The Match Point System™ is intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty procedures which utilize anatomic landmarks that are identifiable on preoperative CT or MRI medical images.

The Match Point System™ can be used with the following total and reverse shoulder implant systems and their respective compatible components: Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873).

The Match Point System™ Guides are intended for single use only.

Device Description

The Match Point System™ consists of a software component, SurgiCase Connect and a hardware component, Match Point System™ guide, and is designed to assist the surgeon in the placement of glenoid components.

The Match Point System is for use within the intended use of the compatible components.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Design, intended use, functionality, technology, material, and performance characteristics comparable to predicate devices.	Device comparison analysis showed that the proposed device is substantially equivalent to the predicate devices in: - design, intended use, functionality, technology, material and performance characteristics for the Signature Personalized Patient Care System - Acetabular Guide System; - intended use and functionality for the conventional instrumentation for shoulder arthroplasty (central drill guide).
Accuracy and performance adequate for intended use.	"Accuracy performance testing was performed in a cadaveric setting to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended."
Guide use, positioning, and accuracy at borders.	"Accuracy performance testing was performed on rapid prototyped models to verify guide use, positioning, and accuracy of the shoulder system at its borders for use."
Safety and effectiveness.	"Non-clinical testing was sufficient to demonstrate safety and effectiveness of the device as intended."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a numerical sample size for the "cadaveric setting" or "rapid prototyped models" used in the non-clinical tests.
Data Provenance: The tests were non-clinical, involving a "cadaveric setting" and "rapid prototyped models." The country of origin for this data is not specified. The tests were presumably prospective as they were specifically conducted for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the non-clinical tests. The tests focused on objective measurements of accuracy and performance in a controlled environment, likely using established anatomical references or engineering specifications rather than expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Given the nature of the non-clinical accuracy and performance testing, it's likely that measurements were taken and compared against predefined engineering tolerances or anatomical landmarks, rather than requiring expert adjudication of subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The provided text indicates that "Non-clinical testing was sufficient to demonstrate safety and effectiveness of the device as intended," and it explicitly states "No Clinical Data" was required. Therefore, no studies comparing human readers with and without AI assistance (which is what the software component does) were performed or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance assessment of the software component (SurgiCase Connect), in terms of its ability to generate the preoperative plan with a certain level of accuracy prior to surgeon modification, is not explicitly detailed as a standalone study. The description implies the software component (SurgiCase Connect) generates an initial plan which is then "fine-tune[d] and approve[d]" by a qualified surgeon. The accuracy testing seems to be for the entire system (software + guide) in transferring the approved plan.

7. The Type of Ground Truth Used

In the context of the non-clinical accuracy performance testing:
- For the cadaveric setting, the ground truth would likely be established anatomical landmarks and precise measurements taken relative to these landmarks.
- For the rapid prototyped models, the ground truth would likely be the precise engineering specifications and measurements of the model, which represent the ideal planned scenario.
- Neither "expert consensus," "pathology," nor "outcomes data" are mentioned as the ground truth for these tests. The ground truth for these tests would be based on objective, quantifiable physical measurements against known standards.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This device appears to be a medical device software that assists in planning and manufacturing a physical guide, rather than a machine learning model that typically requires a large training set. The "software component" (SurgiCase Connect) seems to be based on algorithms and anatomical modeling principles rather than statistical learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Since there's no mention of a traditional machine learning "training set," there's no information on how its "ground truth" was established. The software's functionality is described as generating a plan based on "medical imaging data" and "surgical technique of the respective implant system," implying a rule-based or model-driven approach rather than data-driven machine learning.

Summary

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SEP 27 2013

510(k) Summary

Submitter information

Company name	Materialise N.V.
Establishment registration number	3003998208
Street Address	Technologielaan 15
City	Leuven
Postal code	3001
Country	Belgium
Phone number	+32 16 39 62 80
Fax number	+32 16 39 66 06
Contact name	Alexandra Razzhivina
Contact title	Regulatory Officer
Contact e-mail address	regulatory.affairs@materialise.be
Additional contact person	Mieke Janssen
Contact title	Director Quality and Regulatory Affairs
Contact e-mail address	mieke.janssen@materialise.be
Additional contact person	Johan Ex
Contact title	Brand manager
Contact e-mail address	johan.ex@materialise.be

Submission date

The date of the Traditional 510(k) submission is May 27th, 2013.

