MyKnee® PPS-Pin Positioners are intended to be used as anatomical pin positioners specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding of bone before cutting. MyKnee® PPS-Pin Positioners are intended for use with the GMK Total Knee System and its cleared indications for use. MyKnee® PPS-Pin Positioners are intended for single use only.

Device Description

The MyKnee® PPS-Pin Positioners are single use femoral and tibial pin positioning patientspecific blocks. The MyKnee® PPS-Pin Positioners are designed and manufactured from patient MRI imaging data so the positioners match the patient's anatomy. The MyKnee® PPS-Pin Positioners are used with Medacta International SA's existing GMK Total Knee System. GMK Primary, GMK Sphere and GMK-Primary Narrow. The pin positioners are developed only for placement of the standard metal instruments (distal/tibial cut guide and 4-in-1 femoral cut guide) following the positions planned by the surgeon.

The MRI images are provided by the hospitals to Medacta International SA prepared according to a specific protocol for an individual patient. Medacta International SA uses these images in combination with Mimics (Materialise) and Solidworks (Dassault Systemes) to import DICOM images from a patient's MRI scans and these scans are then processed into accurate 3D models.

The MyKnee® PPS-Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices. MyKnee® PPS-Pin Positioners blocks are available in sizes 1-7 for the femur and sizes 1-6 for the tibia. The pin positioners will be provided in both non-sterile and sterile versions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the MyKnee® PPS-Pin Positioners, based on the provided document:

This device is not an AI/ML device, therefore, please note that some of the requested information, such as sample size for the test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, and training set details, are not applicable or not explicitly detailed in the context of a traditional medical device submission for a physical pin positioner. The provided document focuses on demonstrating substantial equivalence to a predicate device through non-clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance
Non-Clinical Studies
Design comparison (Dimensional/Geometrical)	Evaluation supports no new questions of safety or effectiveness.
Breakage evaluation	(Not explicitly detailed, but implied to meet requirements)
Manufacturing process evaluation	(Not explicitly detailed, but implied to meet requirements)
Functional and fitting evaluation	Conducted with written protocols (implied to meet requirements).
Sterilization Studies
Sterilization dimensional and functional impact study	Conducted with written protocols (implied to meet requirements).
Gamma sterilization criticality assessment	Conducted with written protocols (implied to meet requirements).

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

Sample Size for Test Set: Not explicitly stated in the document as this is not an AI/ML device that would typically have a separate "test set" in that context. The "test" here refers to non-clinical evaluations of physical device properties.
Data Provenance: The studies were non-clinical, involving design comparisons, breakage evaluations, manufacturing process evaluations, functional/fitting evaluations, and sterilization impact studies of the physical device. This data would be generated in a lab or workshop setting by Medacta International SA.

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

This information is not applicable and not provided. The "ground truth" for a physical device like a pin positioner is its physical properties and functionality, which are assessed through engineering and performance testing, not by expert interpretation of data in the same way as an AI/ML diagnostic device.

4. Adjudication Method for the Test Set

Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in interpreting medical images or clinical data, which is not relevant for the testing of this physical device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "no clinical studies were conducted." MRMC studies are generally used to evaluate the diagnostic performance of AI/ML systems with or without human-in-the-loop.

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

Not applicable. The MyKnee® PPS-Pin Positioners are physical, patient-specific surgical guides, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on engineering and performance specifications, design requirements, and established material properties. This is verified through:

Measurement against design specifications (dimensional/geometrical comparison).
Physical testing for durability (breakage evaluation).
Assessment of manufacturing consistency (manufacturing process evaluation).
Evaluation of intended function (functional and fitting evaluation), likely in cadaver workshops.
Compliance with biocompatibility standards (by demonstrating equivalence to predicate materials).
Compliance with sterilization requirements.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth established for training.

Summary of the Study Proving Acceptance Criteria:

The document describes a series of non-clinical studies to demonstrate substantial equivalence of the MyKnee® PPS-Pin Positioners to the predicate device (MyKnee® Cutting Blocks, K093806). These studies focused on:

Design Comparison (Dimensional/Geometrical): This compared the subject device to the predicate, noting the key difference as the removal of integrated cut slots. The evaluation concluded this difference did not raise new safety or effectiveness concerns.
Breakage Evaluation: Assessed the structural integrity and durability of the device.
Manufacturing Process Evaluation: Verified the consistency and control of the manufacturing process.
Functional and Fitting Evaluation: Conducted according to written protocols, likely in cadaver workshops, to ensure the pin positioners function as intended in guiding surgical instruments.
Biocompatibility: Noted that the material (medical grade nylon for sintering) and manufacturing process are identical to the predicate device, for which biocompatibility testing (to ISO 10993-1, -5, -10 for short-term contact) had already been conducted and deemed sufficient.
Sterilization Studies: Included a "sterilization dimensional and functional impact study" and a "gamma sterilization criticality assessment" to ensure the sterilization process does not compromise the device's integrity or function, and that both non-sterile and gamma-sterilized versions are acceptable.

The conclusion is that these non-clinical studies and comparisons support that the MyKnee® PPS-Pin Positioners are as safe and effective as the predicate devices, and the minor design differences do not raise any new questions of safety or effectiveness, thus proving substantial equivalence for device acceptance. No clinical studies were performed.

