The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

· Non-inflammatory degenerative joint diseases including osteoarthritis, post traumatic arthritis and avascular necrosis.
· Rheumatoid arthritis.
· Congenital hip dysplasia.
· Acute traumatic fracture of the femoral head or neck.
· Certain cases of Ankylosis.
Dislocation of the hip.
· Correction of functional deformity.
· Revision of failed joint reconstruction or treatment.
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.

NOTE:

· The Modular Shell, Uncemented Stem and Taper uncemented stem are intended for press-fit, uncemented use only.
· The Cemented stem is intended for cemented use only.

Device Description

The Libertas™ - Taper uncemented femoral stem is fabricated from Ti6Al4V - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Libertas Femoral heads, previously cleared under K180973. The proximal portion of stem is coated with commercially pure Titanium with plasma spray method. Libertas™ - Taper uncemented femoral stem is available in two designs (Standard i.e. full profile design and distally reduced design is available in different sizes with three neck angles (132° Standard, 132° Lateral, and 128° Standard).

AI/ML Overview

The provided text is a 510(k) summary for the Libertas™ - Taper Uncemented Femoral Stem, a medical device used in hip arthroplasty. This document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing.

It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device, which would typically involve clinical performance metrics like sensitivity, specificity, or reader studies. The document describes mechanical and material testing for an orthopedic implant.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving those criteria are met, as the provided text pertains to a different type of medical device (a mechanical implant) and a different regulatory pathway (510(k) for substantial equivalence based on physical and material properties, not AI/ML performance).

To answer your prompt, imagine the prompt was for an AI/ML medical device submission. Here's how I would structure the answer if the provided text contained the relevant information for an AI/ML device:

Hypothetical Answer (if the provided text were about an AI/ML medical device):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Metric)	Threshold/Target	Reported Device Performance	Outcome
Standalone Performance
Sensitivity for Condition X	≥ 90%	92.5%	Met
Specificity for Condition X	≥ 85%	88.2%	Met
AUC for Condition Y	≥ 0.90	0.915	Met
Human-in-the-Loop Performance (Reader Study)
Average Sensitivity (Reader + AI) vs. (Reader Only)	Improvement ≥ 5%	7.2% improvement	Met
False Positive Rate (Reader + AI) vs. (Reader Only)	Reduction ≥ 10%	12.1% reduction	Met
Inter-reader Agreement (Kappa) with AI assistance	Increase of ≥ 0.1	Increase of 0.15	Met

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

Test Set Sample Size: [Number, e.g., 500 cases]
Data Provenance: [e.g., Retrospective cohort from hospitals in the USA and Europe]

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: [e.g., 3]
Qualifications: [e.g., Board-certified radiologists with 10-15 years of experience specializing in [relevant specialty, e.g., musculoskeletal imaging]]

4. Adjudication Method for the Test Set

Method: [e.g., 2+1 adjudication, where two experts independently labeled cases, and a third, senior expert resolved any disagreements. Or, consensus reading by all three experts.]

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

Was an MRMC study done? [Yes/No]
Effect Size (if Yes): [e.g., Human readers showed an average improvement of 7.2% in sensitivity and a 12.1% reduction in false positives when assisted by the AI compared to reading without AI assistance. This translate to a statistically significant improvement in AUC of 0.05 (p < 0.001) for AI-assisted reading.]

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

Was a standalone study done? [Yes/No]
Details (if Yes): [Metrics as per the table, e.g., The algorithm achieved a standalone sensitivity of 92.5%, specificity of 88.2%, and an AUC of 0.915 for detecting [condition].]

7. The Type of Ground Truth Used

Type: [e.g., Expert consensus (multi-reader consensus), pathological confirmation (biopsy results), long-term clinical outcomes data, or a combination thereof.]

8. The Sample Size for the Training Set

Training Set Sample Size: [Number, e.g., 10,000 cases]

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

Method: [e.g., Ground truth for the training set was established through a combination of expert review (e.g., single expert reading with quality checks), existing hospital reports, and/or automated data extraction from electronic health records, followed by a subset verification by experienced staff.]

Summary

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August 23, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

Maxx Orthopedics Inc. Priscilla Herpai Regulatory Manager 2460 General Armistead Ave, Suite 100 Norristown, Pennsylvania 19403

Re: K183684

Trade/Device Name: Libertas - Taper Uncemented Femoral Stem 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 Dated: July 8, 2019 Received: July 26, 2019

Dear Priscilla Herpai:

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 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

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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 mediation-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,

FOR Vesa Vuniqi Acting 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)

K183684

Device Name Libertas™ - Taper uncemented femoral stem

Indications for Use (Describe)

Total hip replacement is indicated for the following conditions:

· Non-inflammatory degenerative joint diseases including osteoarthritis, post traumatic arthritis and avascular necrosis.
· Rheumatoid arthritis.
· Congenital hip dysplasia.
· Acute traumatic fracture of the femoral head or neck.
· Certain cases of Ankylosis.
Dislocation of the hip.
· Correction of functional deformity.
· Revision of failed joint reconstruction or treatment.
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.

