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· Fracture or avascular necrosis of the femoral head.
· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement.
· All forms of osteoarthritis.
· Patients with hips at risk of dislocation.
· Femoral neck fracture or proximal hip joint fracture.

The OR3O Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.

Device Description

The OR3O Hip System was originally cleared via K191002 and K220959. The OR3O Hip System is a modular dual mobility implant system containing two distinct articulating surfaces. The hip system construct consists of a metal acetabular shell, diffusion hardened oxidized zirconium (OXINIUM DH) alloy liner, a cross linked polyethylene (XLPE) Insert and a femoral head.

The purpose of this premarket submission is to describe a proposed design modification isolated to the OR3O Dual Mobility Liners. The proposed modification is to increase the form tolerance of the articulation surface for the subject OR3O Dual Mobility Liners by 150% from 0.010mm to 0.025mm compared to the previously cleared OR3O Dual Mobility System - K191002 and K220959. The current form requirement is intended to limit the deviation of the articular surface to within 0.010mm of a perfect sphere.

The OR3O Dual Mobility Liner contains a machined locking taper and backside of Zr-2.5Nb alloy which is designed to press fit into modular acetabular shells. The OR3O Dual Mobility Liners are manufactured from Zr-2.5Nb alloy materials in accordance with the following ASTM standard: F2384- 10R16 Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "OR30 Dual Mobility Liners." This document primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a detailed study proving device performance against specific acceptance criteria in the manner typically seen for novel software or diagnostic devices.

The "study" described here is a collection of performance data used to support the substantial equivalence claim. It is not a clinical trial in the traditional sense, but rather a series of tests to confirm that the modified device's performance aligns with acceptable standards for similar devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner as typically requested for AI/ML devices. Instead, it states that certain tests were conducted and the device "met the pre-determined acceptance criteria for intended output."

Acceptance Criteria Category	Reported Device Performance Summary
Biocompatibility	Evaluation previously conducted in accordance with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process." The evaluation (provided in predicate submissions K191002 and K220959) remains applicable.
Mechanical Testing (Wear Testing)	Met the pre-determined acceptance criteria for intended output. Design verification testing determined modified OR3O Dual Mobility System Liners are substantially equivalent to predicate devices.
Non-Pyrogenicity (Endotoxin Testing)	Previously completed and met the acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72. (Provided in predicate submissions K191002 and K220959), remains applicable.

Note on "Acceptance Criteria" for this device: The primary focus for this type of device (hip prosthesis component) in a 510(k) submission is to demonstrate that the changes do not introduce new safety or effectiveness concerns and that the device performs equivalently to existing cleared devices. The "acceptance criteria" here refer to meeting established standards and demonstrating performance comparable to the predicates for mechanical and biological properties. The text indicates a specific design modification: "increase the form tolerance of the articulation surface for the subject OR3O Dual Mobility Liners by 150% from 0.010mm to 0.025mm." The biomechanical testing (specifically wear testing) would have evaluated the impact of this change against relevant wear performance standards or predicate device performance.

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

The document does not specify a "test set" in the context of patient data or a dataset for an algorithm. The testing described (biocompatibility, mechanical testing, endotoxin testing) is performed on physical device samples.
The sample sizes for these physical tests are not explicitly stated in the provided text.
"Data provenance" in terms of country of origin or retrospective/prospective does not apply to the type of testing described here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This document describes the performance testing of a physical medical device (hip prosthesis component), not an AI/ML diagnostic or prognostic system that requires expert-established ground truth on a dataset. Therefore, there is no "ground truth" in this context, nor experts establishing it for a test set.

4. Adjudication Method for the Test Set

Not applicable. As there is no "test set" requiring expert evaluation, no adjudication method is relevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI/ML-driven diagnostic or image analysis device, so an MRMC study is not relevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is a physical orthopedic implant; there is no algorithm or software component described that would require standalone performance evaluation.

7. Type of Ground Truth Used

Not applicable. The "ground truth" for this device type is adherence to established mechanical performance standards (e.g., wear rates, material properties) and biocompatibility requirements, often confirmed through physical and chemical testing rather than expert-labeled data.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set is involved.

In summary: The provided text is a 510(k) clearance letter for a modified component of a hip prosthesis. The "study" refers to a series of engineering and biocompatibility tests conducted to ensure the modified device remains substantially equivalent to its predicates. The questions posed in the prompt are largely tailored to the evaluation of AI/ML or diagnostic software devices, which is not the nature of the product described in this document.

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