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For NexGen Augments used with NexGen Knee Systems - Cruciate Retaining (CR), Cruciate Retaining Augmentable (CRA), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS), and Legacy Constrained Condylar Knee (LCCK): This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

• Collagen disorders, and/or avascular necrosis of the femoral condyle.

• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

• Moderate valgus, varus, or flexion deformities.

• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

· CR and LPS porous coated femoral and tibial baseplate components may be used cemented biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.

· NexGen Augments that may be used with cemented CR, CRA, PS, and LCCK femoral and tibial baseplate components are indicated for cemented use only.

For NexGen Augments used with NexGen Rotating Hinge Knee System:

This device is indicated for patients with:

• Moderate to severe knee instability.

• Significant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.

• Valgus, varus, or flexion deformities.

• The salvage of previously failed surgical attempts.
  This device is intended for cemented use only.

The NexGen augments are used with the following NexGen Knee Systems: NexGen Rotating Hinge Knee, NexGen Complete Knee Solution: Cruciate Retaining Augmentable (CRA), Legacy Constrained Condylar (LCCK), Cruciate Retaining (CR), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS). This submission includes tibial and femoral augments of various shapes and sizes. Augments are attached via bone cement or screw to tibial baseplate and femoral components indicated for cemented use only. Use of these augments is optional.

I am sorry, but the provided text from the FDA 510(k) premarket notification for Zimmer NexGen Knee Solution Tibial and Femoral Augments does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria, as typically seen for AI/ML-driven medical devices.

The document is a clearance letter and a 510(k) summary for a physical medical device (knee implants - augments), not a software or AI/ML device. Therefore, it discusses performance based on non-clinical testing (shelf life, attachment strength, PMMA coated titanium substrate to bone cement properties) and states that clinical data and conclusions were were not needed for this device's clearance.

The questions you've asked (regarding acceptance criteria for device performance in terms of AI metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are specifically relevant to the evaluation of AI/ML software as a medical device (SaMD) or AI-assisted devices. This document does not describe such an evaluation.

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General Indications for the NexGen Complete Knee Solution Femoral Components:

• This device is indicated for patients with severe knee pain and disability due to:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration. particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Porous coated femoral components may be used cemented or uncemented (biological fixation).

Specific Indications for the LPS-Flex Porous Femoral Components:

• · LPS- Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation).
• · Specific uses with the LPS-Flex femorals:

Intended Use:

• Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
• The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.

Specific Indications for the NexGen Knee GSF Knee Porous Femoral Components:

• · CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation).
• · Specific uses with CR-Flex GSF or LPS-Flex GSF femorals:
• Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
• The CR-Flex GSF femoral, when used with 90prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong" Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee® Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
• The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

The LPS-Flex Fixed-bearing Knee is a semi-constrained, condylar system for use without the cruciate ligaments when additional stability is required to prevent anterior subluxation of the femur relative to the tibia in flexion. The LPS-Flex Porous femoral component is designed to have a maximum active, load bearing range of motion of 155 degrees. It contains a fiber metal pad to allow for cementless use.

The GSF Porous femoral components include both LPS-Flex GSF and CR-Flex GSF versions and are part of the Zimmer Flex-series of semi-constrained, non-linked, condylar knee prostheses that are designed to have a maximum active, load bearing range of motion of 155 degrees. The GSF designation indicates that the femoral component is designed to better match distal femoral anatomic features more typical of female patients. They contain fiber metal pads to allow for cementless use.

The provided document is a 510(k) summary for a medical device (NexGen® Complete Knee Solution LPS-Flex Porous Femoral Component, NexGen Knee Gender Solutions™ Female (GSF) Porous Femoral Components). It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information related to software or AI-driven diagnostic devices, nor does it present specific acceptance criteria or a study proving that such criteria are met.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI device from this document. The document explicitly states:

"Clinical data and conclusions were not needed for these devices."

And the performance data section states:

"Mechanical testing of the proposed devices indicate that they are substantially equivalent to the predicate devices."

This indicates that the clearance for these orthopedic implants was based on substantial equivalence to existing predicate devices, primarily through non-clinical mechanical testing, rather than through clinical studies with acceptance criteria as would be typical for a diagnostic or AI-driven device.

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This device is indicated for patients with severe knee pain and disability due to:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
· Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
· Moderate valgus, varus, or flexion deformities. · The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Specific uses with LPS-Flex femorals: · Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. · The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

The LPS-Flex Fixed Bearing Knee is a semiconstrained, condylar system for use without the cruciate ligaments when additional stability is required to prevent anterior subluxation of the femur relative to the tibia in flexion.

