Repair of rotator cuff tears
Capsular instability
Slap lesion repair
Acromio-clavicular separation
Capsule shift/capsulolabral reconstruction
Biceps tenodesis
Deltoid repair
KNEE
Extra-capsular repairs, and reattachment of medial collateral ligament, lateral ligament, posterior oblique ligament, joint capsule closure.
Patellar ligament and tendon avuision repairs.
Extra-capsular reconstruction, ITB tenodesis
ANKLE
Lateral instability
Medial instability
Achilles tendon reconstruction and repair
Mid-foot reconstructions
FOOT
Hallux valgus reconstruction
ELBOW
Tennis elbow repair
Biceps tendon reattachment
Medial and lateral repairs

Device Description

The BioROC EZ suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole.

In addition to the Fastener, a stainless steel drill and drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.

The Fastener will be available as a sterile, single use device in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.

AI/ML Overview

This document describes a 510(k) submission for the Innovasive 2.8mm and 3.5mm BioROC EZ Suture Bone Fastener, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive performance data as would be seen for novel devices. Therefore, the information you've requested regarding acceptance criteria and detailed study breakdowns for AI/software devices is not present in this document because it's a different type of medical device submission (a physical fastener) and predates the widespread use of AI in medical imaging interpretation.

Here's a breakdown of the available information based on your request, highlighting what is and isn't applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For the BioROC EZ Suture Bone Fastener, the "acceptance criteria" and "performance" are framed in terms of demonstrating equivalence to existing predicate devices.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Functional Equivalence: Device should perform its intended function of reattaching soft tissue to bone.	Demonstrated efficacy and adequate functioning for intended use.
Material Equivalence: Material properties should be suitable for the intended use and comparable to predicate devices in relevant aspects (e.g., biocompatibility, degradation profile if applicable). (Implied, as the new device uses L-PLA which is a resorbable polymer, while the predicate uses non-resorbable polymers).	BioROC EZ is comprised of L-PLA, a different material than the predicate's polyethylene and acetyl plastic. The submission likely addressed biocompatibility of L-PLA, which is a known biodegradable polymer used in medical devices.
Mechanical Strength (Holding Strength): Device should have comparable or superior holding strength in bone to the predicate device.	Bone Model Testing: "The Innovasive BioROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device."
Biological Response/Efficacy: Device should not cause adverse biological reactions and should effectively facilitate soft tissue reattachment.	Animal Testing: "The testing demonstrated the efficacy of the Innovasive BioROC EZ Suture Bone Fastener and confirmed that the device functions adequately to meet its intended use."
Deployment Mechanism: The deployment mechanism should be effective and comparable in principle to the predicate (radial compression/expansion).	BioROC EZ uses "an expander fitted on a shear pin which is drawn up into an expandable sleeve. The sleeve expands as the expander is drawn up into it. The shear pin then shears resulting in the device being fixed into the bone site," which is described as similar to the predicate.

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

Sample Size (Bone Model Testing): Not specified.
Sample Size (Animal Testing): Not specified.
Data Provenance: The studies were conducted by the manufacturer, Innovasive Devices, Inc., and submitted to the FDA in the USA. They are retrospective to the submission date.

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

This section is not applicable as the device is a physical bone fastener, not an AI or imaging device requiring expert ground truth for interpretation. The "ground truth" for this type of device is its physical performance (e.g., holding strength) and biological compatibility/efficacy, assessed through engineering tests and animal studies.

4. Adjudication method for the test set

This section is not applicable for the reasons stated above.

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

This section is not applicable as the device is a physical bone fastener and not an AI-assisted diagnostic or interpretive tool involving human readers.

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

This section is not applicable as the device is a physical bone fastener and not an algorithm.

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

The "ground truth" for this physical device was established through:

Controlled Mechanical/Engineering Testing: For the "ultimate holding strength" using a "bone model." This involves objective measurements of force.
In-vivo Biological Observation/Efficacy: Through "Animal Testing," demonstrating the device's function and efficacy in a living system. This would typically involve histological analysis, gross observations, and clinical assessments by veterinary professionals.

8. The sample size for the training set

This section is not applicable as the device is a physical bone fastener and does not involve AI or machine learning models that require a training set.

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

This section is not applicable for the reasons stated above.

