The Inion CPS™ 2.0 Orthognathic Plate is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) as a part of the Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System.
a) Fractures of the cranium, midface, maxilla and mandible.
b) Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations.
c) LeFort (I, II, III) osteotomies.
d) Pediatric reconstructive procedures.
e) Orthognathic or reconstructive procedures of the cranium, midface, maxilla or mandible.
f) Craniotomy flap fixation.

Device Description

The Inion CPS" 2.0 Orthognathic Plates are provided in different shapes similar to predicate device. The Inion CPS™ 2.0 Orthognathic Plate is made of resorbable polylactic acid/trimethylenecarbonate copolymer.

AI/ML Overview

This is a medical device premarket notification (510(k)) for the Inion CPS™ 2.0 Orthognathic Plate. This type of submission is for demonstrating that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials.

Therefore, the document does not contain the detailed information requested about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies, as these are typically part of a full Premarket Approval (PMA) application or a de novo submission for novel devices.

Here's what can be inferred from the provided text, and what is missing because it's a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for a 510(k) submission focused on substantial equivalence.
A 510(k) asserts that the device is "substantially equivalent" to a predicate device, meaning it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. There are no explicit "acceptance criteria" presented in the document in the sense of performance metrics with thresholds that the new device must meet, nor is there "reported device performance" from a study specifically designed to establish such performance.

The document states: "Both the plates have the same intended use and principles of operation and there is no change in safety or efficacy." This is the core claim of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable in this context.
No "test set" in the context of a performance study is described. The 510(k) process relies on demonstrating equivalence through comparison of design, materials, and intended use with a predicate device, sometimes supported by basic biocompatibility or mechanical testing if there are material or design changes, but not typically a clinical "test set" of patients to evaluate performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable.
No ground truth establishment process for a test set is described, as there isn't a performance study in the way requested.

4. Adjudication Method

Not applicable.
No adjudication method is described, as there isn't a performance study with expert assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable.
This device is a physical bone plate, not an AI-assisted diagnostic tool. An MRMC study would not be relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable.
This device is a physical bone plate, not a software algorithm.

7. Type of Ground Truth Used

Not applicable.
No ground truth is used in the context of a performance study for this submission. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set

Not applicable.
This is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.
Not an AI/ML device.

Summary of what the document focuses on, instead of the requested information:

Predicate Device: Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352)
Claim of Equivalence: The Inion CPS™ 2.0 Orthognathic Plate is a "line extension" of the predicate, sharing "the same technological characteristics," "same materials," "same packaging and sterility options," "same intended use and principles of operation," and "no change in safety or efficacy."
Intended Use & Indications/Contraindications: Clearly defined for both the new device and implicitly compared to the predicate.
Materials: Resorbable polylactic acid/trimethylenecarbonate copolymer (same as predicate).

The 510(k) process is a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed one, relying heavily on comparative analysis rather than new clinical data demonstrating "acceptance criteria" through a performance study.

Summary

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K013039

September/7/2001

Special 510(k) Summary for the Inion CPS™ 2.0 Orthognathic Plate

ADMINISTRATIVE INFORMATION

Manufacturer´s Name:

Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere

Contact Person: Hanna Marttila Regulatory Affairs Coordinator Lääkärinkatu 2 FIN-33520 Tampere Phone: +358 3 230 6600 +358 3 230 6601 Fax: -

DEVICE NAME

Classification Name: Common/Usual Name: Trade Name:

Bone Plate Bone Plating System Inion CPSTM 2.0 Orthognathic Plate

ESTABLISHMENT REGISTRATION NUMBER

Inion Ltd. has not yet obtained an Establishment Registration Number.

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21 CFR 872.4760 bone plates are classified as Class II. Bone Plates have been assigned Product Code 76 JEY.

PREDICATE DEVICES

(1) Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352)

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INTENDED USE

The Inion CPS" Orthognathic Plate is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) as a part of the Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System.

a) Fractures of the cranium, midface, maxilla and mandible.

b) Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations.

c) LeFort (I, II, III) osteotomies.

d) Pediatric reconstructive procedures.

e) Orthognathic or reconstructive procedures of the cranium, midface, maxilla or mandible.

f) Craniotomy flap fixation.

The Inion CPS™ 2.0 Orthognathic Plate is not intended for use in and is contraindicated for: Mandibular tumor resection; Active or potential infection; Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse). The system is not intended for use in the mandible without appropriate maxillomandibular fixation.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCTS

The Inion CPS™ Orthognathic Plate is a line extension to currently marketed Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System. Inion CPS™ 2.0 Orthognathic Plate has the same technological characteristics as the Inion CPS™ System identified above. Both will be offered in the same materials and with the same packaging and sterility options. Both the plates have the same intended use and principles of operation and there is no change in safety or efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

OCT - 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Hanna Marttila Regulatory Affairs Inion Limited Laakarinkatu 2 Tampere, FINLAND

Re: K013039

Trade/Device Name: Inion CPS 2.0 Orthognathic Plate Regulation Number: 872.4760 Regulation Name: Bone Plating System Regulatory Class: II Product Code: JEY Dated: September 7, 2001 Received: September 10, 2001

Dear Ms. Marttila:

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

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Page 2 - Ms. Marttila

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Susan Kunner

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE D

Applicant: Inion Ltd. 510(k) Number: Device Name: Inion CPS ™ 2.0 Orthognathic Plate

Indications For Use:

Indications:

A. General indications: The Inion CPS™ 2.0 Orthognathic Plate is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) as a part of the Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System.
B. Specific indications:
- Fractures of the cranium, midface, maxilla and mandible. ●
- Infant craniofacial surgery (i.e. craniosynostosis, congenital ● malformations).
- . LeFort (I, II, III) osteotomies.
- Pediatric reconstructive procedures. .
- Orthognathic or reconstructive procedures of the cranium, midface, . maxilla or mandible.
- Craniotomy flap fixation. ●

Contraindications:

The Inion CPS™ 2.0 Orthognathic Plate is not intended for use in and is contraindicated for:

1. Mandibular tumor resection
1. Active or potential infection
1. Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse)
1. DO NOT USE in the mandible without appropriate maxillomandibular fixation.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Susan Runne

(Division Sian-Off Division of Dental, Infection Co and General Hospita 510(k) Number

Special 510(k)

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.