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 1st tarsometatarsal joint, available in different sizes, which are implanted 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 oreates a single /screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. 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 510(k) premarket notification for the Newdeal SAS Lapidus Plates describes a medical device, not an AI/ML-enabled device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test sets in AI studies, expert qualifications for AI ground truth, multi-reader multi-case studies, and training set details, are not applicable.

The document demonstrates the device's substantial equivalence through mechanical testing and comparison to predicate devices, rather than clinical efficacy against acceptance criteria derived from AI performance metrics.

Here's an analysis of the provided text in the context of the device's regulatory submission:

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

Acceptance Criteria: The document does not explicitly state numerical acceptance criteria in the way an AI/ML device would. Instead, the primary acceptance criterion for this 510(k) submission is substantial equivalence to legally marketed predicate devices. This means that the device must perform at least as well as or be equivalent in function and safety to the predicate devices.

Reported Device Performance:

Performance Metric	Reported Device Performance
Bending Resistance	"greater than predicate devices (Synthes Modular Foot System)"
Equivalence	"substantially equivalent to commercially marketed devices" (Acumed K033639, Synthes K010321, Synthes K001941)
Novel Issues	"do not raise any new issues of scientific technology, safety or effectiveness"

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

Not Applicable (N/A): This is a mechanical device, not an AI/ML device that uses data for performance evaluation. The "test set" here refers to the physical devices tested.
Sample Size: Not explicitly stated as "sample size" in relation to a patient cohort. The "Testing and Test Results" section refers to an "evaluation of the bending resistance based upon mechanical calculations." This implies a mechanical engineering analysis, likely involving a limited number of physical prototypes or simulations.
Data Provenance: N/A for this type of device. The "data" pertains to mechanical properties.

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 (N/A): As this is not an AI/ML device, there's no need for experts to establish a "ground truth" for a test set in the conventional sense of image or data interpretation. The "ground truth" for mechanical performance criteria would be established through engineering standards and testing protocols.
Qualifications of Experts: Not specified, but would typically involve mechanical engineers or materials scientists for the design and testing of such implants.

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

Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI evaluations to resolve discrepancies in expert opinions on ground truth. This is a mechanical device submission. The "adjudication" for mechanical testing would involve engineering verification against established test standards.

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: A multi-reader multi-case (MRMC) study is typically performed for imaging or diagnostic devices where human readers interpret data, often with or without AI assistance. This is a bone fixation plate, a passive implant, and such a study is irrelevant for its clearance.

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

No: This question is specifically for AI/ML algorithms. The Lapidus Plate is a physical surgical implant, not an algorithm.

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

Mechanical Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance relies on established mechanical engineering principles, calculations, and the safety and effectiveness profile of the legally marketed predicate devices. The "Conclusion" explicitly states that the device "do not raise any new issues of scientific technology, safety or effectiveness," implying its performance meets accepted industry benchmarks and regulatory requirements for similar devices.

8. The sample size for the training set

Not Applicable (N/A): This is a mechanical device, not an AI/ML device that requires a training set.

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

Not Applicable (N/A): This is a mechanical device, not an AI/ML device that requires a training set or ground truth in this context.

Summary

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Newdeal SAS 510(k): PreMarket Notification Lapidus Plates

MY 17 -

Image /page/0/Picture/2 description: The image contains the word "CONFIDENTIAL" in bold, uppercase letters. Above the word "CONFIDENTIAL" is the alphanumeric string "K060476" in a handwritten style. The text is black against a white background.

V. 510(K) SUMMARY

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:

February 20, 2006

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 Lapidus Plate is substantially equivalent to the Acumed Lower Extremity Congruent Bone Plate System, K033639 the Synthes Modular Foot System - 2.7 mm Module, K010321 and the Synthes Modular Foot System, K001941.

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Newdeal SAS 510(k): PreMarket Notification Lapidus Plates

CONFIDENTIAL

KOREATA

Device Description:

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 1* metatarsocuneiform joint. -

Testing and Test Results:

An evaluation of the bending resistance based upon mechanical calculations has demonstrated that the bending behavior of the Lapidus Plates will be greater than predicate devices (Synthes Modular Foot System).

Conclusion

The Newdeal Lapidus Plates are substantially equivalent to commercially marketed devices, the Acumed Lower Extremity Congruent Bone Plate System, K033639 the Synthes Modular Foot System - 2.7 mm Module, K010321 and the Synthes Modular Foot System, K001941.

The Newdeal Lapidus Plates do not raise any new issues of scientific technology, safety or effectiveness.

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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 a stylized symbol that resembles a caduceus, with three figures connected by flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

Newdeal SA c/o Ms. Judith O'Grady, R.N., M.S.N. Sr. VP. Regulatory Affairs Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K060476

Trade/Device Name: Lapidus Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 10, 2006 Received: May 11, 2006

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

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

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Semer ws

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

Enclosure

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IV. Indications for Use

510(k) Number (if known):

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 metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus,
Lisfranc arthrodesis -
mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint. ﺳ

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Lerner no

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

510(k) Number K060476

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.