The Martin Chair Model C4S1 is indicated for providing mobility to persons limited to a sitting position. It is also specifically indicated to transfer a patient to and from the Martin Examination Table.

The Martin Examination Table is indicated for use during diagnostic examinations or surgical procedures to support and position a patient.

Device Description

The Martin Chair Model C4S1 mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The wheelchair is intended to be manually propelled by a person seated in the wheelchair or by an attendant or clinician. The device is made from composites of steel, plastics and fabrics. The wheelchair is for use by adult persons.

The wheelchair can be secured to a compatible, electrically elevated examination table which allows for the seat of the wheelchair to become part of the examination table. This removes the need for the patient to be lifted during transfer from the wheelchair to the examination table. The wheelchair is latched to the examination table and the side frame and wheels are removed for the examination. The sides and wheels are replaced prior to lowering the examination table allowing the wheelchair to be used according to its intended use.

The Martin Examination Table is a 510(k) exempt device, 21 CFR 878.4960, product code LGX. It is an accessory to the Martin Chair. It is a device intended as a powered examination table to provide positioning and support to patients during general examinations and procedures. It is intended for medical purposes as an electrically operated table with movable components that can be adjusted to various positions, the same intended use as other currently marketed powered tables. The Martin Examination Table is a standard powered examination table that includes standard components and features of other currently marketed powered examination tables including side rails for additional safety. The Martin Examination Table includes latches under the seat cushion that are compatible with the fixed metal receivers of the Martin Chair Model C4S1,

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Koso506 Martin Chair C4S1:

Important Note: The provided document is a 510(k) Summary for a mechanical wheelchair, which is a relatively low-risk Class I device. As such, the depth of performance testing and the types of studies typically required for more complex or higher-risk devices (like those involving AI algorithms, for instance) are not present here. The questions you've asked are more geared towards AI/software as a medical device (SaMD) clearances. I will answer them to the best of my ability based only on the provided text, and will explicitly state if information is not available.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Wheelchair Performance (Martin Chair C4S1)
Meets applicable FDA recognized ANSI/RESNA consensus standards for mechanical wheelchairs.	"The Martin Chair Model C4S1 mechanical wheelchair meets the applicable FDA recognized ANSI/RESNA consensus standards tested by Human Engineering Research Laboratories (HERL) for mechanical wheelchairs and has successfully passed testing."
Meets flame retardant standards.	"Data within the 510(k) demonstrates successful performance against flame retardant standards."
Examination Table Performance (Martin Examination Table)
Meets UL 60601-1 standard.	"The Martin Examination Table has been tested to in accordance with standards: UL 60601-1"
Meets UL 60601-1-2 standard.	"The Martin Examination Table has been tested to in accordance with standards: UL 60601-1-2"
Meets CSA 22.2 No 601-1 standard.	"The Martin Examination Table has been tested to in accordance with standards: CSA 22.2 No 601-1."

Study Details

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 in the provided text. The document states that the devices (Martin Chair C4S1 and Martin Examination Table) were "tested" and "passed testing" according to specific standards (ANSI/RESNA, UL, CSA). These standards typically involve a defined number of test samples (e.g., specific units of the wheelchair or examination table) for various mechanical, safety, and performance evaluations, but the exact number isn't detailed in this summary.
- Data Provenance: Not explicitly stated. The testing was performed by "Human Engineering Research Laboratories (HERL)" for the wheelchair and implicitly by a qualified entity for the examination table standards (UL/CSA). The country of origin of testing data is not mentioned, but given the US FDA submission, it's presumed to be from a reputable testing facility. The nature of these tests is prospective (the actual devices are subjected to specified physical tests).
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 question is not applicable to the type of device and testing described. The "ground truth" for a mechanical wheelchair and examination table is established by direct physical measurement, stress testing, and functional evaluation against engineering and safety standards, not by expert interpretation of data like in medical imaging. The "experts" involved would be engineers and technicians at the testing laboratories (HERL, UL, CSA labs) who are qualified to perform and interpret the results of these standards-based tests. Their specific numbers and qualifications are not detailed in this 510(k) summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 are used for human interpretation tasks, especially in clinical studies or for establishing ground truth in AI model training/testing. This submission pertains to physical device testing against established engineering and safety standards, where outcomes are typically objectively measured (e.g., "passed" or "failed" a specific physical test).
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 study is relevant for AI-assisted image interpretation or diagnostic tools, where human readers (e.g., radiologists) are involved. This submission is for a mechanical wheelchair and examination table, which do not involve human "readers" or AI assistance in a diagnostic context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a mechanical wheelchair and an examination table; it does not contain an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is objective compliance with recognized consensus standards (ANSI/RESNA for wheelchairs, UL/CSA for examination tables) and physical performance criteria (e.g., successful flame retardancy, meeting specified mechanical stress tolerances, electrical safety adherence). There is no "expert consensus" or "pathology" in the sense of medical diagnosis; rather, it's engineering and safety validation.
The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
How the ground truth for the training set was established
- Not applicable, as there is no AI or machine learning "training set" for this device.