This document is a 510(k) premarket notification for a medical device modification, specifically for the NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Tivanium® Ti-6Al-4V Alloy Femoral Components. It seeks to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

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

   This document does not explicitly list quantitative acceptance criteria in a table format in the way one might expect for a software or diagnostic device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence through non-clinical (laboratory) performance testing. The main criterion is that the modified device performs comparably to the predicate device and meets safety and effectiveness standards for its intended use.

   Acceptance Criteria (Implicit)	Reported Device Performance
   Device is safe and effective.	The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
   Device is substantially equivalent to the predicate device (NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Femoral and Articular Surface Components, K991581).	The results of non-clinical (laboratory) performance testing demonstrate that the device is substantially equivalent to the predicate device. The modifications (change in material and surface hardening processing) do not change the intended use or the fundamental scientific technology. Device is packaged using the same materials and processes.

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

   The document states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate device."

   • Sample Size for Test Set: The document does not specify the sample size for the non-clinical (laboratory) performance testing.
   • Data Provenance: The data provenance is "non-clinical (laboratory) performance testing." There's no information about the country of origin or whether it was retrospective or prospective, as these terms typically apply to clinical data.

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)

   This is not applicable. The study conducted was non-clinical (laboratory) performance testing of a mechanical device (femoral components for a knee replacement). There was no "ground truth" to be established by human experts in the context of interpreting medical images or data. Performance was likely evaluated against engineering specifications and comparison to the predicate device's characteristics.

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

   This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in studies involving human interpretation or clinical outcomes, typically for diagnostic devices or AI algorithms. This submission pertains to a mechanical orthopedic implant, where "adjudication" in this sense is not relevant.

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. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, particularly in diagnostic imaging. The device in question is a knee implant component, not a diagnostic AI tool.

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

   This refers to a mechanical device, not an algorithm. Therefore, "standalone algorithm only" testing is not applicable. The "standalone performance" was the non-clinical laboratory testing of the physical components.

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

   This is not explicitly stated in terms of a "ground truth" as it would be for a diagnostic device. For a mechanical implant, "ground truth" generally relates to adherence to design specifications, material properties, mechanical strength, wear characteristics, and biocompatibility, as confirmed through laboratory testing. The implicit ground truth would be that the modified device's performance characteristics (e.g., strength, durability, wear resistance) are equivalent or superior to the predicate device, and meet a predefined set of engineering and biocompatibility standards.

8. The sample size for the training set

   This is not applicable. This device is a mechanical implant, not an AI/ML algorithm that requires a "training set."

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

   This is not applicable, as there is no training set for a mechanical implant.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

This device is indicated for use when the posterior cruciate ligament is absent or deficient.

This device is intended for use as part of a cemented or uncemented knee prosthesis.

This device is part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses.

The provided text is for a 510(k) premarket notification for a medical device, the "NexGen® Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a new, extensive clinical trial to establish novel acceptance criteria and performance against those criteria.

Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets specific performance acceptance criteria in the typical sense of a clinical or analytical validation study for a new technology with novel performance claims.

Instead, the document states:

1. Non-Clinical Performance and Conclusions: "Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device."
2. Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

This indicates that the device's acceptance was based on demonstrating equivalence to a previously cleared predicate device (Prolong™ Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component, K013991) through non-clinical testing, rather than establishing new, independent performance metrics. The implicit "acceptance criteria" here are that the new device performs equivalently to the predicate device in relevant non-clinical tests.

Since a typical performance study with defined acceptance criteria and detailed results is not present, I cannot fill out the requested table or answer the specific questions about sample size, ground truth, expert qualifications, etc., as that information is not in the provided text.

In summary, based on the provided text:

• Acceptance Criteria/Reported Device Performance: Not explicitly stated as new criteria. The device's safety and effectiveness were demonstrated by meeting "performance requirements" in non-clinical testing and being "as safe and effective as the predicate device."
• Sample size used for the test set and the data provenance: Not applicable/not provided. No clinical test set data is presented.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
• Adjudication method for the test set: Not applicable/not provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. Clinical data was explicitly stated as "not needed."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical knee prosthesis, not an AI algorithm.
• The type of ground truth used: Not applicable/not provided. The comparison was to a predicate device based on non-clinical testing.
• The sample size for the training set: Not applicable/not provided. No training set is mentioned as this is not an AI device.
• How the ground truth for the training set was established: Not applicable/not provided.

