The OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.

Device Description

The OSTEOMED Cannulated Screw System is comprised of screws and washers used for bone fixation of the hand and foot following trauma or osteotomy. The System features cannulated screws in the following dimensions:

2.0mm screw diameter - 6mm to 42mm screw length;

2.4mm screw diameter - 6mm to 52mm screw length;

3.0mm screw diameter - 10mm to 40mm screw length;

3.5mm screw diameter - 12mm to 52mm screw length;

4.0mm screw diameter - 12mm to 52mm screw length;

5.5mm screw diameter - 12mm to 52mm screw length;

6.5mm screw diameter - 20mm to 120mm screw length;

8.0mm screw diameter - 30mm to 140mm screw length;

The implants (screws and washers) of the OsteoMed Cannulated Screw System are made from Titanium alloy (ASTM F-136). Modifications to screws and washer of the subject system include redesign of the 4.0mm cannulated screw to increase the strength of the lag portion and addition of a 3.0mm diameter cannulated screw and washer.

The system instruments include depth gauges, screw drivers, drills, countersinks, k-wires, and preparation instruments to facilitate the placement of screws. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.

AI/ML Overview

The provided text describes a Special 510(k) Summary for the OsteoMed Cannulated Screw System. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not detail a study proving the device meets acceptance criteria in the same way a diagnostic AI device would. Instead, it focuses on demonstrating equivalence to existing devices through performance testing.

Here's an analysis based on the provided text, addressing your questions to the best extent possible given the nature of the document:

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

The document states that the 3.0mm and 4.0mm cannulated screws underwent "verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use." It also says, "A performance comparison was performed and verified that the cannulated screws met required mechanical strength criteria for their intended use compared to the legally marketed predicate device and reference device listed in this summary."

However, the specific "required mechanical strength criteria" (i.e., the acceptance criteria) and the particular "reported device performance" values are not explicitly detailed in the provided text. The text only mentions that the criteria were met.

Therefore, a table cannot be fully constructed from the provided information.

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

The document mentions "verification evaluation" and "performance comparison" for the 3.0mm and 4.0mm cannulated screws. This implies a test set of physical screws was used. However, the sample size (number of screws tested) is not specified.

Regarding data provenance, the testing would have been conducted by OsteoMed, likely in-house or by a contracted lab. This would be prospective mechanical testing of newly manufactured devices. The country of origin for the data is not specified but is implicitly associated with OsteoMed (Addison, Texas, USA).

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

This question is not applicable in the context of this device. The OsteoMed Cannulated Screw System is a physical medical implant (bone screw). Its performance is evaluated through mechanical testing, not by expert interpretation of data or images. Therefore, clinical experts are not used to establish a "ground truth" for its mechanical performance.

4. Adjudication method for the test set

This question is not applicable. Since the device's performance is determined by objective mechanical tests (e.g., strength, torque), there's no need for human adjudication of results. The testing would follow established engineering standards and protocols.

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 question is not applicable. The OsteoMed Cannulated Screw System is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance do not apply.

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

This question is not applicable. As stated above, this is a physical medical implant, not an algorithm or AI system.

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

For the mechanical testing performed, the "ground truth" would be objective measurements against established engineering standards or predetermined performance requirements for medical implants. For example, a certain screw might need to withstand a specific torsion force or bending moment. This is a physical, measurable ground truth, not a clinical or pathological one.

8. The sample size for the training set

This question is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context. The manufacturing process involves quality control and established design principles, but not a data-driven training set for an algorithm.

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

This question is not applicable for the reasons outlined in point 8.

In summary, the provided document is a regulatory submission for a physical medical device (bone screws) and focuses on demonstrating substantial equivalence through mechanical performance testing to predicate devices, rather than clinical acceptance criteria or AI study data. The document states that the devices met required mechanical strength criteria, but the specific numerical criteria and results are not included in this summary.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like figure with three heads, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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

July 15, 2015

Osteomed Corp. Mrs. Piedad Peña Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001

Re: K151021

Trade/Device Name: Osteomed Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 16, 2015 Received: June 17, 2015

Dear Mrs. Peña:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K151021 (page 1/1)

Device Name: OsteoMed Cannulated Screw System

Indications for Use:

The OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.

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)

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Image /page/3/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in large, bold letters. The word "Osteo" is in blue, and the word "Med" is in gray. The logo is surrounded by a blue and gray oval shape. The logo is simple and modern, and it is likely used to represent a medical company.

Special 510(k) Summary

Name of Submitter:	OsteoMed3885 Arapaho RoadAddison, Texas 75001Phone: (972) 677-4600Fax: (972) 677-4601
Contact Person:	Piedad Peña
Date Prepared:	July 8, 2015
Device Proprietary Name:	OsteoMed Cannulated Screw System
Device Common Name:	Cannulated bone screws, washers and associated instruments
Classification Name:	21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener
Product Code:	HWC

Predicate Device: OsteoMed Extended 2.0/2.4 Cannulated Screw System, K062863 Classification Name: Smooth or threaded metallic fixation fastener (21CFR 888.3040, Product Code HWC) Device Class: II Reference Device: OsteoMed Super Screw System, K954330 Classification Name: Smooth or threaded metallic fixation fastener (21CFR 888.3040, Product Code HWC) Device Class: II

Summary:

Device Description:

2.0mm screw diameter - 6mm to 42mm screw length;

2.4mm screw diameter - 6mm to 52mm screw length;

3.0mm screw diameter - 10mm to 40mm screw length;

3.5mm screw diameter - 12mm to 52mm screw length;

4.0mm screw diameter - 12mm to 52mm screw length;

5.5mm screw diameter - 12mm to 52mm screw length;

6.5mm screw diameter - 20mm to 120mm screw length;

8.0mm screw diameter - 30mm to 140mm screw length;

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Image /page/4/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue line at the top and a gray line at the bottom. The word "OsteoMed" is written in blue and gray inside the oval.

Indications for Use:

The OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.

Technological Characteristics:

The OsteoMed Cannulated Screw System is available in a variety of sizes and is recommended for bone fixation in the hand and foot.

Cannulated Screw System implants (screws and washers) are manufactured from Titanium alloy (ASTM F-136), the same materials used in the manufacture of the predicate devices. This material is biocompatible.

Performance/Clinical Data:

The OsteoMed Cannulated Screw System was compared to the reference device, OsteoMed Super Screw System (K954330), and predicate device, OsteoMed Extended 2.0/2.4 Cannulated Screw System (K062863). The 3.0mm and 4.0mm cannulated screws underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use. The intended use of the OsteoMed Cannulated Screw System is the same as OsteoMed Extended 2.0/2.4 Cannulated Screw System (K062863).

Performance equivalence was shown through the verification comparison to the predicate device and reference device.

Clinical testing is not required to support substantial equivalence.

Substantial Equivalence:

The basis of substantial equivalence for this device, OsteoMed Cannulated Screw System, is based on similarities in intended use, material, function, performance, design, technology, sterilization, and operational principles to the predicate device, OsteoMed Extended 2.0/2.4 Cannulated Screw System (K062863). A performance comparison was performed and verified that the cannualated screws met required mechanical strength criteria for their intended use compared to the legally marketed predicate device and reference device listed in this summary. OsteoMed believes that the non-clinical tests demonstrate that the device is as safe, and effective as the predicate device.

OsteoMed 3885 Arapaho Road Addison. Texas 75001 (973) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779

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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.