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The intended use of the Dalton Lift Chair, Model LC-106 is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.

The Dalton Lift Chair, Model LC-106 is intended to provide lift assistance for persons who have difficulty rising from a seated position to a standing position. It uses standard AC power from an electrical outlet. The device is mainly made of a welded steel frame, upholstery fabric and foam. The chair is assembled to welded steel lifting frame mechanism having a 24V DC motor/actuator powered by AC power from an electrical outlet. A hand-held control device engages the actuator to position the chair to recline, sitting, or standing position.

This document is a 510(k) Summary for the Dalton Lift Chair, Model LC-106. It details the device's characteristics and its substantial equivalence to a predicate device, rather than presenting a study to prove the device meets acceptance criteria. No information about acceptance criteria or specific study results is provided beyond non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the device's performance. Instead, it lists the device's technical specifications and compares them to a predicate device to establish substantial equivalence.

The non-clinical testing for the Dalton Lift Chair LC-106 included:

• IEC 60601-1:1988/A1:1991/A2:1995 for basic safety: "All tests were completed successfully."
• IEC 60601-1-2 for Electromagnetic Compatibility: "All tests were completed successfully."
• California Technical Bulletin No. 117: Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling Materials Used in Upholstered Furniture: Tests were conducted. (Implied successful, as it contributes to the conclusion of substantial equivalence).
• Biocompatibility (Upholstery Fabric): Evaluated for Cytotoxicity per ISO 10993-5 and for Skin Irritation and Dermal Sensitization per ISO 10993-10. (Implied successful).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as no clinical test set or data relevant to a diagnostic performance study was conducted. The evaluation was based on non-clinical testing and comparison to a predicate device.

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 information is not applicable as no clinical test set requiring expert-established ground truth was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as no clinical test set requiring adjudication was performed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a mechanical lift chair, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation in the context of an algorithm or AI was not performed. This is a mechanical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" would be the specifications and requirements defined by the relevant standards (e.g., IEC 60601-1, IEC 60601-1-2, California Technical Bulletin No. 117, ISO 10993). The device's performance was compared against these standard requirements.

8. The sample size for the training set

This information is not applicable. There is no mention of a training set as this is a mechanical device, not an AI or algorithm-based system that requires machine learning training.

9. How the ground truth for the training set was established

This information is not applicable as there was no training set.

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The Altimate Medical EasyStand Bantam Medium is intended to assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing up to 200lbs.

The EasyStand Bantam Medium is a standing frame for indoor use that allows users with various degrees of physical disability to be supported in a standing, weight-bearing position. The device is a sitto-stand stander with the option of supine positioning. The optional Shadow Tray supports the user from sitting to standing and can be used as a desk/workstation in the seated and /or standing position. The device offers two options to raise the seat, the standard nanual hydraulic lift or the optional Pow'r Up lift. The Bantam Medium accommodates most individuals within the height range of 48"-66" and up to 200 lbs.

This document is a 510(k) summary for Altimate Medical's EasyStand Bantam Medium, a medical device. The document describes the device, its intended use, and its substantial equivalence to a predicate device. It also outlines the performance standards it meets.

Here's the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

The document does not specify a "test set" in the context of patient data or a clinical study. Instead, it refers to the device being tested against various international performance standards. The testing described is likely engineering and safety testing on the device itself, not a study involving human subjects or data from a specific population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The "ground truth" for the device's performance is established by its compliance with recognized international safety and performance standards for medical electrical equipment, not by expert consensus on clinical data. The experts would be the engineers and testing personnel who performed the evaluations against the standards.

4. Adjudication method for the test set:

This information is not applicable as the "test set" refers to compliance with engineering and safety standards, not a clinical trial requiring adjudication of patient outcomes or imaging data.

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. The device is a physical medical device (standing frame), not an AI diagnostic or assistive technology for human readers.

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 and electrical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the device's acceptance is its compliance with recognized international performance standards (IEC 60601-1, CSA C22.2#60601-1, IEC 60601-1-11, IEC 60601-1-2, BS EN 12182:1999). This would involve engineering measurements, stress tests, electrical safety checks, and other objective evaluations against the quantitative and qualitative requirements of these standards.

8. The sample size for the training set:

This information is not applicable. The device is not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as above.

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The Medical Treatment Chair, T688 Series is intended for use in medical procedures such The Medical Preatinent Chalysis to, and collecting blood from, patients in hospital departments or home use, under the supervision of trained medical staff. The Medical Treatment Chair is also intended for use in day surgery and nursing homes. T688 chair is I readined so that the occupant is accommodated in a seated position with the hips moved designed so that the occupant is against the back rest and the legs outstretched and supported by the seat and leg rests.

T688 chair is also used to position patients for easy access by healthcare professionals. The I voo enair is designed so that the occupant is accommodated in a seated position with the hips enair is decired or that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.

