Intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in the fixation of osteopenic bone and fixation of non-unions and malunions.

Device Description

Synthes Locking Compression Plate (LCP) System - T Plate is a buttress plate and screw system. The primary feature of the plate is round holes combined with locking screw holes. The locking screws form a locked, fixed angle construct with the plate, while the standard screws facilitate reduction and create compression between the plate and bone. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0 mm locking screws

AI/ML Overview

Here's an analysis of the provided text regarding the Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate:

Based on the provided document (K010766), this is a 510(k) premarket notification for a Class II medical device (bone plate and screw system). The document describes the device, its intended use, and its classification.

Crucially, the provided text does not contain any information about acceptance criteria or a study demonstrating device performance as it relates to clinical effectiveness or specific quantitative metrics like accuracy, sensitivity, or specificity. This type of information is typically found in performance testing reports, clinical study summaries, or validation reports, none of which are present in these excerpts.

The 510(k) process for devices like this primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device, rather than requiring extensive de novo clinical efficacy trials. Substantial equivalence is often established through materials testing, mechanical testing, and comparison of design features and intended use.

Therefore, for aspects related to acceptance criteria and device performance studies (items 1 through 9 in your request), the information is not available in the provided document.

Here's a breakdown of what can be inferred from the provided text, and where information is missing:

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

Information Not Available in Excerpt. The document does not specify quantitative acceptance criteria or report performance metrics (e.g., in terms of strength, fatigue life, or other mechanical properties) for the device. The 510(k) summary focuses on description and substantial equivalence.

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

Information Not Available in Excerpt. No details on clinical or performance test sample sizes, test set provenance, or type of study (retrospective/prospective) are mentioned.

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 / Information Not Available in Excerpt. For mechanical devices like bone plates, "ground truth" as it pertains to expert interpretation (like in imaging AI) is generally not relevant. The document doesn't describe expert-adjudicated test sets for clinical studies.

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

Not Applicable / Information Not Available in Excerpt. No adjudication method is mentioned as there are no expert-interpreted test sets 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 is a hardware medical device (bone plate and screw system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant or described.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

Not Applicable / Information Not Available in Excerpt. For a bone plate, "ground truth" would typically relate to successful bone healing, implant stability, or other clinical outcomes. These are not discussed in the provided regulatory communication. Performance testing for such devices typically involves biomechanical lab tests (e.g., fatigue, static strength), but the details of such tests are not provided in this 510(k) summary.

8. The sample size for the training set

Not Applicable / Information Not Available in Excerpt. As this is not an AI/machine learning device, there is no "training set."

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

Not Applicable / Information Not Available in Excerpt. As this is not an AI/machine learning device, there is no "training set" or ground truth for it in this context.

Summary of what the document does provide:

Device Name: Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate
Sponsor: Synthes (USA)
Device Classification: Class II (21 CFR 888.3030 and 888.3040)
Predicate Device: Synthes T Plates (This is the key piece of information for a 510(k) – the device is substantially equivalent to this predicate).
Description: Buttress plate and screw system with round holes and locking screw holes, forming a fixed-angle construct. Accepts various screw sizes.
Indications for Use: Buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia; fixation of osteopenic bone, non-unions, and malunions.
Material: 316L Stainless Steel, Titanium
Regulatory Determination: Substantially equivalent to devices marketed prior to May 28, 1976. This allows the device to be marketed.

To get the information you asked for regarding acceptance criteria and performance data, one would need to consult a more detailed technical file, design validation report, and/or mechanical testing reports, which are usually part of the full 510(k) submission but not typically released in the public 510(k) summary letters.

Summary

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KD10766

3. 510(k) Summary:

、

Sponsor	Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Bonnie Smith
Device Name:	Synthes (USA)Large Fragment Locking Compression Plate (LCP) System - T Plate
Device Classification:	21 CFR 888.3030: "Single/multiple component metallic bonefixation appliance and accessories" and 888.3040: "Smooth orthreaded metallic bone fixation fastener".
Predicate Device:	Synthes T Plates
Description of Device:	Synthes Locking Compression Plate (LCP) System - T Plate is abuttress plate and screw system. The primary feature of the plate isround holes combined with locking screw holes. The lockingscrews form a locked, fixed angle construct with the plate, while thestandard screws facilitate reduction and create compression betweenthe plate and bone.
	The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mmcannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0mm locking screws
Indications:	Intended to buttress metaphyseal fractures of the proximal humerus,medial tibial plateau and distal tibia. Also for use in fixation ofosteopenic bone and fixation of non-unions and malunions.
Material:	316L Stainless SteelTitanium

Premarket Notification 510(k) Synthes (USA) Large Fragment LCP System - T Plate CONFIDENTIAL

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Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

JUN 1 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K010766

Trade Name: Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate

Regulation Number: 888.3030 Regulatory Class: Class II Product Code: KTT Dated: March 13, 2001 Received: March 14, 2001

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Bonnie J. Smith

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Bmutheuerston

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

Enclosures

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2. Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name:

Synthes Large Fragment Locking Compression Plate (LCP) System - T Plate

K010766

Indications for Use:

Intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in the fixation of osteopenic bone and fixation of non-unions and malunions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use U (Per 21 CFR 801.109)

Over-The-Counter Use

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Premarket Notification 510(k) estorative Synthes (USA) Large Fragment LCP Sy CONFIDENTIAL

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510(k) Number K010766

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.