The Acufex Screw Cannula is used for fixation of bone-tendon-bone grafts during Anterior or Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.

Device Description

The Acufex Screw Cannula is a cylindrical device that has a distal, screw holding end, and an open back end. The proximal end is shaped to allow for secure grasping of the cannula during insertion. The distal end contains a feature that allows the screw to be held snugly in the cannula. This is accomplished by creating an interference fit between the screw and the cannula walls.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Acufex Screw Cannula." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance data in the context of AI or diagnostic performance.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be answered from the given document. The document describes a traditional medical device submission (a surgical instrument for ACL/PCL reconstruction), not a diagnostic device or an AI-powered system that would typically have performance metrics like sensitivity, specificity, or reader studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be answered from the text. The document does not describe quantitative performance criteria for the Acufex Screw Cannula beyond its basic function and material specifications, which are compared to a predicate device. There are no "reported device performance" metrics in the sense a diagnostic or AI device would have (e.g., accuracy, sensitivity, specificity).

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

Cannot be answered from the text. This document does not describe a "test set" in the context of diagnostic performance or AI model evaluation. It's a 510(k) submission for a surgical instrument, focusing on substantial equivalence to an existing device rather than a clinical trial with a test set of data.

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)

Cannot be answered from the text. This concept is not applicable to the type of device and submission described. There's no "ground truth" establishment in the context of diagnostic assessment.

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

Cannot be answered from the text. Not applicable to this type of device submission.

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

Cannot be answered from the text. This is not an AI-powered device, and no MRMC study is mentioned.

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

Cannot be answered from the text. This is not an algorithm or AI device.

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

Cannot be answered from the text. Not applicable to this type of device submission.

8. The sample size for the training set

Cannot be answered from the text. This is not an AI/machine learning device that would have a "training set."

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

Cannot be answered from the text. Not applicable.

Summary of what the document does provide in relation to "acceptance criteria" and "study":

The document demonstrates substantial equivalence to a predicate device as its "acceptance criteria" for market clearance, rather than meeting specific performance metrics from a study as understood for AI or diagnostic devices.

The "study" in this context is the 510(k) submission process itself, which involves comparing the new device to a legally marketed predicate device.

Here's the relevant information:

Device Name: Acufex® Screw Cannula
Intended Use: Fixation of bone-tendon-bone grafts during Anterior or Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.
Predicate Device: Arthrex® Sheathed Interference Screw (K915424)

Table demonstrating "Substantial Equivalence" (acting as the "acceptance criteria" for this type of submission):

Attribute	Current ProductAcufex®Screw Cannula	Substantially Equivalent ProductArthrex® Sheathed InterferenceScrew510K#: K915424
Indication	Bone Tendon Bone Graft FixationACL & PCL Reconstruction	Bone Tendon Bone Graft FixationACL & PCL Reconstruction
Screw Configuration	Interference	Interference
Screw Size	Outer Length: 20 - 30 mmDiameter: 5.5 - 9 mm	Length: 25 - 55 mmDiameter 6 - 9 mm
Screw Material	Titanium	Titanium
Cannula/Sheath	Polypropylene	Polyethylene
Labeling	Sterile, Single Use Only	Sterile, Single Use Only

Explanation of how the device "meets the acceptance criteria":

The Acufex Screw Cannula meets the acceptance criteria by demonstrating that its design, function, materials, and intended use are similar enough to a legally marketed predicate device (the Arthrex® Sheathed Interference Screw) such that no new questions of safety or effectiveness are raised. The comparison table above directly presents how the new device aligns with the predicate across key attributes. The FDA's "Substantial Equivalence" letter (pages 3-4) confirms that the device has met this standard. The "risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations," as stated in section G.

This document serves as an example of a 510(k) submission for a Class II medical device, which generally relies on demonstrating equivalence rather than extensive clinical efficacy trials with quantitative performance metrics typical for new drugs or high-risk devices.

Summary

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SEP 1 9 1231

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is :

This summary was prepared on July 2, 1997

A. Submitter

Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048

Company Contact B.

Demetrios Tsakonas Clinical/Regulatory Specialist

C. Device Name

Trade Name:	Acufex® Screw Cannula
Common Name:	Screw and Cannula
Classification Name:	Screw, Fixation, BoneCannula, Surgical

D. Predicate/Legally Marketed Devices

Arthrex® Sheathed Interference Screw 3050 North Horseshoe Drive Naples, FL 33942 510(k) #: K915424

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E. Device Description

F. Intended Use

The Acufex Screw Cannula is used for fixation of bone-tendon-bone grafts during Anterior or Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.

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Substantial Equivalence G.

The Acufex Screw Cannula is intended for use for fixation of bone tendon grafts during ACL/PCL reconstructions. The Acufex Screw Cannula is similar in design, function, materials and intended use to other devices currently marketed and in commercial distribution, namely the Arthrex® Sheathed Interference Screw.

Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations.

A summary comparison of the characteristics of the Acufex Screw Cannula and the substantially equivalent device is presented in the table below.

Attribute	Current ProductAcufex®Screw Cannula	Substantially Equivalent ProductArthrex® Sheathed InterferenceScrew510K#: K915424
Indication	Bone Tendon Bone Graft FixationACL & PCL Reconstruction	Bone Tendon Bone Graft FixationACL & PCL Reconstruction
Screw Configuration	Interference	Interference
Screw Size	Outer Length: 20 - 30 mmDiameter: 5.5 - 9 mm	Length: 25 - 55 mmDiameter 6 - 9 mm
Screw Material	Titanium	Titanium
Cannula/Sheath	Polypropylene	Polyethylene
Labeling	Sterile, Single Use Only	Sterile, Single Use Only

Applicant

Demetrios Joakonas

Date 7/11/97

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Demetrios Tsakonas Clinical/Regulatory Specialist Smith & Nephew, Inc. 130 Forbes Boulevard Mansfield, Massachusetts 02048

SEP 1 9 1997

Re: K972599 Trade Name: Acufex® Screw Cannula Regulatory Class: II Product Code: HWC Dated: July 11, 1997 Received: July 14, 1997

Dear Mr. Tsakonas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Demetrios Tsakonas

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

tallyz

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (If Known):

Device Name: Acufex Screw Cannula

Indications for Use: The Acufex Screw Cannula is used for fixation of bone-tendonbone grafts during Anterior or Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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eral Restorative Devices

Prescription Use
(Per 21 CFR 801.109) √

or Over-The-Counter Use __________

Regulation Number and Section

N/A