Summary

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Koso506

510(k) Summary

JUN - 9 2008

A. GENERAL INFORMATION

1. Submitter's Name:	Martin Manufacturing Co., LLC
2. Address:	621-101 Hutton St.Raleigh, NC 27606
3. Contact Person:	Michael Zapata III
4. Date prepared:	25 February 2008
5. Registration Number:	Not currently registered
6. Telephone Number:	(919) 741-4401
7. Fax Number:	(919) 829-8045

B. DEVICE

1. Proprietary or Trade Name:	Martin Chair C4S1
2. Common Name:	Mechanical Wheelchair
3. Classification Name:	Wheelchair, Mechanical
4. Classification Panel(s):	General Hospital, Physical medicine
5. Product Code(s):	IOR, LGX, FRZ
6. Class for New Device:	Class I
7. Regulation Number:	890.3850

C. INDICATIONS FOR USE

Martin Chair Model C4S1 is intended for use for providing mobility to persons limited to a sitting position. It is specifically indicated to transfer a patient to and from a wheelchair. :

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D. DESCRIPTION OF THE DEVICE

ui PERFORMANCE TESTING

The Martin Chair Model C4S1 mechanical wheelchair meets the applicable FDA recognized ANSI/RESNA consensus standards tested by Human Engineering Research Laboratories (HERL) for mechanical wheelchairs and has successfully passed testing. Data within the 510(k) demonstrates successful performance against flame retardant standards.

The Martin Examination Table has been tested to in accordance with standards: UL 60601-1, UL 60601-1-2, and CSA 22.2 No 601-1.

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ட் LEGALLY MARKETED DEVICE FOR SUBSTANTIAL EQUIVALENCE COMPARISON

	MechanicalWheelchair Predicate	TablePredicate	Patient TransferPredicate
Manufacturer:	InvacareCorporation	MidmarkCorporation	NovaTechnologies, Inc.
Model:	Terminator	411	Novabed PatientTransfer System
Cleared Under:	K012167	K894134	K874448, K964246
Date Cleared:	August 1, 2001	08/28/1989	December 17,1987January 22, 1997
Class:	I	I	II
RegulationNumber:	890.3850	878.4960	890.3860880.5100
Product Code(s):	IOR, FRZ, LGX	LGX	FRZ, FNL, IOR

G. SUMMARY OF SUBSTANTIAL EQUIVALENCE COMPARISON

The new device and the predicate devices have the same intended use which is to provide mobility to persons limited to a sitting position and to transfer patients to and from a wheelchair.

The wheelchair is manually powered and has similar weight bearing capacity. The overall dimensions and materials are similar. The ability to remove the side rails and/or wheels via a contained, quick release axle is also similar compared to Invacare Terminator, K012167. The Invacare Terminator uses an enclosed camber to hold the rear quick release axle. Similarly, the Martin Chair has an enclosed quick release axle and an enclosed positioning pin that secure the side frame of the wheelchair. Like the predicates, the Martin Chair has been tested to and found to meet the applicable FDA recognized ANSI/RESNA consensus standards tested by HERL for mechanical wheelchairs.

The one technological difference between the new device and the predicates is the ability to latch to the Martin Examination Table thus facilitating patient transfer. As described within the 510(k), processes for transferring patients in and out of wheelchairs have previously been established by both the predicate wheelchairs and the Novabed Patient Transfer System. While patient transfer currently takes place routinely using the predicated wheelchair, the technological features between the Martin Chair and the Novabed Patient Transfer System are similar in that both devices provide a means for securing the patient during

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transfer and placing the patient directly onto the examination table. The method of patient transfer is well established and does not present new issues of safety and effectiveness.

Thus the Martin Chair is substantially equivalent to the predicate devices.

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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 consists of a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Martin Manufacturing Co., LLC % Mr. Michael Zapata, III President 621-101 Hutton Street Raleigh, North Carolina 27606

Re: K080506

Trade/Device Name: Martin Chair Wheelchair Model C4S1, Martin Examination Table Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR, LGX Dated: May 23, 2008 Received: May 23, 2008

JUN - 9 2008

Dear Mr. Zapata:

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 for assuration to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reviassified 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, 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 (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 that i Dri has made a actor regulations administered by other Federal agencies. You must or any I cataled and 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 Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and quality by overns (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Michael Zapata, III

This letter will allow you to begin marketing your device as described in your Scction 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 Biometric'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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Mulkerson

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): K080506

Device Name:

Martin Chair Wheelchair Model C4S1

Martin Examination Table

Indications For Use:

The Martin Examination Table is indicated for use during diagnostic examinations or surgical procedures to support and position a patient.

Prescription Use (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 OF NEEDED)

DRH, Office of Device Evaluation (ODE)

Yeil R.P. Oglan for AKM
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K080506

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).