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The subject devices are intended for use in total knee arthroplasty.

Indications for use 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 joint replacement procedure.

The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.

The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.

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 and OsseoTi components are intended only for uncemented biologic fixation application.

The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States or Canada.

The Vanguard 360 Revision Knee System is a total knee replacement system intended for use in primary or revision total knee joint arthroplasty. The system is comprised of a series of femoral and tibial components (bearings and trays) designed to work in conjunction with patella components and optional auxiliary components, including stem extensions, offset adaptors, and tibial and femoral augments. This submission includes a modification to the screw hole location in the 57.5mm Vanguard 360 Posterior Femoral Augments and a subcomponent design and material change in the Vanguard 360 Bowed Stem Extension Trials.

The provided document is a 510(k) summary for the Biomet Vanguard 360 Revision Knee System. This type of submission is for medical devices seeking clearance from the FDA by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

As such, the document does not describe a study that validates the device against acceptance criteria in the manner typically associated with AI/ML diagnostic or prognostic devices. Instead, it focuses on demonstrating that the modifications to the existing device (Vanguard 360 Revision Knee System) are substantially equivalent to the predicate device and do not introduce new risks.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to the performance data presented to support substantial equivalence for the modifications to the device itself.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for a mechanical device modification, the "acceptance criteria" are generally related to demonstrating mechanical equivalency and safety, not diagnostic performance. The document doesn't explicitly state numerical acceptance criteria in a detailed table as one would expect for an AI diagnostic. Instead, it refers to "Performance data has demonstrated that the proposed devices are at least as safe and effective as the legally marketed predicate device."

• Tolerance Analysis Report: Submitted and reviewed (implies meeting design tolerances).
• Fit Evaluation: Submitted and reviewed (implies proper fit with existing components).
  Bowed Stem Trials:
• Pull Force Comparison: Data was generated and submitted (implies comparable mechanical strength, specifically pull-out resistance, to the existing trials, suggesting the 416 SST cylindrical pin does not compromise structural integrity). |
  | Material Equivalence| Ensure that new materials or modified components maintain biocompatibility and structural integrity. | For augments: "There are no changes to the augment materials..."
  For bowed stem trials: "materials of the stem, barrel, and shaft are unchanged (Ti-6Al-4V and 17-4PH SST)." The new subcomponent is 416 SST, which is a known and accepted material in medical devices. |
  | Functional Equivalence| Demonstrate the modification does not alter the intended function or clinical performance. | "The subject augments have similar technological characteristics as the predicate."
  "The subject bowed stem extension trials also have similar characteristics as the existing trials." The screw hole location change and pin change are considered minor and not affecting overall function in a way that would require new clinical data. |
  | Safety and Effectiveness| The modified device must be at least as safe and effective as the legally marketed predicate device, with no new risks of safety or efficacy introduced. | "Performance data has demonstrated that the proposed devices are at least as safe and effective as the legally marketed predicate device."
  "Based on the similarities in design, function, intended use and fundamental scientific technology, the devices that are the subject of this submission are similar to the predicate devices and do not introduce any new risks of safety or efficacy." |

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

• Not Applicable. This document describes non-clinical testing of mechanical components (tolerance analysis, fit evaluation, pull force comparison) for demonstrating substantial equivalence. These are laboratory-based tests of physical parts, not clinical trials or AI algorithm performance tests with patient data. No "test set" of patient data is mentioned.

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):

• Not Applicable. As no clinical "test set" or ground truth based on expert review is used, this information is not relevant to this submission. The "ground truth" here is the engineering specifications and performance of the predicate device against which the modified components are compared.

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

• Not Applicable. No expert adjudication of clinical data occurred.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is a medical device for knee arthroplasty, not an AI diagnostic tool. No MRMC study was conducted.

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

• Not Applicable. This device is a mechanical knee replacement system, not an algorithm.

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

• For the non-clinical tests, the "ground truth" or reference is established through engineering specifications, material science principles, and comparison to the performance characteristics of the legally marketed predicate device. For instance, the "pull force comparison" implies a standard mechanical test with a measurable outcome compared against a known baseline for the predicate.

8. The sample size for the training set:

• Not Applicable. This device did not involve AI/ML development, so there is no training set of data.

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

• Not Applicable. No training set was used.

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The indications for the Vanguard™ 360 Revision Knee System 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 joint replacement procedure.
   These devices are single-use implants intended for cemented use only.

The Vanguard™ 360 Revision Knee System is a series of femoral, tibial and offset adapter components designed to work in conjunction with femoral stems, bearings, trays, augments and patella components of Biomet's previously cleared Maxim® and Vanguard™ SSK knee systems. These components can be used for either primary or revision procedures, but are specifically designed for use where there is inadequate bone stock. Biomet has developed this system in order to expand its product line for its currently marketed Vanguard™ [SSK] Knee System (K042757).
The Vanguard™ 360 femoral components are made of Co-Cr-Mo alloy and incorporate the validation features as the predicate Vanguard SSK femoral components. The tibial components incorporate the same tibial tray profile as the current Biomet Tibial Trays and the predicate Offset Tibial Tray design and are made of Ti-6A1-4V titanium alloy. The femoral and tibial components are designed for use with the Biomet knee stems cleared in the predicate MCK (Maxim ) System. A series of tibial and femoral augments made of Ti-6A1-4V titanium alloy, allow for the modularity to accommodate bone defects that may be present during revision surgeries. The Ti-6Al-4V titanium alloy Offset Adapter components in this system, allow the surgeon to offset the centerline between the stem and the femoral or tibial components throughout 360 degrees in the transverse axis. Titanium alloy Ti-6A1-4V bone screws can be used if additional screw fixation is warranted.

The provided document describes a 510(k) premarket notification for the "Vanguard™ 360 Revision Knee System." This submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish novel performance claims through clinical studies. Therefore, much of the information requested, such as sample sizes for test and training sets, expert qualifications, ground truth methods for AI, MRMC studies, and standalone algorithm performance, is not applicable to this type of regulatory submission.

Here's an breakdown of the relevant information provided and an explanation of why other requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically met through non-clinical testing demonstrating that the new device is as safe and effective as the predicate devices. The "performance" is shown by verifying that the device meets safety and functionality standards comparable to existing, legally marketed devices.

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

• Not Applicable. This submission relies on non-clinical engineering and laboratory testing, not a clinical test set with patient data. The "test sets" here refer to test specimens or setups for mechanical and material property evaluations.

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

• Not Applicable. Ground truth in the context of this 510(k) refers to established engineering standards, material specifications, and mechanical performance requirements, not expert clinical interpretations of diagnostic data. The "experts" would be the engineers and scientists conducting the described non-clinical tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods are typically for clinical studies involving human interpretation or uncertain outcomes. For engineering tests, results are typically determined by established test protocols and predefined acceptance limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• Not Applicable. This is a medical device (knee implant) submission, not an AI/software device. No MRMC studies were performed, and AI assistance is not involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For this 510(k) submission, the "ground truth" for non-clinical testing is based on:
  • Established engineering principles and calculations (e.g., for resisting in-vivo torque, and addressing the femoral boss alignment tab removal).
  • Industry standards and specifications (e.g., ASTM standards for MRI compatibility tests: ASTM F2119-07, ASTM F2182-09, ASTM F2052-06e1, ASTM F2503-08).
  • Pre-defined acceptance criteria for mechanical strength and fatigue tests (80/20 Fatigue Strength, Cantilever Beam Fatigue).

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device. No "training set" was used.

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

• Not Applicable. As no training set was used, no ground truth needed to be established for it.

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