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The ONVOY Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.

The ONVOY Acetabular System is used in conjunction with Globus/StelKast Hip Systems. The acetabular components of this hip system are intended for cementless fixation.

The ONVOY™ additional implants consist of acetabular shells, liners, and dual mobility liners and bearings that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. New femoral head sizes are also being introduced. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster-hole design, liners are available in hooded, non-hooded, and lateralized designs used in conjunction with ONVOY shells. Dual mobility polyethylene bearings are used with dual mobility liners.

ONVOY™ acetabular shells are additively manufactured from titanium alloy powder per ASTM F3001. Acetabular liners and dual mobility bearings are manufactured from highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Dual mobility liners are manufactured from Cobalt Chrome (CoCr) alloy and femoral heads are manufactured from alumina matrix composite ceramic.

This document is an FDA 510(k) clearance letter for a medical device called the "ONVOY™ Acetabular System." It details the device's purpose, indications for use, and the basis for its substantial equivalence to other legally marketed devices.

However, it does not contain information about acceptance criteria and a study proving a device meets those criteria for an AI/Software as a Medical Device (SaMD).

This clearance is for an orthopedic implant (hip prosthesis components: acetabular shells, liners, dual mobility implants, and femoral heads), not a software device or an AI application. Therefore, the questions related to MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to the content provided in this FDA 510(k) letter.

The "Performance Data" section solely refers to mechanical and material testing standards relevant to orthopedic implants (fatigue, wear, range of motion, material composition, etc.) and states that "Performance data demonstrate substantial equivalence to the predicate devices." It does not describe any clinical study involving human readers or AI performance metrics.

In summary, based on the provided text, I cannot describe acceptance criteria and a study that proves a device meets those criteria, as the document pertains to an orthopedic implant and not an AI/SaMD.

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ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for single use only in skeletally mature individuals undergoing reconstruction of severely disabled and/or very painful joints.

ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

ACTIFY™ Total Knee System is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use.

ACTIFY™ 3D Total Knee System is indicated for cemented and uncemented use.

The ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System implants consist of modular femoral, tibial, and patellar implants that are used as part of a complete knee system in total knee arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Femoral components and tibial inserts are available in posterior-stabilized (PS) and cruciate-retaining (CR) designs.

Femurs are manufactured from cobalt chromium alloy (CoCr) with a CoCr coating. Tibial inserts and patella implants are manufactured from ultrahigh molecular weight polyethylene (UHMWPE) with and without Vitamin E. ACTIFY™ 3D Total Knee tibia trays and the patella metal base are additively manufactured from titanium alloy powder per ASTM F3001. ACTIFY™ Total Knee tibia trays are manufactured from titanium alloy per ASTM F136.

The provided document describes the K240669 submission for the ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System. This submission focuses on orthopedic implants, specifically knee joint prostheses, not AI/ML-driven medical devices. Therefore, the questions related to AI/ML acceptance criteria, study design for AI models, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC studies are not applicable to this 510(k) summary.

The performance data section mentions mechanical testing conducted in accordance with several ASTM standards and a guidance document. These tests are standard for evaluating the mechanical integrity and performance of orthopedic implants and ensure their substantial equivalence to predicate devices, particularly regarding issues such as fatigue, shear, and tensile strength. However, specific acceptance criteria values and reported device performance from these mechanical tests are not explicitly detailed in the provided text.

The document states:

• Performance Data: Mechanical testing (tray fatigue, A-P shear, shear, and tensile) was conducted in accordance with the "Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses - Class II Special Controls Guidance Document for Industry and FDA Staff," January 16, 2003, ASTM F2083, ASTM F1800, ASTM F1044, ASTM F1147, and ASTM F1672. Performance data demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

This indicates that the device's performance was evaluated against the requirements outlined in these standards and guidance documents, and the results supported a finding of substantial equivalence. Without access to the full submission, the specific numerical acceptance criteria and the device's performance against those criteria cannot be provided.

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General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• 1. Primary and secondary osteoarthritis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformities
• 4. Avascular necrosis
• 5. Femoral neck fractures

6. Revision after implant loosening dependent on bone mass and quality

The MobileLink® Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. The cup system consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either plasma sprayed coating (PlasmaLink®) or a double coating consisting of plasma spray plus calcium phosphate coating (TiCaP®). All shells are implanted cementless. The acetabular inserts are manufactured from conventional UHMWPE or Vitamin E highly crosslinked UHMWPE (E-Dur®). The inserts are available in six designs, neutral, offset, shouldered, offset/shouldered, 10° and 20° inclination. This premarket notification does not include the femoral components. The MobileLink® Acetabular Cup System is compatible with previously cleared femoral heads (K161840, K953653) and hip stems and neck segments (K161840, K151008, K142187, K953653) of Waldemar Link GmbH & Co. KG.

The provided text describes a 510(k) premarket notification for the "MobileLink Acetabular Cup System". This notification is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a study proving the device meets specific acceptance criteria in the same way a novel device might.

Instead, the submission relies on non-clinical performance testing and analysis to demonstrate substantial equivalence to predicate devices. There is no mention of specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria with statistical significance.

Here's an breakdown of the information based on your request, structured to reflect what is actually present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on non-clinical testing, there isn't a table of specific, quantitative "acceptance criteria" for clinical performance. The "performance" is demonstrated through various bench tests and characterizations, aiming to show similarity to predicate devices.

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

• Test Set Sample Size: Not explicitly stated in the document. The testing described is bench testing, involving mechanical specimens rather than patient data.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests conducted in a laboratory setting for the purpose of a 510(k) submission.

