JEROME GLASS RING by THE JEROME GROUP, INC.

The Fiberglass Halo Traction Ring is similar to other halo rings which. when used as part of a Halo System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Jerome Glass Ring, demonstrating its substantial equivalence to a predicate device. This type of submission does not typically include clinical efficacy studies as would be seen for novel or high-risk devices. Instead, it relies on comparative technical performance to established standards.

Here's an analysis of the acceptance criteria and the "study" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ASTM F 1831 - 97)	Reported Device Performance (Jerome Glass Ring)
Mechanical Integrity (defined by ASTM F 1831 - 97 standard for "Standard Specification for Testing Spinal Implants Material Systems")	Meets requirements of ASTM F 1831 - 97 for Mechanical Integrity of Halo Rings

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

Test Set Sample Size: Not explicitly stated. The document refers to meeting a standard (ASTM F 1831 - 97), which would dictate the number of test samples required. However, the specific number of Jerome Glass Rings tested to demonstrate conformance is not provided.
Data Provenance: The device performance is based on mechanical testing conducted to meet an ASTM standard. This implies a laboratory or engineering testing environment. The document does not provide information on the country of origin of this testing data or whether it was retrospective or prospective in a clinical sense. It's a materials and mechanical performance test, not a clinical trial.

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

This type of information is not applicable to this submission. The "ground truth" for mechanical integrity is established by the ASTM F 1831 - 97 standard itself, which defines the test methods and acceptance limits. It would be an engineering determination based on empirical data from the tests, not an expert panel reviewing clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" refers to mechanical performance testing, there is no adjudication process in the sense of clinical review or consensus between experts. The results are compared directly to the specifications of the ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This is a medical device for mechanical support and immobilization, not a diagnostic imaging device utilizing AI. Therefore, the concept of human reader improvement with AI assistance is not relevant to this submission.

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

No, a standalone algorithm performance study was not done. This device does not incorporate an algorithm or AI component.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is adherence to the mechanical specifications and testing methodology outlined in the ASTM F 1831 - 97 standard. This standard serves as the benchmark for demonstrating that the device is fit for its intended mechanical purpose.

8. The Sample Size for the Training Set

Not applicable. This submission describes a mechanical medical device, not a machine learning or AI-based system. Therefore, there is no "training set" in the context of algorithm development.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth to establish in this context.

Summary

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November 22, 2002

023959
page 10f1

510(k) Summary As required by section 807.92(c)

Trade Name: Jerome Glass Ring

FEB 2 1 2003

Common Name: Halo Ring

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

Substantially Equivalent to: Generation 80 Halo Ring (K822780) also manufactured by Jerome Medical. Also similar to Halo Rings included in Lerman Low Profile Halo System, Bremer Halo System (K864746), (now DePuy Acromed - Johnson & Johnson), Friddle Halo System (K980689), PMT Halo Systems, and the V1 Halo Ring (K930153). Copies of product literature for each are included in Competition (Tab 10).

Description: The Fiberglass Halo Traction Ring is similar to other halo rings which. when used as part of a Halo System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury. An engineering drawing of a Standard size Glass Ring is at page 2-2.

Technological Characteristics Summary:

	Jerome Glass Ring	Generation 80
Design	Closed Loop Halo Ring	Closed Loop Halo Ring
Materials	E-glass (fiberglass)	6061 T6 Aluminum
Sterility	EtO Sterilized	EtO Sterilized
Sizes	3 sizes	3 sizes
Pin Sites	31	19
Electrical Safety	Non-conductive	Conductive
Imaging Compatibility	Compatible w/X-ray,CT, MR	Compatible w/X-ray,CT, MR
Performance	Meets requirements ofASTM F 1831 - 97 forMechanical Integrity ofHalo Rings	Meets requirements ofASTM F 1831 - 97 forMechanical Integrity ofHalo Rings

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2003

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

Re: K023959 Trade Name: Jerome Glass Ring Regulation Number: 21 CFR 882.5960 Regulation Name: Skull tongs for traction Regulatory Class: II Product Code: HAX Dated: November 25, 2002 Received: November 27, 2002

Dear Mr. Tatro:

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. Bernie Tatro

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 (301) 594-4659. 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.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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) Number (if known): _K023959

Device Name: Jerome Glass Ring

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Muriam C. Provost

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

510(k) Number K023959

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).