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Intended Use The OR3O Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients.

Indications

• · Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis.
• · Fracture or avascular necrosis of the femoral head.
• · Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, 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 OR30 Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.

Mating components may be indicated for use without bone cement.

The OR30 Hip System is a modular dual mobility implant system consists of diffusion hardened oxidized zirconium (OXINIUM DH) alloy liners with a highly polished zirconium oxide inner surface and a machined locking taper and backside of Zr2.5Nb alloy (F2384-10R16). The locking taper and outside profile is designed to mate with a dedicated Ti6Al4V R3 acetabular shell with OD sizes 44mm to 74mm or REDAPT Modular Press-fit acetabular shell with OD sizes 48mm to 74mm. For each assembled OR30 liner and R3 shell size from 44mm to 74mm and REDAPT Modular shell size from 48mm to 74mm, a dedicated insert is available. Inserts are made of highly crosslinked ultra-high-molecularweight polyethylene (ISO 5834-2/ASTM F648) that is irradiated with a 10 Mrad dose and remelted . These can be combined with oxidized zirconium or CoCr alloy femoral heads of sizes 22 mm (for Size 44mm-52mm) and 28 mm (for size 50mm-74mm). The final OR30 Dual Mobility construct will include an acetabular shell (with optional screws and optional screw hole covers), an OXINIUM DH Liner, a cross linked polyethylene (XLPE) Insert and a femoral head.

The purpose of this Traditional 510(k) submission is to add additional components, namely additional sizes of the OR3O Dual Mobility OXINIUM DH Liners and OR3O Dual Mobility XLPE Inserts to the existing OR30 Dual Mobility System.

This line extension will consist of two smaller size OXINIUM DH Liners and four additional XLPE inserts to allow for a wider range of implant options for physicians to choose from. The materials and manufacturing processes will be the same, with the exception of accounting for different sized implants.

This document is a 510(k) Premarket Notification from the FDA regarding the "OR30 Dual Mobility System," a hip joint prosthesis. The provided text primarily focuses on establishing substantial equivalence to existing predicate devices based on design, materials, indications for use, and performance data, including biocompatibility and mechanical testing.

However, the document does NOT contain information about any study involving AI, human readers, or the establishment of ground truth for evaluating such a system. The "acceptance criteria" and "device performance" described in the document relate to the physical and biological characteristics of the orthopedic implant and its components, not to the performance of an AI or diagnostic system.

Therefore, I cannot extract the information required by your prompt, as it pertains to AI/diagnostic system evaluation, which is absent from this regulatory submission for a hip joint prosthesis.

The document covers:

• Device Description: What the OR30 Dual Mobility System is, its components (liners, inserts, shells, femoral heads), and the materials used (OXINIUM DH, XLPE). It highlights that the current submission is for a line extension – adding smaller sizes of existing components.
• Indications for Use: The medical conditions for which the hip system is intended (e.g., hip degeneration, fracture, failed previous hip surgery, osteoarthritis, risk of dislocation).
• Comparison to Predicate Devices: A detailed comparison of the subject device (OR30 Dual Mobility System line extension) against previously cleared predicate devices, emphasizing similarities in intended use, fundamental scientific technology, materials, and indications for use.
• Performance Data:
  • Biocompatibility: Evaluation according to ISO-10993 for permanent implants (>30 days body contact), confirming compliance with material standards (ASTM F2384-10R16 for Zr-2.5Nb alloy and ASTM F648-14 / ISO 5834-2 for XLPE). A Declaration of Conformity was provided.
  • Mechanical Testing: Listing of various ASTM and ISO standards for tests like push-out, torque to failure, lever-out, environmental fatigue, corrosion assessment, deformation, neck impingement, range of motion, and wear testing. It states that biomechanical testing and/or rationales were completed and "met the pre-determined acceptance criteria for each intended output." The submission concludes that the device does not represent a new worst-case scenario compared to predicates.
  • Non-Pyrogenicity Endotoxin Testing: Bacterial endotoxin testing was completed and met acceptable limits per FDA guidance and ANSI/AAMI ST72.

In summary, this document is a regulatory submission for a physical medical device (orthopedic implant) and does not involve AI or diagnostic imaging. Therefore, it does not contain the specific information requested in your prompt regarding AI system acceptance criteria, study design for AI evaluation, expert ground truth, or MRMC studies.

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Intended Use The OR3O Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients.

Indications

• · Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis.
• · Fracture or avascular necrosis of the femoral head.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, 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 OR30 Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.

Mating components may be indicated for use without bone cement.

The OR30 Hip System is a modular dual mobility implant system. The system consists of diffusion hardened, oxidized zirconium alloy liners with a highly polished inner surface of zirconia and a machined locking taper and backside of Zr-2.5Nb alloy. The locking taper and machined outside profile is designed to mate with a dedicated Ti 6Al 4V R3 or REDAPT Modular Press-fit acetabular shell with OD sizes 48mm to 74mm. For each assembled OR30 Liner and R3 and REDAPT Modular Shell size from 48mm to 74mm, a dedicated plastic insert made of highly crosslinked ultrahigh-molecular-weight polyethylene (10Mrad irradiated and remelt-annealed UHMWPE (XLPE) according to ISO 5834-2/ASTM F648) is available. These can be combined with oxidized zirconium or CoCr alloy femoral heads of sizes 22mm (for size 48mm-52mm) and 28mm (for size 54mm-74mm). The final OR30 Dual Mobility construct will include an acetabular shell, an OXINIUM DH Liner, an XLPE Insert and a femoral head.

