The hip prosthesis MiniMAX is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.

· Avascular necrosis of the femoral head.

· Acute traumatic fracture of the femoral head or neck.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Device Description

MiniMax anatomical stems are coated cementless stems intended to be used in total or partial hip arthroplasty in primary or revision surgery.

The anatomical design of the MiniMax stems results in a 9° anteversion of the neck which is mirror polished with 12/14 Eurocone taper and a 127° neck-shaft angle. The macrostructures are negative medially and positive laterally which increases the contact area. The lateral flare is rounded and non-invasive. The MiniMAX stems' distal tip has a 5° curvature to follow the contours of the femoral canal to aid in the insertion and avoiding distal interference.

MiniMAX stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

MiniMAX stems are made of Titanium Aluminum Niobium Alloy (Ti-6Al-7Nb). The surface treatment consists of titanium plasma spray coating, Ra 300um, in the proximal 2/3 of the shaft to improve proximal fixation and HA (Hydroxyapatite) coating, Ra 80um, along the entire length of the shaft.

This submission seeks add Size 9 left and right anatomical stems to the currently marketed MiniMAX product line.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (MiniMAX hip prosthesis) and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The document is a traditional medical device submission focused on substantial equivalence to a predicate device, primarily through mechanical testing and material characterization.

Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies for an AI/ML device is not present in the provided text.

However, I can extract the information that is present regarding the device's performance data and how it was evaluated.

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

The document does not provide a table of acceptance criteria with numerical targets and reported performance for an AI/ML device. Instead, it lists the types of performance tests conducted for a mechanical hip prosthesis and states that the "subject devices do not represent a new worst case when compared to the previously cleared devices."

Test Type	Standard/Reference	Reported Outcome
Range of Motion (ROM)	EN ISO 21535:2009 (Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants)	"subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)."
Fatigue Testing (Stem)	ISO 7206-4 Third Edition 2010-06-15 (Implants for Surgery Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components)	"subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)."
Fatigue Testing (Head and Neck Region)	ISO 7206-6 Second Edition 2013-11-15 (Implants for Surgery Partial and Total Hip Joint Prostheses - Part 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components)	"subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)."
Static Fatigue Testing (Modular Femoral Heads)	ISO 7206-10:2003 (Implants for Surgery -- Partial and Total Hip-Joint Prostheses -- Part 10: Determination of Resistance To Static Load of Modular Femoral Heads)	"subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)."
Pull Off Force Testing (Taper Connections)	ASTM F2009-00 (Reapproved 2011) (Standard Test Method O for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses)	"subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)."
Coating Characterization Testing	Not explicitly stated, implied to be standard material characterization.	"subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)."
Pyrogenicity	USP <85> and USP <151>	"subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)."
Additional Evaluation (Stem and Neck Fatigue)	ISO 21535 (via Finite Element Analysis)	The analysis concluded that the "additional size (longer stem length and larger neck offset) does not introduce a new worst case with respect to biomechanical or clinical performance."

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

The document mentions "worst-case device" testing for the predicate device, K170845. This typically implies a very small sample size, potentially N=1 or N=3, for each test as per engineering standards for mechanical devices. It's not a 'test set' in the sense of an AI/ML validation. There's no information on data provenance (country of origin, retrospective/prospective).

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. This is a mechanical device submission, not an AI/ML study requiring expert ground truth for interpretation.

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

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 is a mechanical device, not an AI-assisted diagnostic tool.

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

Not applicable.

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

For mechanical testing, the "ground truth" is defined by the passing criteria of the specified international standards (e.g., ISO, ASTM). For example, fatigue tests would have an endurance limit or cycles to failure requirement specified in the standard.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

Summary

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September 27, 2019

Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K192352

Trade/Device Name: MiniMAX Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, MEH, KWY, LZY Dated: August 28, 2019 Received: August 29, 2019

Dear Chris Lussier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192352

Device Name MiniMax

Indications for Use (Describe)

The hip prosthesis MiniMAX is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.

· Avascular necrosis of the femoral head.

· Acute traumatic fracture of the femoral head or neck.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Type of Use (Select one or both, as applicable)

X 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 and Compliance Director Medacta International SA Date Prepared: August 28, 2019 Date Revised: September 26, 2019

Device Proprietary Name:	MiniMAX
Common or Usual Name:	Hip Prosthesis
Classification Name:	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
Primary Product Code:	LZO
Secondary Product Code:	MEH, KWY, LZY
Regulation Number:	21 CFR 888.3353, 21 CFR 888.3390, 21 CFR 888.3360
Device Classification	II

II. Device

Predicate Device III.

Substantial equivalence is claimed to the following devices:

MiniMAX, K170845, Medacta International SA ●

Device Description IV.

MiniMax anatomical stems are coated cementless stems intended to be used in total or partial hip arthroplasty in primary or revision surgery.

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non-invasive. The MiniMAX stems' distal tip has a 5° curvature to follow the contours of the femoral canal to aid in the insertion and avoiding distal interference.

This submission seeks add Size 9 left and right anatomical stems to the currently marketed MiniMAX product line.

V. Indications for Use

The hip prosthesis MiniMAX is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Hip Replacement is indicated in the following cases:

o Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck. ●
Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, ● hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

VI. Comparison of Technological Characteristics

The subject and predicate MiniMAX stems share the following characteristics:

taper:
substrate material;
coating;
device usage:
CCD angle:
. sterility:
shelf life; and ●
packaging. ●

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The subject devices are technologically different from the predicate devices with respect to size, length, and neck offset.

Discussion

As seen above, the subject MiniMAX stems are substantially equivalent to the predicate devices in terms of design, substrate material, coating, device usage, sterility, shelf life, and packaging.

The additional size (longer stem length and larger neck offset) does not introduce a new worst case with respect to biomechanical or clinical performance. The additional size has been designed in order to increase the product range. This technological difference does not raise new questions of safety or effectiveness and a comparison evaluation shows there are no new risks associated with the subject device design.

VII. Performance Data

The predicate MiniMAX stems (cleared under K170845)) were tested using the worst-case device for each of the following tests:

range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants o Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants;
fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants for Surgery Partial o and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components [Including AMENDMENT 1 (2016)];
fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants for Surgery o Partial and Total Hip Joint Prostheses - Part 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components;
static fatigue testing: ISO 7206-10:2003 Implants for Surgery -- Partial and Total o Hip-Joint Prostheses -- Part 10: Determination of Resistance To Static Load of Modular Femoral Heads;
pull off force testing: ASTM F2009-00 (Reapproved 2011) Standard Test Method O for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses;
coating characterization testing; and o
pyrogenicity per USP <85> and USP <151>. O

The subject devices do not represent a new worst case when compared to the previously cleared devices (K170845). Additional evaluation and finite element analysis of stem and neck fatigue testing of the subject device is provided (ISO 21535).

The data and information provided in K170845 support the conclusion that the subject MiniMAX devices are safe and effective and conform to applicable standards and FDA guidance.

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VIII. Conclusion

Based on the above information, the subject MiniMAX stems can be considered substantially equivalent to the identified predicate device.

Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The subject MiniMAX implants are as safe and effective as the predicate devices, Medacta's MiniMAX stems (cleared under K170845).

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.