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

• Number of Experts & Qualifications: Not applicable. For bench testing, "ground truth" is typically established by engineering specifications, material standards (e.g., ASTM, ISO), and regulatory guidelines rather than expert clinical consensus.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a clinical study involving human interpretation of data where adjudication would be necessary. The tests are objective measurements against engineering standards.

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

• MRMC Study: No. This device is a physical implant (acetabular cup system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.

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

• Standalone Performance: Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

• Ground Truth: For bench testing, the "ground truth" refers to established engineering standards (e.g., ASTM, ISO), mechanical properties, material specifications, and performance expectations derived from predicate devices. The goal is to demonstrate that the device meets these engineering and material requirements.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set of data.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

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PROCOTYL® PRIME hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli. and painful hip dysplasia:

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The PROCOTYL® PRIME E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' PROCOTYL® PRIME Acetabular Cup System (K170444). The design features are summarized below:

• Manufactured from E-CLASS™ vitamin E blended highly crosslinked ultra high . molecular weight polyethylene (VEXLPE) conforming to ASTM F2695-12
• Available in Standard, Lipped, or Face-Changing Lateralized Configurations .
• Inner Diameter sizes 22mm to 44mm o

The provided text describes a 510(k) premarket notification for a medical device, the PROCOTYL® PRIME E-CLASS™ XLPE Liner. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials with specific acceptance criteria as might be seen for a novel device. Therefore, the response will focus on the non-clinical testing performed to establish this substantial equivalence.

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission, the "acceptance criteria" are generally implied to be meeting the performance of existing, legally marketed predicate devices and established standards (ASTM, ISO). The "reported device performance" refers to the results of the non-clinical tests that demonstrate this equivalence.

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

The document does not specify the exact sample sizes (e.g., number of test specimens) for each non-clinical test. It generally states that "testing was performed" or "underwent testing." The data provenance is internal to MicroPort Orthopedics, Inc. and is generated through their non-clinical testing. This is typically prospective in nature for these types of bench and animal studies. No country of origin of the data is explicitly mentioned beyond the company's location in Arlington, Tennessee.

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

This information is not applicable to a non-clinical 510(k) submission focused on demonstrating substantial equivalence through bench and animal testing. "Ground truth" established by experts is typically relevant for clinical studies, particularly those involving diagnostic accuracy or human interpretation.

4. Adjudication method for the test set

This information is not applicable to the non-clinical testing described. Adjudication methods (like 2+1, 3+1) are used in clinical studies to resolve discrepancies in expert interpretations or assessments.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical data was not provided for the subject devices." This implies that no human reader studies (with or without AI assistance) were conducted as part of this submission. The device is a physical implant, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. The device is a physical implant, not an algorithm.

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

Given that "Clinical data was not provided," there is no "ground truth" in the sense of clinical outcomes or expert diagnoses from human patients. The "ground truth" for the non-clinical tests would be the established scientific principles, engineering standards (e.g., ASTM F2695-12 for the material), and performance characteristics of predicate devices against which the new liner's properties are compared.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm requiring a training dataset.

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

This information is not applicable, as there is no "training set."

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The Klassic HD™ Acetabular Insert with E-Link™ Poly, for use within the Klassic HD™ Hip System, is intended for prosthetic replacement without bone cement in treatment of the following:

• . Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. ●
• . Those patients with failed previous surgery where pain, deformity or dysfunction persists.
• Revision of a previously failed hip arthroplasty. ●
• o Patients who require a total hip replacement.

The Total Joint Orthopedics Klassic HD™ Acetabular Insert with E-Link™ Poly ("Insert with E-Link'') is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with E-Link is fully compatible for use with the previously cleared Klassic HD™ Hip System and is manufactured from Vitamin E blended UHMWPE crosslinked by gamma irradiation. The Insert with E-Link is sterilized by ethylene oxide gas and intended for single-use only.

The provided FDA 510(k) summary for the "Klassic HD™ Acetabular Insert with E-Link™ Poly" does not contain the type of acceptance criteria and study details commonly associated with AI/ML medical devices. This document describes a traditional medical device (an acetabular insert for hip replacement) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.

Therefore, many of the requested items related to AI/ML device performance (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.

However, I can extract the information that is present and indicate where information is not provided.

Here's the analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document states "Non-clinical bench testing was conducted," implying physical samples of the device were tested, but the number of samples for each test type is not detailed.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). This refers to bench testing performed on manufactured devices.

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

• Number of Experts: Not applicable. Ground truth for non-clinical bench testing is established by recognized standards (ASTM, ISO) and laboratory measurements of physical properties, not by human expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Bench testing results are typically evaluated against pre-defined specifications or predicate device performance, not adjudicated by a panel of human reviewers.

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

• MRMC Study: No. This is a traditional medical device, not an AI/ML device, so MRMC studies are not relevant.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Study: No. This is not an AI/ML algorithm.

7. The type of ground truth used

• Type of Ground Truth: For the non-clinical testing, the "ground truth" (or reference against which performance was assessed) was established by:
  • Recognized Standards: When available (e.g., ASTM, ISO standards for material properties, sterility, mechanical strength).
  • "Non-recognized standards from ASTM and ISO" used as a guide: For tests where no directly recognized standard existed.
  • Established Specifications: The document states that the device "meets the established specifications necessary for consistent performance during its intended use."
  • Predicate Device Performance: Comparison of technological characteristics and performance to legally marketed predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

• Training Set Ground Truth Establishment: Not applicable. This is not an AI/ML device.

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