Search Results

1. Painful and disabled knee joint resulting from osteoarthritis, or traumatic arthritis, or traumatic arthritis where one or more compartments are involved.

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.

Femoral components and tibial tray components with porous coatings are indicated for cemented biological fixation application. Non-coated (Interlok) femoral components and all polyethylene patellar components are indicated for cemented application only.

The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of cobalt-chromium-molybdenum (Co-Cr-Mo), two styles of tibial trays manufactured out of Co-Cr-Mo (with locking bar), and dual bearings machined of Vivacit-E Vitamin-E Highly Crosslinked Polyethylene (VEHXPE). Biomet patellae can be used with the Vanguard XP Knee System. The subject Vanguard XP tibial components are available with a porous plasma spray (PPS®) of titanium alloy powder for uncemented or cemented fixation or with Biomet's Interlok coarse blasted finish for cemented fixation only. The Vanguard XP Knee System offers the flexibility to retain the ACL and PCL ligaments, retain just the PCL ligament and accommodate an intact, partially functioning PCL within a single system.

The provided document, a 510(k) premarket notification for the Vanguard XP Knee System, primarily focuses on demonstrating substantial equivalence to predicate devices for a knee implant, specifically a modification to the tibial bearings. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

The document discusses:

• Device Identity: Vanguard XP Knee System, a total knee replacement system.
• Modification: A modification to the tibial bearings within the system.
• Purpose of Submission: To demonstrate that this modification does not adversely affect safety and efficacy and that the modified device remains substantially equivalent to predicate devices.
• Testing: Engineering analysis and non-clinical tests (e.g., material characteristics, stress analysis, MRI compatibility, non-pyrogenicity).
• Clinical Data: Explicitly states, "Clinical data was not deemed necessary for the subject device." This indicates that no human clinical study was conducted for this specific 510(k) submission, and certainly not a study related to AI/ML performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI/ML device meets them based on the provided text. The document pertains to a traditional orthopedic implant, not an AI/ML medical device.

Ask a specific question about this device

The Vanguard XP Knee System is intended for replacement of a total knee joint and the preservation of the anterior and/or posterior cruciate ligament (ACL/PCL) when used in conjunction with a femoral, tibial and patellar component.

• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic 1. arthritis where one or more compartments are involved.
• 2. Correction of varus, valgus, or posttraumatic deformity.
• 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components* are intended only for uncemented biologic fixation application.

*where available

The subject Vanguard XP Knee System line extension introduces the 59mm XP-XP Tibial Tray, modifications to corresponding 59mm XP-XP and XP-AS bearings, implant-specific instrumentation, differential bearing (thickness and/or articulation) compatibility and MR conditional labeling for the system.

The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of Co-Cr-Mo, two styles of tibial trays manufactured of Co-Cr-Mo (with locking bar), and dual bearings machined of E1 poly. Biomet patellae can be used with the Vanguard XP Knee System. The subject Vanguard XP-XP tibial components are available in Biomet's Interlok coarse blasted finish for cemented fixation.

This document is a 510(k) premarket notification for the "Vanguard XP Knee System". It focuses on a line extension, specifically the introduction of a 59mm XP-XP Tibial Tray and related components. The document describes the device, its intended use, and provides a summary of performance data (non-clinical tests) used to demonstrate substantial equivalence to existing predicate devices.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics in the way one might expect for a new artificial intelligence (AI) device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the performance of the new device (Vanguard XP Knee System line extension) is comparable or equivalent to the predicate devices.

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

This document does not describe a clinical study or a study involving a "test set" of patient data in the context of an AI device. The "tests" described are non-clinical (mechanical and MR compatibility) and would involve physical devices or components, not a patient data set. Therefore, sample sizes for a test set and data provenance (country, retrospective/prospective) are not applicable or provided in this document as it pertains to a traditional medical device, not an AI/software device.

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

Not applicable. This device is a knee implant, not an AI diagnostic or prognostic tool. "Ground truth" in the context of expert consensus on patient data is not relevant to the non-clinical mechanical testing and MR compatibility testing described.

