The Air-Flex is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction, powered flexion and muscle relaxation therapy.

Device Description

The AIR-FLEX with AUTO-DISTRACTION is a modification of the AIR-FLEX table originally cleared under K932810 on 02/17/1995. This new platform will replace the model originally cleared under K932810.

The device is a Hi-Lo multi-function physical therapy table as defined under 21 CFR 890.5880. Neither the proposed device nor the predicate device provides heat.

The proposed device differs from the predicate device in that it utilizes precision pneumatic actuators for distraction force and positioning rather than electric motors that were used on the predicate. The height adjustment of the proposed device is performed using the same electric motor as the predicate.

The proposed device has a new, optional automatic cycling mode intended to provide intermittent distraction and flexion.

Additionally, the AIR-FLEX with AUTO-DISTRACTION can be configured with up to four pneumatically dropped sections including cervical (straight down and forward motion), thoracic, lumbar and pelvic. Each drop is activated by pressing a clearly marked button and is executed via a foot pedal.

An Air-thoracic Breakaway (with release) allows for a thoracic recoil movement and features an adjustable air tension spring controlled by a foot pedal allowing the spring to lock at any point down to 5.5 inches. This allows the use of the table with patients with large abdominal areas. The Air-Breakaway can be combined with thoracic and lumbar drop.

The proposed device can be fitted with an elevation headpiece. This raises up to 5 inches and is fitted with a tilting section. Manual or Air-activated drops can be added as options.

The activation of the selected drop can be made by footswitches or optional cocking foot strips. The AIR-FLEX with AUTO-DISTRACTION table is configured to match the owner's preferences.

The optional Auto-Flex allows the therapist to treat patients manually (for which the AIR-FLEX table is already cleared) or easily switch to AUTO-FLEX for motorized flexion. The stroke (controls the amount of flexion) can be adjusted.

The patient lies prone on the treatment surface and the patent is secured around the waist using a seat-belt type strap with quick release buckle to the stationary part of the table. The ankles are secured using straps to the movable part of the table. Once the therapist is sure that the patient is properly secured, the therapist unlocks the movable section and sets the distraction force, which is read on a gauge on the table. The therapist has the option to perform manual cycling and, where the table is configured with the automatic cycling module, can now set the overall treatment time, relax level, the rate to increase, time to hold (Pull Time) and the time to rest (Rest Time).

AI/ML Overview

This 510(k) premarket notification for the "Air-Flex with Auto-Distraction" device is a submission for a modification of an already cleared device (K932810). For such modifications, the primary focus of the submission is to demonstrate substantial equivalence to the predicate device, rather than proving efficacy from scratch with a new clinical study.

Therefore, the document does not contain a typical study that would "prove the device meets acceptance criteria" in the way a new device submission or a premarket approval (PMA) would. Instead, the "acceptance criteria" are implicitly met by demonstrating that the new features do not introduce new safety or effectiveness concerns and perform similarly to features on the predicate or well-understood mechanisms.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a modified device proving substantial equivalence, formal "acceptance criteria" in the sense of performance targets from an efficacy study are not explicitly stated in this document. The "performance" is primarily assessed by comparing technological characteristics and safety features to the predicate device and relevant consensus standards.

Feature/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Distraction Force	Must provide the same total amount of distraction force as the predicate device (K932810).	The total amount of distraction force is the same as the predicate device. Provided by a pneumatically (air) powered linear actuator, replacing electric motors. Uses a precision, high reliability load cell for force feedback to a microprocessor, similar to the predicate.
Automatic Cycling	Must safely and controllably provide intermittent distraction and flexion.	Microprocessor-controlled automatic cycling allows adjustment of overall treatment time, relax level, rate to increase, time to hold (Pull Time), and time to rest (Rest Time).
Safety Features	Must include safety mechanisms comparable to or improved from the predicate, especially regarding patient discomfort and electrical safety.	Patient-held cut-out switch immediately aborts treatment and gradually bleeds off traction force if pressed. An alarm sounds, and treatment cannot start if the switch is not attached or is defective. Electrical isolation via transformers and power supplies brings voltage for motors, valves, and switches to 24 Volts D.C. Safety Extra Low Voltage (SELV), mirroring the original Air-Flex table.
Material/Construction	Materials should be the same or similar to the predicate.	The materials used in construction (frame, upholstery) are the same or similar.
Compliance to Standards	Designed to comply with relevant consensus standards.	Designed to comply with IEC 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety).

