SURESHOT™ TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.

In addition, SURESHOT™ TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.

SURESHOT™ TAN Nails and Accessories are for single use only.

Device Description

The subject devices are comprised of intramedullary nails and accessories such as lag screws, compression screws and set screws for use in the femur. All described components are manufactured from titanium material. The subject devices are available in the following size ranges:

Device Type	Available Range of Diameters	Available Length Range
Nails	9mm - 13mm	32cm - 42cm
Lag Screws	8.64mm (one diameter only)	70mm - 125mm
Compression Screws	6.22mm (one diameter only)	30mm - 120mm
Set Screws	6.6mm (one diameter only)	25.4mm - 39.3mm

AI/ML Overview

The provided 510(k) summary for the SURESHOT™ TAN Nails and Accessories describes a medical device for femoral fracture treatment. However, it does not include information about acceptance criteria or a study designed to prove the device meets specific performance metrics in the way that an AI/software device would.

This document pertains to a Class II medical device (intramedullary nails and accessories), which typically undergo different types of testing and approval processes compared to AI/ML-driven software as a medical device (SaMD). The evaluation for such devices often focuses on:

Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparisons of indications for use, material composition, and technological design characteristics.
Pre-clinical Testing: Mechanical testing (e.g., fatigue, pullout strength) to ensure the device can withstand the physiological loads it will experience.
Biocompatibility Testing: Ensuring the materials are safe for implantation.

Therefore, the specific questions regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of device accordingment to the provided text.

Here is a summary of the information that is available in relation to your questions, highlighting what is not applicable:

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

Acceptance Criteria (N/A for this device type)	Reported Device Performance (N/A for this device type)
Not defined in the provided document.	Not defined in the provided document.

Explanation: The document does not specify quantitative acceptance criteria for clinical performance metrics (like sensitivity, specificity) as would be expected for a diagnostic or AI device. The "performance" discussed is primarily related to mechanical properties and comparison to predicate devices.

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

Not Applicable: This type of information (sample size, data provenance, retrospective/prospective) is typically relevant for clinical studies or AI algorithm validation. For this orthopedic implant, the "testing" involved pre-clinical mechanical evaluations. The document does not mention any clinical test sets with human subjects or associated data provenance.

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: Ground truth establishment by experts is not described, as there is no clinical test set or diagnostic task presented in the 510(k) summary.

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

Not Applicable: No clinical test set or adjudication method is described.

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: MRMC studies are used for evaluating diagnostic performance, often with AI assistance. This is an orthopedic implant, and no such study is mentioned or relevant to its 510(k) clearance process described here.

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

Not Applicable: There is no algorithm or AI component in this device, so standalone performance is irrelevant.

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

Not Applicable: As there is no diagnostic or AI component, the concept of "ground truth" for classification or diagnosis is not discussed. For mechanical testing, the "ground truth" would be the engineering specifications and material properties against which the device's physical performance (e.g., fatigue life, pullout strength) is measured, often by comparison to predicate devices.

8. The sample size for the training set

Not Applicable: There is no AI/ML model described that would require a training set.

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

Not Applicable: No training set or associated ground truth establishment is mentioned.

Summary of the Study that Proves the Device Meets the Acceptance Criteria (Based on Provided Document):

The "study" described in the 510(k) summary to establish substantial equivalence (which serves as the "acceptance criteria" for this type of device) primarily consisted of:

Comparison to Predicate Devices: The SURESHOT™ TAN Nails and Accessories were compared to several legally marketed predicate devices (TriGen™ Titanium Intramedullary Nail System, TriGen™ InterTAN Nail, TriGen™ Trochanteric Antegrade Nail, TriGen™ Meta-Nails Retrograde Femoral and Tibia Nails, Asian Intramedullary Hip Screw (IMHS), T2 Femoral Nail). The comparison focused on:
- Overall indications for use: The new device shares "very similar indications" with predicates.
- Material composition: Manufactured from identical titanium material as predicates.
- Technological design characteristics: Incorporated "very similar technological design characteristics" to predicates.
Pre-clinical Testing: To further support substantial equivalence, the following pre-clinical tests were conducted:
- Finite Element Analysis (FEA): A computational method to predict how a product reacts to real-world forces, vibration, heat, fluid flow, and other physical effects.
- Construct Fatigue Testing: Evaluation of a nail construct with appropriate accessory devices to determine its resistance to cyclic loading over time, simulating physiological conditions.
- Axial Pullout Testing: Assessment of the force required to pull out the lag screw from an appropriate test medium, indicating fixation strength.

