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The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

• · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Congenital hip dysplasia.
• · Acute traumatic fracture of the femoral head or neck.
• · Certain cases of Ankylosis.
• · Dislocation of the hip.
• · Correction of functional deformity.
• · Revision of failed joint reconstruction or treatment.
• · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.

Note

· The Modular Shell, Uncemented Stem and Taper Uncemented Femoral Stem are intended for press-fit, uncemented use only.

· The Cemented stem is intended for cemented use only.

This 510k is intended to add a Modular Liner made from Vitamin E containing HXLPE (E-XLPE) to the Libertas™ - Hip Replacement System and Libertas™ Acetabular Hooded Liner cleared under K180973 and K183365, respectively. These Modular Liners are designed to be used with the Libertas components already cleared under K180973. These are available in different sizes i.e. MA, MB, MD, MF, MH, MJ, MK and different variants for each size Viz, neutral offset, "+4 mm offset", "Elevated wall", "10° Oblique", "15° Oblique" and "+4 mm offset 10° Oblique".

This looks like a 510(k) summary for a medical device called the Libertas™ E-XLPE Modular Liner, which is a component for hip replacement systems. The document states that the device is substantially equivalent to previously cleared predicate devices.

However, the provided text does not contain information about a study proving the device meets acceptance criteria in the way typically seen for AI/ML-powered medical devices. The "Non-clinical Performance data" section describes a series of mechanical and material tests for the physical hip implant component, not a clinical study or AI/ML performance evaluation.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance studies (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training set details, or ground truth establishment).

Here's an analysis of what is present in relation to "acceptance criteria" and "proof":

Analysis of Provided Information Regarding Acceptance Criteria and Proof

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical and material testing, which is the standard pathway for many Class II medical devices like this hip implant component. The "acceptance criteria" are implicitly tied to meeting the performance standards of these established predicate devices and the relevant ASTM/ISO standards.

The "study that proves the device meets the acceptance criteria" refers to the set of non-clinical bench tests listed.

1. A table of acceptance criteria and the reported device performance

Since this is a mechanical device, the "acceptance criteria" are the passing criteria for the referenced ASTM and ISO standards for properties like axial disassembly, offset pull-out, torque-out disassembly, impingement, range of motion, and material characteristics. The document states that these tests were "conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence," implying that the device met the acceptance criteria defined by these standards. However, the specific quantitative results of these tests and the exact thresholds for acceptance are not provided in this summary.

Implied Acceptance Criteria and Reported Performance (Based on available info):

2. Sample size used for the test set and the data provenance: Not applicable. These were non-clinical bench tests on physical devices, not a test set of data like in AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context refers to the results of the bench tests against established standards, not expert adjudication of medical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests would be the measured physical and material properties meeting the specifications outlined in the referenced ASTM and ISO standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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For E-XPE Cup Liner and U-Motion II Acetabular Cup

The device is used for reduction or relief of pain and/or improved hip function in sketally mature patients with the following conditions:

1. Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.

2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

3. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

4. Correction of functional deformity.

5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cementless use only.

For E-XPE Cemented Cup

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, and painful hip dysplasia:

2. Inflammatory degenerative joint disease such as rheumatoid arthritis;

3. Correction of function deformity;

4. Revision procedures where other treatments or devices have failed;

5. Treatment of nonunion and femoral neck fractures of the proximal femur with head involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cemented use only.

For E-XPE Acetabular Components

The subject E-XPE Acetabular Components includes U-Motion II E-XPE Cup Liner and E-XPE Cemented Cup. U-Motion II E-XPE Cup Liner includes 0° and 20° hood designs, which are available in 28 mm, 32 mm, 36 mm and 40 mm inner diameter (ID). The 28 mm liners fit the acetabular cups with outer diameter (OD) ranging from 44-46 mm, the 32 mm liners fit the acetabular cups ranging from 46-50 mm, the 36 mm liners fit the acetabular cups ranging from 50-70 mm, and the 40 mm liners fit the acetabular cups ranging from 56-70 mm.

The E-XPE Cemented Cup is design for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The cement mantle is built within the outer surface of acetabular cup. The PMMA Spacer is designed for cement fixation with a uniform cement thickness and the X-ray marking wire is designed for X-ray image identification purpose. E-XPE Cemented Cups are available in a range of sizes to fit varying anatomical requirements.

For U-Motion II Acetabular Cup

The indication for use, materials, cup hole types, size distribution, sterilization method, safety and effectiveness of subject device are identical to predicate device (K122185) except the locking design. The subject device are available in sizes from 44 mm through 80 mm outer diameter in 2 mm increments.

This is a medical device submission, specifically a 510(k) summary, for E-XPE Acetabular Components and U-Motion II Acetabular Cups. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/software function. Therefore, the questions related to AI/software performance, such as sample size for test/training sets, expert qualifications, and MRMC studies, are not applicable to this document.