This chair is intended to be used by patients with a weight not exceeding:

• 200kg (T688 series) .

T688 series chair is used to aid medical procedures such as renal dialysis, blood collection and chemotherapy and is called as Medical Treatment Chair.

T688 series is electric-powered treatment chair with the following features:

• Power-operated seat and leg rest and back rest reclines, with options offering one-. touch memorized positions
• Swing Out Side/Arms .
• Adjustable head/neck rest .
• Adjustable height .
• CPR support posts, gas spring assisted back rest and accessories. .
• . Fold-down trays
• Four individually locking castors .
• Heavy duty washable vinyl .
• Removable upholstery .
• The chair will recline to Trendelenburg position .
• Suitable for side transfer of patients .
• No timber included in the frame .
• Battery back-up-24V rechargeable .
• 2 Actuators & 1 Column .
• Compact Design .
• Lighter weight .
• Reduced components ●

The device is classified as:

• 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.

The Fresenius Medical Treatment Chair T688 Series is a medical treatment chair designed for use in medical procedures such as renal dialysis, blood collection, and chemotherapy, under the supervision of trained medical staff. It is also intended for use in day surgery and nursing homes.

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

• Length Tren/CPR: 1800 mm
• Overall Width: 730 mm
• Seat Width: 510 mm
• Seat Height to Floor: 590 mm
• Backrest Length: 800 mm |

2. Sample Size Used for the Test Set and the Data Provenance

The document states that "Representative samples for the device underwent load and repeatability testing to verify functional and performance characteristics." It does not specify the exact sample size for these tests. There is no information provided regarding data provenance (e.g., country of origin of the data, retrospective or prospective) for any of the testing mentioned.

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 medical treatment chair, and its performance is evaluated against engineering standards and functional requirements, not against ground truth established by experts in a diagnostic context.

4. Adjudication Method for the Test Set

Not applicable, as the testing involves engineering and performance standards rather than subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, which is not the case for a medical treatment chair.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The device is a physical medical chair and does not involve an algorithm for standalone performance. Its performance is assessed through physical and electrical testing against established standards.

7. The Type of Ground Truth Used

The ground truth for this device is based on engineering standards, functional specifications, and safety requirements. This includes:

• Specified weight capacity (200 kg).
• Compliance with various ISO, IEC, AS/NZS, BS EN standards for biocompatibility, electrical safety, EMC, flame retardancy, quality management, risk analysis, and component specifications (e.g., castors).
• Internal "self-imposed load and repeatability test requirements" to verify functional and performance characteristics.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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The clinical treatment of persons in wheelchairs presents a significant issue for the clinician. Treatments related to a patient's head often require them to be reclined. The platform allows for reclining the wheelchair giving full support to both patient and clinician. The hazards associated with transfers to other couches or chairs are eliminated. Typical treatments would include: Dental, Maxiliofacial work, Ear, Nose and Throat procedures, Eye treatments and surgery, Podiatry.

The Compact Wheelchair Platform (CWP) is designed to assist in the clinical treatment of wheelchair users by providing a convenient wheelchair accessible platform that can be tilted so that the head is placed in the optimum position of comfort for both staff and patient. It is a direct development of the Mobile Wheelchair Platform (K073565). The complete redesign more than halved the storage area and up-graded the load from a SWL of 594lb to 825lbs. The angle of tilt has been altered to 60deg to provide a recovery position. The Wheelchair platform is supported on two side frames with a high pivot point. The hydraulic cylinders are below the pivot and retract to tilt the platform. This gives a very compact form and with a hinged platform base the whole unit is no more than 24" wide. It can be easily moved through doors for sharing with other opertories. The whole construction is aerospace high strength aluminium alloys or stainless steel giving a high strength weight ratio. The unit is powered at 24v. The main source of power is from a pair of 12v lead acid batteries that can be easily replaced and last for at least 40 full cycles before needing to be recharged. A dc supply is provided to operate the machine from the mains supply if needed. The control is via a PCB with a PIC logic controller. All switching takes place at 5v and makes the controls light and reliable. The logic capability allows continuous monitoring of safety switching and the integration of good safety procedures. A radio handset is normally used to control the platform eliminating any trailing wires. Safety is a major concern and entrapment is eliminated by using sensitive, fail-safe, strip switches at all sensitive points on the mechanism. The radio handset and fixed switches on the machine are supplied to operate the device, duplicating the control function. All control and drive elements are housed safely under a cover. The machine has clean lines and is easily cleaned with wipe over surfaces.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Compact Wheelchair Platform":

The provided document is a 510(k) submission summary for a medical device called the "Compact Wheelchair Platform" (CWP). It primarily focuses on demonstrating substantial equivalence to a previously cleared device, the "Mobile Wheelchair Platform" (K073565). Crucially, the document does not describe a clinical study with a test set, ground truth, or expert involvement as one would typically expect for performance evaluation in the context of diagnostic or AI-driven devices.

