Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures: and intracapsular fractures
· Polytrauma and multiple fractures
· Prophylactic nailing of impending pathologic fractures
· Reconstruction following tumor resection and grafting

Device Description

The TRIGEN INTERTAN 10S Nail System consists of metallic implants including femur nails, leg screw, compression screw, Subtrochanteric lag screw, locking screw, Set Screw, and nail caps.

TRIGEN INTERTAN 10S nail is designed to have a slightly different neck taper from the existing neck design of the predicate TRIGEN INTERTAN 10mm Nail (K040212, SE 02/20/2004). The neck taper of the subject devices has been modified to accommodate the different patient population.

The TRIGEN INTERTAN 10S system is intended to provide a solution for treatment of proximal femoral fractures with one nail product. The INTERTAN nail includes two interlocking screws near the proximal end that form a worm gear, which is designed to provide stability for hip fracture cases.

The subject TRIGEN INTERTAN 10S nails are made of Titanium-6 Aluminum-4 Vanadium (Ti-6Al-4V). The 10S nails are available in both long and short nails. The "S" stands for shey are the smallest diameter nails offered. Design wise, the small diameter and a change to the subject INTERTAN 10S Nail implants are avallable in the 10mm diameter size, with lengths from 18cm to 46cm in 2cm increments, in both 125° or 130° neck angle versions. The INTERTAN 10S nails are single-use and are Gamma sterilized.

AI/ML Overview

The provided text is a 510(k) premarket notification FDA clearance letter for a medical device called the "TRIGEN INTERTAN 10S Nail System." This documentation focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or an AI algorithm's standalone performance.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information for an AI/algorithm-driven device.

The document states:

"No clinical tests were performed to support safety and effectiveness of the subject devices."
"The performance bench tests were used as a basis for the determination of substantial equivalence."

The "acceptance criteria" referred to in the document relate to a pre-market clearance process demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, primarily through bench testing to show similar performance characteristics.

In the context of the provided document, the "study that proves the device meets the acceptance criteria" refers to non-clinical bench tests. These tests assess the mechanical and physical properties of the device, rather than its clinical performance or the performance of an AI algorithm.

Here's what can be extracted from the document, though it won't fulfill all aspects of your request:

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

The document mentions "performance bench tests" but does not provide a table of specific acceptance criteria (e.g., minimum tensile strength, fatigue cycles) or the exact reported device performance values. It generalistically states: "The results of these tests show that the substantially equivalent to the predicate device."

Mentioned Bench Tests:
- Proximal Shaft Fracture Construct Fatigue Testing
- MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013)

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

Sample Size: Not specified for the bench tests.
Data Provenance: Not applicable in the context of clinical data for a 510(k) of this nature. The "data" would be the results of mechanical and material tests conducted on the device components, typically in a lab setting.

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

Not applicable. Ground truth in the context of mechanical bench testing refers to the physical measurements and standards of the materials and device. Expert consensus as you might see in image interpretation for AI is not relevant here.

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

Not applicable. No human interpretation or adjudication method is described for generating "ground truth" for the bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No. The document explicitly states: "No clinical tests were performed to support safety and effectiveness of the subject devices." MRMC studies are clinical studies involving human readers, which were not conducted.

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

No. This device is a physical orthopedic implant, not an AI/algorithm. No algorithm performance was assessed.

7. The type of ground truth used:

Bench Test Results/Standard Specifications: The "ground truth" for demonstrating substantial equivalence for an orthopedic implant through bench testing is typically based on established industry standards (e.g., ASTM standards for mechanical properties) and comparison to the performance of the predicate device.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set was used.

Summary

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August 22, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Smith & Nephew Inc. Hiral Rathod Sr. Regulatory Affairs Specialist 1450 Brooks Rd Memphis. Tennessee 38116

Re: K241804

Trade/Device Name: TRIGEN INTERTAN 10S Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDS, HSB Dated: June 19, 2024 Received: June 21, 2024

Dear Hiral Rathod:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joseph P. Russell Digitally signed by Joseph P. Russell -S -2 Date: 2024.08.22 16:48:52 -04'00"

for: Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241804

Device Name

TRIGEN INTERTAN 10S Nail System

Indications for Use (Describe)

The TRIGEN INTERTAN Nails are indicated for fractures of the femur including:

Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures: and intracapsular fractures
· Polytrauma and multiple fractures
· Prophylactic nailing of impending pathologic fractures
· Reconstruction following tumor resection and grafting

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k)

Prepared on: 2024-08-22

Contact Details	21 CFR 807.92(a)(1)
-----------------	---------------------

Applicant Name	Smith & Nephew Inc.
Applicant Address	1450 Brooks Rd Memphis TN 38116 United States
Applicant Contact Telephone	901-205-4852
Applicant Contact	Ms. Hiral Rathod
Applicant Contact Email	hiral.rathod@smith-nephew.com

Device Name	21 CFR 807.92(a)(2)
-------------	---------------------

Device Trade Name	TRIGEN INTERTAN 10S Nail System
Common Name	Nail, Fixation, Bone
Classification Name	Single/multiple component metallic bone fixation appliances and accessories
Regulation Number	888.3030
Product Code(s)	JDS

Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
------------------------------------	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K040212	TRIGEN INTERTAN	JDS
K040462	TRIGEN TROCHANTERIC ANTEGRADE NAIL	HSB

Device Description Summary	21 CFR 807.92(a)(4)
----------------------------	---------------------

The TRIGEN INTERTAN 10S Nail System consists of metallic implants including femur nails, leg screw, compression screw, Subtrochanteric lag screw, locking screw, Set Screw, and nail caps.

Intended Use/Indications for Use

for hip fracture cases.

21 CFR 807.92(a)(5)

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The TRIGEN INTERTAN Nails are indicated for fractures of the femur including:

· Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft
fractures, and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures;
ipsilateral femoral shaft/neck fractures; and intracapsular fractures
· Polytrauma and multiple fractures
· Prophylactic nailing of impending pathologic fractures
· Reconstruction following tumor resection and grafting

Indications for Use Comparison

The subject device indications are identical to the predicate indications for use.

Technological Comparison

The subject devices have a different neck taper geometry then the predicate device. The subject INTERTAN 10S nail has a modified, steeper neck taper vs predicate INTERTAN 10mm where the design transitions from a larger, proximal end, to the smaller, distal end diameter.

The overall technological characteristic including device design, and sterilization of the subject devices are similar to that of the predicate Smith & Nephew systems cleared under the premarket notifications TRIGEN INTERTAN (K040212, S.E. 02/20/04) and TRGEN TAN (K040462, 03/23/2004).

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

· Proximal Shaft Fracture Construct Fatigue Testing

· MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013)

No clinical tests were performed to support safety and effectiveness of the subject devices.

The performance bench tests were used as a basis for the determination of substantial equivalence. The results of equivalence testing demonstrate acceptable outcomes. The results of these tests show that the substantially equivalent to the predicate device.

K241804 - Page 2 of 2

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.