The purpose of this 510(k) submission is to add additional options of dual mobility implants to the Smith & Nephew collection of hip implants.

This document is a 510(k) premarket notification for a medical device, the OR30 Dual Mobility System, and focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria and study data for a diagnostic device in the usual sense (e.g., performance metrics like sensitivity, specificity, or AUC). Instead, the performance data provided is for biocompatibility and mechanical testing of the implantable device.

Therefore, many of the requested categories for a diagnostic device's acceptance criteria and study data (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary.

I will interpret the request within the context of the provided document, focusing on the "acceptance criteria" for the mechanical testing of the OR30 Dual Mobility System, as this is the closest equivalent to performance evaluation in this type of submission.

Here's the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify sample sizes for any of the mechanical or biocompatibility tests.
• Data provenance is not mentioned. It can be inferred that testing was conducted as part of the device development and submission process, likely by the manufacturer or a contracted lab. This is industrial testing, not clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a physical device intended to be implanted. "Ground truth" for mechanical testing is based on engineering specifications and adherence to standards, not expert clinical interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable, as this refers to clinical evaluation and consensus building for diagnostic accuracy, which is not part of this submission.

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 a physical implantable device, not a diagnostic AI system or a system requiring human interpretation.

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

• Not applicable. This is a physical implantable device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For mechanical testing: The "ground truth" or reference for performance is established by pre-determined acceptance criteria based on engineering standards (e.g., ASTM, ISO), regulatory guidelines, and comparison to predicate devices, ensuring the device meets safety and performance requirements for its intended use. The document states the device "met the pre-determined acceptance criteria for each intended output."
• For biocompatibility: Ground truth is adherence to international standards like ISO-10993.
• For non-pyrogenicity: Ground truth is adherence to established endotoxin limits in FDA Guidance and ANSI/AAMI ST72.

8. The sample size for the training set

• Not applicable. This is a physical implantable device; there is no "training set" in the context of machine learning or diagnostic device development.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set mentioned in this context.

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· Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

· Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection: fracture-dislocation of the hip; and correction of deformity.

REDAPT™ Augments are intended for single use only and are to be implanted with bone cement to the mating acetabular shell and without bone cement to the bone interface

Augments are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously.

Subject of this Traditional premarket notification are the REDAPT® Augments. The subject devices are acetabular augment hip components to be used to fill bone voids where significant bone loss is present and a cup alone cannot fill the void.

This document is a 510(k) Premarket Notification from the FDA regarding the "Smith & Nephew, Inc. REDAPT Augments." It describes the device, its intended use, and the pre-clinical testing performed to establish substantial equivalence to legally marketed predicate devices.

Summary of Acceptance Criteria and Study:

The document focuses on substantiating the equivalence of the REDAPT Augments to predicate devices, primarily through engineering analysis and mechanical testing, rather than an AI/ML-based study with specific acceptance criteria for algorithm performance. Therefore, many of the requested points related to AI/ML performance, ground truth, expert review, MRMC studies, and training data are not applicable to this 510(k) submission.

The "acceptance criteria" in this context are implicitly the successful completion of the described pre-clinical tests and the demonstration that the results are equivalent to or better than the predicate devices, thereby ensuring safety and effectiveness.

Here's a breakdown of the requested information based on the provided text, with "N/A" for sections not covered by this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document refers to "worst-case products" and "representative samples" for testing. Specific numerical sample sizes for each mechanical or chemical test are not provided in this summary.
• Data Provenance: N/A for this type of testing (not clinical data or image data). The tests were conducted on manufactured device samples.

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

• N/A. This is pre-clinical engineering and laboratory testing, not a study requiring human expert interpretation of data for ground truth establishment in the context of AI/ML.

4. Adjudication Method for the Test Set:

• N/A.

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:

• N/A. This is not an AI/ML device, nor is it a clinical study comparing human reader performance.

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

• N/A. This is a medical implant device, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for these tests is based on established engineering principles, material science standards, and in vitro testing methodologies. For example, "successful completion" of fatigue testing means the device withstood the specified cyclical loads without failure or excessive deformation, as defined by the test protocol and industry standards. Comparison to predicate device performance also serves as a benchmark.

8. The Sample Size for the Training Set:

• N/A. This product does not involve machine learning or a "training set."

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

• N/A.

Additional Context from the Document:

• Clinical Data: The summary explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."
• Substantial Equivalence: The overarching goal of this 510(k) submission is to demonstrate "substantial equivalence" to predicate devices based on intended use, indications, and performance characteristics, primarily through the pre-clinical engineering and laboratory testing described.
• Technological Characteristics: The augment devices use the same titanium alloy, sterilization method, porous structure, and manufacturing as previous cleared devices. Key differences identified are geometry, size offering, and additive manufacturing method (Ti-6Al-4V).

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