The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and the PMT Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provides cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.

The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions:

Static magnetic field of 1.5T and 3T only .
Maximum spatial gradient magnetic field of 720 Gauss/cm or less .
Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) ● of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).

Device Description

The PMT Halo System is designed for positioning and stabilization of the cervical spine area. It provides optimum external immobilization and traction for the cervical region while allowing the patient to leave the hospital and resume their normal activities.

To enhance the magnetic resonance imaging compatibility, the PMT Halo system utilizes non-magnetic titanium skull pins and hardware, brass positioning pins, and advanced non-metallic support materials such as carbon graphite upright bars and composite head fixation subassemblies.

AI/ML Overview

The provided text describes the PMT Halo System, a device for cervical immobilization. It details the device's components, materials, and its MRI compatibility. However, the document does not contain information about acceptance criteria, specifics of a study proving device performance against such criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to predicate devices and outlining the device's characteristics and intended use, particularly its MR Conditional designation.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be extracted or inferred:

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

The document does not explicitly state "acceptance criteria" or a study proving performance against them. It states:

Characteristic	PMT Halo System Performance
Imaging Capability	Compatible with C-ray, CT and 3-Tesla MR Conditional
Performance	Halo ring and skull pins meet ASTM F1559:1994
MR Conditional Conditions	- Static magnetic field of 1.5T and 3T only- Maximum spatial gradient magnetic field of 720 Gauss/cm or less- Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).
Sterility	Skull pins, rings, and positioning pins ETO Sterilized to ANSIAAMI/ISO 11135:2007 and EN556:2001

Comment: The "acceptance criteria" appear to be compliance with specific ASTM and ISO standards, and safe operation under defined MRI conditions. The "reported device performance" is that the device meets these standards and conditions.

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 in the document. The document refers to meeting standards (ASTM F1559:1994, ANSIAAMI/ISO 11135:2007, EN556:2001) for performance and sterility, which implies testing was performed, but details of the test sets (sample size, provenance) are absent.

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 in the document.

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

This information is not provided in the document.

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 is not applicable as the device described (PMT Halo System) is a physical medical device (halo system for cervical immobilization), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study involving human readers with/without AI assistance would be relevant or performed.

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

This is not applicable as the device is a physical medical device, not an algorithm.

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

The "ground truth" for this type of device would likely be adherence to engineering specifications, material properties, and functionality under test conditions. The document states that the "Halo ring and skull pins meet ASTM F1559:1994" and sterility meets specific ISO standards. These standards themselves define the "ground truth" for performance.

8. The sample size for the training set

This is not applicable for a physical medical device. There is no "training set" in the context of machine learning.

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

This is not applicable for a physical medical device.

Summary

{0}------------------------------------------------

K090733

EXHIBIT 5

PMT Corporation 510(k) Summary

JUL 28 2009

Submitter's Name, Address, and Date of Submission

Eric Caillé General Manager PMT Corporation 1500 Park Road Chanhassen, MN Phone: 952-470-0866 Fax: 952-470-0865

Submitted:

Device Name	PMT Halo System
Trade Name:	PMT Halo System
Classification Name:	HAX, Skull Tongs for Traction 882.5960
Common/Usual Name:	Halo
Predicate Device:

Predicate Device

PMT Halo System (834047) Jerome Medical Skull Pins (040363)

Indication for Use

The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions:

Static magnetic field of 1.5T and 3T only .
Maximum spatial gradient magnetic field of 720 Gauss/cm or less .
Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) ● of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).

Device Description

{1}------------------------------------------------

K090733

Technological Characteristics and Performance

イ

The technological characteristics of the product are not affected in this submission.

Characteristic	PMT Halo System
System components	Ring set (open and closed back), superstructure (headblocks and upright bars),vest, liner, and wrench
Component materials:
Ring set	Graphite
Vest	Polyethylene
Positioning pins	Sterile, brass
Head block	Delrin or Zytel Polymer
Buckle block	Delrin or Zytel Polymer
Screws	Titanium
Traction Bail	Aluminum
Fasteners (MRI nuts)	Zytel Polymer
Vest liner	Lambswool or Acrylic
Fasteners (hook and loop)	Velcro
Chestblock	Zytel Polymer
Skull pins	Titanium (ASTM F136-08c1)
Sterility	Skull pins, rings, and positioning pins ETO Sterilized to ANSIAAMI/ISO
	11135:2007 and EN556:2001
Imaging Capability	Compatible with C-ray, CT and 3-Tesla MR Conditional
Performance	Halo ring and skull pins meet ASTM F1559:1994

: 上一

: :

. · ·

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PMT® Corporation c/o Eric Caillé General Manager 1500 Park Road Chanhassen, MN 55317

JUL 2 8 2009

Re: K090733

Trade/Device Name: PMT Halo System Regulation Number: 21 CFR 882.5960 Regulation Name: Skull Tongs for Traction Regulatory Class: II Product Code: HAX Dated: June 22, 2009 Received: June 23, 2009

Dear Mr. Caillé:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

{3}------------------------------------------------

Page 2 - Mr. Eric Caillé

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Eric G. Anderson

Malvina B. Eydelman, Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known)

K090733

Device Name PMT Halo

Indications for Use

Pr (P

The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and John Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provide: cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.

The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions:

Static magnetic field of 1.5T and 3T only
Maximum spatial gradient magnetic field of 720 Gauss/cm or less
Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	X	Over the Counter Use
Per 21 CFR 801.109
	JOE HUTTEROR(Division Sign-Off)
	Division of Ophthalmic, Neurological and Ear,Nose and Throat Devices	(Optimal Format 1-2-96)
510(k) Number	K090733

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).