The Stryker Trauma Pelvic Set consists of reconstruction plates, acetabulum plates, and symphysis-pubis plates. All reconstruction plates, acetabulum plates, and symphysis-pubis plates are available in 1.2mm, 2.0mm, and 2.5mm thicknesses. The symphysis-pubis plates are also available in a 12.5mm width and 1.2mm thickness. The subject components vary in length from 20mm to 200mm. The system also includes 3.5mm diameter and 4.5mm diameter screws. All devices in the system are provided both sterile and non-sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification Summary for the Stryker Trauma Pelvic Set, a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, AUC).

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the United States. In this context, "acceptance criteria" are related to satisfying the regulatory requirements to show that the new device is as safe and effective as a legally marketed predicate device.

Here's why the requested information cannot be provided from this document:

AI/ML Device Performance Metrics: The Stryker Trauma Pelvic Set is a set of bone fixation plates and screws, not an AI/ML diagnostic or predictive device. Therefore, metrics like sensitivity, specificity, AUC, or the concepts of "ground truth," "test set," "training set," "experts," or "adjudication methods" as applied to AI/ML performance are not relevant or discussed in this type of submission.
Substantial Equivalence: The "study" mentioned here is the comparison made by the manufacturer to demonstrate substantial equivalence to a predicate device (Synthes Pelvic Implant Set). The "proof" is the argument presented to the FDA that the devices are similar in design, materials, and intended use.
No Clinical Effectiveness Study (in the AI/ML context): This document does not detail a clinical study designed to measure the performance of the device in terms of diagnostic accuracy or a human-AI comparison. Substantial equivalence typically relies on technological comparison and, if needed, non-clinical bench testing or materials testing, rather than large-scale comparative clinical trials for performance metrics.

Based on the provided document, I can only extract information relevant to the regulatory approval process for a traditional medical device, not the performance evaluation of an AI/ML algorithm.

If this were an AI/ML device, the table would look like this (but the data is not available in the provided text):

Acceptance Criteria	Reported Device Performance
[e.g., Sensitivity ≥ X%]	[e.g., Y%]
[e.g., Specificity ≥ Z%]	[e.g., W%]
[Other relevant metrics]	[Reported values]

Here's what can be extracted from the document regarding the device and its regulatory submission:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Regulatory): The primary acceptance criterion for this 510(k) submission is that the Stryker Trauma Pelvic Set is substantially equivalent to the Synthes Pelvic Implant Set in design, materials, and intended use.
- Reported Device Performance: The document states, "The subject components of the Stryker Trauma Pelvic Set are substantially equivalent in design and intended use to the predicate device offered by Synthes." No specific performance metrics (e.g., mechanical strength benchmarks, clinical outcome data) are quantified and presented for comparison against a pre-defined acceptance threshold in this summary. The "performance" is implicitly deemed equivalent to the predicate.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not mentioned in the context of device performance testing. This is a traditional medical device submission, not an AI/ML algorithm requiring a test dataset of patient data. The "test" here refers to the FDA's evaluation of the substantial equivalence claim.
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 "test set" in the AI/ML sense, nor is there a "ground truth" established by experts for performance evaluation of a diagnostic or predictive algorithm.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a traditional medical device demonstrating substantial equivalence.
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 an implantable surgical kit, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not a standalone algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the AI/ML sense. The "ground truth" for this submission is the regulatory standard of substantial equivalence, which is assessed against the predicate device.
The sample size for the training set:
- Not applicable. There is no AI/ML model being "trained."
How the ground truth for the training set was established:
- Not applicable.

Summary

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4 2000 AUG

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Stryker Trauma Pelvic Set

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 201-825-4900

Regulatory Affairs Team Member

Mary-Catherine Dillon

March 23, 2000

Contact Person:

Date Summary Prepared:

Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

Stryker Trauma Pelvic Set

Pelvic Set

Plate, Fixation, Bone 21 CFR §888.3030

Predicate Device Identification

The Stryker Trauma Pelvic Set is substantially equivalent to the Synthes Pelvic Implant Set.

Device Description

Device Description I he buyker Trainia Perrobulum plates, and symphysis-pubis plates. All curves and straight plate pervice plates, buttight accuse pravidens and 2.5mm thicknesses. The symphysis-pubis plates are components arouventions in rotening 1.2mm thickness. The subject components vary in length from also available in a 12.5mm Water and shincludes 3.5mm diameter and 4.5mm diameter screws. All devices in the system are provided both sterile and non-sterile.

Intended Use

The Stryker Trauma Pelvic Set is indicated for:

Fractures of the acetabulum, sacrum, illium, and entire pelvic ring .
Revision surgery of pseoduarthroses, non-unions and mal-unions .

Kooib14

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Osteonomies ●
Arthrodeses ●
. Sacroilic joint dislocations
Symphysis pubis disruptures ●

Materials

The subject components are manufactured from stainless steel which conforms to ASTM F-138.

Statement of Technological Comparison

The subject components of the Stryker Trauma Pelvic Set are substantially equivalent in design and intended use to the predicate device offered by Synthes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2000 AUG

Ms. Mary-Catherine Dillon Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K001614

Trade Name: Stryker Trauma Pelvic Set Regulatory Class: II Product Code: KTW Dated: May 24, 2000 Received: May 25, 2000

Dear Ms. Dillon:

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 control provisions of the Act. The general control 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 Flectronic 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 parketed predicate device results in a classification for your device and thus, permits your dryice to proceed to the market.

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Page 2 - Ms. Mary-Catherine Dillon

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,

Duma R. Lochner.

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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510(k) Number (if known): KOO ﺎ ﻫﺎﻟﻢ ﺍ ﻫﺎﻟﻜ

Device Name: Stryker Trauma Pelvic Set

Indications For Use:

The Stryker Trauma Pelvic Set is indicated for:

Fractures of the acetabulum, sacrum, illium, and entire pelvic ring
Revision surgery of pseoduarthroses, non-unions and mal-unions
Osteonomies
. Arthrodeses
Sacroilic joint dislocations
Symphysis pubis disruptures

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dune R. Vochner.

(Division Sign-Off) Division of General Restorative Devices 510(k) Number KOO 1614

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.