The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical muscles and vertebrae when used in conjunction with fixed or variable height traction tables. It is indicated for use as a treatment for spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain and compression fractures.

Device Description

The ATP9 machine mounts on available Akron traction tables and mobile traction stand. Traction force is applied to the patient using Akron traction harnesses. The ATP9 utilizes a DC-powered motor gearbox connected to a rope drum via a clutch. The rope is connected to a harness attached to the patient. The high force hold time and low force rest time programs are selectable from 1 second minimum to 99 seconds maximum, with a high traction force range of 2-200 lbs. and low traction force range of 2-196 lbs. There are seven combinations of therapy including static, intermittent, progressive, regressive and cyclic.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Akron ATP9 Traction Machine), not a study report or clinical trial. Therefore, most of the requested information regarding acceptance criteria and performance studies is not explicitly provided in this type of document.

A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already legally marketed. It typically relies on design comparisons, performance testing (often to industry standards), and safety considerations rather than extensive clinical studies with human subjects to prove new efficacy claims or compare against human readers.

However, I can extract what is available and explain why other requested information is not present.

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

The document does not provide a table of acceptance criteria with reported device performance in the manner one would expect for a study evaluating a diagnostic or AI-driven device. Instead, it describes general safety and performance parameters:

Acceptance Criteria (Implied)	Reported Device Performance/Features
Force Range	High traction force range: 2-200 lbs.Low traction force range: 2-196 lbs.
Hold/Rest Time	Selectable from 1 second minimum to 99 seconds maximum.
Therapy Combinations	Seven combinations available (static, intermittent, progressive, regressive, cyclic).
Safety Fault Conditions	Detects eleven fault conditions: control system failure, low supply voltage, AC power failure, motor power supply failure, battery failure, excess tension detected, high force control setting failure, strain gauge failure, strain gauge mismatch, motor malfunction, unexpected increase in tension, and cord drive fault.
International Standards	Conforms to IEC601-1, EN60601-1-2: 1993, EN60601-1/A2: 1995, EN60601-1-4: 1997. Manufactured to ISO9002 and EN46002. (This implies that the device has met the requirements of these standards during its development and testing).

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 provided. The 510(k) submission generally discusses engineering testing and adherence to standards rather than clinical "test sets" or patient data provenance.

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 and not provided. The "ground truth" concept is relevant for studies evaluating diagnostic accuracy, often with expert consensus, which is not the focus of this 510(k) for a traction machine.

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

This information is not applicable and not provided for the reasons stated above.

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

This information is not applicable and not provided. An MRMC study is typically for evaluating diagnostic performance (especially with AI assistance), which is not relevant for a physical therapy traction machine. There is no AI component mentioned in this device description.

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

This information is not applicable and not provided. There is no algorithm mentioned that would operate standalone or without human intervention; the device is a physical therapy machine.

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

This information is not applicable and not provided. The assessment of this device is based on its mechanical performance, safety features, and compliance with recognized standards, not on "ground truth" for diagnostic accuracy.

8. The sample size for the training set

This information is not applicable and not provided. There is no machine learning or AI component mentioned that would require a training set.

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

This information is not applicable and not provided for the reasons stated above.

Summary

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HUNTLEIGH HEALTHCARE7324461938 NOV. 9. 1999 11:42AM

Nov 10 1999	K 992733
	510(k) Summary
	Akron ATP9 Traction Machine
Submitters Name:	Audrey WitkoV.P., Administration & ComplianceHuntleigh Healthcare Inc.227 Route 33 EastManalapan, NJ 07726Telephone: (732) 446-2500Fax: (732) 446-1938
Name of Device:	Akron ATP9 Traction Machine
Manufactured By:	Huntleigh Akron1 Farthing RoadIpswich, Suffolk IP1 5APUnited Kingdom
Classification Name:	Power traction equipment (21 CFR §890.5900) ITH
Predicate Devices:	TEC Traction Machine (K834405)ESCOTEK EST TRAC 401 (K844385)

Device Description:

Safety Considerations:

There are eleven fault conditions detected by the ATP9 including, control system Failure, low supply voltage, AC power failure, motor power supply failure, battery failure, excess tension detected, high force control setting failure, strain gauge failure, strain gauge mismatch, motor malfunction, unexpected increase in tension, and cord drive fault. The ATP9 conforms to the following international standards: IEC601-1, EN60601-1-2: 1993, EN60601-1/A2: 1995, EN60601-1-4: 1997. Manufactured to ISO9002 and EN46002.

On, 2 - 11/60

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 0 1999

Ms. Audrey Witco Vice President Administration, Compliance and Clinical Affairs Huntleigh Healthcare Incorporated 227 Route 33 East Manalapan, New Jersey 07726

K992733 Re: Akron ATP9 Traction Machine Product Code: ITH Regulatory Class: II Dated: August 9, 1999 Received: August 13, 1999

Dear Ms. Witco:

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 The general controls provisions of the Act 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. ਕੇ 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 requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Ms. Audrey Witco

requlations. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 at (301) 443-6597, or at its Internet address

"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Eriller los Mesen essame Chuliatorgiene Henline & .. P

510(k) Number (if known):	K992733
Device Name:	AKRON ATP9 TRACTION MACHINE
Indications for Use:

The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical
ist the and vertebrae when used in conjunction with fixed are in the below to the muscles and verte interned to provide mobilization of lumbar and cervices
tables. It is indicated to provide with fixed of variable height traction tables . It is indicated for use as a treatment with fixed or variable height he work in the mated for use as a treatment for spinal root impingement, joint
hypomobility, degenerative joint disease, discogenic pain, joint pain and compression
fracture

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF Mapped)

Prescription Use(Per 21 CFR 801.109)	X
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Concurence of CDRH, Office of Device Evaulation (ODE)

(Division Sign-Off)
Division of General Restorative Devices	K992733
510(k) Number

(Optional Format 3-10-98)

(Posted July 1, 1998)

Back to the Indications for Use Page

Rev. B- 1/99

Regulation Number and Section

§ 890.5900 Power traction equipment.

(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).