The Smith & Nephew Cannulated Captured Screw is intended for use for internal bone fixation including fractures of the tibia, fibula, clavicle, scapula, olecranon, metacarpals, metatarsals, humerus, ulna, middle hand bones, middle foot bones, and calcaneous. Screws are additionally intended for arthrodeses and osteotomies of small bones and small joints including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, clavicle, scapula, olecranon, ulnar styloid, radial head, and radial styloid.

Device Description

The Smith & Nephew Cannulated Captured Screw is used during the healing period of osteotomies for orthopedic reconstruction and to assist in the management of fracture fixation. The device consists of a titanium alloy or stainless steel fixation device. This device is provided sterile, for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the Smith & Nephew Cannulated Captured Screw, focusing on acceptance criteria and the study conducted:

The provided documents describe a 510(k) premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical trials to establish new safety and efficacy data. Therefore, the "study" described herein is primarily mechanical testing to prove equivalence, not a clinical study involving human subjects or AI performance.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Insertion Torque	Meet or exceed performance of the predicate device.	"demonstrates the device has met the performance specifications for the torsional, and compression capabilities of the Smith & Nephew Cannulated Captured Screw" (implicitly meeting or exceeding predicate performance for substantial equivalence).
Pull-out Strength	Meet or exceed performance of the predicate device.	"demonstrates the device has met the performance specifications for the torsional, and compression capabilities of the Smith & Nephew Cannulated Captured Screw" (implicitly meeting or exceeding predicate performance for substantial equivalence).
Static Torsional Strength	Meet or exceed performance of the predicate device.	"demonstrates the device has met the performance specifications for the torsional, and compression capabilities of the Smith & Nephew Cannulated Captured Screw" (explicitly mentioning torsional capabilities).
Three-point Bend Fatigue	Meet or exceed performance of the predicate device.	"demonstrates the device has met the performance specifications for the torsional, and compression capabilities of the Smith & Nephew Cannulated Captured Screw" (implicitly meeting or exceeding predicate performance for substantial equivalence, ensuring durability under bending).
Overall Performance for Substantial Equivalence	Demonstrated to be substantially equivalent to the predicate device (Arthrex, Inc. Low Profile Screws, K103705) in intended use and fundamental scientific technology.	"it is considered substantially equivalent to the currently marketed predicate device." and "Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate device."

Explanation of Implied Acceptance Criteria: For 510(k) submissions, the primary "acceptance criterion" for mechanical testing is that the new device performs at least as well as or is equivalent to the predicate device in relevant mechanical properties. The text explicitly states "demonstrates the device has met the performance specifications," which are understood to be established in comparison to the predicate.

Study Details (Mechanical Testing for Substantial Equivalence)

Given that this is a 510(k) for a traditional medical device, not an AI/software device, many of the requested items (sample size for test set, data provenance, number of experts for ground truth, MRMC study, AI performance) are not applicable. The "study" here refers to pre-clinical mechanical testing.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not specified in the provided documents. Mechanical testing typically involves a set number of samples per test type (e.g., n=5 or n=10 per test) to ensure statistical significance, but the exact numbers are not detailed here.
Data Provenance: The testing was conducted by Smith & Nephew, Inc. It's a prospective series of tests performed on newly manufactured devices. There's no geographical "data provenance" in the clinical sense, as it's laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not Applicable. This is pre-clinical mechanical testing, not a study requiring expert clinical interpretation for ground truth. "Ground truth" here is the empirically measured mechanical performance of both the new device and the predicate device. Engineers and materials scientists within Smith & Nephew would have designed and conducted these tests, comparing results to established standards and the predicate's performance.

4. Adjudication Method for the Test Set

Not Applicable. Again, this is mechanical testing. Adjudication methods like "2+1" typically apply to clinical image interpretation or diagnostic performance where human disagreement needs resolution. The "adjudication" in this context would be the objective measurement against pre-defined test methodologies and comparison criteria.

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. This is not an AI-assisted device; it is a physical bone fixation screw. Therefore, no MRMC study or AI-related performance metrics are relevant or applicable.

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

No. This is not an AI algorithm. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

Empirical Mechanical Measurements: The ground truth for this mechanical testing is the objectively measured physical properties (insertion torque, pull-out strength, static torsional strength, three-point bend fatigue) of the Smith & Nephew Cannulated Captured Screw and, presumably, equivalent measurements of the predicate device. This data is compared against established performance specifications and the predicate's known performance.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of mechanical testing for a physical medical device. This term applies to machine learning models.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, there is no ground truth for it.

Summary

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MAY 1 5 2014

K133662

Page 1 of 2

> We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division150 Minuteman RoadAndover, MA 01810
Date of Summary:	May 12, 2014
Contact Person and Address:	Katherine MarcaccioRegulatory Affairs Specialist IIT (508) 261-3602F (978) 749-1443
Name of Device:	Smith & Nephew Cannulated Captured Screw
Common Name:	Screw, Fixation, Bone
Device Classification Name andReference:	21 CFR 888.3040 Smooth or threaded metallicbone fixation fastener
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HWC

Device Description

Indications for Use

Technological Characteristics

The Smith & Nephew Cannulated Captured Screw is substantially equivalent in design and fundamental scientific technology to the defined predicate device and does not raise any new issues of safety and efficacy.

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K133662

Performance Data

Mechanical testing, including insertion torque, pull-out strength, static torsional strength, and three-point bend fatigue testing, demonstrates the device has met the performance specifications for the torsional, and compression capabilities of the Smith & Nephew Cannulated Captured Screw; therefore, it is considered substantially equivalent to the currently marketed predicate device.

Substantial Equivalence Information

The Smith & Nephew Cannulated Captured Screw is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed predicate device:

Table 1: Substantially Equivalent Predicate to the Cannulated Captured Screw

Manufacturer	Description	SubmissionNumber	Clearance Date
Arthrex, Inc.	Low Profile Screws	K103705	3/18/2011

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Smith & Nephew Cannulated Captured Screw. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 15, 2014

Smith & Nephew, Incorporated Ms. Katherine Marcaccio Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810

Re: K133662

Trade/Device Name: Smith & Nephew Cannulated Captured Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 14, 2014 Received: April 15, 2014

Dear Ms. Marcaccio:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Katherine Marcaccio

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 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/ReportalProblem/dcfault.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.

Ronald.P. Jean -S for

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

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Premarket Notification Indications for Use Statement

ﺴﺮﺓ

510(k) Number (if known): K133662

Device Name: Smith & Nephew Cannulated Captured Screw

Indications for Use:

Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _ 1 -

Elizabeth புதுank -S

Division of Orthopedic Devices

· Exhibit 2-2

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.