The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include:

· Hammer toe deformity
· Claw toe deformity
Mallet toe deformity
Other deformities of the feet and hands

The DigiFuse® implants are intended for single use only.

Device Description

The Integra® DigiFuse® Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options.

AI/ML Overview

This document is a 510(k) premarket notification for the Integra® DigiFuse® Cannulated Intramedullary Fusion System. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a separate, extensive study to define new acceptance criteria and prove performance against them.

Therefore, the requested information regarding acceptance criteria, device performance from a specific study, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not typically present or required in this type of submission.

Instead, the submission relies on demonstrating substantial equivalence to existing devices, meaning it performs as safely and effectively as a legally marketed device that does not require premarket approval (PMA).

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance:

This document does not present a table of specific acceptance criteria (e.g., specific clinical outcomes, sensitivity/specificity thresholds) and reported device performance against those criteria. The acceptance is based on demonstrating substantial equivalence to predicate devices, not on meeting new quantitative performance metrics from a distinct study.

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

No specific "test set" and corresponding sample size for clinical or AI performance evaluation are mentioned.
The document states "Non-clinical evaluation and dimensional analysis was done to confirm substantial equivalence." This refers to engineering and material testing, not a clinical trial or performance study on a "test set" of patient data in the context of AI or diagnostic performance.

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

Not applicable. There is no mention of a "test set" requiring ground truth established by experts in the context of clinical or diagnostic performance.

4. Adjudication method for the test set:

Not applicable. No such test set or adjudication is described.

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 MRMC study or AI assistance is mentioned. This device is a physical implant (Cannulated Intramedullary Fusion System), not a software or AI-powered diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm, so standalone AI performance is irrelevant.

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

For a traditional 510(k) submission like this, the "ground truth" for the device's equivalence isn't clinical outcomes from a new study, but rather the established safety and effectiveness of the identified predicate devices. The "proof" is in demonstrating that the new device shares fundamental technological characteristics and has similar intended use, materials, and design principles to the predicates without raising new questions of safety or effectiveness. "Non-clinical evaluation and dimensional analysis" would be used to ensure the physical properties meet engineering standards applicable to the predicate devices.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of AI or machine learning for this physical implant device.

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

Not applicable. As there is no training set mentioned, this question is not relevant.

Summary of what the document does provide regarding equivalence:

Predicate Devices:
- Metasurg DigiFuse Implant – K111536
- OsteoMed Extend 2.0/2.4 Cannulated Screw System – K062863
- NewDeal K-Wire – K022599
Basis for Equivalence:
- The Integra® DigiFuse® Implant is made of the same material (Titanium Alloy (Ti 6A1-4V ELI)) as the Metasurg predicate device (K111536).
- The only difference with the Metasurg predicate is the addition of two new lengths for the Integra® DigiFuse® implant.
- These two new lengths are already within the length range of the Osteomed predicate device (K062863).
- The submission explicitly states: "There are no design, material, or indication differences between the proposed device and predicate devices." (This is crucial for 510(k) acceptance).
- Substantial equivalence was confirmed through "Non-clinical evaluation and dimensional analysis." This refers to engineering tests to ensure physical and mechanical properties are comparable to the predicates, not a clinical trial on patient-specific data.

In essence, the "acceptance criteria" for this specific 510(k) clearance are derived from the characteristics and performance of the legally marketed predicate devices. The study proving this "acceptance" is the non-clinical evaluation and dimensional analysis demonstrating that the Integra® DigiFuse® device is fundamentally the same as or comparable to its predicate devices, especially regarding materials, design, and intended use, and that any minor differences (like additional lengths) do not introduce new safety or effectiveness concerns.

Summary

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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 29, 2015

Ascension Orthopedics % Ms. Jayana Kenana Regulatory Associate Integra LifeSciences 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K152527

Trade/Device Name: Integra® Digifuse® Cannulated Intramedullary Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 19, 2015 Received: September 3, 2015

Dear Ms. Kenana:

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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Jayana Kenana

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration

Indications for Use

510(k) Number (if known) K152527

Device Name

Integra® DigiFuse® Cannulated Intramedullary Fusion System

Indications for Use (Describe)

The DigiFuse® implant is indicated for the fixation

of osteotomies and reconstruction of the lesser

phalanges during procedures to correct deformities of the toes and fingers.

Indications include:

· Hammer toe deformity

· Claw toe deformity
· Mallet toe deformity
· Other deformities of the feet and hands

The DigiFuse® implants are intended for single use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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6. 510(k) Summary

Submitter Information – 807.92(a)(1)
Sponsor Name	Integra LifeSciences Corporation
Address	311 Enterprise DrivePlainsboro, NJ 08536
Name of Contact Person	Jayana Kenana
Phone Number	609-936-2657
Fax Number	609-275-9445
Establishment Registration Number	1651501
Date Prepared	October 21, 2015
Name of Device – 807.92(a)(2)
Trade of Proprietary Name	Integra® DigiFuse®
Common or Usual Name	Cannulated Intramedullary Fusion System
Classification Name	Smooth & threaded metallic bone fixation fasteners
Classification Panel	Orthopedics
Regulation	Class II, 21 CFR 888.3040
Product Code	HWC
Material	Titanium Alloy (Ti 6A1-4V ELI)
Legally marketed device(s) to which equivalence is claimed – 807.92(a)(3)
Metasurg DigiFuse Implant – K111536
OsteoMed Extend 2.0/2.4 Cannulated Screw System – K062863
NewDeal K-Wire – K022599
Device Description – 807.92(a)(4)
The Integra® DigiFuse® Implant is a one-piece threaded device intended to be implanted into

the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options.

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Integra LifeSciences Corporation

Traditional 510(k) Integra DigiFuse Cannulated Intramedullary Fusion System

Intended Use

The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include:

· Hammer toe deformity
· Claw toe deformity
Mallet toe deformity
Other deformities of the feet and hands

The DigiFuse® implants are intended for single use only.

Conclusion:

The Integra® DigiFuse® Implant is composed as the same material as the predicate device from MetaSurg (K111536) and the only difference is the proposed device will be adding two new lengths. The two new lengths are also included in the length range of the predicate device passed by Osteomed (K062863). There are no design, material, or indication differences between the proposed device and predicate devices. Non-clinical evaluation and dimensional analysis was done to confirm substantial equivalence.

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.