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 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 Femoral Stem are intended for press-fit, uncemented use only.

· The Cemented stem is intended for cemented use only.

Device Description

This 510k is intended to add a Modular Liner made from Vitamin E containing HXLPE (E-XLPE) to the Libertas™ - Hip Replacement System and Libertas™ Acetabular Hooded Liner cleared under K180973 and K183365, respectively. These Modular Liners are designed to be used with the Libertas components already cleared under K180973. These are available in different sizes i.e. MA, MB, MD, MF, MH, MJ, MK and different variants for each size Viz, neutral offset, "+4 mm offset", "Elevated wall", "10° Oblique", "15° Oblique" and "+4 mm offset 10° Oblique".

AI/ML Overview

This looks like a 510(k) summary for a medical device called the Libertas™ E-XLPE Modular Liner, which is a component for hip replacement systems. The document states that the device is substantially equivalent to previously cleared predicate devices.

However, the provided text does not contain information about a study proving the device meets acceptance criteria in the way typically seen for AI/ML-powered medical devices. The "Non-clinical Performance data" section describes a series of mechanical and material tests for the physical hip implant component, not a clinical study or AI/ML performance evaluation.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance studies (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training set details, or ground truth establishment).

Here's an analysis of what is present in relation to "acceptance criteria" and "proof":

Analysis of Provided Information Regarding Acceptance Criteria and Proof

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical and material testing, which is the standard pathway for many Class II medical devices like this hip implant component. The "acceptance criteria" are implicitly tied to meeting the performance standards of these established predicate devices and the relevant ASTM/ISO standards.

The "study that proves the device meets the acceptance criteria" refers to the set of non-clinical bench tests listed.

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

Since this is a mechanical device, the "acceptance criteria" are the passing criteria for the referenced ASTM and ISO standards for properties like axial disassembly, offset pull-out, torque-out disassembly, impingement, range of motion, and material characteristics. The document states that these tests were "conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence," implying that the device met the acceptance criteria defined by these standards. However, the specific quantitative results of these tests and the exact thresholds for acceptance are not provided in this summary.

Implied Acceptance Criteria and Reported Performance (Based on available info):

Acceptance Criterion	Reported Device Performance
Mechanical Performance:
Axial Disassembly (ASTM F1820:13)	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
Offset Pull-out (ASTM F1820:13)	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
Torque-out Disassembly (ASTM F1820:13)	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
Impingement Test (ASTM F2582:14)	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
Range of Motion (ISO 21535-2007/Amd 1:2016)	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
Material Characterization (E-XLPE):
ASTM F2565:13	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
ASTM F2695:12	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
ASTM F2759:11	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
ASTM F648:14	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
ASTM F2003:15	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
ISO 5834-3:19	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
ISO 5834-1:19	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
ISO 5834-2:19	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
Extraction Testing	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)
Biocompatibility testing	Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided)

2. Sample size used for the test set and the data provenance: Not applicable. These were non-clinical bench tests on physical devices, not a test set of data like in AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context refers to the results of the bench tests against established standards, not expert adjudication of medical images or data.

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests would be the measured physical and material properties meeting the specifications outlined in the referenced ASTM and ISO standards.

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. This is not an AI/ML device.

Summary

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October 29, 2020

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

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

Re: K192989

Trade/Device Name: Libertas E-XLPE Modular Liner 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: OQI, LZO, OQG Dated: September 18, 2020 Received: October 1, 2020

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.

Vesa Vuniqi, M.S. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K192989

Device Name Libertas™ E-XLPE Modular Liner

Indications for Use (Describe)

Total hip replacement is indicated for the following conditions:

· Non-inflammatory degenerative joint diseases including osteoarthritis 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 Femoral 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/1 description: The image is a logo for Maxx Orthopedics. The word "maxx" is in large, bold, dark blue font. Below the word "maxx" is a thin, curved, orange line. Below the orange line is the word "orthopedics" in a smaller, dark blue font.

5. 510(k) SUMMARY

510(k) Summary

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

5.1 Applicant:

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

5.2 Maxx Contact Person:

Priscilla Herpai Regulatory Manager Maxx Orthopedics E-mail: priscilla.herpai@maxxortho.com Phone: +484-342-0092 x 507

5.3 Alternate contact Person:

Gayathri Nair Senior Manager- Regulatory Affairs/ Quality Assurance Meril Healthcare Private Limited E mail: gayathri.nair(@merillife.com Cell: +91 9909033393

Date prepared: September 20, 2019 5.4

ર્સ્ડ Device information:

Proprietary Name:	Libertas TM E-XLPE Modular Liner
Common / Usual Name:	Hip Joint Prosthesis
Classification name:	Hip joint metal/Ceramic/Polymer Semi-constrained Cemented or Nonporous Uncemented Prosthesis (21 CFR 888.3353)
Product Code:	OQI, LZO, OQG
Device Class:	Class II

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Image /page/4/Picture/1 description: The image shows the logo for Maxx Orthopedics. The word "maxx" is in large, bold, dark blue letters. Below the word "maxx" is a thin, curved, orange line. Below the orange line is the word "orthopedics" in smaller, dark blue letters.

Component	Equivalentdevicecategory	Manufacturer	Trade name	510(k)
Vitamin EcontainingHXLPEModular Liner	PrimaryPredicatedevice	Maxx OrthopedicsInc., USA	Libertas™ – HipReplacement System	K180973
(E-XLPEModular liner)	PredicateDevice	Maxx OrthopedicsInc., USA	Libertas™ AcetabularHooded Liner	K183365
	Referencedevice	Corin, USA	Trinity Acetabular cupSystem ECIMA Liners	K111481

Predicate Devices: 5.6

5.7 Device Description:

5.8 Indications for use:

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.

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Image /page/5/Picture/1 description: The image is a logo for Maxx Orthopedics. The word "maxx" is written in large, bold, dark blue letters. Below the word "maxx" is a thin, curved, orange line. Below the orange line, the word "orthopedics" is written in smaller, dark blue letters.

· 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 femoral stem are intended for press-fit, uncemented use only.
The Cemented stem is intended for cemented use only. ●

5.9 Comparison of technological characteristics:

The Libertas™ E-XLPE Modular Liner is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, device design/technological characteristics, materials, and sterilization method.

5.10 Non clinical Performance data:

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

. Axial disassembly (push out) test (ASTM F1820:13)
Offset pull out ( Lever out) test (ASTM F1820:13) ●
. Torque out disassembly test (ASTM F1820:13)
Impingement Test (ASTM F2582:14) .
Range of Motion (ISO 21535-2007/Amd 1:2016)
Material Characterization of E-XLPE (ASTM F2565:13, ASTM F2695:12, ASTM ● F2759:11, ASTM F648:14, ASTM F2003:15, ISO 5834-3:19, ISO 5834-1:19 and ISO 5834-2:19)
Extraction Testing ●
Biocompatibility testing ●

5.11 Conclusion

Based on performance testing results and similarities in intended use, device design/technological characteristics, materials, and sterilization method, the Libertas™ E-XLPE Modular Liner is considered substantially equivalent to the previously cleared predicate and reference devices.

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.