Mono or Bi-Cortical osteotomies in the foot or hand
Distal or Proximal metatarsal or metacarpal osteotomies
Weil osteotomy
Fusion of the first metatarsophalangeal joint and interphalangeal joint
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
Akin type osteotomy
Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
Calcaneus/ cuboid arthrodesis
Talar/ navicular arthrodesis

Device Description

The DARCO® Headless Compression Screw is manufactured from Titanium Alloy conforming to ASTM F136. The screws are offered in varying overall lengths and thread lengths to accommodate variability among patients.

AI/ML Overview

This document, K080850, is a 510(k) summary for the DARCO® Headless Compression Screw. This type of submission is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

Crucially, this document does not describe a clinical study with acceptance criteria and device performance results in the way you might expect for a diagnostic or AI-based device.

Instead, the "study" demonstrating the device meets acceptance criteria in a 510(k) for a medical implant like a screw typically involves demonstrating substantial equivalence to a predicate device. This is achieved through:

Design features comparison: Showing the new device has similar design principles to the predicate.
Material information: Confirming the materials used are common, biocompatible, and have established properties (e.g., Titanium Alloy conforming to ASTM F136).
Analysis data: This usually refers to non-clinical, benchtop testing to evaluate mechanical properties (e.g., strength, compression, fatigue) against established standards or in comparison to the predicate device. These tests aim to ensure the device performs its intended function safely and effectively within expected physiological loads.

Therefore, many of your requested items for AI/diagnostic studies are not directly applicable to this type of submission. I will answer what is inferable from the document and explicitly state when information is not present.

1. Table of acceptance criteria and the reported device performance

This document does not contain a table of acceptance criteria and reported device performance in the context of a clinical study or performance metrics for a diagnostic algorithm. For a 510(k) for a surgical implant, the "acceptance criteria" are typically met by demonstrating that the device is substantially equivalent to a predicate device through:

Material conformity: The device uses Titanium Alloy conforming to ASTM F136. This is a common and accepted material for medical implants, implicitly meeting acceptance for biocompatibility and mechanical properties as per the standard.
Design similarities: The design features are stated to be "substantially equivalent" to a previously cleared predicate device.
Performance via analysis data: "Analysis data" is mentioned as supporting safety and effectiveness. This would refer to non-clinical tests (e.g., mechanical testing, biocompatibility testing) that demonstrate the device performs as intended and meets relevant engineering and safety standards, comparable to the predicate. Specific numerical criteria or results are not provided in this summary.

Acceptance Criteria (Inferred for Mechanical Implant)	Reported Device Performance (Inferred from Substantial Equivalence Claim)
Material meets recognized standards for medical implants (e.g., ASTM F136 for Titanium Alloy).	Manufactured from Titanium Alloy conforming to ASTM F136.
Design features are comparable to a legally marketed predicate device and support the stated indications for use.	Design features are "substantially equivalent to previously cleared predicate device."
Mechanical performance (e.g., strength, compression, fatigue) is sufficient for intended use and comparable to predicate, as demonstrated by non-clinical analysis.	Safety and effectiveness are "adequately supported by the substantial equivalence information, materials information, and analysis data." (Specific numerical results from these analyses are not provided in this summary, but would have been part of the full 510(k) submission and compared against internal or standard acceptance limits. The FDA's clearance indicates these were met.)

Regarding the Absence of Information for AI/Diagnostic Study Elements:

The following items are not applicable or findable in this 510(k) summary because it is for a physical medical implant (a screw), not a diagnostic device or an AI-based system. Therefore, details about test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not relevant to this submission.

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 is a physical implant, not a diagnostic or AI device that utilizes a test set of data. The "testing" involved non-clinical mechanical and material analyses.

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: No clinical test set with ground truth established by experts is mentioned for this device. Ground truth, in a sense, would be conformance to engineering standards.

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

Not Applicable: No clinical test set requiring adjudication is mentioned.

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: This device is a surgical screw, not an AI-assisted diagnostic tool.

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

Not Applicable: This device is a surgical implant; there is no algorithm or standalone performance in this context.

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

Not Applicable in the traditional sense: For this device, "ground truth" for demonstrating safety and effectiveness involves compliance with material standards (ASTM F136), mechanical testing results (which would typically be compared to established benchmarks or predicate device performance), and successful demonstration of substantial equivalence to a predicate device.

8. The sample size for the training set

Not Applicable: There is no "training set" for a physical medical implant.

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

Not Applicable: As there is no training set, this question is not relevant.

Summary

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K080850 pg lot 2

510(K) SUMMARY APR 1 0 2008 OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the DARCO® Headless Compression Screw.

Submitted By:	Wright Medical Technology, Inc.
Date:	February 28, 2008
Contact Person:	Theresa Leister
	Senior Regulatory Affairs Specialist
Proprietary Name:	DARCO® Headless Compression Screw
Common Name:	Compression Screw
Classification Name and Reference:	21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener - Class II
Device Product Code and Panel Code:	Orthopedics/87/HWC

DEVICE INFORMATION

A. INTENDED USE

The 7.0mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

Fixation of bone fragments, in long bones or small bones fractures .
Fracture management in the foot or hand .
Arthrodesis in hand, foot or ankle surgery
Mono or Bi-cortical osteotomies in the foot or hand or in long bones
. Treatment of inferior tibio fibular diastasis
. Hindfoot arthrodesis

The 4.3mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

· Mono or Bi-Cortical osteotomies in the foot or hand
· Distal or Proximal metatarsal or metacarpal osteotomies
· Weil osteotomy
· Fusion of the first metatarsophalangeal joint and interphalangeal joint
· Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
· Akin type osteotomy

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Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
· Calcaneus/ cuboid arthrodesis
· Talar/ navicular arthrodesis

B. DEVICE DESCRIPTION

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the DARCO® Headless Compression Screw are substantially equivalent to previously cleared predicate device. The safety and effectiveness of the DARCO® Headless Compression Screw is adequately supported by the substantial equivalence information, matcrials information, and analysis data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Ms. Theresa Leister 5677 Airline Road Arlington, TN 38002

APR 1 0 2008

Re: K080850 Trade/Device Name: DARCO Headless Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 28, 2008 Received: March 26, 2008

Dear Ms. Leister:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Theresa Leister

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: DARCO® Headless Compression Screw

Indications For Use:

The 7.0mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

Fixation of bone fragments, in long bones or small bones fractures ●
Fracture management in the foot or hand ●
Arthrodesis in hand, foot or ankle surgery �
Mono or Bi-cortical osteotomies in the foot or hand or in long bones ●
. Treatment of inferior tibio fibular diastasis
t Hindfoot arthrodesis

The 4.3mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

Mono or Bi-Cortical osteotomies in the foot or hand .
Distal or Proximal metatarsal or metacarpal osteotomies .
Weil osteotomy .
Fusion of the first metatarsophalangeal joint and interphalangeal joint �
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) �
. Akin type osteotomy
Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus . varus primus
Calcaneus/ cuboid arthrodesis .
Talar/ navicular arthrodesis .

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

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

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

Concurrence of G e Evaluation (ODE)

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K080850

1 of 1

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.