All Ortho Solutions Sterile Single-Use Drills Bits are manufactured from common Stainless Steel materials that are either cold-worked or heat treated for hardness cutting durability and for corrosion resistance. Ortho Solutions sterile drill bits are available in various sizes and lengths, have a fluted design, and are either in a solid or cannulated form and may be calibrated. The Ortho Solutions drill bits have various end coupling mechanisms. Ortho Solutions drill bits will be provided to the user 'sterile'. Gamma Radiation will be used to sterilize the device.

AI/ML Overview

The provided 510(k) summary for Ortho Solutions Sterile Drill Bits (K102743) states that the device is substantially equivalent to the Synthes K962913 Sterile Drill Bits. This means that the device's acceptance criteria and the study proving it meets these criteria are based on demonstrating equivalence, rather than a standalone clinical study with detailed performance metrics.

Here's the information extracted from the provided text, recognizing the nature of a 510(k) SE submission:

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

Acceptance Criteria Category	Acceptance Criteria (Implied by SE)	Reported Device Performance (Implied by SE)
Material	Identical to predicate device	Identical to Synthes Sterile Drill Bits
Geometry Design/Markings	Identical to predicate device	Identical to Synthes Sterile Drill Bits
Indications for Use	Identical to predicate device	Identical to Synthes Sterile Drill Bits (Intended use: "to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.")
Sterilization Method	Gamma Radiation	Gamma Radiation used

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

Sample size: Not explicitly stated as a separate test set. The claim of "identical" in material, geometry, and indications implies that the design and manufacturing specifications of the Ortho Solutions drill bits conform to the established characteristics of the predicate device (Synthes K962913). Demonstrating this identity typically involves detailed engineering comparisons and possibly verification testing on a sample of the manufactured devices, rather than a clinical "test set" in the traditional sense of a clinical trial.
Data provenance: Not applicable in the context of a comparative effectiveness study or clinical trial. The data provenance would relate to the manufacturing specifications and design verification documentation of the Ortho Solutions device, showing its equivalence to the predicate. The predicate device's country of origin is not specified, but the manufacturing firm for the new device is based in the United Kingdom.

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

Not applicable. Ground truth as established by experts for a test set (e.g., in an AI or diagnostic device context) is not part of this type of 510(k) submission. The "truth" here is the equivalence to the predicate device, which is a regulatory and technical assessment.

4. Adjudication method for the test set:

Not applicable. There was no clinical "test set" requiring adjudication in the context of a clinical trial. The adjudication is regulatory, based on the FDA's assessment of the provided documentation for substantial equivalence.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging) involving human interpretation with or without AI assistance, which is not applicable to a surgical drill bit.

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

No, a standalone (algorithm-only) performance study was not done. This is also relevant for AI/software-as-a-medical-device (SaMD) products, which does not apply to a physical surgical instrument.

7. The type of ground truth used:

The "ground truth" in this context is the identity and performance characteristics of the predicate device (Synthes Sterile Drill Bits, K962913). The Ortho Solutions device's performance is demonstrated to be equivalent to this established standard. This is based on a technical and regulatory comparison, rather than pathology, expert consensus on clinical cases, or outcomes data from the new device itself.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for physical surgical instruments in this type of 510(k) submission. Training sets are relevant for machine learning algorithms.

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

Not applicable, as there is no training set.

Summary

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pg lofz

Ortho Solutions Limited - K102743 510(k) Summary:

JAN 2 0 2011

ﻟﺴﺘ

510(k) Summary of Safety and Effectiveness

SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

510(K) Summary

Ortho Solutions Limited NAME OF FIRM: West Station Buisness Park Spital Road Maldon ESSEX, CM9 6FF United Kingdom 510(k) FIRM CONTACT: Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200th St. Prior Lake, MN 55372 Telephone No: 952-492-5858 E-mail: allippincott@msn.com September 13, 2010 DATE: Ortho Solutions Sterile Drill Bits TRADE NAME: Sterile Single-Use - Drill Bits COMMON NAME: CLASSIFICATION: Surgical instrument motors and accessories/attachments (see 21 CFR Sec. 878.4820) DEVICE PRODUCT CODE: HWE GFF, HSZ, GFA SUBSEQUENT PRODUCT CODE:
Synthes Sterile Drill Bits (K962913) SUBSTANTIALLY EQUIVALENT DEVICES

All Ortho Solutions Sterile Single-Use Drills Bits are manufactured DEVICE DESCRIPTION: from common Stainless Steel materials that are either cold-worked or heat treated for hardness cutting durability and for corrosion resistance. Ortho Solutions sterile drill bits are available in various sizes and lengths, have a fluted design, and are either in a solid or cannulated form and may be calibrated. The Ortho Solutions drill bits have various end coupling mechanisms. Ortho Solutions drill bits will be provided to the user 'sterile'. Gamma Radiation will be used to sterilize the device.

INTENDED USE: Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

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' pg 2 of 2

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Ortho Solutions Limited - K102743 510(k) Summary:

The Ortho Solutions Sterile Drill Bits are Substantially Equivalent EQUIVALENCE: (SE) to the Synthes K962913 Sterile Drill Bits.

SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS

The Ortho Solutions Sterile Drill Bits are identical in Material, Geometry Design/Markings, and Indications to the Synthes Sterile Drill Bits.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.

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

Ortho Solutions Limited % Engineering Consulting Services, Inc. Mr. Al Lippincott 3150 East 200th Street Prior Lake, Minnesota 55372

JAN 2 0 201

Re: K102743

Trade/Device Name: Ortho Solutions Sterile Drill Bits Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: Class II Product Code: HWE, GFF, HSZ, GFA Dated: December 20, 2010 Received: December 27, 2010

Dear Mr. Lippincott:

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 misJeading.

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

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Page 2 - Mr. Al Lippincott

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Mello

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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Image /page/4/Picture/0 description: The image shows the text "ORTHO (S) SOLUTIONS". The word "ORTHO" is in all caps and is followed by a large, bold "S" enclosed in a circle. The word "SOLUTIONS" is also in all caps and is placed after the circled "S". The font appears to be a serif typeface.

West Station Business Park, Spital Road, Maldon, Essex CM9 6FF Tel: 0870 7777515 Fax: 0870 7777525 Email: sales@orthosol.com www.orthosolutions.com

pg. 1 of 1

Indications for Use

510(k) NUMBER: K102743

DEVICE NAME: Ortho Solutions Sterile Drill Bits

INDICATIONS FOR USE:

Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

Mildredle firmxn

(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K|02743

Prescription Use ×

AND/OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

(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)

Registered Office: West Station Business Park, Spital Road, Maldon, Essex CM9 6FF Registered in England No: 4311933

Regulation Number and Section

§ 878.4820 Surgical instrument motors and accessories/attachments.

(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.