The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:

Post-traumatic and degenerative arthritis involving both ankle and subtalar ioints
rheumatoid arthritis -
revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
revision of failed total ankle arthroplasty with subtalar intrusion ー
talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) -
avascular necrosis of the talus -
Neuroarthropathy or neuropathic ankle deformity ー
severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
severe pilon fractures with trauma to the subtalar joint -

Device Description

The Newdeal Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 11mm, 12mm and 13mm, and lengths of 150mm and 180mm. It allows for proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long by 5mm increment. The nail, the end cap and the locking screws are all made from Ti-6Al-4V ELI alloy.

AI/ML Overview

Based on the provided text, the device in question is the Newdeal Ankle Nail, an intramedullary fixation rod. The document is a 510(k) Summary, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study establishing efficacy or safety against acceptance criteria in the same way a new drug or novel medical device might.

Therefore, the "acceptance criteria" and "device performance" in this context refer to demonstrating that the Newdeal Ankle Nail's technological characteristics and intended use are substantially equivalent to existing predicate devices, not that it meets specific numeric clinical performance metrics through new studies. The "study" mentioned is a "Summary of Studies" meant to support this substantial equivalence.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Characteristic	Acceptance Criteria (Predicate Device Characteristics)	Reported Device Performance (Newdeal Ankle Nail)
Intended Use	Tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia (as per predicate devices: Smith & Nephew ReVision Nail, DePuy VersaNail, Biomet Ankle Arthrodesis Nail). Specific examples: traumatic/degenerative arthritis (ankle/subtalar), rheumatoid arthritis, revision of failed ankle arthrodesis (subtalar/insufficient talar body), revision of failed total ankle arthroplasty (subtalar intrusion), talar deficiency, avascular necrosis, neuroarthropathy, severe deformity (talipes equinovarus, CVA, paralysis, neuromuscular disease), severe pilon fractures (trauma to subtalar joint).	The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Specific examples: traumatic/degenerative arthritis (ankle/subtalar), rheumatoid arthritis, revision of failed ankle arthrodesis (subtalar/insufficient talar body), revision of failed total ankle arthroplasty (subtalar intrusion), talar deficiency, avascular necrosis, neuroarthropathy, severe deformity (talipes equinovarus, CVA, paralysis, neuromuscular disease), severe pilon fractures (trauma to subtalar joint). (Identical to predicate uses)
Design Characteristics
- Holed for proximal and distal locking	Present in predicate devices.	Present. (Uses proximal and distal locking, using locking cortical screws).
- Material	Titanium alloy or stainless steel.	Ti-6Al-4V ELI alloy (Titanium alloy).
- Cannulated	Present in predicate devices.	Cannulated.
- Size Range	Equivalent size range to predicate devices.	Diameters of 11mm, 12mm, and 13mm; lengths of 150mm and 180mm. (Implicitly "Equivalent size range" as stated for comparison).
- Intended for tibiocalcaneal arthrodesis	Present in predicate devices.	Intended to be implanted for tibiocalcaneal arthrodesis.

Note: The acceptance criteria for a 510(k) submission are based on demonstrating "substantial equivalence" to one or more legally marketed predicate devices. The "reported device performance" here describes how the new device matches the characteristics of those predicates. The document states, "The technological characteristics of the Newdeal Ankle Nail are the same as the predicate devices in terms of intended use and design."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not report on a test set in the traditional sense of a clinical or ex-vivo performance study with a specific sample size. The "Summary of Studies" section only states "Summary of Studies. Ankle Nail meets our acceptance criteria," without detailing any specific studies, their methodology, or data provenance. The assessment is based on comparing technological characteristics and intended use to predicate devices, not on a new performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As noted above, there is no disclosed "test set" or independent clinical study requiring expert ground truth establishment for a novel device performance claim. The claims are based on substantial equivalence to existing devices.

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

Not applicable. There is no disclosed "test set" or independent clinical study requiring adjudication.

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 device is a medical implant (an ankle nail), not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this submission.

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

Not applicable. This device is a medical implant, not an algorithm, and does not operate as a standalone AI system.

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

Not applicable. For a 510(k) submission focused on substantial equivalence for an implantable medical device, the "ground truth" is typically established by the regulatory history and accepted performance of the predicate devices already on the market, combined with engineering and biocompatibility testing (which are not detailed in this summary). There's no new "ground truth" established for clinical outcomes in this document for the Newdeal Ankle Nail itself.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device submission.

