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The Consensus® Posterior Stabilized Knee system employs a router device to remove the intercondylar bone from the distal portion of the femur. This bone must be removed to accommodate the spine of the posterior stabilized tibial insert. This procedure occurs after all bone resections of the distal femur have been completed in the traditional manner with the existing Consensus® Knee instruments.

A template is placed on the distal femur. This template is made from stainless steel (17-4PH SS @ H900). The template contains a central groove with adequate markings that ensure proper guidance of the router.

The router itself consists of a router bit (17-4PH SS @ H900), the shank of which is encased in a plastic body (Ultem® 4000) that acts as a handle for the surgeon and as a journal bearing for the shaft of the router bit.

The base of the body has a large diametrical flange that rests on the superior surface of the template. This flange acts to stabilize the router against torsional forces created by the router bit. The superior end of the router shank is attached to a standard flexible shaft. A standard Zimmer fitting is integrally machined to the superior side of the flexible shaft in order to accommodate a standard operating room power drill (Stryker, 3M, etc.).

The router body and bit are available in one size. The template is available in three sizes; size 1/2, size 3/4, and size 5/6. This accommodates the range of Consensus® Knee posterior stabilized femoral components.

This document is a 510(k) summary for a medical device called the Consensus® Posterior Stabilized Knee-Intercondylar Notch Router. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document explicitly states:

• "No performance data exists for this device."
• "Clinical Data: None Required"
• "Conclusions from Non-clinical and Clinical Data: None Required"

Therefore, I cannot provide the requested information. The submission appears to be based on substantial equivalence to predicate devices rather than new performance data.

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The Consensus® Posterior Stabilized Knee is indicated for use in:

• 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis in the absense of the posterior cruciate ligament.
• 2. Failed osteotomy or unicompartmental replacements
• 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

The Consensus® PS Knee tibial insert component is manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648), and is designed to articulate with the Consensus® PS femoral component. The insert has a spine on the central eminence which engages the crossbar of the PS femoral component. The spine is positioned so that the crossbar of the PS femoral component engages at approximately 65° flexion. The inferior surface of each component employs dovetail grooves for positive interlocking with the Consensus® Primary Knee tibial baseplate. The design is available in three sizes and each size is available in five thicknesses.

The Consensus® PS Femoral component is made of CoCrMo alloy (ASTM F75). Both the outer articulating surface and the inner box geometry of the Consensus® PS femoral component are identical to the respective surfaces of the Consensus® Primary Knee femoral component. Therefore, the PS femoral component contains the same deepened patella groove as the Consensus® Primary Knee femoral component for increased range of motion, utilizes the same instrumentation as the Consensus® Knee for preparing the distal femur, and employs smooth distal pegs for added Medial/Lateral stability. The Consensus® PS femoral component has a shortened patella groove to accommodate the spine of the Consensus® PS tibial insert. It also contains a stabilizing bar located between the posterior condyles which engages the spine of the Consensus® PS tibial insert at high flexion angles.

The Consensus® Posterior Stabilized Knee System will be provided sterile.

The Consensus® Posterior Stabilized Knee is designed for use with the following Consensus® Total Knee System components:

Consensus® All Poly or metal back Patellar component
Consensus® Porous Titanium Stemmed Tibial Baseplate
Consensus® Nonporous Titanium Stemmed Tibial Baseplate
Consensus® CoCr Stemmed Tibial Baseplate

This document describes a medical device, the Consensus® Posterior Stabilized Knee System, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically understood in the context of diagnostic or AI-driven devices.

The provided text focuses on:

• Device Description: What the Consensus® PS Knee System is made of and how its components interact.
• Intended Use: The medical conditions it is designed to treat.
• Technological Characteristics: Specific design features.
• Substantial Equivalence: The primary regulatory pathway, comparing it to an existing approved device (Johnson&Johnson PFC® Modular Knee System).

Therefore, I cannot populate the requested table or answer the specific questions related to acceptance criteria, test sets, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.

