Used as an accessory to aid in the auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.

Device Description

X12's Sterile Reflective Marker Spheres consist of two hemispheres, coated with a retroreflective foil, bonded together on a central pin to form a sphere. The central pin can be threaded with an M3 female thread or have a snap hole to mate with a mounting pin. The retro-reflective foil is applied in such a way as to provide reflectivity from all angles that is equivalent to the predicate devices. The spheres are individually packaged in a special sterile package and are gamma sterilized.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the X12 Sterile Reflective Marker Sphere:

This submission (K111443) is for a Class II medical device, specifically a "Neurological Stereotaxic Instrument" and "Orthopedic Stereotaxic Instrument" in the form of a "Disposable Reflective Marker Sphere." The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

The information provided does not describe a study involving human subjects or AI assistance, nor does it present specific quantitative acceptance criteria in the format of a performance table with reported device performance metrics. Instead, it relies on comparative performance testing against predicate devices to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text, with explicit notes on what is not available or applicable:

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

No specific quantitative acceptance criteria or a direct performance table are provided in the document. The device's performance is described as "equivalent" or "substantially equivalent" to predicate devices for the tested characteristics.

Acceptance Criteria (Implicit)	Reported Device Performance
Retro-reflectivity equivalent to predicate devices	Both polar and equatorial views showed retroreflectivity that was equivalent to the predicate devices.
Maintain mechanical properties after water soak	Maintained mechanical properties after being soaked in water.
Surface durability substantially equivalent to predicate devices	Surface durability was substantially equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. The text mentions "X12's Sterile Reflective Marker Spheres were tested" and implies testing of multiple units for water soak and surface abrasion ("the markers," "which showed the surface durability"). For retro-reflectivity, it refers to "Both the polar and equatorial views."
Data Provenance: Not specified (e.g., country of origin). The testing seems to have been conducted by the manufacturer, X12 Co., Ltd. (Bulgaria), or on their behalf. The testing is for premarket notification, indicating it's prospective for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical marker sphere. Its performance characteristics (retro-reflectivity, mechanical properties, surface durability) are assessed through physical and optical tests, not by expert interpretation of clinical data to establish a "ground truth" in the diagnostic sense.

4. Adjudication method for the test set

Not applicable. As noted above, this device relies on physical and optical tests, not human interpretation requiring an adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a passive reflective marker sphere, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of human readers or AI assistance.

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

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

7. The type of ground truth used

The "ground truth" for this device's performance is established by physical and optical measurements of its properties (retro-reflectivity, mechanical integrity after water soak, surface durability) compared against predicate devices that are already legally marketed. There is no biological or diagnostic "ground truth" like pathology or outcomes data associated with the markers themselves, other than their intended function in surgical navigation.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an algorithm or machine learning for this physical device.

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

Not applicable, as there is no training set.

Summary

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K111443

PREMARKET NOTIFICATION 510 (K) SUMMARY SEP 2 9 2011

1.	Submitters Name:	Dancho Jordanov
2.	Address:	X12 Co., Ltd.J&L Center, fl.4, rm.40346 Lubliana str.1618 SofiaBulgaria
3.	Telephone No:Fax:	+359 878 350 021
4.	Date Prepared:	April 28, 2011
5.	Trade Name:	X12 Sterile Reflective Marker Sphere
6.	Common Name:	Disposable Reflective Marker Sphere
7.	Classification Name:	Neurological Stereotaxic InstrumentOrthopedic Stereotaxic Instrument

X12's Sterile Reflective Marker Spheres are substantially 8. Predicate Devices: equivalent to those legally marketed by BrainLAB AG, Norhern Digital Inc. and ILUMARK GmbH (see table, below). This is based upon their intended use, design and materials of construction.

Name	Common Name	Product Code	510(k) Number	Date
BrainLAB AG	Disposable ReflectiveMarker Spheres	HAW, OLO	K100038	July 14, 2010
Northern Digital	NDI Passive Spheres	HAW	K033621	January 27, 2004
ILUMARK GmbH	Navigation Marker	HAW, OLO	K103192	February 7, 2011

Device Description: 9.

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predicate devices. The spheres are individually packaged in a special sterile package and are gamma sterilized.

10. Indications For Use:

Passive Retro-Reflective Markers, disposable, used as an accessory to aid in the autoregistration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.

l ] . Performance Testing:

X12's Sterile Reflective Marker Spheres were tested to verify their retro-reflectivity in comparison to the predicate devices. Both the polar and equatorial views showed retroreflectivity that was equivalent to the predicate devices.

A water soak test was conducted to show that the markers maintain there mechanical properties after being soaked in water. A surface abrasion test was performed which showed that the surface durability was substantially equivalent to the predicate devices.

12. Sterilization:

X12's Sterile Reflective Marker Spheres are inserted (6 each), in special "made for sterilization" plastic shells which are sealed in a nitrogen environment in plastic sterilization packets. Each packet is inserted in a box and is gamma sterilized in a carton containing 50 boxes. Each box is printed with pertinent labeling which includes the date of manufacture, expiration date, manufacturer batch and sterilization lot numbers and the manufacturer's name and address, as well as instructions for use.

13. Conclusion:

Based on the available 510 (K) summaries and statements and the information provided here, we conclude that X12's Sterile Reflective Marker Spheres are substantially equivalent to the predicate devices which are legally marketed in the United States under the FDA regulations.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MIJ 20993-0002

Pinsco Inc. dba B & L Engineering % Mr. Lee A. Barnes 1901 Carnegie Avenue, Suite Q Santa Ana, California 92705

SEP 29 201

Re: K111443

· Trade/Device Name: X12 Sterile Reflective Marker Sphere Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Requlatory Class: Class II Product Code: OLO, HAW Dated: September 07, 2011 Received: September 12, 2011

Dear Mr. Barnes:

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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Lee A. Barnes

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 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.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.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/MedicalDevices/Safetv/ReportalProblem/default.htm for the CDRH3'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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K111443

Device Name: X12 STERILE REFLECTIVE MARKER SPHERE

Indications for Use:

Used as an accessory to aid in the auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number K111443

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Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).