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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.

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 previously cleared sizes of Delta Multihole TT Pro Acetabular System (K191622) 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.

This document is a 510(k) summary for the Limacorporate S.P.A. Delta Multihole TT Pro Acetabular System. It details the device, its intended use, and substantial equivalence to predicate devices, but does not describe acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text. 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.

This means there is no clinical study described in this document that would include acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies related to AI device performance. The information provided is for a total hip arthroplasty system, a physical medical device, not an AI or software as a medical device.

If you intended to ask about the acceptance criteria and study for a different type of device (e.g., an AI/ML powered diagnostic device), please provide the relevant document.

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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.

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.

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.

Study Details

1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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