VOLAR RADIUS PLATE WITH ANGULAR STABILITY by I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

Indications for Use include comminuted extra and intra-articular distal radius fractures, failed original fracture fixation, osteotomy and repair of a distal radius malunion, and comminuted volar shearing fractures

The I.T.S. Volar Radius Plate system provides immediate stability, rapid recovery, and prompt wrist functionality.

Device Description

The I.T.S. Volar Radius Plate with Angular Stability provides various width 4 and 6 hole standard plates, various width 8, 10, and 12 hole long plates, various length stabilization screws, and various length cortical fixation screws. The volar radius plates are made from CP Titanium according to ASTM F 67-00 and the screws are made from 6-4 Alloyed Titanium according to ASTM F 136-98.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

The provided documents do not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, these documents are a 510(k) summary and the FDA's clearance letter for a medical device called the "Volar Radius Plate with Angular Stability." The 510(k) process is primarily a regulatory pathway in the US for demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trial data demonstrating performance against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from these documents. Here's what can be inferred or stated based on the provided text:

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

Not Applicable. The documents do not define specific acceptance criteria (e.g., in terms of biomechanical performance, clinical outcomes, etc.) or report detailed device performance data against such criteria. The basis for clearance is "substantial equivalency" to predicate devices, not meeting novel performance benchmarks.

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

Not Applicable. No test set or associated data (clinical or otherwise, beyond potentially design specifications or bench testing to demonstrate similarity to predicates) is described in these documents.

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. There is no mention of a test set requiring expert ground truth establishment.

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

Not Applicable. No test set or adjudication is described.

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 fracture fixation plate, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

Not Applicable. This question is relevant for AI/software devices. This is a physical implant.

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

Not Applicable. For the substantial equivalency determination, the "ground truth" implicitly refers to the established safety and effectiveness of the predicate devices. The applicant needed to demonstrate that the new device is as safe and effective as these legally marketed devices, based on similar design principles, materials, and intended use, rather than proving a new scientific assertion with a novel ground truth.

8. The sample size for the training set

Not Applicable. No training set for an algorithm is relevant here, as this is a physical medical device clearance, not an AI/ML product.

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

Not Applicable. As above, no training set is relevant.

Summary of what can be extracted from the documents:

The basis of approval for the I.T.S. Volar Radius Plate with Angular Stability was its substantial equivalency to existing legally marketed predicate devices:

Avanta SCS/V Distal Radius Plate - Volar
Hand Innovations DVR Plate
Synthes Locking Distal Radius System 2.4

The 510(k) summary states that "The I.T.S. Volar Radius Plate is substantially equivalent to the Avanta, Hand Innovations, and Synthes fracture plating systems." This implies that the sponsor demonstrated similarity in terms of:

Intended Use: Stabilizing distal radius fractures in the wrist with accurate retention of articular fracture elements.
Technological Characteristics: Made from CP Titanium (plate) and 6-4 Alloyed Titanium (screws), similar to predicate devices.
Performance: Likely demonstrated through bench testing (e.g., mechanical tests like fatigue, tensile, bending strength, but these specific results are not provided in the summary) to show comparable performance to the predicates. The FDA's clearance letter affirms this substantial equivalency finding.

Summary

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

FEB - 6 2004	SAFE MEDICAL DEVICES ACT OF 1990510(k) Summary
NAME OF FIRM:	I.T.S. Implantat-Technologie-Systeme GmbH.Autal 28.Lassnitzhoche A-8301AUSTRIA
510(k) FIRM CONTACT:	Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372
TRADE NAME:	Volar Radius Plate with Angular Stability
COMMON NAME:	Fracture Fixation Plating system for fracture fixation of the end oflong bones
CLASSIFICATION:	Single/multiple component metallic bone fixation appliances andaccessories (see 21 CRF, Sec. 888.3030).
DEVICE PRODUCT CODE: HRS
SUBSTANTIALLYEQUIVALENT DEVICES:	Avanta SCS/V Distal Radius Plate - VolarHand Innovations DVR PlateSynthes Locking Distal Radius System 2.4
DEVICE DESCRIPTION:	The I.T.S. Volar Radius Plate with Angular Stability providesvarious width 4 and 6 hole standard plates, various width 8, 10,and 12 hole long plates, various length stabilization screws, andvarious length cortical fixation screws. The volar radius plates aremade from CP Titanium according to ASTM F 67-00 and thescrews are made from 6-4 Alloyed Titanium according to ASTM F136-98.
INTENDED USE:	The I.T.S. Volar Radius Plate is used to stabilize distal radiusfractures in the wrist with an accurate retention of articular fractureelements.
BASIS OF SUBSTANTIALEQUIVALENCY:	The I.T.S. Volar Radius Plate is substantially equivalent to theAvanta, Hand Innovations, and Synthes fracture plating systems
SUMMARY OF SAFETYAND EFFECTIVENESS:	The I.T.S. Volar Radius Plate system is shown to be safe andeffective for use in fracture fixation of the distal radius in the wrist.

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FEB - 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I.T.S. Implantat-Technologie-Systeme GMBH Al Lippincott c/o Engineering Consulting Services, Inc. 3150 East 2000 Street Prior Lake, Minnesota 55372

Re: K033756

Trade/Device Name: Volar Radius Plate with Angular Stability Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: November 24, 2003 Received: December 1, 2003

Dear Mr. 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, 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 docs 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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely you

Mark A. Mulkeen

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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Spectromed

Geschäftsführer: Herbert Seinsteiner & Dr Eva Rapter Mer

8301 Laßnitzhohe/Grat, Austria Antal 28

Spectromed GmbH lef=043 Ho241 21 0 - 1ax=43 316 211 21 30 l mail verkant-spectromed net IN 34940 h. DVR 0747473

1.T.S. Implantat · Technologie-Systeme GmbH lel .: . 43 316 211 21 0 Tax: +43 316 211 21 20 www.ts implant.com - [ mail:its@its amplant.com I N 16396ab - DVR 0934704

510(k) NUMBER: K033756
DEVICE NAME: Volar Radius Plate
INDICATIONS FOR USE:

The I.T.S. Volar Radius Plate with Angular Stability is a titanium implant fracture fixation system for distal radius fractures of the wrist.

The I.T.S. Volar Radius Plate system provides immediate stability, rapid recovery, and prompt wrist functionality.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

001 FUB B

Over-The-Counter-Use

(Optional Format)

for Mark A. Melber

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.