The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
· Rheumatoid arthritis;
· Post-traumatic arthritis,
· Correction of functional deformity;
· Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
· Revisions in cases of good remaining bone stock;
· Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only).

The Delta Acetabular System is intended for cementless use.

Device Description

The Delta Multihole TT Pro Acetabular System consists of a Delta Multihole TT Pro cup, an acetabular liner and a modular femoral head. Bone screws can also be used to provide additional stability of the cup.

The Delta Multihole TT Pro cup is manufactured from titanium alloy; the Delta Multihole TT Pro liners are manufactured from cross-linked UHMWPE with Vitamin E and the femoral heads made of Biolox Delta ceramic or Cobalt Chrome Molybdenum alloy.

The design of shell is similar to the Delta TT Pro Acetabular System (K182099) and the G7 Acetabular System (Biomet, Inc., K140669) devices. The acetabular liners, the Biolox Delta heads, the CoCrMo heads and the bone screws are the same as those cleared in K182099. The Multihole TT Pro cup has a hemispherical design and provides holes in cranial and caudal aspects of the cup to provide additional cup stability by means of fixation screws. The Multihole TT Pro cup is coupled with a Delta TT Pro acetabular liner that is available in neutral, protruded and high wall versions.

AI/ML Overview

This document describes the Delta Multihole TT Pro Acetabular System, a medical device for total hip arthroplasty, and its review by the FDA for substantial equivalence.

Based on the provided text, the device clearance was not based on studies involving AI or complex statistical analysis of human reader performance. Instead, it relied on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested categories related to AI performance, human reader studies, and ground truth establishment for such studies are not applicable to this specific submission.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the acceptance criteria for this device as demonstrating substantial equivalence to existing predicate devices through non-clinical testing.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance (via ASTM F1820-13)	Device ability to perform in a substantially equivalent manner to predicate devices in "Push-out, lever-out and torque-out test".
Mechanical Performance (via ISO 7206-12:2016)	Device ability to perform in a substantially equivalent manner to predicate devices in "Stiffness test".
Mechanical Performance (Other)	Device ability to perform in a substantially equivalent manner to predicate devices in "Unsupported anatomical fatigue deformation".

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The studies were non-clinical mechanical tests, not clinical studies with human subjects. The number of samples/units tested for the mechanical tests is not specified in the provided text, but these would be physical device units, not "data" in the sense of patient information.
- Data Provenance: Not applicable. The tests were performed on the device itself, not on data from specific countries or patient populations. The tests are non-clinical (laboratory-based).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement equipment, not by human experts interpreting clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to clinical image interpretation or diagnosis, not mechanical testing.
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:
- No. A MRMC study was not conducted. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Multihole TT Pro Acetabular System to the predicate devices."
- Effect size of human reader improvement with AI assistance: Not applicable as no such study was performed or required.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical hip implant, not an algorithm or AI software. Therefore, standalone algorithm performance studies are not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the mechanical tests consists of the established engineering standards and requirements set forth in ASTM F1820-13 and ISO 7206-12:2016. Performance against these standards demonstrates "substantial equivalence" for the mechanical properties.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; there is no training set in this context.
How the ground truth for the training set was established:
- Not applicable. There is no training set. The "ground truth" for the device's design and mechanical properties is based on established engineering principles and the performance of predicate devices, which the new device aims to match or exceed for relevant parameters.

Summary

{0}------------------------------------------------

November 1, 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Limacorporate S.p.A. % Stephen Peoples President Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814

Re: K191622

Trade/Device Name: Delta Multihole TT Pro Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, MBL Dated: October 9, 2019 Received: October 11, 2019

Dear Stephen Peoples:

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

{1}------------------------------------------------

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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191622

Device Name

Delta Multihole TT Pro Acetabular System

The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
· Rheumatoid arthritis;
· Post-traumatic arthritis,
· Correction of functional deformity;
· Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
· Revisions in cases of good remaining bone stock;
· Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only).

The Delta Acetabular System is intended for cementless use.

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."

{3}------------------------------------------------

Summarv of Safety and Effectiveness

Date: September 12, 2019

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy

U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: 260-645-0327 Email: SPeoplesVMD@gmail.com

Product	Product Code	Regulation and Classification Name
Delta Multihole TT ProPro Acetabular System	LPH, MBL	Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis per 21CFR 888.3358

Common name:

Acetabular Cup System

Description:

Intended Use/Indications:

The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular ● necrosis and hip dysplasia;
Rheumatoid arthritis;
Post-traumatic arthritis, ●
Correction of functional deformity; ●

Traditional 510(k) – Delta Multihole TT Pro Acetabular System

{4}------------------------------------------------

Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
Revisions in cases of good remaining bone stock;
Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only). ●

The Delta Acetabular System is intended for cementless use.

Predicate Devices:

The LimaCorporate Delta Multihole TT Pro Acetabular System is similar to the following cleared devices in regards to design features, indications, and materials:

-Delta TT Pro Acetabular System (LimaCorporate, K182099), primary predicate
-G7 Acetabular System (Biomet, Inc., K140669)

Summarv of technology comparison:

The intended use, design, and materials of the Delta Multihole TT Pro Acetabular System are substantially equivalent to the intended use, design, and materials of the predicate devices. Design Control Activities have been completed and the results indicated that the subject device is safe and effective.

Non-clinical testing

Mechanical testing had demonstrated the device's ability to perform in a substantially equivalent manner to the predicate devices in terms of:

Push-out, lever-out and torque-out test according to ASTM F1820-13 ●
Stiffness test according to ISO 7206-12:2016 ●
Unsupported anatomical fatigue deformation ●

Clinical testing

Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Multihole TT Pro Acetabular System to the predicate devices.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.

Acceptance Criteria and Device Performance

Study Details

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

Summarv of Safety and Effectiveness

Common name:

Description:

Intended Use/Indications:

Predicate Devices:

Summarv of technology comparison:

Non-clinical testing

Clinical testing

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

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