The I.T.S. Epiphysis Screw is a titanium implant fracture fixation screw system for a slipped femoral capital epiphysis and alternative cancellous bone screw fixation where accurate screw placement is required such as in the pelvis, ankle, knee, etc.,

Indications for Use include fracture fixation of large bone fragments, such as femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.

The system is not intended for spinal use.

Device Description

The I.T.S. Epiphysis Screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guidewire pin. Screws are available partially threaded in lengths from 50mm to 120mm in 5mm increments. A full complement of instrumentation is available to assist in placement. The screws are manufactured from 6-4 ELI Titanium alloy with a Tiodize, Type II surface.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the I.T.S. Epiphysis Screw:

Missing Information:

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the manner you've requested for a clinical trial or AI device validation. Most of the information you've asked for (such as MRMC studies, sample sizes, ground truth establishment, expert qualifications, and detailed performance metrics beyond basic equivalence) is not present in these regulatory documents.

The 510(k) process for this type of device (a bone screw) relies heavily on comparing the new device's design, materials, and intended use to existing, legally marketed predicate devices to show that it is "substantially equivalent" and thus as safe and effective. It does not typically involve the kind of rigorous, quantitative human-in-the-loop or standalone performance studies with detailed acceptance criteria that are characteristic of, for example, diagnostic imaging AI.

Here's a breakdown of what can be extracted or inferred, and what is explicitly unobtainable from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided documents, explicit acceptance criteria and corresponding reported device performance as numerical metrics (e.g., sensitivity, specificity, accuracy) are NOT available.

For a device like a bone screw, "acceptance criteria" in the context of a 510(k) are typically met by demonstrating:

Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device. This is the primary "acceptance criterion" for 510(k) clearance.
Biocompatibility: The materials used are biologically safe.
Mechanical Performance: The device meets certain strength, fatigue, and other engineering specifications (often tested in-vitro).
Sterility: The device can be sterilized and maintained as sterile.
Labeling: Clear instructions for use and warnings are provided.

The provided text focuses on the conclusion of substantial equivalence, not the detailed test results against specific criteria.

Acceptance Criteria (Inferred from 510(k) process for bone screws)	Reported Device Performance (Inferred from FDA Clearance)
Substantial Equivalence to Predicate Devices	Achieved: FDA determined the device is substantially equivalent to legally marketed predicate devices (K021932, K000080, K862157, K903810).
Material Composition (6-4 ELI Titanium alloy with Tiodize, Type II surface)	Meets Specifications: Explicitly stated material composition. Implied to be equivalent to predicate materials.
Intended Use (Specific fracture fixations, not spinal use)	Meets Specifications: The stated intended use aligns with the FDA's acceptance for the device.
Design Characteristics (Self-tapping, self-drilling, cannulated, screw lengths)	Meets Specifications: Device description provided and implied to be equivalent to predicate designs.
Biocompatibility, Mechanical Strength, Sterility, Shelf Life, etc.	Implied to be met: These are fundamental requirements for medical devices, and their successful assessment is prerequisite for 510(k) clearance, even if not explicitly detailed in the summary.

Study Details (Based on the provided documents)

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 applicable/not provided. This type of 510(k) submission for a bone screw does not typically involve a patient "test set" in the way a diagnostic AI device would. Performance is demonstrated through engineering tests (which are not detailed here) and comparison to predicate devices.
Data Provenance: Not applicable/not provided.

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 not part of this type of 510(k) submission.

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

Not applicable/not provided.

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. An MRMC comparative effectiveness study is not relevant or performed for a bone screw. This type of study is typically for diagnostic devices or AI applications where human interpretation is a factor.

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

No. This is a physical bone screw, not an algorithm. Standalone performance studies are not applicable.

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

Not applicable in the context of a "ground truth" for a patient test set. The "ground truth" for this device's safety and effectiveness relies on established engineering principles, material science, clinical consensus for predicate devices, and in-vitro testing for mechanical properties (not detailed here).

