The Integrity™ Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs.

Device Description

The Integrity™ Bone Staple Fixation System consists of bone staples and a delivery instrument. The bone staple is a staple-shaped tack with barbed ends and is comprised of non-absorbable poly(ether ether ketone) [PEEK]. The bone staples are designed to provide fixation of soft tissue grafts or reinforcement meshes to bone at surgery and are used in conjunction with a Delivery instrument from Anika. The device is sterilized by radiation with a SAL of 10-9. The bone staples and delivery instruments are provided sterile for single use only. The staples are packaged in a caddy within a dual sterile packaging configuration.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Integrity™ Bone Staple Fixation System," which is a Class II medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy through multi-reader, multi-case studies or extensive standalone AI performance evaluations.

Therefore, the document does not contain the kind of information typically found in studies for AI/ML-driven diagnostic devices, such as:

Acceptance criteria tables for AI performance metrics (e.g., sensitivity, specificity, AUC)
Sample sizes for test sets used to evaluate AI performance
Details on data provenance for AI model development/testing (e.g., country of origin, retrospective/prospective)
Number and qualifications of experts for ground truth establishment
Adjudication methods for ground truth
Multi-reader multi-case (MRMC) comparative effectiveness studies
Standalone algorithm performance
Training set sample sizes
Methods for establishing training set ground truth

Instead, the submission focuses on mechanical performance testing, biocompatibility, and comparison of physical characteristics to the predicate device to demonstrate substantial equivalence.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Device Performance (Mechanical/Biocompatibility):

The document does not present a formal table of "acceptance criteria" for AI performance metrics. Instead, it describes performance testing related to the physical and biological characteristics of the bone staple. The "reported device performance" is summarized qualitatively as having "higher tensile and shear retention strength" demonstrated in mechanical performance testing, and passing biocompatibility tests.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Retention Strength	Sufficient to demonstrate safety and effectiveness for intended use	"higher tensile and shear retention strength have been demonstrated"
Insertion and Removal Evaluation	Safe and effective operation	Implied satisfactory performance to support substantial equivalence
Biocompatibility Testing	Compliance with ISO 10993 standards: Cytotoxicity, Sensitization, Irritation	Device passed these tests
Bacterial Endotoxin Limit Test	Within acceptable limits	Device passed this test

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

Test Set Sample Size: Not specified in terms of number of cases/patients. "Performance Testing Summary" indicates mechanical, insertion/removal, biocompatibility, and bacterial endotoxin testing were performed. These tests would involve a specific number of device samples, but this detail is not provided.
Data Provenance: Not applicable in the context of clinical image data for AI. The data provenance here refers to the source of the materials and manufactured devices used for the described non-clinical tests. No geographical or retrospective/prospective data details are relevant to this type of device submission.

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

Not applicable. This submission does not involve diagnostic image interpretation or clinical expert-established ground truth. The "ground truth" for this device is based on laboratory-measured physical properties and biological responses to materials.

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

Not applicable. No clinical expert adjudication was performed as part of this non-clinical testing.

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:

No, an MRMC comparative effectiveness study was not done. This device is a bone staple, not an AI-assisted diagnostic tool. The submission explicitly states: "No clinical or animal data were required to support the substantial equivalence."

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

Not applicable. There is no AI algorithm being evaluated.

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

For this device, the "ground truth" for performance is based on objective measurements derived from standardized mechanical testing protocols (e.g., tensile strength, shear strength, insertion/removal forces) and biocompatibility testing standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation) and bacterial endotoxin assays. There is no "expert consensus" or "pathology" as would be seen in diagnostic imaging.

8. The sample size for the training set:

Not applicable. There is no AI model or "training set" involved.

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

Not applicable. There is no AI model or "training set" involved.

In summary, this FDA 510(k) submission for a bone staple system is for a conventional medical device and therefore does not include any information related to AI/ML performance testing. The "study that proves the device meets the acceptance criteria" refers to a battery of non-clinical, bench-top mechanical tests and biocompatibility assays, rather than a clinical study evaluating diagnostic accuracy or reader performance.