The key takeaway is that for this 510(k) submission, the "study" proving the device met "acceptance criteria" was non-clinical testing demonstrating equivalence to a predicate device, as opposed to a novel performance study against new, predefined clinical metrics.

Ask a specific question about this device

This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is ratellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  This device is intended for cemented use only.

The NexGen MIS Modular Tibial Plates and Keels are part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses.

The provided text is a 510(k) summary for the Zimmer NexGen MIS Modular Tibial Plates and Keels. It is a premarket notification for a medical device seeking clearance based on substantial equivalence to a predicate device, not a study reporting on the device's performance against specific acceptance criteria.

Therefore, the document does not contain the information required to populate the requested table about acceptance criteria, device performance, or details about a study proving the device meets those criteria.

Specifically, the document states:

• Performance Data (Nonclinical and/or Clinical): "Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device."
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

This indicates that the Zimmer NexGen MIS Modular Tibial Plates and Keels were cleared based on design assurance performance testing and substantial equivalence to a previously cleared predicate device (NexGen Complete Knee Solution, K933785, cleared January 30, 1995), not on clinical studies with specific acceptance criteria as you've requested. The modifications from the predicate device were considered minor and not to change the intended use or fundamental scientific technology.

Ask a specific question about this device

This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  This device is intended for cemented use only.

The Distal Femoral Spacer is a poly(methyl methacrylate) [PMMA] cement spacer designed to help adjust extension gaps and maintain a uniform cement mantle when used with the femoral component of a cemented total knee prosthesis. It is used in pairs; each Distal Femeral Spacer fits over one of the femoral posts. This creates a defined space between the femoral component and the prepared bone, helping maintain a uniform cement mantle. The Distal Femoral Spacers themselves are then incorporated into the cement mantle by the polymerizing bone cement. The Distal Femoral Spacer is available in 2mm and 4mm thicknesses.

The provided document K050105 is a 510(k) summary for the NexGen® Complete Knee Solution Distal Femoral Spacers. It describes a medical device, its intended use, and its comparison to a predicate device. However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert ground truth, or adjudication methods that would typically be found in a study proving a device meets acceptance criteria.

The document explicitly states:

• "Non-clinical performance testing was not required for this device."
• "Clinical data and conclusions were not needed for this device."

This means that the device's clearance was based on substantial equivalence to a predicate device, and not on the results of a performance study with acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Explanation: The 510(k) summary states that "Non-clinical performance testing was not required for this device" and "Clinical data and conclusions were not needed for this device." The clearance was based on substantial equivalence to a predicate device (ZCA® All-Poly Acetabular Cup, Snap-In (PMMA spacer), K030153). Therefore, there are no specific acceptance criteria or performance results from a study to report.

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

• Sample Size (Test Set): Not applicable. No test set was used for a performance study.
• Data Provenance: Not applicable. No performance study data was generated or analyzed.

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)

• Number of Experts: Not applicable. No ground truth was established for a test set, as no performance study was conducted.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. No test set or adjudication was used.

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 physical medical device (knee spacers), not an AI/software device involving human readers or AI assistance.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This is not a software algorithm; it is a physical implantable device.

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

• Type of Ground Truth: Not applicable. No performance study requiring a gold standard or ground truth was conducted for this 510(k) submission.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This is not an AI/machine learning device, so there is no training set.

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

• Ground Truth Establishment (Training Set): Not applicable.

Ask a specific question about this device

This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  This device is intended for cemented use only.

The NexGen MIS Tibial Components are part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses.

Here's an analysis of the provided FDA 510(k) summary, focusing on the absence of specific acceptance criteria and detailed study information, as is often the case with predicate device submissions.

Acceptance Criteria and Device Performance:

Explanation: This 510(k) submission for the NexGen® Complete Knee Solution MIS™ Tibial Components relies on substantial equivalence to previously cleared predicate devices (K933785, K991581, K031061). In such cases, detailed, de novo acceptance criteria and performance metrics are typically not provided as they would be for a new device. Instead, the device is deemed acceptable if it can demonstrate equivalent safety and effectiveness to legally marketed predicate devices, usually through non-clinical performance testing that confirms the modifications do not alter the fundamental scientific technology or intended use. The document explicitly states that clinical data was not needed.

Study Information (Based on the Provided Document):

This submission does not describe a clinical study comparing the device to a set acceptance criterion, but rather relies on non-clinical performance testing and substantial equivalence to predicate devices. Therefore, many of the requested categories are not applicable or cannot be determined from the provided text.

