The Advanced Spinal Mobilization Instrument (ASMI) is for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional. The device is for external use only.

Device Description

The Advanced Spinal Mobilization Instrument (ASMI) is a handheld electromechanical device intended for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional. The device operates in three distinct modes: introductory, mobilization, and recovery. The system incorporates a handset connected to a console. The handset consists of a metal body containing pistons and two five-port solenoid-operated valves. The console consists of a filter/regulator/filter (FRF) and a metal case which contains a proportional valve and printed circuit board (PCB). The pads, the only patient contact part, are made of silicon. The system is designed for standard connection to a compressed air source. The equipment is failsafe. The power supply is via a transformer with an output of 1.7 A at 12V. In recovery mode, the ASMI transmits a peak force of 50N. In mobilization mode, the pistons act as air springs or cushions and therefore primarily transmit the mobilizing effort applied by the practitioner.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Advanced Spinal Mobilization Instrument (ASMI), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in the way one might expect for a diagnostic or imaging device. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through functional and technological comparisons rather than performance against pre-defined numerical thresholds.

However, based on the narrative and comparison chart, we can infer the de facto "acceptance criteria" were alignment with the intended use and technological characteristics of the predicate devices.

Acceptance Criteria (Inferred)	Reported Device Performance
Intended Use: Adjustment, mobilization, or manipulation of musculoskeletal joints of the spine by a licensed healthcare professional.	"The Advanced Spinal Mobilization Instrument (ASMI) is substantially equivalent to other FDA listed and 510(k) cleared hand-held chiropractic adjusting/mobilization instruments. Specifically, the ASMI has the same intended use and similar technological characteristics as the above-listed devices. All of these devices are used by licensed professionals to impart or transmit controlled force to musculoskeletal joints..."
Hand-held adjusting device?	Yes (explicitly stated in comparison chart)
Adjustable impact force?	Yes (explicitly stated in comparison chart)
Silicone rubber body contact member?	Yes (explicitly stated in comparison chart)
Activated pneumatically?	Yes (explicitly stated in comparison chart)
More than one body contact member available?	Yes (explicitly stated in comparison chart)

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

The provided document does not describe a "test set" or any clinical study involving human subjects or data analysis in the context of typical device performance evaluation (e.g., measuring accuracy, sensitivity, specificity). The submission for the ASMI is a substantial equivalence determination, which relies on demonstrating that the new device is as safe and effective as already legally marketed predicate devices through comparison of technological characteristics.

Therefore, there is:

No reported sample size for a test set.
No data provenance (country of origin, retrospective/prospective) for a performance study, as no such study is described.

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

Since no performance study with a test set generating ground truth is described, this information is not applicable and not provided in the document.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

As no test set or performance study is described, an adjudication method is not applicable and not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or appears to have been conducted for this 510(k) submission. The submission relies solely on a direct comparison of the device's technical specifications and intended use against existing predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical instrument for manual interaction by a healthcare professional. Therefore, the concept of a "standalone algorithm" is not applicable. The device's function is inherently human-in-the-loop.

7. Type of Ground Truth Used

No ground truth as typically understood for diagnostic or AI systems (e.g., pathology, outcomes data) was used for this submission. The "ground truth" equivalent in a substantial equivalence filing for a device like this is the established safety and effectiveness of the legally marketed predicate devices. The ASMI's characteristics are compared to these predicates to demonstrate that it functions similarly and, by extension, is equally safe and effective.

8. Sample Size for the Training Set

Since no AI component or machine learning algorithm is described for the ASMI, there is no training set and therefore no sample size for a training set mentioned.

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

Given that there is no training set for an AI/ML algorithm associated with this device, this question is not applicable.

Summary

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K050428

Advanced Spinal Technologies, Inc.

. #

433 Plaza Real. Suite 255 Boca Raton, Florida 33432 Phone: (561) 886-3224 • Facsimile: (561) 886-3244

'JUN 1 4 2005

510(k) Summary Advanced Spinal Mobilization Instrument (ASMI)

Date of Preparation:	February 14, 2005
Submitter:	Advanced Spinal Technologies, Inc.433 Plaza Real, Suite 255Boca Raton, Florida 33432
Contact:	Jeffrey R. Perelman, M.D.Phone: (561) 338-9700Fax: (561) 338-9780E-Mail: jperelman@advancedspinaltech.com
Specification developer:	Alteristic Instruments Limited66 Lemon StreetTruro, Cornwall TR1 2PNUnited Kingdom
Contract manufacturer:	SMC Pneumatics (UK) Ltd.Vincent AvenueCrownhill, Milton Keynes MK8 OANUnited Kingdom
Trade Name:	Advanced Spinal Mobilization Instrument (ASMI)
Common Name:	Adjusting or Joint Mobilization Instrument
Classification Name:	Plunger-Like Joint Manipulator
Intended Use:	Adjustment, mobilization, or manipulation of the musculoskeletaljoints of the spine by a licensed health care professional.
Predicate Devices:	K023462 – Impulse™ Adjusting InstrumentK003185 – Full Spectrum Activator® IIIK021238 - Frye Adjusting InstrumentK962239 - Smart Adjuster Adjusting or Joint Mobilization

