KNEE
Extra-Capsular repairs
Reattachment of medial collateral ligament
Reattachment of lateral collateral ligament
Reattachment of posterior oblique ligament
Joint capsule closure
Patellar ligament and tendon avulsion repairs
Extra-capsular reconstruction
ITB tenodesis

ANKLE
Lateral and medial instability
Achilles tendon reconstruction and repair

Device Description

The Titan RC Tack is a bioabsorbable implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three individual components: a tip, sleeve and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The Titan RC Tack is a sterile, single use device offered in one size, 4.5mm.

AI/ML Overview

Here's an analysis of the provided text regarding the Innovasive Titan RC Tack, focusing on acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Ultimate holding strength at 3, 6, and 12 weeks in-vitro	"demonstrates substantially equivalent performance between the two devices" (Titan RC Tack and predicate RC Tack)

Notes:

The document explicitly states that the "Bone Model Testing" was conducted to evaluate the "ultimate holding strength at 3, 6, and 12 weeks in-vitro."
The acceptance criteria themselves (e.g., a specific threshold in Newtons or a percentage of the predicate device's strength) are not provided in this document. The study's conclusion is that the new device's performance is "substantially equivalent" to the predicate, implying that the observed holding strengths met an unstated criterion for equivalence.

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify the sample size used for the bone model testing.
Data Provenance: The study was "in-vitro" and involved "Bone Model Testing." This suggests a synthetic bone model rather than human or animal tissue. The country of origin of the data is not specified. It is a prospective study as it was conducted for the purpose of the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

This type of device (bone anchor) typically does not involve human expert interpretation for "ground truth" in performance studies of this nature (ultimate holding strength). The ground truth is objective, quantifiable mechanical measurements.
Therefore, there were no experts establishing ground truth in the traditional sense, as this was a physical performance test, not an image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

No adjudication method like 2+1 or 3+1 was used. This is because the performance data is from objective mechanical testing, not subjective expert assessment or image review. The "adjudication" would be based on the objective measurement and comparison against predefined (but unstated in this document) statistical equivalence thresholds.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. The Titan RC Tack is a surgical implant designed for mechanical fixation, which is evaluated through biomechanical testing, not image interpretation.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The "Bone Model Testing" evaluated the Titan RC Tack's "ultimate holding strength." While directly compared to the predicate device, it generated performance data for the Titan RC Tack itself, allowing for an assessment of its mechanical properties.

7. Type of Ground Truth Used

The ground truth used was objective mechanical measurement (ultimate holding strength) from "in-vitro" bone model testing. This is a quantifiable physical property, not expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

This device is not an AI/ML algorithm, so there is no concept of a "training set" in the context of machine learning. The term "training set" is not applicable here.

9. How Ground Truth for the Training Set was Established

As this is not an AI/ML algorithm, there is no training set and thus no ground truth established for a training set. The "ground truth" for the performance study was the direct, objective measurement of the device's mechanical holding strength in the bone model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Innovative Devices. The logo consists of a stylized letter "A" on the left, followed by the word "INNOVATIVE" in bold, sans-serif font. Below the word "INNOVATIVE" is the word "DEVICES" in a smaller font size.

JAN 1 0 2000

510(K) SUMMARY

1. SUBMITTER:

Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229 Fax: 508-460-6661

Contact: Kathleen Morahan, Regulatory Affairs Specialist Date Prepared: December 17, 1999

2. DEVICE:

Trade Name: Innovasive Titan RC Tack Common Name: Bone Anchor Class: II Classification Name: "Single/Multiple Component Bone Fixation Appliances and Accessories"

3. PREDICATE DEVICE:

Innovasive RC Tack (K992377)

4. DEVICE DESCRIPTION:

5. INTENDED USE:

The Titan RC Tack is intended for fixation of soft tissue to bone for the following indications:

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1082

SHOULDER

Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair

KNEE

Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis

ANKLE

Lateral and medial instability Achilles tendon reconstruction and repair

6. COMPARISON OF CHARACTERISTICS:

The proposed Titan RC Tack, is a bioabsorbable version of the predicate RC Tack, and is therefore similar in design. The proposed device is molded from L-PLA with a color additive for implant visibility. The predicate device is molded from Delrin and HDPE. The proposed and predicate devices utilize the same method of bone fixation: radial expansion of the sleeve. Lastly, the indications being requested for the proposed Titan RC Tack are already cleared for the predicate RC Tack.

7. PERFORMANCE DATA:

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

Bone Model Testing: the ultimate holding strength at 3, 6, and 12 weeks in-vitro.

The testing demonstrates substantially equivalent performance between the two devices

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2000

Ms. Kathleen Morahan Regulatory Affairs Specialist Innovasive Devices Incorporated 734 Forest Street Marlborough, Massachusetts 01752

Re: K994269 Titan RC Tack Product Code: MAI Regulatory Class: II Dated: December 17, 1999 Received: December 20, 1999

Dear Ms. Morahan:

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 requirement, 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. 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.

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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) 594-4659. 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thos. W. Hays.

Sames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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INDICATIONS FOR USE

The Titan RC Tack is intended for soft tissue to bone fixation for the following indications:

SHOULDER

Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair

KNEE

ANKLE

Lateral and medial instability Achilles tendon reconstruction and repair

Prescription Use
(Per 21 CFR 801.109)

Verrell Ingram or Jr

(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Devices
510(k) Number ____________________________________________________________________________________________________

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.