Summary regarding AI/Software relevance:

It's crucial to understand that the provided document is a 510(k) summary for a physical medical implant (a suture bone fastener) submitted in 1997. The requirements and types of studies for such a device are fundamentally different from those for AI/software as a medical device (SaMD). The concepts of "acceptance criteria," "test set," "ground truth," "experts," "adjudication," "MRMC studies," "standalone performance," and "training set" as you've defined them are primarily relevant to SaMD, particularly those involving image interpretation or clinical decision support where AI performance needs to be evaluated against human expertise or definitive diagnoses. This document fulfills the requirements for a physical device seeking substantial equivalence based on material properties, mechanical performance, and biological efficacy, as was typical for the regulatory environment of the late 1990s.

Summary

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510(K) SUMMARY

g73381

FEB 1 8 1998

1. SUBMITTER:

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

Contact: Stephen M. Page, Manager of Regulatory Affairs Date Prepared: December 10, 1997

2. DEVICE:

Innovasive 2.8mm and 3.5mm BioROC EZ Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices BioROC EZ Suture Bone Fastener

3. PREDICATE DEVICE:

The predicate devices used to determine substantial equivalence for the Innovasive Devices BioROC EZ Suture Bone Fastener were (1) the 2.8mm and 3.5mm Innovasive Devices ROC EZ Suture Bone Fastener marketed by Innovasive Devices, Marlborough, MA, and (2) the Bio-Anchor marketed by Linvatec, Largo, FL.

4. DEVICE DESCRIPTION:

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The Fastener will be available as a sterile, single use device in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.

5. INTENDED USE:

The 2.8mm and 3.5mm BioROC EZ Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:

SHOULDER

Repair of rotator cuff tears 1.
Capsular instability 2.
Slap lesion repair 3.
Acromio-clavicular separation 4.
Capsule shift/capsulolabral reconstruction ડ.
Biceps tenodesis ર્.
Deltoid repair 7.

KNEE

Extra-capsular repairs, and reattachment of medial collateral ligament, lateral ligament, ﻨﺴ posterior oblique ligament, joint capsule closure.
Patellar ligament and tendon avuision repairs. 2.
1. Extra-capsular reconstruction, ITB tenodesis

ANKLE

1. Lateral instability
Medial instability 2.
1. Achilles tendon reconstruction and repair
1. Mid-foot reconstructions

FOOT

1. Hallux valgus reconstruction

ELBOW

1. Tennis elbow repair
Biceps tendon reattachment 2.
Medial and lateral repairs 3.

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6. COMPARISON OF CHARACTERISTICS:

The existing Innovasive Devices ROC EZ Suture Bone Fastener is comprised of two polymer components, high density polyethylene and acetyl plastic. This device is used to secure a suture in a predrilled hole in bone. It remains fixed in the bone through radial compression as the device is deployed. This remains true for all sizes of the device.

The BioROC EZ device is comprised of L-PLA. As with the predicate device, the BioROC EZ uses an expander fitted on a shear pin which is drawn up into an expandable sleeve. The sleeve expands as the expander is drawn up into it. The shear pin then shears resulting in the device being fixed into the bone site.

7. PERFORMANCE DATA:

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

1. Bone Model Testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive BioROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.
1. Animal Testing: The testing demonstrated the efficacy of the Innovasive BioROC EZ Suture Bone Fastener and confirmed that the device functions adequately to meet its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1998

Mr. Stephen M. Page Manager of Regulatory Affairs Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts

K973381 Re: Innovasive 2.8mm and 3.5mm Trade Name: BioROC™ EZ Suture Bone Fastener Regulatory Class: II MAI and HWC Product Code: Dated: December 10, 1997 December 11, 1997 Received:

Dear Mr. Page:

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 In addition, FDA may publish further announcements action. 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. Stephen M. Page

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

Sincerely yours,

a M. Witten, Ph.D., M.D. Celli 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 2.8mm/3.5mm BioROC EZ

SHOULDER

Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction 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 Mid-foot reconstructions.

FOOT

Hallux valgus reconstruction

ELBOW

Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs

Prescription Use
(Per 21 CFR 801.109)

colefo

(Division Sign-On)
Division of General Restorative Devices
510(k) Number K97338/

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.