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EstablishmentRegistration Number:	3005096823
Regulatory Class:	Unclassified
Product Code:	LXM
Panel:	Physical Medicine
Performance Standards:	None known established

Device Description & Specifications:

The Advanced Spinal Mobilization Instrument (ASMI) is a handheld electromechanical The Advanced Spinal Hoomobilize, or manipulate the musculoskeletal joints of the spine. The motions assure assure as a licensed health care professional. Because manual spinal device is intended for ass of the ASMI gives the licensed health care professional the moontanton is diffreent spinal mobilization with a handheld electromechanical device.

The device operates in three distinct modes. The introductory mode initiates a therapy session The device operated in the touch and feel of the instrument. The mobilization mode is and accrimatizes the patient to me actions of a physical therapist's hands performing spinal mobilization. The recovery mode is used between the mobilization treatments to lightly massage the paraspinal area and promote a soothing feeling of well-being.

The system incorporates a handset connected to a console. The handset consists of a metal body The system moorporates a ing pistons and two five-port solenoid-operated valves. The console consists of a filter/regulator/filter (FRF) and a metal case which contains a proportional valve and printed circuit board (PCB). The pads, the only patient contact part, are made of silicon and printThe system is designed for standard connection to a compressed air source.

The equipment is manufactured to the highest possible standards and is failsafe, i.e., if it r no oquipment is malling the seases to operate. The power supply is via a transformer with an output of 1.7 A at 12V. In recovery mode, the ASMI transmits a peak force of 50N. In mobilization mode, the pistons act as air springs or cushions and therefore primarily transmit the mobilizing effort applied by the practitioner.

Substantial Equivalence Comparison:

The Advanced Spinal Mobilization Instrument (ASMI) is substantially equivalent to other FDA listed and 510(k) cleared hand-held chiropractic adjusting/mobilization instruments. Specifically, the ASMI has the same intended use and similar technological characteristics as the above-listed devices. All of these devices are used by licensed professionals to impart or transmit controlled force to musculoskeletal joints as part of the practice of physical therapy, chiropractic medicine, and related professional fields. While substantially equivalent to the identified predicate devices in their totality, the ASMI is similar to, for example, the Impulse

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(K023462) fitted with the dual stylus attachments. The Smart Adjuster (K962239) is also available with a dual prong attachment. Additionally, while all means of activating the impact force are substantially equivalent, the Frye Adjusting Instrument (K021238) is, like the ASMI device, activated pneumatically.

A comparison of the technological characteristics of the current device and the predicate devices is set forth in the chart below.

Comparison Chart:

Feature	ASMI	Impulse	Activator III	SmartAdjuster	Frye
Indicated foradjustment andmobilization ofthe spine?	Yes	Yes	Yes	Yes	Yes
Hand heldadjustingdevice?	Yes	Yes	Yes	Yes	Yes
Adjustableimpact force?	Yes	Yes	Yes	Yes	Yes
Silicone rubberbody contactmember?	Yes	Yes	Yes	N/A	Yes
Activatedpneumatically?	Yes	No	No	N/A	Yes
More than onebody contactmemberavailable?	Yes	Yes	No	Yes	No

N/A = information not available

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, representing the department's focus on people and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2005

Jeffrey R. Perelman, M.D. President Advanced Spinal Technologies, Inc. 433 Plaza Real, Suite 255 Boca Raton, Florida 33432

Re: K050428

Trade/Device Name: Advanced Spinal Mobilization Instrument (ASMI) Regulatory Class: Unclassified Product Code: LXM Dated: June 9, 2005 Received: June 10, 2005

Dear Dr. Perelman:

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 -- Jeffrey R. Perelman, M.D.

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Hup E. Elurde
Miriam C. Provost, Ph.D.

Miriam C. Provost. Acting 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: K050428

Device Name: Advanced Spinal Mobilization Instrument (ASMI)

The Advanced Spinal Mobilization Instrument (ASMI) is for adjustment, Indications for Use: mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional. The device is for external use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

. I

Concurrence of

Atut. Qurlis

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number K050428

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Regulation Number and Section

N/A