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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

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.

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