Here's why and what kind of information would be needed to answer your request:

• Acceptance Criteria & Performance: For a diagnostic or AI device, this would typically involve metrics like sensitivity, specificity, accuracy, precision, recall, AUC, etc., demonstrated against a clinical ground truth. The Consensus® PS Knee System is a surgical implant, not a diagnostic tool. Its "performance" is assessed differently (e.g., mechanical testing, wear resistance, biocompatibility, long-term clinical outcomes which are typically evaluated post-market or through clinical trials beyond initial 510(k) clearance).
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These are all concepts relevant to evaluating diagnostic accuracy, particularly for AI/CAD devices where human interpretation is assisted or replaced. They are not applicable to the pre-market submission of a knee implant based on substantial equivalence.

In summary, the provided document does not contain the information required to answer your specific questions, as the device and its regulatory submission paradigm are different from what your questions anticipate.

If the request was for a device where these criteria are relevant, the input document would need to include details about:

• Specific performance metrics (e.g., sensitivity, specificity for detecting a condition).
• A clinical study protocol and results.
• The dataset used (e.g., images, patient records).
• How ground truth was established for that dataset.
• Details about reader studies if human interaction is involved.

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The Consensus® PCL Substituting Tibial Insert is indicated for use in:

• 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
• 2. Failed osteotomy or unicompartmental replacements
• 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

The Consensus® Knee PCL Substituting Tibial Insert component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is an asymmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for positive interlocking with the tibial baseplate. The design is available in three sizes and each size is available in five thicknesses. The Consensus® PCL Substituting Tibial Insert will be provided sterile.

The provided text describes a medical device, the Consensus® PCL Substituting Tibial Insert, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.

Specifically, the document states:

• "Performance Data: The device performs with substantial equivalence to predicate devices."
• "Clinical Data: None Required"
• "Conclusions from Non-clinical and Clinical Data: The Consensus® PCL Substituting Tibial Insert is substantially equivalent to the predicate device."

This indicates that the regulatory approval was based on demonstrating equivalence to an already approved device, rather than explicit acceptance criteria and corresponding performance metrics from a dedicated study of the Consensus® PCL Substituting Tibial Insert itself.

Therefore, I cannot populate the requested table or provide details about a study proving the device meets acceptance criteria, as that information is not present in the provided text.

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The Consensus® All Poly Tibia is indicated for use in:

• 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
• 2. Failed osteotomy or unicompartmental replacements
• 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

The Consensus® Knee All Poly Tibia component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is a symmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for macro-cement interdigitation between the implant and the bone. Each component has two titanium X-Ray markers for postoperative evaluation: one placed vertically in the distal end of the stem, and one placed horizontally in the central anterior aspect of the component. The design is available in six sizes and each size is available in five thicknesses. The minimum thickness of polyethylene under the articulating surface is 7.5mm for all sizes. The Consensus® All Poly Tibia will be provided sterile.

This document describes a medical device submission (510(k)) for a knee replacement component, specifically a Consensus® Knee All Poly Tibia. It is a traditional premarket notification seeking to demonstrate substantial equivalence to previously cleared devices, rather than a de novo submission that would require extensive clinical studies to establish safety and effectiveness from scratch.

Therefore, the information you're asking for, which is common for AI/ML-driven device submissions or those requiring novel performance data, is largely not applicable in this context. This submission relies on a comparison to predicate devices, not on specific performance criteria met through a dedicated study of the device itself.

Here's why and what information can be gleaned:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For this type of submission, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity, specificity, accuracy) but rather as the demonstration of substantial equivalence to predicate devices under 21 CFR 888.3560. This involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The primary reported performance is that "The device performs with substantial equivalence to predicate devices." No specific quantitative performance metrics are provided for the Consensus® Knee All Poly Tibia itself, as it's not a diagnostic or AI-driven tool.

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

• Not applicable. This submission doesn't involve a "test set" in the sense of a dataset used to evaluate an algorithm or a diagnostic device. The evaluation is based on a comparison of device characteristics to legally marketed predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This isn't a study involving human interpretation or "ground truth" establishment for diagnostic purposes. The ground truth for device equivalence is established by regulatory standards and comparison to established predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or adjudication process of this type was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a hardware device (a knee implant), not a diagnostic tool or algorithm where MRMC studies would be relevant.

