The ReSOLVE Open Back Halo Traction Ring is similar to other rings which, when used as part of a Halo System, are designed to hold the skull immobilized following surgery or injury.

AI/ML Overview

This document describes a 510(k) premarket notification for the "ReSOLVE Open Back Halo Ring." The submission aims to demonstrate substantial equivalence to a predicate device, the "ReSOLVE Closed Back Halo Ring (K023959)," and also references the "V1 Halo Ring (K930153)".

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria (Standard)	Reported Device Performance
Meets or exceeds requirements of ASTM F 1831-97 for Mechanical Integrity of Halo Rings	ReSOLVE Open Back Ring: Meets or exceeds requirements of ASTM F 1831-97 for Mechanical Integrity of Halo Rings
	ReSOLVE Closed Back Ring: Meets or exceeds requirements of ASTM F 1831-97 for Mechanical Integrity of Halo Rings

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Non-clinical Tests" and "Laboratory tests confirm," but does not explicitly state the sample size used for the testing of the ReSOLVE Open Back Halo Ring or the ReSOLVE Closed Back Halo Ring. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

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 provided. The study is a non-clinical, mechanical integrity test, so expert ground truth establishment in a medical diagnostic context is not applicable.

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

This is not applicable as the study involves non-clinical mechanical testing, not a human reader assessment.

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

No, an MRMC comparative effectiveness study was not done. This device is a medical hardware device (Halo Ring for cervical immobilization), not an AI-assisted diagnostic tool.

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

Yes, a standalone performance test was done, but it's a mechanical performance test, not an algorithm's performance. The "laboratory tests" confirmed that the "new open back design meets the standard for mechanical integrity as the previously approved ReSOLVE Closed Back Ring." This refers to the device's physical properties.

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

The "ground truth" for this non-clinical test is the standard of ASTM F 1831-97, Section 11. This is a recognized industry standard for the mechanical integrity of Halo Rings. The testing determines if the device meets or exceeds the specified requirements of this standard.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI model.

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

This information is not applicable, as there is no "training set" for this type of device and study. The "ground truth" for the performance evaluation is the ASTM standard.

Summary

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Page 1 of 2

Image /page/0/Picture/1 description: The image shows a logo for "Jerome Cervical Spine System". The logo has a stylized spine graphic on the left, followed by the word "JEROME" in large, bold letters. Below "JEROME" is the text "CERVICAL SPINE SYSTEM" in a smaller font. The tagline "Helping You Meet The Challenge" is at the bottom of the image.

AUG 1 7 2005

05/9/8

July 14, 2005

510(k) Summary

As required by section 807.92(c)

ReSOLVE Open Back Halo Ring Trade Name:

Common Name: Halo Ring

Tong, Skull for Traction, Sec. 882.5960, Neurological Classification Name: Devices, Class II, HAX

ReSOLVE Closed Back Halo Ring (K023959) Substantially Equivalent To: Oubstantially Equivalian Also similar to the V1 Halo Ring (K930153) manufactured by Jerome Medical.

Description: The ReSOLVE Open Back Halo Traction Ring is similar to other rings which, when used as part of a Halo System, are designed to hold the skull hings which, when used as part of a hale of the eyes are immobilized following surgery or injury.

Technological Characteristics Summary:

	ReSOLVE Open BackRing	ReSOLVE Closed BackRing
Design	Open back halo ring	Closed loop halo ring
Materials	E-glass (glass composite)	E-glass (glass composite)
Sterility	EtO Sterilized	EtO Sterilized
Electrical Safety	Nonconductive	Nonconductive
Imaging Compatibility	Compatible w/X-ray, CT,MR	Compatible w/X-ray, CT,MR
Performance	Meets or exceedsrequirements of ASTM F1831-97 for MechanicalIntegrity of Halo Rings	Meets or exceedsrequirements of ASTM F1831-97 for MechanicalIntegrity of Halo Rings

The ReSOLVE Open Back Ring is substantially equivalent to the ReSOLVE The ReGOEVE Open Back Aing local aspects. The only variation is the shape of the ring. Laboratory tests confirm that the new open back design meets the the ling. Edad for mechanical integrity as the previously approved ReSOLVE Closed Back Ring.

Jcrome Medical, 305 Harper Drive, Moorestown, NJ 08057-3239 • (800) 257-8440 • FAX (856) 778-5333

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Non-clinical Tests: Both the ReSOLVE Open Back and ReSOLVE Closed Back were tested to the standard of ASTM F 1831-97, Section 11. Each met the were tested to the otandard on Hoes not adversely affect product performance.

Intended Use: The ReSOLVE Open Back Halo Ring is intended for use in intended 000: "The Neoone Halo Vest, Superstructure and Accessories (Halo System) that provide cervical immobilization and/or traction for healing and rehabilitation of cervical spinal cord injuries.

Conclusions: The ReSOLVE Open Back Halo Ring is similar to the ReSOLVE Closed Back Halo Ring in material, function and indications for use. The devices are substantially equivalent.

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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal features a stylized eagle with its head turned to the left. The eagle's body is composed of three curved lines. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2005

Mr. Bernie Tatro Director of Marketing Jerome Medical 305 Harper Drive Moorestown, New Jersey 08057-3239

Re: K051918

Trade/Device Name: ReSOLVE Open Back Halo Ring Regulation Number: 21 CFR 882.5960 Regulation Name: Skull tongs for traction Regulatory Class: II Product Code: HAX Dated: July 14, 2005 Received: July 19, 2005

Dear Mr. Tatro:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications ferenced above and have acterials and marketed predicate devices marketed in interstate for use stated in the encreate) ve tegains and the Medical Device Amendments, or to commerce proc to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been receised in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general volurols provision 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 if your device is elassinod (over a controls. Existing major regulations affecting your device can may oe subject to back adderal 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 or any I odolar statuation and 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. Bernie Tatro

This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to organ maing of substantial equivalence of your device to a legally premailted 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 If you desire spochis aarroliance at (240) 276-0120. Also, please note the regulation entitled, eoniael the Office of Dremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnal 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/industry/support/index.html.

Sincerely yours,

Mark N. Molkerson

Mark N. Melkerson 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 (if known): K051918

ReSOLVE Open Back Halo Ring __________________________________________________________________________________________________________________________________________________ Device Name:

Indications for Use:

The ReSOLVE Open Back Halo Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.

Prescription Use X (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

200

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K051918

Regulation Number and Section

§ 882.5960 Skull tongs for traction.

(a)
Identification. Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.(b)
Classification. Class II (performance standards).