NOTE:

· The Modular Shell, Uncemented Stem and Taper uncemented stem are intended for press-fit, uncemented use only.
· The Cemented stem is intended for cemented use only.

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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Image /page/3/Picture/1 description: The image shows the logo for Maxx Orthopedics. The word "maxx" is in bold, black letters, with a gray line underneath. Below the line, the word "orthopedics" is written in a smaller, black font. The logo is simple and modern.

510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 92.

Applicant

Date of Summary: December 27, 2018

Maxx Orthopedics Inc. 2460 General Armistead Ave Suite 100, Norristown, PA 19403 USA

Contact Person	Alternate Contact:
Priscilla Herpai	Gayathri Nair
Regulatory Manager	Senior Manager – Regulatory Affairs/Quality Assurance
Maxx Orthopedics, Inc.	Email: gayathri.nair@merillife.com
Phone: +1 484.342.0092 x 507	Cell: +91 9909033393
Email: priscilla.herpai@maxxortho.com

Device information:

Proprietary Name:	LibertasTM – Taper Uncemented Femoral Stem
Common / Usual Name:	Hip Joint Prosthesis
Classification name:	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis per 21 CFR 888.3353
Product Codes:	LZO
Device Class:	Class II

Predicate Devices

Equivalentdevice category	Manufacturer	Trade name	510(k)
Predicate device	Biomet ManufacturingCorp., USA	Taperloc® Complete StemsTaperloc® Complete MicroplastySystem	K120030,K110400,K103755,K101086,K062994,K043537,K921301,

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Equivalentdevice category	Manufacturer	Trade name	510(k)
ReferenceDevice	Maxx Orthopedics,Inc, USA	Libertas™ – HipReplacement System	K180973
ReferenceDevice	Meril Healthcare Pvt.Ltd., India	Latitud™ – Hip ReplacementSystem	K172857

Device Description:

Libertas™ Hip Replacement System cleared under K180973 consists of a modular acetabular cup system, femoral heads, femoral stems, and related accessories.

The purpose of this 510(k) is to add Taper uncemented femoral stem under the Libertas™ Hip device family.

Intended use/Indications:

Total hip replacement is indicated for the following conditions:

Non-inflammatory degenerative joint diseases including osteoarthritis, post traumatic arthritis . and avascular necrosis.
Rheumatoid arthritis. ●
. Congenital hip dysplasia.
Acute traumatic fracture of the femoral head or neck. ●
Certain cases of Ankylosis.
. Dislocation of the hip.
. Correction of functional deformity.
. Revision of failed joint reconstruction or treatment.
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur. .

NOTE:

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Image /page/5/Picture/1 description: The image shows the logo for Maxx Orthopedics. The logo consists of the word "maxx" in bold, black letters, with a gray curved line underneath. Below the line, the word "orthopedics" is written in a smaller, sans-serif font, also in black.

The Modular Shell, Uncemented Stem and Taper uncemented stem are intended for press-fit, . uncemented use only.
. The Cemented stem is intended for cemented use only.

Comparison of technological characteristics:

The subject device is substantially equivalent to the previously cleared predicate devices based on similarities in intended use and technological characteristics, and sterilization method.

Non clinical Performance data:

Non-clinical testing was conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence.

Proximal fatigue test (ISO 7206-6:2013)
Distal fatigue test (ISO 7206-4:2010) ●
. Range of motion test (ISO 21535-2007/Amd 1:2016)
Axial pull-off test (ISO 7206-10:2003) ●
Fretting corrosion (ASTM F1875-98; Reapproved 2014) ●
Evaluation of Ceramic femoral head includes Burst test, Post fatigue burst test, . Pull-off test (ISO 7206-10:2003) and Torque test (ASTM F1820-13) (Biolox® delta Modular femoral head and Uncemented Stem)
. Ti coating adhesion (shear) test (ASTM F1044-05; Reapproved 2017)e1

ASTM F2003-15, ISO 5834-3 and ISO 5834-2)

Endotoxin testing has demonstrated that the manufacturing process does not introduce Endotoxin as a bi-product of the manufacturing and cleaning process.

Conclusion

Based on performance testing results and similarities in intended use, device design/technological characteristics, material, and sterilization method, the Libertas™ - Taper uncemented femoral stem is considered substantially equivalent to the previously cleared predicate device.

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.