Summary

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May 22, 2023

Anika Therapeutics Inc. Shajunath Nirupama Sr. Regulatory Affairs Specialist 32 Wiggins Avenue Beford, Massachusetts 01730

Re: K223860

Trade/Device Name: IntegrityTM Bone Staple Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 4, 2023 Received: May 5, 2023

Dear Shajunath Nirupama:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sara S. Thompson -S

For

Yu-Chieh Chiu, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223860

Device Name

IntegrityTM Bone Staple Fixation System

Indications for Use (Describe)

The Integrity™ Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

[As required by 21 CFR 807.92]

Date Prepared: May 18, 2023,

510(k) Number: K223860

Submitter Name

Anika Therapeutics, Inc. 32 Wiggins Avenue Bedford, MA 01730 Establishment No: 3007093114

Contact Person

Shajunath Nirupama Sr. Regulatory Affairs Specialist Phone: 781-457-9230 Email: snirupama@anika.com

General Information

General Information of Subject Device
Trade Name	Integrity™ Bone Staple Fixation System
Common Name	Non-Degradable Bone Staple
510(k) Submitter	Anika Therapeutics, Inc.
Class	II
Classification Name	Bone Fixation Fastener
Regulation	21 CFR 888.3040
Product Code	MBI
Review Panel	Orthopedic
Primary Predicate & 510(K)	Rotation Medical Bone Staple (RMB)- K131635Rotation Medical (Now Smith & Nephew)

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Device Description

Indication for Use

The Integrity™ Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs.

Substantial Equivalence Summary

Anika Therapeutics has demonstrated that for the purposes of the FDA's regulation of medical devices, the Integrity™ Bone Staple Fixation System is substantially equivalent to the predicate Rotation Medical Bone Staple (K131635) in terms of intended use, material, design principles and performance.

Device Name	Integrity ™ BoneStaple FixationSystem	Rotation Medical Bone Staple (RMBStaple)	Comparison
510(k) No:	K223860	K131635	N/A
Manufacturer	Anika Therapeutics,inc.	Rotation Medical(now Smith & Nephew)	N/A
Classification	II	II	Same
Product code	MBI	MBI	Same
Regulation	21 CFR 888.3040	21 CFR 888.3040	Same
RegulationDescription	Bone Fixation Fastener	Bone Fixation Fastener	Same
Panel	Orthopedics	Orthopedics	Same
Indications forUse	The Integrity ™ BoneStaple Fixation Systemis indicated for thefixation of soft tissuegrafts or reinforcementmeshes to bone duringrotator cuff repairs.	The RMB Staple is indicated for fixation ofsoft tissue grafts during rotator cuff repair.	Substantially Equivalent (Seediscussion below)
General Physicalform	Staple Shaped Tack	Staple Shaped Tack	Same

Table 5B- Substantial Equivalence Comparison

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Material	PEEK	PEEK	Same
Color	Natural	Natural	Same
Dimensions	11.5 mm in overall height,6.1 mm width	11 mm in overall height,6.1mm width	Substantially Equivalent (Seediscussion below)
Body Contact	Implant (>30 days)	Implant (>30 days)	Same
Packaging	Staples are pre-loadedinto a caddy that ispackaged in a doublepouch	Staples are pre-loaded onto an inserterdevice in a dual blister pack	See discussion below

Discussion

Indications for Use Statement:

Both the subject and predicate devices are indicated for use during rotator cuff repair surgery to aid in the management tendon injuries. The subject device is designed to affix soft tissue graft or reinforcement mesh to bone which has been mechanically tested and did not raise any concerns on safety and effectiveness. There are no additional questions on safety and effectiveness of the subject device as compared to the predicate.

Dimensions:

The difference in dimension is not expected to impact the safety and effectiveness of the device as higher tensile and shear retention strength have been demonstrated in the subject device mechanical performance testing.

Packaging:

The package for both subject and predicate devices are industry standard packages. The Integrity Bone Staples has double sterile barrier packaging. They are pre-loaded into a caddy that is packaged in a double pouch to ensure adequate protection and sterility of the subject device during the shelf life. The predicate device is packaged in a sealed dual blister pack that provides protection and maintains sterility during the shelf life. The difference in package configuration from the predicate does not raise any new concerns of safety and efficacy of the subject device.

Performance Testing Summary

The following non-clinical tests and/or analysis were performed for the Subject Device to demonstrate the substantial equivalence to the predicate devices:

Mechanical retention strength, tensile & shear ●
Insertion and removal evaluation
Biocompatibility Testing; Cytotoxicity, Sensitization, and Irritation
Bacterial endotoxin limit test

No clinical or animal data were required to support the substantial equivalence.

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Conclusion

The Integrity ™ Bone Staple Fixation System subject to this submission has similar indications for use statement, same intended use, same material, and general physical form. The testing data has demonstrated the performance of the Integrity ™ Bone Staple Fixation System and the predicate device, Rotation Medical Bone Staple is substantially equivalent. Any differences in characteristics do not raise additional questions of safety and effectiveness.

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.