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

   • Test Set Sample Size: Not applicable for a clinical study, as "Clinical data and conclusions were not needed for this device." For non-clinical performance testing, the sample sizes for mechanical tests (e.g., fatigue, static strength) are not specified in this summary.
   • Data Provenance: Not applicable for a clinical study. For non-clinical testing, it would be internal laboratory data generated by Zimmer, Inc.

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

   • Not applicable as no clinical ground truth was established for this submission.

3. Adjudication Method for the Test Set:

   • Not applicable as no clinical ground truth was established for this submission.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical data and conclusions were not needed for this device."

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Not applicable. This device is a physical knee prosthesis component, not an algorithm or AI-driven system.

6. Type of Ground Truth Used:

   • Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be established engineering specifications and accepted testing standards for mechanical performance of knee implants.

7. Sample Size for the Training Set:

   • Not applicable. This device is a physical knee prosthesis component, not an AI/algorithm-driven system requiring a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. This device is a physical knee prosthesis component, not an AI/algorithm-driven system requiring a training set.

Conclusion from the Document:
The FDA clearing document (K043101) indicates that the device's safety and effectiveness were demonstrated through non-clinical performance testing and by establishing substantial equivalence to predicate devices. The modifications made to the NexGen MIS Tibial Components were considered "minor" and "do not change the intended use or the fundamental scientific technology." Therefore, detailed clinical studies, specific acceptance criteria in the clinical sense, or sophisticated ground truth establishment methods were not required for this 510(k) clearance.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  The device is indicated for use when both cruciate ligaments have been excised.
  The device is intended for use as part of a cemented or uncemented knee prosthesis.

The NexGen LPS-Flex Prolong articular surfaces are part of the NexGen system of semiconstrained,

The provided document describes a 510(k) premarket notification for a medical device, specifically NexGen® Complete Knee Solution LPS-Flex Prolong™ Highly Crosslinked Polyethylene Articular Surfaces. The document focuses on demonstrating substantial equivalence to predicate devices rather than a de novo study with explicit acceptance criteria and performance data.

Therefore, many of the requested categories (2-9) are not directly applicable or explicitly stated in this type of submission which primarily relies on equivalence to devices already on the market.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a 510(k), which asserts substantial equivalence to predicate devices rather than establishing new performance acceptance criteria and showing performance against them in a de novo study. The "Performance Data" section explicitly states "Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

Therefore, a table of explicit acceptance criteria and reported device performance, as one would see in a de novo study, is not provided in this type of submission. The 'acceptance criterion' for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate. The 'performance' is therefore inherently linked to the performance of the predicate device.

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

Not applicable. No dedicated "test set" or clinical study with a prospectively collected sample size is described as clinical data was not needed. The non-clinical performance refers to design assurance testing, which would typically involve laboratory testing, not a clinical test set. The provenance of such non-clinical data would be internal lab reports.

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

Not applicable. As clinical data and a test set requiring ground truth establishment by experts were not needed or presented, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

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

Not applicable. No clinical study, let alone an MRMC study comparing human readers with or without AI assistance, was performed or presented for this 510(k) submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical knee prosthesis component, not an algorithm or AI. Therefore, a standalone performance study in the context of an algorithm's performance is not relevant.

7. Type of Ground Truth Used

Not applicable, as no external "ground truth" for a clinical assessment was required. The "truth" in this context is established through engineering and material science testing that demonstrates the physical properties and performance characteristics (e.g., wear, strength) of the device are equivalent to the predicate.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.

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The NexGen Trabecular Metal femoral and tibial augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal femoral and tibial augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.

The NexGen Trabecular Metal Augments are designed for attachment to selected commercially available NexGen tibial base plates and femoral components using either bolts, cement or a combination of both (depending on the augment). In the USA, the augment must be cemented to the bone surface; outside the USA the use of cement along the bone surface is optional. The augments are manufactured to interface with selected femoral and tibial NexGen components. The femoral augments come in four different sizes (sizes C, D, E and F) that correspond with the sizes of the femoral components. Each NexGen LCCK or RHK femoral component has two corresponding augments, one for the distal segment and one for the posterior segment of the femoral component. The thickness options of the augments vary from 5mm to 20mm. The tibial augments are sized to match the tibial base plates. There are 6 sizes (sizes 2 through 7) of tibial augments to match the six sizes of the augmentable NexGen tibial base plates. Within each size, there are different thickness options (from 5mm - 20mm for sizes 2 and 7; from 5mm - 20mm for sizes 3, 4, 5, 6, and 10mm thick for full blocks for sizes 1-7), right-left configurations and the thicker sizes are tapered to mimic proximal tibial anatomy. The NexGen RHK full block tibial augments are 10mm thick and are offered in sizes 1 through 6.

