The Synthes Calcaneal Plate is a flat metal plate with multiple arms that can accommodate a variety of screws. It designed to be applied to the lateral side of the calcaneus and comes in right and left versions.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Synthes Calcaneal Plate. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given text.

The document states: "Documentation was provided which demonstrated the Synthes Calcaneal Plate to be substantially equivalent to another legally marketed device." This implies that the primary "study" was a comparison to a predicate device, focusing on material, design, and intended use, rather than a clinical performance study with specific metrics like accuracy, sensitivity, or specificity.

Here's what can be extracted based on the provided text, and what information is missing:

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

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to a legally marketed predicate device	Device was found to be "substantially equivalent" to legally marketed predicate devices for its stated indications for use.
Material: Stainless Steel	Device is made of Stainless Steel.
Indications for Use: Fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.	Device's intended use matches the stated indications.
Design: Flat metal plate with multiple arms, accommodates various screws, applied to lateral side of calcaneus, comes in right and left versions.	Device description aligns with the design.

Missing: The document does not specify quantitative performance acceptance criteria (e.g., specific thresholds for fracture fixation strength, bone healing rates, complication rates, or imaging accuracy) because it's a substantial equivalence submission.

2. Sample size used for the test set and the data provenance

Missing. The document does not describe a clinical "test set" in the context of device performance metrics. Its equivalence claim relies on comparing characteristics to existing devices, not on new clinical data from a specific patient sample.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing. Not applicable as a clinical performance study with a test set and ground truth established by experts is not detailed.

4. Adjudication method for the test set

Missing. Not applicable.

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 fixation plate, not an AI-assisted diagnostic or treatment planning tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Missing/Not applicable in the traditional sense. For a substantial equivalence claim, the "ground truth" is typically conformance to established standards for materials, manufacturing, and comparison to the predicate device's proven safety and efficacy profile. There's no clinical "ground truth" derived from patient outcomes or expert consensus described here.

8. The sample size for the training set

Missing. Not applicable, as this is not a machine learning or AI device that requires a training set.

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

Missing. Not applicable.

Summary

{0}------------------------------------------------

MAY 0 8 2002

K020401

page 1 of 1

3. Summary of Safety and Effectiveness Information

Sponsor	Synthes (USA)1690 Russell RoadPaoli, PA 19301
Company Contact	Matthew M. Hull(610) 647-9700 ext. 7191
Name of the Device	Synthes Calcaneal Plate
Device Classification(s)	Class II, §888.3030 - Plate, Fixation, Bone
Substantial Equivalence	Documentation was provided which demonstrated the SynthesCalcaneal Plate to be substantially equivalent to another legallymarketed device.
Device Description	The Synthes Calcaneal Plate is a flat metal plate with multiple armsthat can accommodate a variety of screws. It designed to be applied tothe lateral side of the calcaneus and comes in right and left versions.
Indications	The Synthes Calcaneal Plate is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.
Material	Stainless Steel

CONFIDENTIAL

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The words are arranged on a single line and are left-aligned. The text is likely a heading or title.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 8 2002

Mr. Matthew M. Hull, RAC Senior Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, PA 19301

Re: K020401

Trade/Device Name: Synthes Calcaneal Plate Regulation Number: 888.3030 Regulation Name: Solo.5050
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: February 5, 2002

Received: February 7, 2002

Dear Mr. Hull:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated) 75 the enactment date of the Medical Device Amendments, or to conniner of the for to rite) 20, 2017 - 11:57
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been roomstiled in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelore, mainer 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 If your device 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 or cary I 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

{2}------------------------------------------------

Page 2 -- Mr. Matthew M. Hull, RAC

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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,

Miriam C. Provost
for Celia Witte, Ph.D., M.D.

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

Enclosure

{3}------------------------------------------------

page loft

2. Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

OdOYO/

Synthes Calcaneal Plate

The Synthes Calcaneal Plate is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020401

Synthes(USA) Synthes Calcaneal Plate 510(k) CONFIDENTIAL

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.