Instead, the "acceptance criteria" can be inferred from the technical characteristics and improvements made over the predicate device, and the "study" is more akin to a design and engineering validation against established safety and performance standards for this type of medical equipment.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• None. This document does not describe a clinical study with a "test set" in the context of data analysis or machine learning. The evaluation is for a physical medical device. The "performance" assessment is based on engineering specifications, design improvements, and adherence to safety standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. There is no "ground truth" established by experts for a test set in the way you'd expect for a diagnostic device. The "ground truth" for this device's performance is derived from engineering standards, user feedback (clinical feedback), and the physical testing of the device against its specifications (e.g., load capacity).

4. Adjudication Method for the Test Set

• Not applicable. No test set or expert adjudication process is described.

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

• Not applicable. This device is a mechanical patient positioning platform, not an imaging or diagnostic AI device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. No algorithms are described as operating in a standalone capacity that would require such testing. The device has a PIC logic controller for safety and control, but this is an embedded system, not a standalone AI application.

7. The Type of Ground Truth Used

• The "ground truth" for this device's safety and performance is based on:
  • Engineering Specifications and Standards: "Rated capacity 660lb (BSEN1570:1999)" is an example, indicating adherence to an established standard.
  • Clinical Feedback/User Experience: "By utilising extensive clinical feedback Design Specific has been able to develop a backrest assembly..." indicates user input informed design changes.
  • Physical Testing/Validation: Implicit in meeting load capacities, tilt angles, and safety features like entrapment elimination.
  • Substantial Equivalence: The primary "ground truth" for FDA clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of machine learning. The design improvements were based on "extensive clinical feedback" (qualitative data from users) and engineering principles.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set as defined for AI or statistical modeling, this question does not apply. The evolution of the design, however, was informed by:
  • User feedback: "users expressed a need for a smaller lighter platform that would require a Timuse" and "The increase in body mass of the general population required that the new platform should be able to carry higher loads."
  • Clinical consultation: "By utilising extensive clinical feedback Design Specific has been able to develop a backrest assembly..."

In summary: The provided text is a 510(k) summary for a physical medical device, not a diagnostic tool or AI-driven system. Therefore, the concepts of "acceptance criteria," "test set," "ground truth," and "expert adjudication" are interpreted through an engineering and regulatory lens, rather than a clinical study or AI performance evaluation framework. The primary "study" demonstrated how the new "Compact Wheelchair Platform" is substantially equivalent to a predicate device and incorporates improvements based on user feedback and adherence to relevant safety and performance standards.

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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.

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.

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The Altimate Medical EasyStand Bantam is intended to assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing between 50 - 100 lbs., including pediatrics.

The EasyStand Bantam is a standing frame for indov use that allows users with various degrees of pirysical disability to ob supported in a suitioning, weight-bearing position. The optional Shadow Tray device is a sit-io stands standing and can be used as a desk/workstation in the seated and/or standing position. The device comes in two il (accommodating individuals ranging in height from 28" – 40" (71cm – 102 cm) and so books (23kg) and small (accommodating individuals ranging in height from 20" – 10 – 10 – 10 – 137 cm - 137 cm) and up to 100lbs (23kg).

The provided document is a 510(k) summary for the EasyStand Bantam, an electric lift chair. It primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about acceptance criteria, device performance metrics, or a study design to measure such performance, as would be typical for a clinical or performance study of an AI/ML device.

Therefore, I cannot provide the requested information in the format specified. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance (country, retrospective/prospective).
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or human reader improvement.
6. Standalone algorithm performance.
7. Type of ground truth used (pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document focuses on:

• Device identification: Trade name, common name, classification, manufacturer.
• Intended Use: To assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing between 50 - 100 lbs., including pediatrics.
• Substantial Equivalence: Comparing the EasyStand Bantam to a legally marketed predicate device (Altimate Medical EasyStand Evolv; K062402) based on intended use, construction, and functionality. Key differences noted are user population (pediatric vs. larger persons) and additional features like a gas cylinder for seat elevation and a supine position option.
• Regulatory Status: 510(k) clearance by the FDA (K091242) for marketing the device.
• Performance Standards: States that "Although no performance standards or special controls have been developed to test positioning chairs, Altimate Medical has chosen to test the EasyStand Bantam against the standards as referenced in this submission." (The specific standards referenced are not detailed in the provided pages).

This document serves as regulatory submission for device marketing authorization, not a clinical or performance study with the detailed metrics you've requested for an AI/ML device.