Summary

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October 20, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medacta International SA % Elizabeth Rose Manager, Regulatory Affairs Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504

Re: K170106

Trade/Device Name: MyKnee® PPS-Pin Positioners Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 20, 2017 Received: September 21, 2017

Dear Ms. Rose:

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 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);

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Page 2 - Elizabeth Rose

and if applicable, the electronic 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 Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/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 Industry and Consumer Education (DICE) 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.

Katherine D. Kavlock -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K170106

Device Name MyKnee® PPS-Pin Positioners

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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3.0 510(k) Summary

I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory Affairs Manager Date Prepared: January 10, 2017 Date Revised: September 20, 2017

II.	Device
Device Proprietary Name:	MyKnee® PPS-Pin Positioners
Common or Usual Name:	Total Joint Replacement
Classification Name:	Knee joint patellofemorotibial polymer/metal//polymer semi-constrained cemented prosthesis
Primary Product Code:	JWH
Regulation Number:	21 CFR 888.3560
Device Classification	2

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary Predicate:

0 MyKnee® Cutting Blocks, K093806, Medacta International SA
Reference Devices
MySpine Pedicle Screw Placement Guides-LP, K153273, Medacta International SA
GMK Total Knee System, K090988, Medacta International SA
GMK-Line Extension, K120790, Medacta International SA (also referred to as GMK-● Primary)
GMK Sphere, K121416, Medacta International SA
GMK Sphere Extension, K140826, Medacta International SA ●
GMK Narrow, K122232, Medacta International SA (also referred to as GMK-Primary o Narrow)

IV. Device Description

The purpose of this submission is to gain clearance for the MyKnee® PPS-Pin Positioners which is a line extension to the currently marketed MyKnee® Cutting Blocks (K093806). The integrated

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cut slots have been removed to make the pin positioners suitable for use in Standard or MIS (muscle sparing approach) surgical techniques.

V. Indications for Use

MyKnee® PPS-Pin Positioners are intended to be used as anatomical pin positioners specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. MyKnee® PPS-Pin Positioners are intended for use with the GMK Total Knee System and its cleared indications for use. MyKnee® PPS-Pin Positioners are intended for single use only.

VI. Comparison of Technological Characteristics

The MyKnee® PPS-Pin Positioners and the predicate devices share the following characteristics:

. indications for use;
materials; ●
packaging;
sizes; and
o applicable mechanical axis.

The MyKnee® PPS-Pin Positioners are technologically different from the predicate devices as follows:

design, removal of cut slots;
image file applicable, MRI only; and
sterile and non-sterile. ●

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Biocompatibility testing was conducted on the predicate devices for the same material and testing supports the biological safety of the MyKnee® PPS-Pin Positioners. Additional biocompatibility testing was deemed unnecessary because the materials and manufacturing process are identical to the predicate devices described below.

A comparison of the subject and predicate devices is provided in the table below.

Parameter	MyKnee® PPS-Pin Positioners(Subject Device)	MyKnee® Cutting BlocksK093806(Predicate Device)
Design/Types	Distal femoral and proximaltibial pin positioning blocks.	Distal femoral and proximaltibial cutting blocks.
Material	Medical Grade Nylon forsintering	Medical Grade Nylon forsintering
Sizes	Femoral blocks- Sizes 1-7Tibial blocks- Sizes 1-6	Femoral blocks- Sizes 1-7Tibial blocks- Sizes 1-6
Compatibilitywith implantsystem	GMK Total Knee SystemGMK Primary Femur (size 7)GMK SphereGMK-Primary Narrow	GMK Total Knee System
Device usage	Single Use	Single Use
Shelf Life	6 months	6 months
Biocompatibility	Short term <24 hours contact(Equivalency determined)	Short term <24 hours contactTested to ISO 10993-1, -5, -10
Sterilization	Non Sterile and Gamma	Non Sterile and Gamma
Packaging	Individual packaging	Individual packaging
Image FilesApplicable	MRI	CT, MRI
AlignmentTechnique	Mechanical axis	Mechanical axis

Technological comparison

Discussion

As seen above, the differences between the subject and predicate devices are the subject devices do not have an integrated cut slot like the predicate devices. This technological difference does not raise new questions of safety or effectiveness. A comparison evaluation shows there are no new risks associated with the subject devices design.

Medacta International SA has not made any changes to the patient contacting material of the subject devices which is identical to the predicate devices. There have been no changes to subject devices' sterilization method, sterilization process or packaging materials which are identical to the predicate devices.

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VII. Performance Data

Based on the risk analysis, a design comparison and cadaver workshops were conducted according to written protocols. The following studies were performed in support of a substantial equivalence determination:

Non-Clinical Studies

o design comparison (dimensional/geometrical);
breakage evaluation;
o manufacturing process evaluation; and
o functional and fitting evaluation.

Sterilization

sterilization dimensional and functional impact study; and ●
gamma sterilization criticality assessment. ●

Clinical Studies

no clinical studies were conducted. ●

VIII. Conclusion

The information provided above supports that the MyKnee® PPS-Pin Positioners are as safe and effective as the predicate devices. Although minor differences in design exist between the subject and predicate devices, the evaluation supports that the differences do not raise any new questions of safety or effectiveness. Therefore, it is concluded that the MyKnee® PPS-Pin Positioners are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.