The provided 510(k) summary does not contain the kind of information typically associated with establishing acceptance criteria and proving device performance for a diagnostic device via a study with a test set, ground truth, or expert review.

Instead, this document is for a medical implant (knee augments) and focuses on substantial equivalence to previously approved predicate devices, rather than a performance study.

Here's an breakdown of why the requested information is absent and what the document does state:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria for Performance Study: Not applicable to this type of submission. The document states: "Testing of the subject devices were not performed."
• Reported Device Performance: Instead of performance metrics from a study, the document relies on prior testing of the material (Trabecular Metal) and the geometric similarity to already cleared NexGen Knee System augments. The "performance" here is an assertion of equivalence based on material and design.

2. Sample Size for Test Set and Data Provenance

• Not Applicable: No clinical or laboratory test set was used for this 510(k) submission as "Testing of the subject devices were not performed."

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

• Not Applicable: There was no ground truth establishment in the context of a performance study, as no such study was conducted for this submission.

4. Adjudication Method for the Test Set

• Not Applicable: No test set, no adjudication method.

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

• Not Applicable: This is an implant, not a diagnostic device involving human readers. No MRMC study was performed or is relevant.

6. Standalone (Algorithm Only) Performance

• Not Applicable: This is an implant, not an algorithm or AI device.

7. Type of Ground Truth Used

• Not Applicable: No ground truth in the context of a performance study. The "truth" for this submission is that the device is substantially equivalent to existing, cleared devices based on its material and design.

8. Sample Size for the Training Set

• Not Applicable: No training set was used, as this is not an AI/ML device.

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

• Not Applicable: No training set or ground truth in that context.

Summary of Device Acceptance (as per this 510(k) document):

The device (NexGen® Complete Knee Solution - Trabecular Metal Augments) was "accepted" and cleared by the FDA based on substantial equivalence to predicate devices. This means the FDA determined that the new device is as safe and effective as a legally marketed device (predicate device) that is not subject to premarket approval (PMA).

Specifically, the document states:

• "Testing of the subject devices were not performed."
• "Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence."
• "Additionally, these augments have the same geometry as cleared NexGen Knee System augments."

The FDA's letter explicitly confirms: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the "acceptance criteria" here implicitly revolve around demonstrating that the device shares the same fundamental scientific technology, indications for use, and performance characteristics (as defined by material and design similarity) with the following predicate devices:

The "study that proves the device meets the acceptance criteria" in this case is the comparison to predicate devices detailing the material (Trabecular Metal, previously tested/cleared) and the geometry (same as cleared NexGen Knee System augments).

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This device is indicated for: Patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders and/or avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy), and moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended for cemented use only Specific uses with CR-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.

The NexGen CR-Flex femoral components are part of the Zimmer Flex-series of semiconstrained, nonlinked condylar knee prostheses that are designed to have a maximum active flexion of 155 degrees. Except for modifications to allow flexion to 155 degrees, CR-Flex femoral components are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged and sterilized using the same materials and processes

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document describes a device modification for the NexGen® Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components. As such, the acceptance criteria are primarily focused on demonstrating substantial equivalence to existing predicate devices rather than establishing new independent performance benchmarks.

Study Details

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

   • Test Set Sample Size: Not explicitly stated for a clinical test set. The document indicates "Performance testing completed as part of the design assurance procedure," which implies an engineering/bench test. There is no mention of a patient-based test set or its size.
   • Data Provenance: The document does not specify a country of origin for any data. The study is non-clinical (bench testing), so the concept of retrospective or prospective data from patients does not apply.

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

   • Not applicable. This was a non-clinical performance study.

3. Adjudication method for the test set:

   • Not applicable. This was a non-clinical performance study.

4. 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. This is a medical device (knee implant), not an AI diagnostic tool.

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

   • Not applicable. This is a medical device (knee implant), not an algorithm.

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

   • The "ground truth" for this device modification was based on engineering performance specifications and design principles to ensure "safe and effective and substantially equivalent" performance to the predicate devices. This would involve mechanical testing for attributes like wear, strength, and range of motion, rather than clinical ground truth from patients.

7. The sample size for the training set:

   • Not applicable. This is a medical device for which the submission relies on non-clinical performance testing and substantial equivalence to predicate devices, not machine learning model training.

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

   • Not applicable. See point 7.

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