Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair

Device Description

Panthera mechanical wheelchairs are manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both indoor and outdoor environments, and to transport one (1) person at a time These wheelchairs are made available by Panthera Production AB in five (5) different top-level models, with each model designed for a specific end-user application The five different models of chairs are the S2, U2, Bambino, Micro, and BT. There are no basic differences in the general construction of each model wheelchair frame, or the materials and components used to make them The Chassis are made form chrome-molly steel, while their Pushrims and Footrests are made from a titanium alloy Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design The seat cushion and back are made from flame retardant polyurethane coated polyester fabric, over a foam core The primary differences in the models of wheelchairs are in their dimensions, gross weights, weight carrying capacities, adjustability features, wheels, accessories and hardware options

AI/ML Overview

The provided text describes a 510(k) summary for Panthera Mechanical Wheelchairs. However, it does not include information about acceptance criteria, detailed study designs, sample sizes, expert ground truth establishment, or comparative effectiveness studies of the kind requested in the prompt. The document focuses on demonstrating substantial equivalence to predicate devices based on regulatory standards.

Therefore, most of the information requested cannot be extracted from the given text.

Here is what can be inferred or explicitly stated from the provided document:

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

Acceptance Criteria: Not explicitly stated as pass/fail metrics in the document. The general acceptance criterion is demonstrating substantial equivalence to predicate devices (Invacare Top End Terminator Titanium wheelchair and Invacare Top End Terminator SS wheelchair) concerning safety and effectiveness.
Reported Device Performance: "Panthera mechanical wheelchairs passed all required consensus standards testing for conformance to the FDA's Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles." No specific performance metrics (e.g., durability, maneuverability test scores) are provided. The document also states the wheelchairs "have been designed, manufactured and tested for conformance to the applicable ISO and EN standards as referenced in this submission."

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

Sample Size: Not specified. The document refers to "testing for conformance to the applicable ISO and EN standards" but does not detail the number of units tested or the nature of the test subjects (if any human subjects were involved, which is unlikely for a mechanical wheelchair's primary performance testing).
Data Provenance: Not specified.

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)

Not applicable. Ground truth as typically defined in AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant for the type of device and testing described (mechanical wheelchair performance against standards).

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

Not applicable. This concept is for diagnostic accuracy studies, not for mechanical device performance testing against regulatory 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 type of study is for diagnostic or AI-assisted medical imaging devices, not for mechanical wheelchairs.

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

Not applicable. This is not an AI device.

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

For a mechanical wheelchair, "ground truth" would generally relate to objective measurements of physical performance (e.g., weight capacity, stability, maneuverability, durability) against defined engineering standards (ISO, EN, FDA guidance). The document confirms testing against these standards.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. As above, there is no training set for this mechanical device.

In summary, the provided document is a regulatory submission for a mechanical wheelchair, focusing on demonstrating substantial equivalence to existing predicate devices by conforming to established safety and performance standards. It does not contain the detailed clinical study information often found for diagnostic devices or AI-powered tools.

Summary

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KOr3231

SECTION 5 - 510(k) SUMMARY

く

1 1

Submission Correspondent:	JAN 2 6 2009Emergo Group, Inc
Address:	1705 S Capital of Texas HwySuite 500Austin, TX 78746
Phone	(512) 327-9997
Fax:	(512) 327-9998
Contact	Mr Stuart Goldman
Submission Sponsor:	Panthera Production ABGunnebogatan 26163 53 SpångaSwedenTel 46-8-761 50 40Fax 46-8-621 08 10E-Mail panthera@panthera sewww panthera se/index-eng html
Date Prepared:	September 23, 2008
Trade Name(s):	Panthera Mechanical WheelchairsModels S2, U2, Bambino, Micro and BT
Common/Usual Name:	Mechanical Wheelchair
Classification Name:	Wheelchair, Mechanical
Classification Number:	890 3850
Classification Panel:	Physical Medicine Devices
CDRH Product Code:	IOR
Regulatory Class:	I

Section 5 1 - Device Description

Panthera mechanical wheelchairs are manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both

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ındoor and outdoor environments, and to transport one (1) person at a tıme These wheelchairs are made available by Panthera Production AB in five (5) different top-level models, with each model designed for a specific end-user application The five different models of chairs are the

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� U2
Bambıno .
. Micro
0 BT

There are no basic differences in the general construction of each model wheelchair frame, or the materials and components used to make them The Chassis are made form chrome-molly steel, while their Pushrims and Footrests are made from a titanıum alloy Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design The seat cushion and back are made from flame retardant polyurethane coated polyester fabric, over a foam core The primary differences in the models of wheelchairs are in their dimensions, gross weights, weight carrying capacities, adjustability features, wheels, accessories and hardware options

Section 5 2 - Intended Use

Panthera mechanical wheelchairs are manually operated muitifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheeichair

Section 5 3 - Predicate Devices

5 3 1 - Invacare Top End Terminator Titanıum wheelchair (ref K012167) 5 3 2 - Invacare Top End Terminator SS wheelchair (ref K990157)

Section 5 4 - Safety and Effectiveness

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics But, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device

As such, it has been shown in this 510(k) submission, that the differences between the Panthera mechanical wheelcharrs and the predicate devices, the Invacare Top End Terminator Titanıum wheelchair (ref K012167) and the

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Invacare Top End Terminator SS wheelchair (ref K990157) (K051387), do not raise any questions regarding their safety and effectiveness

Panthera mechanical wheelchairs as designed and manufactured are as safe and effective as the predicate devices and therefore are determined to be substantially equivalent to the referenced predicate devices

Section 5 5 - Performance Data

Panthera mechanical wheelchairs have been designed, manufactured and tested for conformance to the applicable ISO and EN standards as referenced in this submission In addition, Panthera mechanical wheelchairs passed all required consensus standards testing for conformance to the FDA's Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Mechanical and Powered Wheelchars, and Motorized Three-Wheeled Vehicles

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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2009

Panthera Production AB % Emergo Group, Inc Mr Stuart R Goldman 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746

Re K083231

Trade Name Panthera Mechanical Wheelchairs Models (S2, U2, Bambino, Micro and BT) Regulation Number 21 CFR 890 3850 Regulation Name Mechanical wheelchair Regulatory Class I Product Code IOR Dated September 30, 2008 Received November 5, 2008

Dear Mr Goldman

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 indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 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. Drug. 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, Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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), good manufacturing practice requirements as set 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

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Page 2 - Mr Stuart R Goldman

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours,

Mark N Millerson

Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known)· ________________________________________

Device Name

Panthera Mechanical Wheelchairs

Models (S2, U2, Bambino, Micro and BT)

Indications for Use

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off) Division of General. Restorative, and Neurological ver

510(k) Number

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).