The document states that substantial equivalence was based on these similarities and pre-clinical tests, implying that the results of these tests demonstrated comparable performance to the predicate devices and met general engineering and safety standards for such implants. The specific numerical results or detailed acceptance thresholds for these pre-clinical tests are not provided in this summary.

Summary

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K092748

510(k) Summary of Safety and Effectiveness SURESHOT™ TAN Nails and Accessories

Submitted By:	Smith & Nephew, Inc.Orthopaedics1450 Brooks RoadMemphis, TN 38116	APR 8 3 2010
Date:	September 4, 2009
Contact Person:	David Henley, Regulatory Affairs Project ManagerTel: (901) 399-6487 Fax: (901) 398-5146
Proprietary Name:	SURESHOT™ TAN Nails and Accessories
Common Name:	Intramedullary Nails and Accessories
Classification Name and Reference:	21 CFR 888.3030, Single/multiple component metallbone fixation appliances and accessories - Class II
Device Product Code and Panel Code:	JDS / Orthopedics / 87

Device Description:

Device Type	Available Range of Diameters	Available Length Range
Nails	9mm - 13mm	32cm - 42cm
Lag Screws	8.64mm (one diameter only)	70mm - 125mm
Compression Screws	6.22mm (one diameter only)	30mm - 120mm
Set Screws	6.6mm (one diameter only)	25.4mm - 39.3mm

Intended Use:

Technological Characteristics:

Components comprising SURESHOT™ TAN Nails and Accessories are very similar to legally marketed devices listed below in that they share very similar indications for use (compared to devices cleared under K981529, K040212, K040462, K061019, K050226 and K010801), are manufactured from identical material, and incorporate very similar technological design characteristics.

p. 1 of 2

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Substantial Equivalence Information:

When compared to the predicate devices listed below, substantial equivalence is based on similarities with regard to overall indications for use, material composition, and technological design characteristics.

Titanium Nail System (TriGen™ Titanium Intramedullary Nail System) K981529
· TriGen™ InterTAN Nail K040212
· TriGen™ · Trochanteric Antegrade Nail K040462
· TriGen™ Meta-Nails Retrograde Femoral and Tibia Nails K061019
· Asian Intramedullary Hip Screw (IMHS) K050226
· T2 Femoral Nail (Stryker/Howmedica/Osteonics Corp.) K010801

To further support a determination of substantial equivalence, various types of pre-clinical testing were conducted on the subject devices in comparison against one or more of the previously cleared predicate devices described above. The types of pre-clinical testing included: finite element analysis, construct fatigue testing of a nail construct with appropriate accessory devices and axial pullout testing of the lag screw from appropriate test media.

p. 2 of 2

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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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, and a small, curved line that forms the head.

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

APR 2 3 2010

Smith and Nephew Inc. % Mr. David Henley Regulatory Affairs Project Manger 1450 Brooks Road Memphis, Tennessee 38116

Re: K092748

Trade/Device Name: SURESHOT™ TAN Nails and Accessories Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB, HWC Dated: February 24, 2010 Received: February 25, 2010

Dear Mr. Henley:

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 - Mr. David Henley

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/AboutFl)A/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/ReportalProblem/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,

Chubur Budup

Mark N. Melkers VDirector Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications for Use Statement

K092748 510(k) Number (if known): __

Device Name: SURESHOT™ TAN Nails and Accessories

Indications for Use:

SURESHOT™ TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; bono naotaroo, covery connytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; imponding patifores; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.

In addition, SURESHOT™ TAN Nails contain holes/slots proximally to accept screws that in addition, OOT(2017) head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.

SURESHOT™ TAN Nails and Accessories are for single use only.

AND/OR Over-the-Counter Use Prescription Use XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Onetu for mxn
(Division Sign 20)

Division Sign-Q Division of Surgical. Orthopedic. and Restorative Devices

510(k) Number K092748

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.