The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as: - Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

Device Description

The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1* tarsometatarsal joint, available in different sizes, which will be fixed using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking System includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single plate/screw unit fixed into the bone. The ostedsynthesis screws must be driven into the bone through the holes in the mo one. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

AI/ML Overview

The provided text describes a 510(k) summary for Lapidus Plates and a letter from the FDA. It does not contain information about acceptance criteria, device performance metrics, or details of a study that would demonstrate the device meets such criteria in the way typically seen for AI/ML medical devices (e.g., sensitivity, specificity, AUC).

Instead, this document pertains to a traditional medical device (bone fixation plates) and its equivalence to a predicate device based on mechanical testing.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical properties similar to predicate device (K060476)	"Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified LAPIDUS PLATES are thus similar to the properties of the unmodified devices, Lapidus Plates, K060476."
No change in intended use or fundamental scientific technology	"The modifications do not change the intended use or fundamental scientific technology of the device..."
No new issues of safety or effectiveness	"...and do not raise any new issues of safety or effectiveness."

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

Sample Size: Not specified. "Mechanical tests" were performed, but the number of plates tested is not mentioned.
Data Provenance: Not applicable. This refers to mechanical testing, not clinical data or patient data.

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. Ground truth as typically defined for AI/ML devices (e.g., expert labels on images) is not relevant for mechanical testing of bone plates. The "truth" here is the physical measurement of mechanical properties.

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

Not applicable. This concept is for resolving disagreements among human readers or labelers in diagnostic studies.

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. This is a mechanical device, not an AI/ML diagnostic aid.

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

Not applicable. This is a mechanical device.

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

Ground Truth: For mechanical testing, the "ground truth" would be the objectively measured physical properties (e.g., strength, stiffness, fatigue resistance) of the devices, compared against the known properties of the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it's not a machine learning model.

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

Not applicable. This device does not involve a training set.

Summary

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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 "n" connected to a circular graphic made of a thin line and four solid black circles. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller, italicized font. The logo is simple and modern, with a focus on the company name.

510(K) SUMMARY

FEB 8 2007

Lapidus Plates

Submitter's name and address

Newdeal SAS 10, place d'Helvétie 69006 Lyon, France Tel: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52

Contact person and telephone number

Morgane Grenier Regulatory and Clinical Affairs Director Newdeal SAS 10, place d'Helvétie 69006 Lyon, France Tel: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52

Alternate Contacts

Authorized Agent in the United States

Judith E. O'Grady, RN, MSN Sr. Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: (609) 936-2311 Fax: (609) 275-9445 E-mail: jogrady@integra-ls.com

Date Summary was prepared

January 23, 2007.

Name of the device

Proprietary Name:	Lapidus Plate
Common Name:	Plate, Fixation, Bone
Classification Name:	Single/multiple component metallic bone fixation appliances andaccessories (21CFR 888.3030)
Device Product Code:	HRS
Classification Panel:	Orthopedic

Substantial Equivalence

The modified Lapidus Plates (with stainless steel locking system) are substantially equivalent to commercially marketed device, Lapidus Plates, K060476.

Device Description

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screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single plate/screw unit fixed into the bone. The ostedsynthesis screws must be driven into the bone through the holes in the mo one. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

Intended Use

The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as:

Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus
Lisfranc arthrodesis
Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

Testing and Test Results

Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified LAPIDUS PLATES are thus similar to the properties of the unmodified devices, Lapidus Plates, K060476.

Conclusion

The modified Lapidus Plates (with stainless steel locking system) are substantially equivalent to commercially marketed device, Lapidus Plates, K060476.

The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with a staff and intertwined snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Newdeal SAS % Judith O'Grady, R.N., M.S.N. Senior Vice President, Regulatory Affairs Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

8 2007

Re: K070241 Trade/Device Name: Lapidus Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 23, 2007 Received: January 25, 2007

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.

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Page 2 - Judith O'Grady, R.N., M.S.N.

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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

barbare Onchins
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K070241

Device Name:

Lapidus Plates

Indications For Use:

The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as: - Arthrodesis of the 1st metatares and stable to bout inkation such as:
primus your primus varus

Lisfranc arthrodesis
Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform 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)

Jombare Bmeum

(Division Sign-Off Division of General, Rest rative, and Neurological Devices

510(k) Number Ko70241

Page 1 of 1

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.