The Permobil powered wheelchair 1280 is front wheel driven, battery powered, motor driven and is controlled by the Penny & Giles compact powered wheelchair controller Pilot +. The joystick is integrated in the controller. The wheelchair is powered by two 12V 73 Ah batteries. Theoretical driving range on the fully charged batteries is 35 km. The wheelchair consists of two basic sub-sections. These are the base with motor controller and the body supporting system. In this submission, only the design changes made to base is included. The base is of welded steel construction and includes the base frame, front drive wheels with drive unit (motor/gear/brakes), batteries and pivoting rear casters. The motor controller is mounted to the left or right armrest, depending on user needs. The motor controller, including the joystick, is housed in a pressure die cast aluminum enclosure.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the Permobil Powered Wheelchair 1280. It concludes that the device is substantially equivalent to predicate devices and does not raise new questions of safety and effectiveness due to minor design changes.

Based on the provided text, the Permobil Powered Wheelchair 1280 is not an AI/ML device and therefore the concept of "acceptance criteria" for AI performance, "study that proves the device meets the acceptance criteria," "sample size," "ground truth," "MRMC study," or "standalone performance" do not apply in the context of this traditional medical device submission.

The document discusses the "substantial equivalence" of the Permobil Powered Wheelchair 1280 to existing predicate devices (Permobil Chairman L/CS 8 (K960951) and G-424 power wheelchair (K983677)). Substantial equivalence is the primary regulatory pathway for many devices, where the new device is compared to a legally marketed predicate device.

Here's an analysis of what is provided, framed in terms of a traditional medical device submission, and how it relates to the questions:

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

Acceptance Criteria (Implied by Substantial Equivalence): The Permobil Powered Wheelchair 1280 must have "substantially the same technological characteristics and the same safety and effectiveness as the predicate device(s)." The "minor design changes declared in this submission do not raise new questions of safety and effectiveness."
Reported Device Performance: The document does not provide a table of performance metrics in the way an AI/ML study would. Instead, it asserts its equivalence based on:
- Intended Use: Identical to predicate device(s) ("to provide indoor and outdoor mobility to persons restricted to a sitting position").
- Energy Source: Identical to predicate device(s).
- Materials: Identical to predicate device(s).
- Key Changes: Frame suspension and use of Penny & Giles Pilot + controller instead of PG8 controller. The document explicitly states these changes do not raise new questions of safety and effectiveness.
- Theoretical Driving Range: 35 km on fully charged batteries (this is a performance spec, but not tied to a specific "acceptance limit" or comparison in a table within this document).

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

Not Applicable. This is not an AI/ML study. Performance is asserted through comparison to predicate devices, and the inherent safety/effectiveness of its components (e.g., standard wheelchair frame, motor, battery, controller). There is no "test set" in the sense of a dataset for an algorithm.

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

Not Applicable. No "ground truth" establishment in the context of AI/ML evaluation. Regulatory review is performed by FDA staff (e.g., Division of General and Restorative Devices).

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

Not Applicable. No "test set" requiring adjudication.

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/ML device, so no MRMC study, human readers, or AI assistance is involved.

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

Not Applicable. This is a hardware medical device (a powered wheelchair), not an algorithm.

7. The type of ground truth used:

Not Applicable. No "ground truth" in the AI/ML sense. The "truth" for this submission revolved around demonstrating that the device's design, materials, and function align with established safe and effective powered wheelchairs (the predicate devices).

8. The sample size for the training set:

Not Applicable. No training set for an algorithm.

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

Not Applicable. No training set for an algorithm.

In summary: The provided document is a 510(k) submission for a non-AI powered wheelchair. The "acceptance criteria" are implicitly defined by the FDA's substantial equivalence requirements, which focus on comparing the device's intended use, technological characteristics, and safety/effectiveness to previously cleared predicate devices, rather than a quantifiable performance study against a ground truth dataset as would be seen for an AI/ML device.

Summary

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OCT 8 1999

1252

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K991658

PERMOBIL POWERED WHEELCHAIR 1280

Submitter	Permobil ABBox 120S-861 23 TimråSweden
PhoneFax	+46 60 59 59 00+46 60 57 52 50
Contact personE-mail address	Bengt Perssonbengt.persson@permobil.se
Date Prepared	May 10 1999
Device name	Powered wheelchair 1280
Classification name	Powered wheelchair
Identification of predicate devices	Permobil Chairman L/CS 8 (K960951)G-424 power wheelchair (K983677)
Intended use	The intended use of Permobil powered wheelchair 1280 is to provide indoor andoutdoor mobility to persons restricted to a sitting position.
Description of the device	The Permobil powered wheelchair 1280 is front wheel driven, battery powered,motor driven and is controlled by the Penny & Giles compact powered wheelchaircontroller Pilot +. The joystick is integrated in the controller.The wheelchair is powered by two 12V 73 Ah batteries.Theoretical driving range on the fully charged batteries is 35 km.The wheelchair consists of two basic sub-sections. These are the base with motorcontroller and the body supporting system. In this submission, only the designchanges made to base is included. The base is of welded steel construction andincludes the base frame, front drive wheels with drive unit (motor/gear/brakes),batteries and pivoting rear casters. The motor controller is mounted to the left orright armrest, depending on user needs.The motor controller, including the joystick, is housed in a pressure die castaluminum enclosure.
Substantial equivalenceThe Permobil powered wheelchair 1280 is substantial equivalent with respect to,intended use, energy source and materials, because those are identical to thepredicate device(s).

The key changes are frame suspension and use of the Pilot + controller from Penny & Giles instead of the PG8 controller from Penny & Giles.

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

PERMOBIL POWERED WHEELCHAIR 1280

Jos
1699/1658

Safety and effectiveness

The Permobil powered wheelchair 1280 has in substantials the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the minor design changes declared in this submission do not raise new questions of safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 1999

Mr. Bengt Persson Quality Manager Permobil A.B. Engelbrekts Vag 101 S-191 62 Sollentuna, Sweden

Re: K991658

Trade Name: Permobil Powered Wheelchair 1280 Regulatory Class: II Product Code: ITI Dated: July 7, 1999 Received: July 12, 1999

Dear Mr. Persson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Bengt Persson

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Mark N Milhusan

Celia M. Witten, Ph.D., M.D. Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PERMOBIL POWERED WHEELCHAIR 1280

Indication for Use

The intended use is to provide indoor and outdoor mobility to persons restricted to a sitting position.

510(k) number

Not assigned at the writing of this submission

Device name

Not decided at writing of this submission Working name, also use in this submission, 1280

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (per 21 CFR 801.109) □

Over the counter use of

Mark M. Mellikerson

(Division Sign Off)

(Division Sign-Off) Division of Ggeneral Restorative Devices

510(k) number

(k) number K99/65Y

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).