Submission information

Trade Name	Match Point System™, Match Point System™ guide, SurgiCase Connect
Common Name	Patient specific instrumentation for shoulder arthroplasty
Classification Name	Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660)
Product codes	KWS

Predicate devices

Trade or proprietary or modelname	Signature Personalized Patient Care System - AcetabularGuide System
510(k) number	K111863
Decision date	06/15/2012
Product codes	JDI, KWY, KWZ, LPH, LZO, MAY, MEH
Manufacturer	Materialise NV

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510(k)number	Decisiondate	Productcode	Trade or proprietaryor model name	Manufacturer
K051075	05/27/2005	KWS	Encore ShoulderSystem	Encore Medical, L.P.
K080402	03/28/2008	KWS	Turon™ ShoulderSystem	Encore Medical, L.P.
K111629	09/16/2011	KWS	Turon™ to RSPConversion Shell	Encore Medical, L.P.
K092873	10/27/2009	KWS	Reverse® Shoulderprosthesis	DJO Surgical

Conventional instrumentation for shoulder arthroplasty (central drill guide) predicate:

Device Information

Description of the device

The Match Point System is for use within the intended use of the compatible components.

Functioning of the device

The Match Point System generates a preoperative plan based on medical imaging data using SurgiCase Connect, the software component. This software is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the preoperative plan. The preoperative plan displays a virtual 3D model of the patient's scapula, a glenoid implant for either reverse or total shoulder replacement positioned onto the glenoid surface, and the central pin which corresponds to the glenoid implant's position. The implant and pin are initially displayed in a default location according to the surgical technique of the respective implant system. The surgeon modifies the default position by rotating and translating the pin and implant Once the implant is in the desired position, the surgeon approves the orientation. preoperative plan.

Once approved, a Match Point System guides is designed and manufactured based on the preoperative plan. Match Point System guides are patient specific templates that transfer the preoperatively approved pin positioning to the patient intraoperatively. The guide consists of a patient specific baseplate which conforms to the patient's anatomy. The drill cylinder's position corresponds to the planned drill position. This drill cylinder's inner diameter matches the corresponding instrumentation's diameter. A Kirschner wire may be optionally used to help stabilize the guide's position while drilling.

Intended use

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The Match Point System™ guides are intended for single use only.

Summary of technological characteristics

Device comparison analysis showed that the proposed device is substantially equivalent to the predicate devices in:

design, intended use, functionality, technology, material and performance . characteristics for the Signature Personalized Patient Care System ~ Acetabular Guide System;
intended use and functionality for the conventional instrumentation for shoulder . arthroplasty (central drill guide).

Performance data

Non-clinical tests

Accuracy performance testing was performed in a cadaveric setting to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Accuracy performance testing was performed on rapid prototyped models to verify guide use, positioning, and accuracy of the shoulder system at its borders for use.

Clinical data

Non-clinical testing was sufficient to demonstrate safety and effectiveness of the device as intended.

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Image /page/3/Picture/0 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 symbol that resembles an abstract human figure embracing or protecting another smaller figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 27, 2013

Materialise N.V. Ms. Alexandra Razzhivina Regulatory Officer Technologielaan 15 Leuven 3001 Belgium

Re: K131559

Trade/Device Name: Match Point System™ (Match Point System™ Guides, SurgiCase Connect) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: K WS Dated: September 16, 2013 Received: September 18, 2013

Dear Ms. Razzhivina:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Alexandra Razzhivina

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/McdicalDcvices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N! Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K131559

Indications for Use

KI 31559 510(k) Number (if known): นทหาอพก

Device Name: Match Point System™ (Match Point System™ Guides, SurgiCase Connect)

Indications for Use:

The Match Point System™ Guides are intended for single use only.

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Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”