used for load and repeatability testing. A specific number is not provided.
- Data Provenance: Not explicitly stated, but the company (Fresenius Medical Care South Asia Pacific Pty Ltd) has its primary contact in Australia, and several cited standards are Australian (AS/NZS, AS). Testing would likely have been conducted in a relevant facility that adheres to these international and local standards, potentially in Australia or a subcontracted testing lab. The testing for substantial equivalence is implied to be prospective verification against defined standards.
2. 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 as the device is a medical chair, not a diagnostic or AI device requiring expert ground truth for output evaluation. Performance is assessed against engineering and safety standards.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Performance is determined by meeting specified technical requirements of the cited standards, not by human consensus or adjudication of results.
4. 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-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (a chair).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the device's performance is against established engineering, electrical, mechanical, safety, flame retardancy, and biocompatibility standards (e.g., ISO, IEC, AS, EN, California standards). These standards define acceptable performance metrics and test methods. The weight capacities are also a form of "ground truth" against which the chairs were tested.
7. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
8. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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.