The Inion OTPS™ Biodegradable Mini Plating System is intended for use in fixation of non-comminuted diaphyseal fractures of the metacarpal, proximal phalangeal, middle phalangeal and osteotomies in the presence of appropriate immobilization.

Device Description

The Inion OTPS™ Biodegradable Mini Plating System is consisted of biodegradable screws and plates intended to be used in fractures of phalanges and metacarpal. Implants will be utilized by using common surgical techniques. The Inion OTPS™ Biodegradable Mini Plating System is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)). The Inion OTPS™ Biodegradable Mini Plating System implants gradually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.

AI/ML Overview

The provided text describes a 510(k) submission for the Inion OTPS™ Biodegradable Mini Plating System. It focuses on the device's substantial equivalence to predicate devices and its intended use. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with clinical trial data analysis (like sample sizes for test/training sets, expert consensus for ground truth, or MRMC studies).

Therefore, I cannot fill out the requested table and answer the questions based solely on the provided text. The document is a regulatory submission for premarket clearance, which often relies on comparison to existing legally marketed devices (predicates) and mechanical testing rather than extensive human reader studies or detailed performance metrics against specific acceptance criteria in a clinical setting.

Here's what I can infer or state based on the document's content:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative values. The primary acceptance criterion for a 510(k) submission is "substantial equivalence" to predicate devices.
Reported Device Performance: The document states, "Mechanical testing demonstrates that the device is substantially equivalent to the predicate ones." It doesn't provide specific mechanical testing results (e.g., tensile strength, fatigue life) or clinical performance metrics (e.g., healing rates, complication rates).

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

Not provided. The document primarily references mechanical testing for substantial equivalence, not clinical study data for a "test set."

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/Not provided. Ground truth establishment with experts is relevant for studies involving diagnostic or interpretive tasks, not typically for the premarket clearance of devices like bone plating systems where equivalence is established through mechanical and material properties.

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

Not applicable/Not provided for the reasons stated above.

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 bone plating system, not an AI or diagnostic imaging device that would involve human readers or AI assistance in a clinical interpretation role.

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

Not applicable. This is a physical medical device.

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

Not explicitly stated for a clinical "ground truth." For mechanical equivalence, the "ground truth" would be established by validated test methods (e.g., ASTM standards) comparing the new device's mechanical properties to those of the predicate devices.

8. The sample size for the training set:

Not applicable/Not provided. Training sets are relevant for AI/machine learning models, not for this type of physical device.

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

Not applicable for the reasons stated above.

Summary based on the provided text:

The document describes a 510(k) premarket notification for a biodegradable bone plating system. The primary method for demonstrating its suitability for market was through showing substantial equivalence to existing predicate devices (Biomet Inc.'s ReUnite Bone Screw and LactoSorb Hand System, and Synthes Compact Hand 1.0/1.3). This equivalence was supported by mechanical testing, which indicated that the new device had "the same intended use and principles of operation and very similar design characteristics" to the predicates, and that "The differences between the Inion OTPS™ Biodegradable Mini Plating System and predicate devices do not raise new questions of safety and effectiveness."

The text does not provide specific quantitative acceptance criteria or detailed study results (like sample sizes, expert involvement, or clinical outcomes) that would be common when evaluating AI/diagnostic devices against specific performance metrics.

Summary

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MAY 3 0 2003

Ko13887

pge 'f=

510(k) SUMMARY Inion OTPS™ Biodegradable Mini Plating System

MANUFACTURER Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere

Contact Person: Hanna Marttila Regulatory Affairs Manager Phone: +358 3 2306 600 Fax: +358 3 2306 601 Hanna.Marttila@Inion.fi

DEVICE NAME

Trade name: Inion OTPS™ Biodegradable Mini Plating System Common/Usual Name: Bone Plating System Classification Name: Bone Plate, Screw

ESTABLISHMENT REGISTRATION NUMBER 9710629

DEVICE CLASSIFICATION AND PRODUCT CODE

Classification panel: Orthopedic Regulatory Class: Class II 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87 HWC (screw) 21 CFR 888.3030 - Single multiple component metallic bone fixation appliances and accessories, 87 HRS (plate)

PREDICATE DEVICES

(1) Biomet Inc .; ReUnite Bone Screw (K992301) (2) Biomet Inc .; LactoSorb Hand System (K991763) (3) Syntehes(USA); Synthes Compact Hand 1.0/1.3 (pre-amendment device)

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DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

EQUIVALENCE TO MARKETED PRODUCTS

The Inion OTPS™ Biodegradable Mini Plating System is substantially equivalent to biodegradable implants, intended for metacarpal and phalangeal fracture fixation procedures, which have received 510(k) clearance. Inion OTPS™ Biodegradable Mini Plating System LactoSorb Hand System (K991763) and ReUnite Screw (K992301) have the same intended use and principles of operation and very similar design characteristics. Mechanical testing demonstrates that the device is substantially equivalent to the predicate ones. The differences between the Inion OTPS™ Biodegradable Mini Plating System and predicate devices do not raise new questions of safety and effectiveness

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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 an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or body.

Public Health Service

MAY 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Hanna Marttila Regulatory Affairs Manager Inion Ltd. Lääkärinkatu 2 Fin-33520 Tampere Finland

Re: K023887

Trade/Device Name: Inion OTPS™ Biodegradable Mini Plating System Regulation Number: 21 CFR 888.3040 and 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener, and Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC and HRS Dated: March 4, 2003 Received: March 6, 2003

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 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

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Page 2 - Ms. Hanna Marttila

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 (301) 594-4639. 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 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.

sincerely yours,

L. Mark A. Mellekerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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D STATEMENT OF INDICATIONS FOR USE

Applicant: Inion Ltd. 510(k) Number: Device Name: Inion OTPS™ Biodegradable Mini Plating System

Indications:

The Inion OTPS™ Biodegradable Mini Plating System is intended for use in fixation of noncomminuted diaphyseal fractures of the metacarpal, proximal phalangeal, middle phalangeal and osteotomies in the presence of appropriate immobilization.

Contraindications:

Inion OTPS™ Biodegradable Mini Plating System is not intended for use in and is contraindicated for:

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. Load bearing procedures.

ﺴﻴﺴﺎ

Prescription use	Yes
Over the Counter use	No

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

Date:	15
Status:	F

KO 2388

510(k) Number_

5.11.2002 Status: Final

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.