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

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

7. The Type of Ground Truth Used:

• For this type of submission, the 'ground truth' is effectively the established safety and effectiveness profile of the identified predicate devices. The new device is argued to be safe and effective because its characteristics are sufficiently similar to those already deemed safe and effective by the FDA.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" for a physical medical implant in this context. Training sets are relevant for AI/ML algorithms.

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

• Not applicable. As above, no training set was used.

Summary of Relevant Information from the Provided Text:

• Device Name: Consensus® Knee All Poly Tibia
• Manufacturer: US Medical Products, Inc.
• Classification: Prosthesis, knee, patello/femorotibial, semi-constrained, cemented, polymer/metal/polymer (21CFR888.3560)
• Intended Use:
  • Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
  • Failed osteotomy or unicompartmental replacements.
  • Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
• Key Technological Characteristics: Symmetric UHMWPE cruciate-retaining tibial component, designed to articulate with Consensus® Knee primary femoral component, dovetail grooves for macro-cement interdigitation, two titanium X-Ray markers, available in six sizes/five thicknesses (minimum 7.5mm articulating surface thickness).
• "Study" (Basis for Equivalence): Comparison to predicate devices.
• Predicate Devices Identified:
  • Howmedica Duracon All Plastic Tibial component (K922048, Sep 8, 1992)
  • Intermedics Orthopedics All-Poly Tibia (K923443, Mar 31, 1993)
  • Johnson&Johnson PFC All Plastic Tibia (K910563, May 23, 1991)
• Performance Data: "The device performs with substantial equivalence to predicate devices."
• Clinical Data: "None Required"
• Non-Clinical Data: Implicitly, the comparison of technological characteristics to predicates.

In essence, this 510(k) submission doesn't involve a "study" to meet acceptance criteria in the way you might envision for a diagnostic or AI device. Instead, it argues that the device's design and materials are similar enough to already approved devices that it poses no new or different safety concerns and is equally effective.

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The CONSENSUS® Acetabular Shell, All UHMWPE is indicated for use in:

1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
2. Osteoarthrosis involving femoral and acetabular articular surfaces.
3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
4. Fracture-dislocation of the hip.
5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

The Consensus® Acetabular Shell, All UHMWPE is intended for use with the Consensus® Total Hip System as an alternative to the the metal acetabular shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Acetabular Shell, All UHMWPE is designed for use with size compatible Consensus® Total Hip System components. The Concensus® Acetabular Shell, All UHMWPE will be provided sterile and will be available in fourteen sizes for 22mm heads (42mm to 68mm increments), in twelve sizes for 26mm heads (46mm to 68mm in 2mm increments), and in eleven sizes for 28mm heads (48-68mm in 2mm increments). The material will be ultra high molecular weight polyethylene (UHMWPE), ASTM F648.

This document describes a medical device, the Consensus® Acetabular Shell, All UHMWPE, which is a component of a hip replacement system. The submission is for a 510(k) premarket notification, aiming to demonstrate substantial equivalence to predicate devices. As such, the concept of "acceptance criteria" and "study proving the device meets acceptance criteria" as it typically applies to AI/software performance metrics is not directly applicable here.

Instead, the "acceptance criteria" for a 510(k) submission generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparison of technological characteristics and, where applicable, performance testing to show that differences do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, reinterpreting "acceptance criteria" and "study" within the context of a 510(k) for a physical medical device:

Analysis of Acceptance Criteria and Evidence for the Consensus® Acetabular Shell, All UHMWPE

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

• Sterility: Provided sterile. This is a standard characteristic for implantable devices.
• Sizing: Available in a range of sizes (e.g., 42mm to 68mm for 22mm heads) which are comparable to predicate devices. |
  | Performance Equivalence (Mechanical/Functional) | The text states: "The Consensus® Acetabular Shell, All UHMWPE, device performs with substantial equivalence to predicate devices." While no specific test results are provided in this summary, this statement implies that mechanical performance (e.g., wear, fatigue strength) was evaluated and found comparable to predicate devices. |
  | Clinical Safety & Effectiveness Equivalence | "Clinical Data: None Required." This indicates that the FDA did not require new clinical studies for this device, implying that its technological characteristics and performance were sufficiently similar to predicate devices such that existing clinical data for the predicates could be leveraged. |

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a physical orthopedic implant. There isn't a "test set" of patient data in the way one would analyze for an AI algorithm. The performance evaluation would typically involve in-vitro mechanical testing of the device itself.
• Data Provenance: Not applicable for a software/AI context. Any mechanical testing would be conducted within a laboratory setting.

