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.

Device Description

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.

AI/ML Overview

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

Characteristic / Acceptance Criteria (Derived)	Reported Device Performance (Compact Wheelchair Platform)
Structural Material: Improved over steel fabrication	Aluminium and Stainless steel (Aerospace high strength)
Drive Mechanism: Improved over electrical linear	Hydraulic operation (allows compact form)
Power Source: Maintain 24V battery/mains	Battery 24v and Power supply delivering 24v (40 full cycles before recharge)
Backrest Support: Adjustable height over fixed height	Pivots in and out, adjustable by worm and wheel. Adjustable height backrest pad
Headrest: Maintain adjustable support	Adjustable using a slotted arm with an adjustable headrest cushion for neck and head support
Wheelchair Type Compatibility: All types	All types including battery driven wheelchairs and specially moulded chairs
Command Input: Maintain remote and fixed switches	Fixed switches on the mechanism cover and remote radio transmitter handset
Foot Crush Protection: Maintain safety features	Pressure sensitive strip switches (fail-safe at all sensitive points)
Max. Angle of Tilt: Increased over 45 degrees	60 degrees (provides recovery position; clinicians can still opt for smaller angles)
Rated Capacity (SWL): Increased over 594lb	660lb (BSEN1570:1999) - Note: The description mentions an upgrade to 825lbs but the table states 660lb.
Storage Area: Reduced from predicate	More than halved the storage area (vs. Mobile Wheelchair Platform)
Lightness: Lighter than predicate	Lighter platform (implied by "smaller lighter platform" and aluminium/stainless steel construction)
Maneuverability: Easily moved through doors	No more than 24" wide; easily moved through doors for sharing with other opertories
Safety - Entrapment: Eliminated	Eliminated by using sensitive, fail-safe, strip switches at all sensitive points on the mechanism.
Control Reliability: Light and reliable controls	All switching at 5v via PCB with PIC logic controller; continuous monitoring of safety switching.
Power Endurance: >40 cycles without recharge	Last for at least 40 full cycles before needing to be recharged
Optimal Clinician Operating Position	Optimal height at 45 degrees tilt (800mm); clinical stool can optimize seating position if desired for smaller angles.

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.

Summary

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design ↓ specific K10/723 DEC 2 3 2010

Summary 510(k) Submission

Compact Wheelchair Platform

Device name and contacts

Device Name

'Compact Wheelchair Platform'

Contact

Mr. Richard Fletcher Design Specific Ltd Unit 10 Caburn Enterprise Park The Broyle Ringmer East Sussex BN8 SNP

Trade Name Common Name Classification Code Compact Wheelchair Platform Wheelchair Reclining Platform 890.3110 Class II

Date prepared

21.4.10

R. Fletcher 17.10.07

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Compact Wheelchair Platform Trade Name Wheelchair Reclining Platform Common Name Dental Chair and Accessories (CFR 890.3110 Class II) Classification Name Mobile wheelchair Platform Equivalence

Equivalence

Design Specific Ltd K073565

Image /page/1/Picture/3 description: The image contains two separate pictures. The picture on the left shows a chair and a board. The picture on the right shows a person sitting in a chair.

Description

The 'Mobile wheelchair Platform' received good reviews but users expressed a need for a smaller lighter platform that would require a expressed a nood for a timuse. The increase in body mass of the general population required that the new platform should be able to carry higher loads. The complete redesign more than halved the storage area and up-graded the load from a SWL of 594lb to Storage area and up Erdece to 825lbs. The angle of tilt has been altered to 60deg to provide a recovery position.

The clinician operating position is optimal. After tilting to 45 The Childclain operating postciation is only 800mm, quite low enough degrees the pation i near not include opinion indicates that this head for normal seated working. Onlyarable with that desired for optimal

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work, however a large number of clinicians prefer a smaller angle of tilt. A clinical stool with a pump-up rise and fall motion can be used to optimise the seating position if desired

By utilising extensive clinical feedback Design Specific has been able to develop a backrest assembly that has vertical adjustment to accommodate a wide range of patient statures in comfort. The previous Mobile platform had a fixed height backrest.

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.

The wheelchair Platform is to treat patients that cannot reasonably Intended use be removed from their chairs and transported to another device. The concerns would include health and safety of the clinical staff and the patients, medical conditions of the patient and the special nature of some wheelchairs. Clinical environments, particularly dental opertories, would be high in the order of need others would be Maxio facial, ear nose and throat, eye treatments.

Design

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Technical Characteristics

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Characteristic	Design SpecificWheelchair Platform	Compact WheelchairPlatform
Basic Platform Shape	Steel Fabrication	Aluminium and Stainlesssteel
Drive mechanism	Electrical Linear Drive	Hydraulic operation
Power source	Battery 24v and Powersupply delivering 24v	Battery 24v and Powersupply delivering 24v
Backrest support	Pivots in and outadjustable by worm andwheel. Fixed heightbackrest pad	Pivots in and outadjustable by worm andwheel. Adjustable heightbackrest pad
Headrest	Adjustable using aslotted arm with anadjustable headrestcushion for neck andhead support.	Adjustable using aslotted arm with anadjustable headrestcushion for neck andhead support
Wheelchair type	All types includingbattery drivenwheelchairs and speciallymoulded chairs	All types includingbattery drivenwheelchairs and speciallymoulded chairs
Command input	Fixed switches on themechanism cover andremote radio transmitterhandset.	Fixed switches on themechanism cover andremote radio transmitterhandset.
Foot crush protection	Pressure sensitive matand guarding	Pressure sensitive stripswitches
Max. angle of tilt	45deg	60deg
Rated capacity	594lb (BSEN1570:1999)	660lb (BSEN1570:1999)

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Design Specific Ltd. % Mr. Richard Fletcher Unit 10 Caburn Enterprise Park The Broyle Ringmer East Sussex United Kingdom BN8 5NP

DEC 2 3 200

Re: K101723

Trade/Device Name: Compact Reclining Wheelchair Platform Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: October 18, 2010 Received: November 3, 2010

Dear Mr. Fletcher:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the iddictions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr 10 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract libility warranties. We remind you; however, that device labeling must be truthful and not miseading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Richard Fletcher

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

A.S. R.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use

510(k) Number: K101723

DEC 2 3 2010

Compact Reclining Wheelchair Platform Device Name:

Indications for use:

The clinical treatment of persons in wheelchairs presents a significant issue for The cannon freathigh of personedures related to a patient's head often require them confident and patients anke. I receining the wheelchair giving full support to both to be rechnict. It planetin for for working environment for 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 .

Over-The-Counter Use X, AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS) LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division of Surgical, Orthopedic, a storative Devices

5.0(k) Number K101723

Regulation Number and Section

§ 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.