2. Sample Size Used for the Test Set and Data Provenance

No test set or clinical data is mentioned in this submission. The demonstration of substantial equivalence relies on technological comparison and compliance with standards, not on a new clinical study with a test set of patients.

Sample Size: Not applicable.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no external "test set" and corresponding ground truth establishment is described for a clinical study. The "ground truth" for the device's technical specifications and safety would be based on engineering specifications, testing against standards, and comparison with the predicate device.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication 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 is a physical therapy table, not an AI-assisted diagnostic or therapeutic device that involves "human readers" or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The type of "ground truth" implicitly used for this 510(k) submission is:

Engineering Specifications and Design Verification: The device's components and functionalities (e.g., distraction force, automatic cycling, safety cut-out) are verified against their design specifications, which are themselves derived from safety standards and the performance of the predicate device.
Compliance with Standards: Verification that the device design and manufacturing processes comply with recognized consensus standards (e.g., IEC 60601-1).
Predicate Device Performance: The "ground truth" for what constitutes acceptable overall performance and safety is largely established by the performance and safety record of the legally marketed predicate device (Air-Flex K932810). The submission argues that the new device's changes do not negatively impact this established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable, as this device does not involve machine learning or AI models that require training sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this device does not involve machine learning or AI models.

Summary

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K063C34
Page 1 of 4

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Air-Flex with Auto-Distraction

DEC 1 4 2006

1. Submitter's Name and Address

1.1	Submitter's Name:	Hill Laboratories
1.2	Address:	3 Bacton Hill Rd
1.3	City, State, and Zip:	Frazer, PA 19355

2. Contact Person

2.1	Name:	Brady Aller
2.2	Title:	Sales/Service Manager
2.3	Telephone:	(610) 644-2867
2.4	Facsimile:	(610) 647-6297
2.5	E-mail:	bradvaller@hilllabs.com

3, Manufacturing Facility Address

3.1 Manufacturer:	Hill Laboratories
3.2 Address:	3 Bacton Hill Rd
3.3 City, State, and ZIP:	Frazer, PA 19355

Establishment Registration Number 4.

Est. Registration Number: 2510425

5. Date of Summary Preparation

Date of Preparation:

September 21, 2006

6. New Device Details

6.1	Proprietary or Trade Name:	Air-Flex with Auto-Distraction
6.2	Common Name:	Multi-function physical therapy table
6.3	Classification Name:	Table, Physical Therapy, Multi Function

7. Class and Reference

7.1	Class:	Class II
7.2	Reference:	21 CFR 890.5880.

8. Product Code

Product Code:

JFB

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KC6 3C3Y
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Device Description 9.

The AIR-FLEX with AUTO-DISTRACTION is a modification of the AIR-FLEX table originally cleared under K932810 on 02/17/1995. This new platform will replace the model originally cleared under K932810.

The device is a Hi-Lo multi-function physical therapy table as defined under 21 CFR 890.5880. Neither the proposed device nor the predicate device provides heat.

The proposed device has a new, optional automatic cycling mode intended to provide intermittent distraction and flexion.

Additionally, the AIR-FLEX with AUTO-DISTRACTION can be configured with up to four pneumatically dropped sections including cervical1 (straight down and forward motion), thoracic, lumbar and pelvic. Each drop is activated by pressing a clearly marked button and is executed via a foot pedal.

The proposed device can be fitted with an elevation headpiece. This raises up to 5 inches and is fitted with a tilting section. Manual or Air-activated drops can be added as options.

The activation of the selected drop can be made by footswitches or optional cocking foot strips. The AIR-FLEX with AUTO-DISTRACTION table is configured to match the owner's preferences.

