The proposed RC Tack is intended for soft tissue reattachment to host bone for the following indications: 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

Device Description

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

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (RC Tack Bone Anchor). It describes the device, its intended use, and comparison to predicate devices, and reports performance data in support of substantial equivalence. However, this document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets that criteria with the requested level of detail (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance details).

This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, as opposed to providing a detailed performance study with explicit acceptance criteria from an AI/algorithm perspective. There is no mention of an algorithm or AI in this document.

Despite this, I will extract and infer information where possible based on the provided text, and clearly state where information is not available.

Here's an analysis based on the provided text:

Device: RC Tack Bone Anchor

Intended Use: Soft tissue reattachment to host bone in the shoulder, knee, and ankle for specific indications (listed in the document).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes a "Bone Model Testing" study that compares the RC Tack's ultimate holding strength. The acceptance criteria are implicitly tied to demonstrating performance "substantially equivalent" to or better than the predicate devices.

Acceptance Criteria (Inferred from "Substantial Equivalence")	Reported Device Performance
Ultimate holding strength should be at least equivalent to the predicate device (ROC EZ Suture Bone Fastener) and another comparison device (ConTack Fastener).	"The proposed RC Tack holding strength was greater than that of the predicate device and the ConTack Fastener, demonstrating substantially equivalent performance between the devices."

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

Sample Size for Test Set: Not specified. The document only mentions "Bone Model Testing" was performed.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. It is likely laboratory-based biomechanical testing.

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

Not Applicable. This device is a mechanical implant, and the assessment of "holding strength" in a bone model test does not typically involve expert clinical review to establish ground truth in the way an AI diagnostic algorithm might. The ground truth (holding strength) would be measured directly using biomechanical testing equipment.

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

Not Applicable. Adjudication methods are typically relevant for clinical studies or evaluations where subjective assessments (e.g., image interpretation) are made by multiple observers. For a biomechanical test of holding strength, the result is an objective measurement, not subject to adjudication in this manner.

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 document pre-dates and does not involve AI. The device is a mechanical bone anchor, not an AI-assisted diagnostic or therapeutic tool.

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

Not Applicable. This document does not describe an algorithm or AI.

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

Type of Ground Truth: The ground truth for the performance test ("ultimate holding strength") was based on direct biomechanical measurement in a bone model.

8. The sample size for the training set

Not Applicable. This document does not describe an AI/algorithm, so there is no training set in that context. The "training set" concept is not relevant for this type of mechanical device submission.

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

Not Applicable. As there is no training set in the context of AI/algorithms, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Innovative Devices. The logo consists of a large, stylized "A" formed by two overlapping triangles. To the right of the "A" is the word "INNOVASIVE" in a bold, italicized font. Below "INNOVASIVE" is the word "DEVICES" in a smaller, non-italicized font.

OCT 8 1999

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: July 9, 1999

2. DEVICE:

Trade Name: RC Tack

Common Name: Bone Anchor

Classification Name: "Single/Multiple Component Bone Fixation Appliances and Accessories"

3. PREDICATE DEVICE:

The Innovasive ROC EZ Suture Bone Fastener (K970089, K971922).

4. DEVICE DESCRIPTION:

5. INTENDED USE:

The proposed RC Tack is intended for soft tissue reattachment to host bone for the following indications:

SHOULDER

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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 RC Tack and the predicate ROC EZ Suture Bone Fastener implants utilize the same materials. Both devices also utilize the same method of bone fixation: radially expansion of the sleeve. Lastly, the indications being requested for the proposed RC Tack are already cleared for the ROC EZ Suture Bone Fastener.

7. PERFORMANCE DATA:

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

Bone Model Testing: the ultimate holding strength of the proposed RC Tack was compared to Innovasive's currently marketed ROC EZ Suture Bone Fastener and the ConTack Fastener. The ConTack Fastener was chosen as a second comparison device because it tack soft tissue to bone, although its materials and design differ from the proposed RC Tack. The proposed RC Tack holding strength was greater than that of the predicate device and the ConTack Fastener, demonstrating substantially equivalent performance between the devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol, which is a staff with a serpent entwined around it, representing healing and medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 OCT

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

Re: K992377 Trade Name: RC Tack Bone Anchor Product Code: MBI Regulatory Class: II Dated: July 9, 1999 Received: July 15, 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 (OS) 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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Page 2 Ms. Kathleen Morahan

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,

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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INDICATIONS FOR USE

K992377

The 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)

besle

Division of General Restorative Device 510(k) Num

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.