The Hydroxyapatite (HA) Coated Lag Screws are used with the Compression Hip Screw Systems and Intramedullary Hip Screw (IMHS) Systems in adult patients for the following indications:
Compression Hip Screws/ IMHS

Intracapular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
Osteotomies for patients with diseases or deformities of the hip.
Hip arthrodesis.
Supracondylar fractures and distal femoral fractures using a supracondylar plate.
Ipsilateral femoral shaft/neck fractures (long IMHS only).
HA Coated Lag Screws are for single use only.

Device Description

HA (Hydroxylapatite) Coated Lag Screws are large metallic screw devices that are used in conjunction with Compression Hip Screw Systems and Intramedullary Hip Screw Systems to obtain purchase inside the femoral head or condyles to help provide support for compression of the fracture. HA Coated Lag Screws are available in various sizes made from either 316L stainless steel or Titanium-6Al-4V metal materials.

AI/ML Overview

The provided text describes a 510(k) summary for HA Coated Lag Screws, which is a medical device submission seeking market clearance based on substantial equivalence to existing devices. This type of submission does not typically involve the rigorous clinical study design, acceptance criteria, and performance metrics as might be seen for devices requiring a PMA (Premarket Approval) or for AI/ML-driven diagnostic devices.

Instead, the submission focuses on demonstrating equivalence through mechanical testing, material comparison, and similarities in indications for use and design features to predicate devices. Therefore, many of the requested categories for AI/ML device studies are not applicable here.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

This 510(k) summary for HA Coated Lag Screws does not define explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic AI tools. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices.

Acceptance Criteria for Substantial Equivalence (Implicit from the text):
The device is considered to meet acceptance criteria if it can demonstrate:

Similar Indications for Use: The HA Coated Lag Screws address the same clinical uses as the predicate devices.
Similar Design Features: The device's design is comparable to the predicate devices.
Similar Operational Principles: The way the device functions is similar to the predicate devices.
Similar Material Composition: The materials used (316L stainless steel or Titanium-6Al-4V) are comparable to those in predicate devices.
Mechanical Equivalence: The device can withstand expected in vivo loading without failure, as indicated by mechanical test data, demonstrating it is "equivalent to devices currently used clinically."

Reported Device Performance:
The text states: "A review of the mechanical test data indicated that the HA Coated Lag Screws are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."

Acceptance Criteria (Derived)	Reported Device Performance
Similar Indications for Use	Confirmed (listed for Compression Hip Screw/IMHS Systems)
Similar Design Features	Confirmed (based on comparison to predicate devices)
Similar Operational Principles	Confirmed (based on comparison to predicate devices)
Similar Material Composition	Confirmed (316L SS or Ti-6Al-4V, comparable to predicates)
Mechanical Equivalence (withstanding in vivo load)	Confirmed ("capable of withstanding expected in vivo loading without failure")

Details Regarding a Study for Device Performance (where applicable)

Given this is a 510(k) for a mechanical implant, the type of "study" is a mechanical test data review, not a clinical trial with human subjects in the way an AI diagnostic device would be evaluated.

Sample Size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of screws or tests, but it refers to "mechanical test data." These tests are typically performed on a statistically relevant number of samples to ensure robust results, but the exact number isn't in the summary.
- Data Provenance: The data is from "mechanical test data," which would be conducted in a laboratory setting by the manufacturer (Smith & Nephew, Inc. Orthopaedic Division). There is no mention of country of origin of clinical data or retrospective/prospective nature, as this is pre-market mechanical testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for mechanical testing. "Ground truth" in this context would be the physical properties and performance measured against engineering specifications and industry standards, not expert clinical consensus. The experts involved would be engineers and materials scientists interpreting the mechanical test results.
Adjudication method for the test set:
- Not applicable. Mechanical testing involves objective measurements rather than adjudication of interpretations.
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. This device is a mechanical implant, not an AI-driven diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm. Performance is assessed on the physical device itself.
The type of ground truth used:
- The "ground truth" for mechanical equivalence is established through objective engineering measurements (e.g., strength, fatigue, torque, pullout force) against predefined specifications and industry standards for similar implant devices. The "equivalence" aspect also relies on comparison to the known mechanical performance of the predicate devices.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires training data.
How the ground truth for the training set was established:
- Not applicable.