1 The cervical headpiece is also available with a manual drop.

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KC63034
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Indications for Use 9.1

9.2 Technological Characteristics

The proposed device is AC powered and incorporates electrical isolation via transformers and power supplies to bring the voltage for motors, valves and switches to 24 Volts D.C Safety Extra Low Voltage (SELV) in the same manner as the original Air-Flex table originally cleared under K932810 on 02/17/1995.

The proposed device allows automatic cycling of the distraction force from the set value to a lower (Rest) value and back again in a specific amount of time with a settable pause (Hold) time. The automatic cycling is microprocessor controlled.

Distraction force for the proposed device is provided by a pneumatically (air) powered linear actuator that is very quiet and produces almost no vibration. The total amount of distraction force is the same as the predicate device. A small air compressor charges a 2 liter air reservoir that provides air to the different actuators on the table. The reservoir is fitted with an overpressure cut out as is the compressor.

A precision, high reliability load cell, rated for many times more force than the device will produce, provides force feedback to the microprocessor and this is used to measure the distraction force applied to the patient.

The proposed device is equipped with a hand-held cut-out switch which is held by the patient during the treatment time. If the patient feels discomfort and presses the cut-out switch, the treatment is immediately aborted and the traction force bleeds off gradually. The action of pressing the cut-out switch overrides all other functions. An alarm will sound whenever the button of the cut-out switch is pressed. The treatment cannot be started until the cut-out switch is attached to the equipment. If for any reason the switch or cable are defective, the treatment cannot be started.

Standards 10.

Section 514 Performance Standards 10.1

There are no known mandatory Standards for this type of device

10.2 Consensus Standards

The proposed device is designed to comply with the following Consensus Standard:

STANDARD NO.	TITLE
IEC 60601-1	Medical Electrical Equipment- Part 1: GeneralRequirements for Safety

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K063034
Page 4 of 4

11.0 Predicate Device

510(k) Number	Trade or Proprietary or ModelName	Manufacturer
K932810	Air-Flex	Hill Laboratories

Substantial Equivalence (SE) Rationale 11.1

The proposed modified device shares the same or similar basic characteristics and the same general use in physical medicine as the predicate device.

The predicate device provides manually-controlled distraction. The new device requires the therapist to manually set the upper distraction force as before but can automatically cycle between a lower force and the original force set by the therapist.

The predicate device requires the therapist apply the amount of flexion and to manually cycle the therapy. This can cause fatigue to the therapist. The Auto-Flex option allows the therapist to set the speed, number of cycles and amount of flexion. The new device automates a process that is already performed by the therapist and alleviates the fatigue.

The source of energy to provide distraction motion is electric on the predicate device and pneumatic on the new device. Both provide linear motion that is controlled by a force feedback mechanism linked to an industrial grade load cell (reliable and robust). The force feedback mechanism (load cell) is the same for the proposed modified device and the predicate.

The materials used in construction of the new device, including the frame and upholstery are the same or similar. The product code and overall intended use is the same as the predicate device. There are no new issues of safety and effectiveness posed by the new device. The risks posed by the difference in technology between the proposed modified device and the predicate are no greater than the legally marketed device.

The labeling for the new device is the same as the cleared device.

Therefore the new device is considered by Hill Laboratories to be Substantially Equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hill Laboratories Company % Mr. Brady Aller 3 N. Bacton Hill Road, P.O. Box 2028 Frazer. Pennsylvania 19355

DEC 1 4 2006

Re: K063034

Trade/Device Name: Air-Flex with Auto-Distraction Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function physical therapy table Regulatory Class: Class II Product Code: JFB Dated: November 21, 2006 Received: November 27, 2006

Dear Ms. Aller:

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, 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 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. Brady Aller

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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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510(k) No. K063034 lf known

Indications For Use statement

Device Name:

Air-Flex with Auto-Distraction

Indications For Use:

This device is for prescription use only.

Prescription Use	X
(Per 21 CFR 801 Subpart

AND/OR

Over-The-Counter Use
(Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	K063034
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Air-Flex with Auto-Flex 510(k)	Page 13 of 48	September 21, 2006
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Regulation Number and Section

§ 890.5880 Multi-function physical therapy table.

(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).