4. Adjudication Method

Not applicable, as this is not a study involving expert review or a patient data test set.

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

No. This is a traditional medical device (knee implant) premarket notification, not an AI device. An MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

No. This document is for a physical medical device (knee implant), not an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described would be based on established engineering principles, material science standards (e.g., ASTM standards for MR compatibility, fatigue testing), and comparison to the performance of legally marketed predicate devices. The "truth" is determined by whether the device meets specific physical and performance characteristics as defined by these standards and comparison.

8. Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set of data.

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

Not applicable for the same reason as above.

Ask a specific question about this device

The Vanguard™ XP Knee System is intended for replacement of a total knee joint and the preservation of the anterior and/or posterior cruciate ligament (ACL/PCL) when used in conjunction with a femoral, tibial and patellar component.

Indications For Use:

• I. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
• 2. Correction of varus, valgus, or posttraumatic deformity.
• 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation. Non-coated (Interlok") femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.

• Where Available

The purpose of the submission is to update the locking mechanism cleared in K122160.

The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of Co-Cr-Mo, two styles of tibial trays/plates manufactured of Co-Cr-Mo (with locking bar), and dual bearings machined of El poly. Biomet® patellae can be used with the Vanguard XP Knee System. Both the XP femoral and the XP-CR tibial components are available with a previously cleared porous plasma spray (PPS) coating of titanium alloy and Biomet's Interlok coarse blasted finishes. The Vanguard XP-XP tibial components are available in Biomet's Interlok® coarse blasted finish. Porous coated femoral and tibial components are indicated for cemented and uncemented biological fixation application. Non-coated coarse blasted (Interlok®) femoral and tibial components are indicated for cemented application only. Accessory components are available including removable femoral pegs and femoral augments.

The Vanguard™ XP Knee System is made up of multiple components. including: instrumentation, femoral components, several types of bearings and tibial trays.

The technological characteristics of the Vanguard™ XP Knee System are the same as those of predicate devices (K122160, K904448, and K113550) in terms of design. material, and principle of operation with the exception of slight modifications as described in this 510(k). The subject locking bar mechanism. tibial and bearing components of the Vanguard™ XP Knee System utilize the identical manufacturing processes as the predicates. The previously cleared, porous plasma spray characterization data on identical substrate was provided in K113550 and used in support of K122160 and subject 510(k). The porous plasma spray coating on the ASTM F75 substrate is for both cemented and uncemented, biologic fixation. Non-clinical testing was conducted to demonstrate that the differences did not adversely affect safety and to demonstrate substantial equivalence to the predicate components. All testing met or exceeded the established acceptance criteria. This information is detailed below in the Performance (Nonclinical) section.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biomet Vanguard™ XP Knee System:

Device: Biomet Vanguard™ XP Knee System

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K132873) focuses on a modification to the locking mechanism of an already cleared knee system. As such, the acceptance criteria are not explicitly numerical performance targets in the sense of a new device's efficacy, but rather a demonstration that the modification does not adversely affect safety and maintains substantial equivalence to predicate devices. The "reported device performance" is essentially that all tests met or exceeded established acceptance criteria, confirming this non-adverse effect.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of components tested) for each non-clinical test. It only states that the tests were performed.
• Data Provenance: The data is from non-clinical testing (mechanical tests). The origin country is not explicitly stated, but given the submitter and FDA context, it is presumed to be conducted under standards relevant to the US market. The nature of the study is purely retrospective in the sense that it's testing a modified device against established standards and predicate data, not a de novo prospective clinical trial.

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

Not applicable. This submission relies on non-clinical mechanical testing, not expert-reviewed clinical data or images. The "ground truth" for these tests is the performance against pre-defined engineering and mechanical standards.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is non-clinical mechanical testing, not a clinical study involving human readers or adjudication. The results are quantitative measurements against defined criteria.

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

No. This document explicitly states: "No clinical testing was necessary for a determination of substantial equivalence." Therefore, no MRMC study was conducted. The nature of this submission is a modification to a previously cleared device, relying on non-clinical testing to demonstrate that the modification does not introduce new safety or effectiveness concerns.