However, I can extract information regarding non-clinical performance tests conducted to establish safety and effectiveness for these medical implants.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of pre-defined acceptance criteria with specific numerical targets. Instead, it lists the types of non-clinical tests performed to demonstrate safety and effectiveness and states that the "Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices." This implies that the devices met the expected performance benchmarks or were comparable to the predicate devices in these tests.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in this 510(k) summary for any of the non-clinical tests. Medical device testing often uses specific numbers of samples based on industry standards, but these details are not provided here.
• Data Provenance: The document does not specify the country of origin of the data. As these are non-clinical (laboratory) tests, the concept of "retrospective or prospective" as applied to clinical studies is not directly relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable. The document describes laboratory-based non-clinical performance tests for an orthopedic implant, not an AI/software device that requires expert ground truth labeling.

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

This question is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI model training/testing, which is not the subject of this 510(k) summary.

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:

This question is not applicable. This is not an AI-assisted device.

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

This question is not applicable. This is not an AI/software device.

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

This question is not applicable in the context of an AI/software device. For these orthopedic implants, the "ground truth" and "acceptance criteria" are implied by the established standards and performance expectations for medical devices of this type, which are assessed through the specified non-clinical tests (e.g., measuring locking strength, wear, impingement, material properties).

8. The sample size for the training set:

This question is not applicable. This is not a machine learning or AI device that requires a training set.

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

This question is not applicable. This is not a machine learning or AI device.

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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

• Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
• Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
• Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Exactech Novation and AcuMatch E-HXL Acetabular Liners are intended for use in total hip replacement as an interface between acetabular shells and femoral heads. Both Novation E-HXL Acetabular Liners and AcuMatch E-HXL Acetabular Liners are manufactured from Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol). The Novation E-HXL Acetabular Liners are available in five configurations (neutral, lipped, anterior lipped, +5mm lateralized, and 10 deg. face changing) with inner diameter ranging between 22mm and 40mm. The AcuMatch E-HXL Acetabular Liners are available in four configurations (0 deg., ext coverage, and +5mm lateralized) with inner diameter ranging between 28mm and 36mm. The overall design goals of the proposed Exactech Novation and AcuMatch E-HXL Acetabular Liners are to improve wear performance and provide oxidative stability in comparison to the predicate Exactech Novation and AcuMatch GXL Acetabular Liners.

The provided text is a 510(k) summary for the Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners. It focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, primarily through non-clinical testing. This type of document describes the device and its intended use, lists predicate devices, and summarizes the non-clinical tests performed to support the claim of substantial equivalence.

It does not contain the kind of information requested in the prompt regarding acceptance criteria and a study proving device meets acceptance criteria, particularly for a diagnostic AI/imaging device. The categories of information requested (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are typical for the evaluation of AI-powered medical diagnostic devices, which involve performance metrics like sensitivity, specificity, accuracy, etc., when compared against a defined ground truth derived from human experts or pathology.

Since the provided text describes a hip joint prosthesis component and not an AI/imaging device, it does not include the relevant information to answer your questions. The "Non-Clinical Testing" section lists material characterization, biocompatibility, wear analyses, mechanical testing, and range of motion analysis, which are appropriate for a physical implant, but not for an AI diagnostic algorithm.

Therefore, I cannot extract the requested information from the provided document as it does not pertain to an AI device or a study structured to evaluate diagnostic performance against acceptance criteria in the manner described in your prompt.

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The indications for the Trinity Acetabular System as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
  The Trinity Acetabular System is intended for cementless use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell, acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW, ceramic and Co-Cr modular heads and titanium femoral stems.
The purpose of this submission is to add ECIMA acetabular liners to the Trinity Acetabular System. Corin's ECIMA is a cold irradiated, mechanically annealed, vitamin E blended ultra high molecular weight polyethylene.

The provided document is a 510(k) summary for the Corin Trinity Acetabular System ECIMA Liners. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical trial or a standalone algorithm performance study.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

• Acceptance Criteria/Device Performance: The document does not describe specific acceptance criteria for performance metrics in a clinical context. Instead, it relies on non-clinical testing to demonstrate performance in various aspects (tensile strength, impact strength, wear, etc.) and states that the new components are "similar to the predicate devices in terms of intended use and indications, materials, sizes, designs and performance." The implicit acceptance criterion is "substantial equivalence" to the predicate device based on these similarities and the non-clinical test results.

• Study Proving Acceptance Criteria Met: No clinical study is presented to prove the device meets acceptance criteria.

Let's address the specific points you asked for, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable. No clinical test set. The non-clinical tests would have their own sample sizes but these are not disclosed in the summary.
• Data Provenance: Not applicable. No clinical data is presented.

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

• Not applicable. No clinical test set or ground truth established by experts.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set.

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

• Not applicable. No clinical study, and no human-in-the-loop AI component discussed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This device is a physical medical implant, not an algorithm or AI system.

7. Type of Ground Truth Used

• For the non-clinical tests, the ground truth would be the objectively measured values of the material and mechanical properties. For the purpose of the 510(k), the "ground truth" for substantial equivalence is the predicate device's characteristics and performance, against which the new device's non-clinical test results are compared.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical implant, not an AI model requiring a training set.

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

• Not applicable.

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