The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.

Device Description

The SAMBA screw is a cannulated metallic bone screw designed to stabilize the sacroiliac (SI) joint. The SAMBA screw is composed of implant-grade Titanium, Ti-6Al-4V ELI, conforming to ASTM F-136. The SAMBA screw is 9 mm in diameter and offered in 25-50 mm lengths with multiple longitudinal slots on its shaft. Each slot set consists of four (4) holes oriented 90 degrees apart around the circumference of the screw at specified axial location. It will be provided as sterile, single units packaged in a sealed tray and pouch. The screw is a single use device and is not intended to be resterilized.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with acceptance criteria in the way a diagnostic AI product might. Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, MRMC study, ground truth for training set) are not applicable or not provided in this type of document.

The document primarily describes mechanical testing for the device's functional and performance requirements.

Here's a breakdown of the information that can be extracted or noted as not applicable:

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

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Functional & Performance Requirements	Device design meets functional and performance requirements.	Representative samples underwent mechanical testing. The results imply that the device met these requirements, as the conclusion states substantial equivalence. Specific thresholds are not listed in this summary.
Static Axial Pull Out Strength	Measured in accordance with ASTM F2193-02 (2007) and F543-07.	Testing was performed as per ASTM F2193-02 (2007) and ASTM F543-07. Specific numerical results are not provided in this summary.
Static Torsion	Measured in accordance with ASTM F2193-02 (2007) and F543-07.	Testing was performed as per ASTM F2193-02 (2007) and ASTM F543-07. Specific numerical results are not provided in this summary.
Static Cantilever Bending	Measured in accordance with ASTM F2193-02 (2007) and F543-07.	Testing was performed as per ASTM F2193-02 (2007) and ASTM F543-07. Specific numerical results are not provided in this summary.
Dynamic Cantilever Bending	Measured in accordance with ASTM F2193-02 (2007) and F543-07.	Testing was performed as per ASTM F2193-02 (2007) and ASTM F543-07. Specific numerical results are not provided in this summary.
Material Composition	Implant-grade Titanium, Ti-6Al-4V ELI, conforming to ASTM F-136.	The SAMBA screw is composed of implant-grade Titanium, Ti-6Al-4V ELI, conforming to ASTM F-136.

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

Sample Size: Not specified for the mechanical testing, but refers to "representative samples." This document does not describe a clinical "test set" in the context of an AI/diagnostic device.
Data Provenance: The mechanical testing is laboratory-based, not patient-data based.

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)

Not Applicable: This is a hardware device (bone screw) undergoing mechanical testing, not a diagnostic AI product requiring expert-established ground truth from images or clinical data.

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

Not Applicable: As above, this is mechanical testing, not a diagnostic study with a test set requiring adjudication.

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

Not Applicable: This is a hardware implant, not an AI or diagnostic imaging device.

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

Not Applicable: This is a hardware implant.

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

Not Applicable (in the clinical/diagnostic sense): For this device, the "ground truth" for compliance would be the established engineering and materials standards (ASTM F2193-02, ASTM F543-07, ASTM F-136) that the device must meet through mechanical testing.

8. The sample size for the training set

Not Applicable: There is no "training set" in the context of a hardware device undergoing mechanical testing.

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

Not Applicable: There is no "training set" for this type of device submission.

Summary

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. K121148

510(k) Summary .

AUG 200 2012

Submitter:	Medical Designs LLC6709 S. Minnesota Ave. Suite 204Sioux Falls, SD 57108-2593
Contact Person:	Kristi VondraVice President of OperationsTelephone: (605) 275-1032Fax: (605) 335-3734e-mail: kvondra@medicaldesignsllc.com
Date Prepared:	April 13, 2012
Trade Name:	SAMBA™ Screw System
Classification:	Class II, Smooth or threaded metallic bone fixation fastener (21CFR 888.3040)
Product Code:	HWC, OUR
Predicate Device(s):	The subject device is equivalent to the following devices:• Synthes 6.5mm Cannulated Screw (K021932)• SI-LOK Sacroiliac Joint Fixation System (K112028)
Device Description:	The SAMBA screw is a cannulated metallic bone screwdesigned to stabilize the sacroiliac (SI) joint. The SAMBAscrew is composed of implant-grade Titanium, Ti-6Al-4V ELI,conforming to ASTM F-136. The SAMBA screw is 9 mm indiameter and offered in 25-50 mm lengths with multiplelongitudinal slots on its shaft. Each slot set consists of four (4)holes oriented 90 degrees apart around the circumference of thescrew at specified axial location. It will be provided as sterile,single units packaged in a sealed tray and pouch. The screw is asingle use device and is not intended to be resterilized.
Intended Use:	The SAMBA™ Screw System is intended for fixation ofsacroiliac joint disruptions. This fixation device is to only beused in skeletally mature patients.
Functional andSafety Testing:	To verify that device design met it's functional and performancerequirements, representative samples of the device underwentmechanical testing for static axial pull out strength, statictorsion, static cantilever bending, and dynamic cantileverbending in accordance with the following standards:• ASTM F2193-02 (2007) Standard Specifications andTest Methods for Components Used in the SurgicalFixation of the Spinal Skeletal System• ASTM F543-07 Standard Specification and TestMethods for Metallic Medical Bone Screw
Conclusion:	Medical Designs considers the SAMBA Screw System to beequivalent to the predicate device listed above. This conclusionis based upon the devices' similarities in principles of operation,technology, materials and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

AUG 2 0 2012

Medical Designs, LLC. % Kristi Vondra Vice President of Operations 6709 S. Minnesota Ave. Suite 204 Sioux Falls, South Dakota 57108-2593

Re: K121148

Trade/Device Name: SAMBA1M Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, OUR Dated: July 16, 2012 Received: July 19, 2012

Dear Ms. Kristi Vondra:

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. 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.

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Page 2 - Ms. Kristi Vondra

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.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address

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

Sincerely yours,
Mark A. Mulkison

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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K121148

Indications for Use Statement 4.

Device Name: SAMBA™ Screw System

Indications for Use:

The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.

Prescription Use X (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)

A. S

(Division Sign-Off) Division of Surgical, Orthopsdic, and Restorative Devices

510(k) Number K921148

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.