Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Oxinium DH femoral heads are for single use only.

The Oxinium DH femoral heads are designed for use with existing Smith & Nephew hip stems featuring a 12/14 taper and will articulate against existing acetabular shell and liner constructs. A complete list of hip stems and acetabular components intended for use with the Oxinium DH heads is provided in Tables 1 and 2, respectively. The overall design of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Oxinium DH Femoral Heads:

The provided document (K081566) is a 510(k) Summary of Safety and Effectiveness for a medical device. It's important to understand that 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, rather than proving stand-alone clinical efficacy through randomized controlled trials. Therefore, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, human reader improvement with AI, etc., will likely not be present in this type of regulatory submission.

Instead, the "acceptance criteria" for a 510(k) device like this are typically related to:

• Mechanical performance: Ensuring the device meets strength, durability, and biocompatibility standards.
• Indications for Use: Confirming the device is intended for the same or similar purposes as the predicate device.
• Design and Materials: Demonstrating similarity in overall design and materials to a legally marketed predicate.

The "study" proving these criteria are met is often a combination of mechanical testing and a comparison to predicate devices.

Given this context, here's the information extracted from the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Note: As explained above, "acceptance criteria" for a 510(k) submission are generally not expressed in clinical performance metrics (like sensitivity/specificity) but rather in engineering and design equivalence.

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

• Test Set Sample Size: Not applicable in the context of clinical performance evaluation (like for diagnostic AI). The "test set" here refers to the samples used in mechanical testing. The document states "A review of the mechanical testing results," implying tests were conducted, but does not specify the sample size (e.g., number of heads tested for fatigue, static strength, etc.).
• Data Provenance: Not applicable in the context of clinical data. The "data" primarily comes from mechanical laboratory testing performed on the device prototypes or production samples. The country of origin for such testing is not specified. It is a prospective test in the sense that the device was manufactured and then tested to confirm its properties.

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

• Number of Experts: Not applicable. For mechanical testing, "ground truth" is established by engineering standards, specifications, and physical measurements, not by expert consensus in a clinical sense. The review of these results would be done by internal engineers, potentially external consultants, and ultimately FDA reviewers.
• Qualifications of Experts: Not specified. If "experts" refers to those who designed or evaluated the mechanical tests, they would typically be biomechanical engineers, materials scientists, or other relevant technical professionals.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth (e.g., diagnosis from imaging). For mechanical testing, the "adjudication" is typically a direct comparison of measured values against established engineering specifications or performance of predicate devices. There isn't a "consensus" process for adjudicating if a material broke at a certain load.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools or AI systems where human readers interpret results. This submission is for a physical implantable device (femoral head) and focuses on mechanical and material equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This question is irrelevant to the device described. This is a physical orthopedic implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • For mechanical performance: Engineering specifications, material properties, and performance data from predicate devices. The "ground truth" is that the device must withstand "expected in vivo loading without failure," which is assessed via standardized biomechanical testing (e.g., fatigue testing, static load testing to ISO or ASTM standards, though specific standards aren't cited in this summary).
  • For design, materials, and indications: The characteristics and performance of the legally marketed predicate devices (K021673 and K022958).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is not describing an AI/machine learning model, so there is no "training set" in that context. If interpreted very broadly as the historical data used to design the device, it would be the cumulative knowledge and clinical experience with previous hip prostheses, but specific numbers are not given.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the common understanding for an AI/ML device. The "ground truth" for the design of the device is based on established biomechanical principles, historical clinical performance of similar devices, and regulatory standards for orthopedic implants.

In summary: The K081566 document is a regulatory submission for substantial equivalence for a physical medical device. It relies on a comparison to existing, legally marketed predicate devices and demonstrates equivalence through mechanical testing and design/material similarity, rather than clinical performance studies (like those used for diagnostic AI or new drug approvals). The terms "acceptance criteria" and "study" in this context are interpreted differently than they would be for software-as-a-medical-device (SaMD) or AI medical devices.

Ask a specific question about this device