The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.

Device Description

The TriTis Tibial ACL Reconstruction System consists of a three piece implant designed to provide soft tissue fixation for tibial anterior cruciate ligament (ACL) reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secure the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray. The modifications made to the device that are the subject of this submission are: Add a new, 12 mm diameter graft cleat implant size, and a new, 12 mm Dilator instrument. All other device features and instruments remain unchanged.

AI/ML Overview

The provided text describes modifications to the Scandius TriTis™ Tibial ACL Reconstruction System and its substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving that the device meets specific performance metrics in terms of clinical accuracy, diagnostic performance, or human reader improvement. The device is a physical implant system, not an AI or diagnostic tool.

Therefore, many of the requested fields are not applicable to the provided document.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

Acceptance Criteria and Device Performance Study Details (Based on K063499)

Given that this device is a physical implant (Scandius TriTis™ Tibial ACL Reconstruction System) and not an AI or diagnostic software, the typical acceptance criteria and study designs for AI/diagnostic devices (e.g., sensitivity, specificity, reader studies, ground truth establishment) are not applicable or described in this 510(k) summary.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, particularly for modifications (addition of a new implant size). This typically involves showing that the safety and effectiveness are maintained, often through bench testing and verification of design integrity, rather than clinical trials with human subjects or diagnostic performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in terms of quantitative performance metrics for clinical acceptance (e.g., accuracy, sensitivity, specificity). The "acceptance criteria" for this type of submission are generally related to demonstrating that the modified device maintains its design integrity and safety and effectiveness as compared to the predicate, as evidenced by the performance data mentioned.

Acceptance Criteria Category	Reported Device Performance (as per document)
Design Integrity	Confirmed (via simulated use test)
System Strength	Confirmed (via system strength test)
Safety & Effectiveness	No new questions raised (based on bench testing, comparison to predicate)
Material Equivalence	Uses the same implant materials as predicate
Intended Use Equivalence	Has the same intended and indication for use as predicate

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

Test Set Sample Size: Not applicable. The "test set" here refers to physical bench tests (simulated use, system strength), not a dataset of patient cases. The document does not specify the number of units tested.
Data Provenance: Not applicable in the context of patient data. The "data" comes from engineering bench testing.

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

Not applicable. Ground truth in the context of diagnostic/AI performance is not relevant here. The "ground truth" for the device's mechanical performance would be established by engineering standards and test specifications.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists) in diagnostic studies. This document describes mechanical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size

No, an MRMC study was NOT done. This type of study assesses human readers' performance with and without AI assistance, which is irrelevant for a physical surgical implant system.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used

Not applicable in the AI/diagnostic sense. For the device's mechanical performance, the "ground truth" is defined by engineering specifications and standards for tensile strength, fixation, etc., which are verified through the simulated use and system strength tests.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. As there is no training set, there is no ground truth for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as reported in K063499):

The submission for the Scandius TriTis™ Tibial ACL Reconstruction System (K063499) did not involve a clinical study in the typical sense of measuring patient outcomes or diagnostic performance. Instead, the study that demonstrated the device meets the (implied) acceptance criteria for substantial equivalence consisted of bench testing.

Specifically, the "performance data" generated in support of the substantial equivalence determination included:

Simulated use test: To confirm that the design integrity of the modified device (including the new 12mm graft cleat and dilator) is maintained.
System strength test: To confirm that the overall system's design integrity and mechanical strength are maintained.

These tests would have been performed against predetermined engineering specifications to ensure that the modifications did not negatively impact the device's performance compared to the previously cleared predicate device. The document states that "Bench testing demonstrates that any minor technological differences do not raise any new questions of safety and effectiveness." This implies that the tests confirmed the modified device performs comparably and safely.

The 510(k) process for device modifications often relies on such bench testing rather than extensive clinical trials, especially when the changes are minor and the predicate device has a well-established safety and effectiveness profile.

Summary

{0}------------------------------------------------

K063499

Page 1 of 2

510(k) SUMMARY

1. SUBMITTER:

Scandius Biomedical, Inc. 11A Beaver Brook Road Littleton, MA 01460

DEC 1 9 2006

Contact: Ralph Zimmerman, Quality Assurance Manager Date Prepared: November 17, 2006

2. DEVICE:

Trade Name: Scandius TriTis™ Tibial ACL Reconstruction System Classification Name: Fastener, Fixation, Non-Degradable, Soft Tissue The Product Code: MBI

3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for modifications to the Scandius TriTis Tibial ACL Reconstruction System was the previously cleared Scandius TriTis Tibial ACL Reconstruction System.

4. DEVICE DESCRIPTION:

The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray.

The modifications made to the device that are the subject of this submission are:

Add a new, 12 mm diameter graft cleat implant size, and a new, 12 mm Dilator instrument. All other device features and instruments remain unchanged.

5. INTENDED USE:

The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.

{1}------------------------------------------------

KO63499 age 2 of 2

6. COMPARISON OF CHARACTERISTICS:

트 The devices have the same intended and indication for use, and have similar technical characteristics and principles of operation
The devices use the same implant materials i
Bench testing demonstrates that any minor technological differences do not . raise any new questions of safety and effectiveness.

7. PERFORMANCE DATA:

The following performance data was generated in support of the substantial equivalence determination:

Simulated use test to confirm that design integrity is maintained .
System strength test to confirm that design integrity is maintained .

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Scandius Biomedical, Inc. c/o Mr. Ralph Zimmerman Quality Assurance Manager 11A Beaver Brook Road Littleton, MA 01460

DEC 1 9 2006

Re: K063499

Trade/Device Name: Scandius TriTis™ Tibial ACL Reconstruction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HWC Dated: November 17, 2006 Received: November 20, 2006

Dear Mr. Zimmerman:

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

{3}------------------------------------------------

Page 2 - Mr. Ralph Zimmerman

product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 Office 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nabane Bneehup

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known):__K063499

Device Name:

Indications for Use: The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.

Prescription Use __ X (Per 21 C.F.R. 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Riemensperger
Sign-Off

(Division Sign Restorative, Division of Gener and Neurologica 510(k) Number

(Optional Format 1-2-96)

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.