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

Not applicable. This is not a machine learning or AI device submission.

Summary

{0}------------------------------------------------

KOSO882

Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in a bold, sans-serif font, with the "®" symbol next to it. To the left of the word is a circle with five dots around it, one of which is shaded gray.

MAY 2 7 2005

510(k) SUMMARY

Applicant's Name and Address: A.

Newdeal SA Newaterra LifeSciences Company 10, place d'Helvétie 69006 LYON FRANCE Tel.: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52 ESTABLISHMENT REGISTRATION NUMBER: 9615741

Authorized Agent and Official Contact Person: B.

Judith O'Grady Sr. VP Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA TEL: 609-936-2311 FAX: 609-275-9445

Date Summary Prepared: C. April 6, 2005
Name of Device: D. Proprietary Name: Newdeal Ankle Nail

Common Name: Ankle nail

Classification Name and Reference: Intramedullary fixation rod (21 CFR 888.3020)

Device Product Code: HSB

Proposed Regulatory Class: Class II

Panel: Orthopedic

Device Description E.
Device Description
The Newdeal Ankle Nail is a straight, cannulated intramedullary nailable in The Newcal 11mm, 12mm and 13mm, and lengths of 150mm and 180mm. dialiciers of 11 mm, TEMP proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long by 5mm increment. Screws Shim anameter, the end cap and the locking screws are all made from Ti-6Al-4V ELI alloy.

{1}------------------------------------------------

The Newdeal Ankle Nail is to be implanted by insertion through the calcaneus, the The Newton Ankie Fran is to to otalocalcaneal arthrodesis, for correction of deformity, or fixation of fractures.

K050882

Indications for Use F.

Indications for USC
The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and The Newtrair Annue Nair nindfoot and distal tibia. Examples include:

liment of traumatic and degenerative arthritis involving both ankle and subtalar joints
Rheumatoid arthritis -
Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
nisurioient tailer total ankle arthroplasty with subtalar intrusion -
Revision of faired total ons (requiring a tibiocalcaneal arthrodesis) -
Avascular necrosis of the talus -
Neuroarthropathy or neuropathic ankle deformity -
Newroalthropatity of nearspants. Inclipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
pararyons or ofractures with trauma to the subtalar joint -

Substantial Equivalence G.

Substantial Equivalence indications for use and dimensions with the following predicate devices:

Smith & Nephew	ReVision Nail	K983942
DePuy	VersaNail	K023115
Biomet	Ankle Arthrodesis Nail	K021786

Comparison of Technological Characteristics H.

Comparison of 1 cennotogical Onf the Newdeal Ankle Nail are the same as the The technological charges in terms of intended use and design. All of these nails have the following characteristics:

Holed for proximal and distal locking -
Made from Titanium alloy or stainless steel -
Cannulated -
Equivalent size range -
Intended to be implanted for tibiocalcaneal arthrodesis -

Summary of Studies I.

Sunninary of Statures Ankle Nail meets our acceptance criteria.

J. Conclusion

Conclusion & Nephew ReVision nail, K983942, DePuy ACE VersaNail, K023115 and Biomet Ankle Arthrodesis Nail, K021786.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.

MAY 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Newdeal SA C/o Ms. Judith E. O'Grady Senior V.P Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K050882

Trade/Device Name: Newdeal Ankle Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: April 6, 2005 Received: April 7, 2005

Dear Ms. O'Grady:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set 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.

{3}------------------------------------------------

Page 2 - Ms. Judith E. O'Grady

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and in your of substantial equivalence of your device 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), please If you dealer specific and Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ecterers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D.

m C. Provost. Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: NEWDEAL ANKLE NAIL

Indications For Use:

The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:

Post-traumatic and degenerative arthritis involving both ankle and subtalar ioints
rheumatoid arthritis -
revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
revision of failed total ankle arthroplasty with subtalar intrusion ー
talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) -
avascular necrosis of the talus -
Neuroarthropathy or neuropathic ankle deformity ー
severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
severe pilon fractures with trauma to the subtalar joint -

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)
Division of General,
and Neurological Devices

Page 1 of 1

5110(1) Number K050882

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.