Summary of Inapplicability:
It's crucial to understand that the queries primarily relate to the evaluation of AI/ML diagnostic or assistive devices. The provided document concerns a 510(k) submission for a traditional mechanical medical implant (HA Coated Lag Screws). Therefore, most of the questions regarding AI-specific evaluation methodologies (like MRMC studies, ground truth for training/test sets in an AI context, expert readers, etc.) are not relevant to this particular device submission. The device demonstrates safety and effectiveness through mechanical testing and substantial equivalence to legally marketed predicate devices.

Summary

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510(k) Summary of Safety and Effe

Contact Person and Address

MAY - 4 2005 Pate of Summary: April 1, 2005

David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 (901) 399-6487

Name of Device: HA Coated Lag Screws Common Name: Lag Screws

Device Description

Device Classification

21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories - Class II

Mechanical and Clinical Data

A review of the mechanical test data indicated that the HA Coated Lag Screws are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

Indications for Use

The Hydroxyapatite (HA) Coated Lag Screws are used with the Compression Hip Screw Systems and Intramedullary Hip Screw (IMHS) Systems in adult patients for the following indications:

Compression Hip Screws/ IMHS

Intracapular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to 1. select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
1. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
1. Osteotomies for patients with diseases or deformities of the hip.
1. Hip arthrodesis.
Supracondylar fractures and distal femoral fractures using a supracondylar plate. ട്.
Ipsilateral femoral shaft/neck fractures (long IMHS only). 6.

Substantial Equivalence Information

Substantial equivalence of the HA Coated Lag Screw is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices -Smith & Nephew Trauma Internal Fixation System (K993289), Smith & Nephew HA Global Taper Tapered (Synergy) Hip System (K970337), and Smith & Nephew Jet-X HA Coated Half Pins (K033289 and K023921).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2005

Mr. David Henley Senior Regulatory/Clinical Affairs Specialist Smith & Nephew, Inc. Orthopaedics Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K050849

Trade/Device Name: HA Coated Lag Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 1, 2005 Received: April 4, 2005

Dear Mr Henley:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have reviewe a your we determined the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass backed in 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 nu v ooth rot 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 eonly of provisions see, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device to such additional controls. Existing major regulations affecting your device can be may be subject to saon adam 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 r was oo advisor and a determination that your device complies with other requirements of the Act or that 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); an the Ave of equirements) ; good manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 800); gover 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David Henley

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse ough inding of substantial equivalence of your device to a legally premaired notification: "The Privation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D.
Acting Director
Division of General, Restorative
and Neurological Devices

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known): _

HA Coated Lag Screws Device Name:

Indications for Use:

The Hydroxylapatite (HA) Coated Lag Screw is used with the Compression Hip Screw Systems rrie Tyuloxytapulle In A Seated Signers in adult patients for the following indications:

Compression Hip Screws/ IMHS

Intracapular fractures of the femoral neck. (For high subcapsular fractures it may be more 1. infliatapular fractures of the sembled of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
a avascular necrosis or the lombratives with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
Osteotomies for patients with diseases or deformities of the hip. 3.
Hip arthrodesis. 4.
r lip at frirousers: ട്.
ipsilateral femoral shaft/neck fractures (long IMHS only) 6.

HA Coated Lag Screws are for single use only.

Prescription Use(Part 21 CFR 801, 109)	X
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and/or

Over-The-Counter Use(Optional Format 1-2-96)
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(Please do not write Below THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styp Rhodes

Division of Gener A Restorative. and Neurological Devic

510(k) Number K050849

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.