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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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Patients in wheelchairs present problems to clinicians who need to treat them and the patients themselves can be seriously disadvantaged by their situation. This is particularly true of dental treatment. To be treated the dentist would need to bend around the patient in the wheelchair, that cusses back pain and sometimes injury. An alternate approach is to transfer the patient to a conventional chair by slings and hoists or other approaches, all of which hold significant health and safety risks. The wheelchair platform offers a safe environment for both clinician and patient. The wheelchair is moved onto the platform up against a back wall support and the wheelchair and patient are then supported by a backrest and a head support. The platform is reclined, and possibly raised and lowered, to present the patient in the best position for treatment.

The device accommodates wheelchairs in a secure way, to enable them to be tilted backwards. Patient support is by an adjustable backrest with head support using an adjustable head cushion. The primary use is with patients who cannot be easily transferred from their chairs for such procedures as dentistry, Podiatry, Ear, nose and throat, maxio-facial work. Basic Platform shape: Steel fabrication. Drive mechanism: Electrical Linear Drive. Power source: Battery 24v and Power supply delivering 24v. Backrest support: Pivots in and out adjustable by worm and wheel. Headrest: Adjustable using a slotted arm with an adjustable headrest cushion for neck and head support. Motions command input: Tilt only Fixed switches and radio remote control. Foot crush protection: Pressure sensitive mat and guarding. Max. angle of tilt: 45deg. Rated capacity: 594lb (BSEN1570:1999). Proposed uses: Dental and medical applications. Static or mobile: Mobile on air cushion pads or ball castors.

Here's a breakdown of the acceptance criteria and the study information for the Wheelchair Platform, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Wheelchair Platform are primarily derived from the standard BSEN1570:1999. The submission confirms that the device meets these requirements.

Note: The provided text states that testing was carried out under BSEN1570:1999 and that this standard specifies the allowable stresses and types of tests. It then explicitly states the rated capacity of 594lb as per this standard. This implies that the device successfully met all the specified criteria within that standard.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not specified in the provided text. The testing seems to be focused on a single device prototype or production model, as is typical for mechanical device performance testing against a standard. It's not a study involving a "test set" in the sense of a population of patients or data points.
• Data Provenance: Not explicitly stated, however, the standard BSEN1570:1999 is a European standard, suggesting testing might have been done in a location adhering to these standards, possibly the UK given the "Ltd" in "Design Specific Ltd". The submission date is October 21, 2008, indicating retrospective data collection relative to the submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is not a study requiring expert-established ground truth for a test set. The performance is assessed against engineering and safety standards.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a mechanical device, not an AI or imaging diagnostic device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for proving device performance is defined by the engineering and safety standards outlined in BSEN1570:1999. This standard specifies objective, measurable criteria related to stress, load capacity, and operational tests.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning model, so there is no "training set."

9. How Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an algorithm, there's no ground truth established for it.

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To assist persons who have difficulty rising from a seated position to a standing position.

The Winco Models Power Series Lift Chairs are electro mechanical devices designed for use in the home or a health care setting. Their intended function and use is to raise persons from a seated position to a standing position. They are designed for use by elderly or physically challenged individuals who have difficulty rising to a standing position, when seated.

The Winco Series Lift Chairs consist of two models; the model 696 lift chair and the model 905 lift chair. The model 696 chair is the standard version and is designed to accommodate most users. It is smaller and lighter than the model 905 chair, and has a maximum weight capacity of 300 lbs. The model 905 lift chair is designed for bariatric users. It is wider than the standard 696 chair and has a maximum weight capacity of 600 lbs.

The provided text describes a medical device, the Winco Model Power Series Lift Chair, and its 510(k) premarket notification. However, it does not contain the level of detail typically found in reports for AI/ML-driven diagnostic devices, which would include specific acceptance criteria, performance metrics, and detailed study methodologies.

Based on the provided text, the device is a physical medical device (a lift chair), not a diagnostic AI/ML system. Therefore, many of the requested categories (like number of experts, adjudication method, AI assistance, ground truth for training set, etc.) are not applicable to this type of device and are not present in the document.

Here’s an attempt to answer the questions based only on the provided text, highlighting where information is missing or not applicable:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the document. The testing mentioned appears to be for structural and material properties, not a clinical trial with a patient test set.
• Data Provenance: Not applicable in the context of clinical data. The tests refer to compliance with standards (IEC 60601-1, CAL 117).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a physical device, and the "ground truth" relates to engineering and material safety standards, not diagnostic interpretations by medical experts.

4. Adjudication method for the test set

• Not Applicable. As above, this is for a physical device, not an AI/ML diagnostic system. No adjudication of expert opinions is mentioned.

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

• Not Applicable. This is not an AI-assisted diagnostic device. No human reader studies with AI assistance were 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

• The "ground truth" refers to established engineering and safety standards (IEC 60601-1 for electrical safety, CAL 117 for flame retardancy) and the physical specifications/capabilities of the chair (e.g., weight capacity).

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established

• Not Applicable. As above, no training set for an AI/ML system is involved.

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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

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.

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