8. The sample size for the training set

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

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

Not applicable/not provided.

Summary of what the documents do provide:

Device Name: Epiphysis Screw
Manufacturer: I.T.S. Implantat-Technologie-Systeme GmbH. (AUSTRIA)
Device Description: Self-tapping, self-drilling, cannulated bone screw from 6-4 ELI Titanium alloy with Tiodize, Type II surface. Available in lengths 50mm-120mm.
Intended Use: Stabilize slipped capital femoral epiphysis and fracture fixation in the pelvis of large bones and large bone fragments. Specific indications include: femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses. Not intended for spinal use.
Predicate Devices: Synthes 6.5mm Cannulated Screw (K021932), Howmedica Osteonics ASNIS III Cannulated Screw (K000080), Orthomet/Wright Medical Cannulated Screw (K862157), Ace/Depuy Cannulated Self Tapping Cancellous Bone Screw (K903810), Zimmer MAGNA-Fx Cannulated Screw Fixation system, Richards/Smith Nephew Universal Cannulated Screw, DePuyAce ACE SCFE Screw.
Regulatory Conclusion: FDA found the device "substantially equivalent" to the predicate devices and cleared it for marketing.

Summary

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FEB * 4 2005

K043410

Section XII: 510(k) Summary of Safety and Effectiveness

SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

NAME OF FIRM:	I.T.S. Implantat-Technologie-Systeme GmbH.Autal 28.Lassnitzhoehe A - 8301AUSTRIA
510(k) FIRM CONTACT:	Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372
TRADE NAME:	Epiphysis Screw
COMMON NAME:	Cannulated Bone Screw
CLASSIFICATION:	Smooth or threaded metallic bone fixation fastener(see 21 CRF, Sec. 888.3040).
DEVICE PRODUCT CODE:	HWC
SUBSTANTIALLYEQUIVALENT DEVICES:	Synthes 6.5mm Cannulated Screw (K021932)Howmedica Osteonics ASNIS III Cannulated Screw (K000080)Orthomet/Wright Medical Cannulated Screw (K862157)Ace/Depuy Cannulated Self Tapping Cancellous Bone Screw(K903810)Zimmer MAGNA-Fx Cannulated Screw Fixation systemRichards/Smith Nephew Universal Cannulated ScrewDePuyAce ACE SCFE Screw
DEVICE DESCRIPTION:	The I.T.S. Epiphysis Screw is a self-tapping and self-drilling screwwith a cancellous thread that can be guided into a position via aguidewire pin. Screws are available partially threaded in lengthsfrom 50mm to 120mm in 5mm increments. A full complement ofinstrumentation is available to assist in placement. The screws aremanufactured from 6-4 ELI Titanium alloy with a Tiodize, Type IIsurface.
INTENDED USE:	The I.T.S. Epiphysis Screw is used to stabilize a slipped capitalfemoral epiphysis and fracture fixation in the pelvis of large bonesand large bone fragments. The system is not intended for spinaluse

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

FEB 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I.T.S. Implant-Technologie-SystemeGMBH Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200th Street Prior Lake, Minnesota 55372

Re: K043410

Trade/Device Name: Epiphysis Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 10, 2004 Received: December 10, 2004

Dear Mr. Al Lippincott:

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. Iisting 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.

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Page 2 - Mr. Al Lippincott

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,

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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I.T.S. Implant-Technology-Systems GmbH

chäftsführende Gesellschafterin: Dr

1081 69 4 11 1 STORE CONSTITUTION

Indications for Use

510(k) NUMBER: DEVICE NAME: EPIPHYSIS SCREW INDICATIONS FOR USE:

The system is not intended for spinal use.

Prescription Use

AND/OR Over-The-Counter-Use

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Section X

EN ISO 1349

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

(Division Sign-Off)

Comeral, Regenciality of CDRH, Office of Device Evaluation (ODE) Division and Neurological Dev

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.