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

No. This is a physical prosthetic device (a knee system), not an algorithm or AI-based device. "Standalone performance" in this context would refer to the mechanical performance of the device components themselves, which was assessed through non-clinical testing.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on:

• Pre-defined engineering standards and mechanical test protocols (e.g., for fatigue, stability, locking mechanism integrity).
• Performance data from legally marketed predicate devices (K122160, K113550, K904448), to which substantial equivalence is claimed.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing processes and design principles are based on established engineering practices and predicate devices.

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

Not applicable, as there is no "training set." The design and manufacturing of the device were established through conventional engineering and medical device development processes, drawing upon existing knowledge, materials science, and the performance characteristics of predicate devices.

Ask a specific question about this device

The Vanguard™ XP Knee System is intended for replacement of a total knee joint and the preservation of the anterior and/or posterior cruciate ligament (ACL/PCL) when used in conjunction with a femoral, tibial and patellar component.

Specific indications are as follows:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.
   Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.

The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of Co-Cr-Mo, two styles of tibial trays/plates manufactured of Co-Cr-Mo (with locking bar), and dual bearings machined of E1 poly. Biomet® patellae can be used with the Vanguard XP Knee System. Both the XP femoral and the XP-CR tibial components are available with a previously cleared porous plasma spray (PPS) coating of titanium alloy and Biomet's Interlok® coarse blasted finishes. The Vanguard XP-XP tibial components are available in Biomet's Interlok® coarse blasted finish. Porous coated femoral and tibial components are indicated for cemented and uncemented biological fixation application. Non-coated coarse blasted (Interlok®) femoral and tibial components are indicated for cemented application only. Accessory components are available including removable femoral pegs and femoral augments.

This document is a 510(k) summary for the Vanguard™ XP Knee System, a knee replacement device. It establishes substantial equivalence to previously cleared predicate devices through non-clinical performance testing.

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

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

The document does not explicitly present a table of acceptance criteria alongside performance data with specific numerical values or success/failure metrics. Instead, it lists various non-clinical tests performed and states:

"All testing met or exceeded the established acceptance criteria."

This indicates that acceptance criteria were internally defined and met, but the specific thresholds and quantitative results are not disclosed in this summary.

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

The document relates to non-clinical (mechanical) testing of a medical device (knee implant components). These types of tests typically do not involve human subjects or retrospective/prospective data from patients.

• Sample size for the test set: Not explicitly stated but implied to be sufficient for mechanical testing according to established standards. The tests mentioned (e.g., Tibiofemoral Mechanical Stability, Cyclic Fatigue of Tibial Tray, Wear Test) would involve multiple samples of the components under various load conditions.
• Data provenance: Not applicable in the context of human data. The tests were performed on the device components themselves.
• Retrospective or prospective: Not applicable.

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 as the study involves non-clinical mechanical testing of an orthopedic implant, not medical image analysis or clinical diagnosis. Ground truth would be defined by engineering specifications and physical measurements, rather than expert clinical consensus.

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

Not applicable. This concept applies to clinical studies or studies where human expert review is required to establish ground truth or evaluate outcomes, typically in image analysis or diagnostic contexts. For mechanical testing, outcomes are determined by physical measurements against predefined 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation systems, which is not the nature of this medical device (a knee implant). The submission focuses on demonstrating the physical and mechanical performance of the implant components.

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

No, a standalone (algorithm-only) performance study was not done. This is not an AI/software device. The product is a physical knee implant system.

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

The ground truth for this type of non-clinical performance data is based on engineering specifications, established industry standards (e.g., ASTM standards for medical devices), and predefined physical and mechanical thresholds. For example, a wear test would have an acceptance criterion for maximum allowable material loss after a certain number of cycles, and the "ground truth" is measured wear, compared against this criterion. Similarly, fatigue tests would have criteria for the number of cycles to failure at a given load.

8. The sample size for the training set

Not applicable. This device is a physical implant, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device