Fixation of fractures in long bones
Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow .
Arthrodesis of the foot, wrist and elbow
A Small and long bone osteotomies

Device Description

The Ascension® Cannulated Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel or titanium. Washers, as well as guide wires, and various orthopedic surgical instruments will be included in the system.

AI/ML Overview

The provided text is a 510(k) summary for the Ascension® Cannulated Screw System, a medical device for bone fixation. It focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with the device itself.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because a 510(k) summary for a Class II device like this typically does not require such detailed clinical study data if substantial equivalence can be demonstrated through design, material, and indications comparison with existing devices.

Here's what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics from a study. For a 510(k), the primary "acceptance criterion" is often demonstrating substantial equivalence to predicate devices in design, materials, and intended use.
Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics from a dedicated study. The document states "similarities in design, materials and indications" as the basis for substantial equivalence.

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/Not Provided. The 510(k) summary does not describe a test set or data from a clinical study for the Ascension device itself.

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/Not Provided. No ground truth establishment is described for a test set of the Ascension device.

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

Not Applicable/Not Provided. No test set or adjudication process 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/Not Provided. This device is a bone fixation screw, not an AI-assisted diagnostic tool. An MRMC study is irrelevant in this context.

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

Not Applicable/Not Provided. This is a physical medical device, not an algorithm.

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

Not Applicable/Not Provided. No ground truth for a performance study is mentioned. The "ground truth" for substantial equivalence would be the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not Applicable/Not Provided. No training set for an algorithm is mentioned.

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

Not Applicable/Not Provided. No training set or ground truth establishment for it is mentioned.

Summary of available information:

Device Name: Ascension® Cannulated Screw System
Intended Use: Fixation of fractures in long bones; Fixation of small bones (foot, patella, ankle, wrist, elbow); Arthrodesis of the foot, wrist, and elbow; Small and long bone osteotomies.
Basis of Substantial Equivalence: Similarities in design, materials, and indications to legally marketed predicate devices (K991151, K991197 - Vilex Cannulated Screws; K962823 - Synthes Cannulated Screws; K893512 - DePuy Cannulated Bone Screw; K901616 - Smith & Nephew Cannulated Interference Screw System).

For devices like this, the "study" demonstrating it meets acceptance criteria for FDA clearance is the comparison to predicate devices to show substantial equivalence. The detailed performance metrics, clinical studies, and expert assessments typically associated with software or AI-based devices (as implied by the structure of your questions) are generally not required for these types of 510(k) submissions. Instead, mechanical testing (e.g., tensile strength, fatigue, torque strength) to ensure the device meets engineering specifications and industry standards, and biocompatibility testing, would be performed and submitted as part of the 510(k) package, but these specific results are not detailed in this public summary.

Summary

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K092yyo

510(k) Summary

NOV - 5 2009

SUBMITTER NAME: Ascension Orthopedics, Inc. 8700 Cameron Road, #100 Austin, TX 78754-3832

510(k) CONTACT: Debbie Stearns Phone: (512) 836-5001 x1548
Ascension® Cannulated Screw System TRADE NAME:

COMMON NAME: Cancellous Cannulated Bone Screws

CLASSIFICATION: 21 CFR 888.3040 - Bone Fixation Screw

PRODUCT CODE: HWC

Orthopedic PANEL:

PREDICATE DEVICES:

K991151 and K991197 - Vilex Cannulated Screws K962823 - Synthes Cannulated Screws K893512 - DePuy Cannulated Bone Screw K901616 - Smith & Nephew Cannulated Interference Screw System

DEVICE DESCRIPTION:

INTENDED USE:

The Ascension Cannulated Screw System is intended for the following:

Fixation of fractures in long bones
Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow .
Arthrodesis of the foot, wrist and elbow
A Small and long bone osteotomies

BASIS OF SUBSTANTIAL EQUIVALENCE:

Ascension Orthopedics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials and indications.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV - 5 2009

Ascension Orthopedics, Inc.

% Ms. Debbie Stearns Director, Regulatory/Clinical Affairs 8700 Cameron Road, Suite 100 Austin, Texas 78754-3832

Re: K092440

Trade/Device Name: Ascension® Cannulated Screw System Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 5, 2009 Received: October 5, 2009

Dear Ms. Stearns:

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 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

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Page 2 - Ms. Debbie Stearns

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Williamson

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

Enclosure

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Indications for Use Statement

KB92440 510(K) Number.

Device Name:

Ascension® Cannulated Screw System

Indications for Use:

The Ascension Cannulated Screw System is intended for the following:

Fixation of fractures in long bones a
Fixation of small bones, including those in the foot, patella, ankle, wrist and A elbow
Arthrodesis of the foot, wrist and elbow A
Small and long bone osteotomies A

Prescription Use × OR

Over-The-Counter Use

(Part 21 CFR 801Subpart B) C)

(Part 21 CFR 801Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Souther for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092440

K092440 - Ascension Cannulated Screw System

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.