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

• This is not applicable to a physical medical device submission like this. Ground truth establishment with experts is relevant for diagnostic or AI-driven devices where interpretation of medical images or data is involved.

4. Adjudication method for the test set

• This is not applicable to a physical medical device submission of this nature. Adjudication methods are used to establish ground truth in datasets, typically for AI or diagnostic performance studies.

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 is not applicable. MRMC studies are used to evaluate the performance of diagnostic devices or AI-assisted interpretation, often involving human readers. This submission is for a hip implant.

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

• This is not applicable. This device is a physical implant, not a software algorithm.

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

• For a physical implant, "ground truth" generally refers to established scientific principles, engineering standards (e.g., ASTM F648 for UHMWPE), and the known performance characteristics of predicate devices. The "truth" is that the material meets its specifications and the device performs mechanically in a manner demonstrably equivalent to already approved devices.

8. The sample size for the training set

• This is not applicable. There is no concept of a "training set" for a physical medical device in the typical AI/machine learning sense.

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

• This is not applicable for the reasons stated above.

In summary: The provided document is a 510(k) summary for a physical orthopedic implant. The "acceptance criteria" and "study" in this context refer to demonstrating substantial equivalence to predicate devices through comparisons of material, design, intended use, and implied mechanical performance testing (as evidenced by the "Performance Data: The Consensus® Acetabular Shell, All UHMWPE, device performs with substantial equivalence to predicate devices" statement), rather than clinical efficacy trials or AI algorithm performance metrics. No specific details about mechanical testing (like sample sizes or specific test results) are provided in this high-level summary but would have been part of the full 510(k) submission.

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The CONSENSUS® Apex Dome Hole Plug (PMMA) is indicated for use in:

• 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
• 2. Osteoarthrosis involving femoral and acetabular articular surfaces.
• 3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
• 4. Fracture-dislocation of the hip.
• 5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

The Consensus® Apex Dome Hole Plug (PMMA) is intended for use with the Consensus® Total Hip System as an addition to the the metal acetabilar shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Apex Dome Hole Plug (PMMA) is designed for use with size compatible Consensus® Total Hip System components:

Porous coated Acetabular Shell K922561 SE 07/21/93
Nonporous Acetabular Shell K922561 SE 07/21/93
Acetabular Insert, UHMWPE K922561 SE 07/21/93

The Concensus® Apex Dome Hole Plug (PMMA) will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.

The acceptance criteria and study information cannot be extracted from the provided text. The document is a 510(k) summary for a medical device (CONSENSUS® Apex Dome Hole Plug (PMMA)) and primarily focuses on establishing substantial equivalence to previously approved predicate devices, rather than presenting a performance study against specific acceptance criteria.

Here's why the requested information cannot be found:

• No acceptance criteria or device performance table: The document states "Performance Data: The Consensus® Apex Dome Hole Plug (PMMA), device performs with substantial equivalence to predicate devices." This is a claim of equivalence, not a presentation of specific performance metrics against defined acceptance criteria.
• No sample sizes, data provenance, expert information, or adjudication methods: Since no performance study (clinical or standalone) with a test set is described, there's no mention of these details.
• No MRMC comparative effectiveness study: The document does not describe any study involving human readers or AI assistance.
• No standalone (algorithm only) performance study: The device described is a physical medical implant, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
• No specific ground truth: The concept of "ground truth" as it applies to AI/algorithm performance studies is not relevant to this type of device submission.
• No training set information: Similarly, as this is a physical device, there is no "training set" in the context of machine learning.

The 510(k) process for this device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and material properties, rather than new, extensive performance trials with defined acceptance criteria and ground truth. The statement "Clinical Data: None Required" further supports this, indicating that new clinical trials were not deemed necessary for this submission.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device