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1. Painful and disabled knee joint resulting from osteoarthritis 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®) devices and all polyethylene patellar components are indicated for cemented application only.

The Vanguard® Complete Knee System is a total knee replacement system for either primary or revision knee arthroplasty. It is modular in design consisting of five components: a cobalt-chromium-molybdenum (Co-Cr-Mo) or Titanium (Ti) alloy femoral component, with either a porous plasma spray (PPS) or Interlok® surface finish; a cobalt-chromium-molybdenum (Co-Cr-Mo) or Titanium (Ti) alloy tibial tray; a patellar component, manufactured from polyethylene (UHMWPE); a locking bar, manufactured from a Titanium (Ti) alloy; and tibial bearings, manufactured from a Vitamin-E Highly Crosslinked polyethylene (VEHXPE).

This is a 510(k) premarket notification for the Vanguard Complete Knee System, a medical device. This document focuses on the claim of substantial equivalence to predicate devices rather than providing a study where the device meets specific acceptance criteria in the way an AI/software device would.

Therefore, the requested information elements related to algorithms, ground truth, expert adjudication, MRMC studies, and sample sizes for training/test sets are not applicable to this type of medical device submission.

Here's a breakdown of what is available in the document regarding the device's characteristics and the basis for its clearance:

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

The document does not present acceptance criteria or reported device performance in the format of a clinical study with metrics like sensitivity, specificity, or accuracy. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices.

The "performance data" provided relates to non-clinical engineering analysis and material characteristics to show that modifications do not adversely affect safety and efficacy.

2. Sample sized 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 a physical medical device (knee implant components) and its clearance is based on substantial equivalence, primarily through non-clinical bench testing and material comparisons, not AI/software performance studies.
• The "test reports" mentioned (e.g., Vivacit-E material characteristics, FEA evaluation, MRI compatibility, Pyrogenicity Testing) refer to engineering and biocompatibility evaluations, not clinical trials with human subjects.

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. See point 2.

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

• Not applicable. See point 2.

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. See point 2.

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

• Not applicable. See point 2.

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

• Not applicable. The "ground truth" for this device's clearance is established through engineering principles, material science standards, and comparison to existing, legally marketed predicate devices. For example, material strength might be compared to industry standards or predicate device specifications, which serves as the "ground truth" for material performance.

8. The sample size for the training set

• Not applicable. See point 2.

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

• Not applicable. See point 2.

Summary of the K183583 Submission:

• Device: Vanguard® Complete Knee System (specifically, modifications to the tibial bearings).
• Purpose of Submission: To introduce a modification to the tibial bearings within the existing Vanguard® Complete Knee System.
• Basis for Clearance: Substantial Equivalence to legally marketed predicate devices.
• Key Argument for Substantial Equivalence:
  • Identical Intended Use and Indications for Use as predicates.
  • Similar Technological Characteristics to predicates (materials, design features, sterilization).
  • Non-Clinical Testing: Engineering analyses, material characteristic evaluations (Vivacit-E material characteristics, material and dimensional comparison, FEA for stress evaluation), laser etching analysis, MRI compatibility, and pyrogenicity testing were conducted.
  • Clinical Testing: "Clinical data was not deemed necessary for the subject device." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means.

The document concludes that the differences introduced by the modification "do not raise new questions of safety and effectiveness" and that "the proposed device is at least as safe and effective as the legally marketed predicate devices."

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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.

The Vanguard® Complete Knee System is a total knee replacement system for either primary or revision knee arthroplasty. It consists of femoral components composed of cast Co-Cr-Mo per ASTM F-75 with either a porous plasma spray (PPS) or Interlok® surface finish, tibial bearings molded of polyethylene (UHMWPE) conforming to ASTM F-648 or machined of polyethylene (UHMWPE or UHMWPE with a-tocopherol) conforming to ASTM F-648, tibial trays (not part of this submission) and patellar components machined of polvethylene (UHMWPE) conforming to ASTM F-648.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Important Note: The provided document is a 510(k) summary for a Vanguard® Complete Knee System (Knee Prosthesis). For this type of medical device, the "acceptance criteria" and "study" described are primarily related to mechanical and physical testing to demonstrate substantial equivalence to previously cleared devices, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested fields regarding expert adjudication, effect size of human readers with AI assistance, and training set information are not applicable (N/A) in this context.

Acceptance Criteria and Study for the Vanguard® Complete Knee System

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

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

• Test Set Sample Size: Not explicitly stated as a number of "samples" in a clinical sense. The "test set" here refers to the collection of mechanical tests performed on the device components.
• Data Provenance: The tests were "previously performed" and the "test reports were provided in the predicate 510(k)s," suggesting that new, independent tests specifically for this submission were not all conducted, but rather existing data from predicate devices or previous versions demonstrating the performance of similar components. The tests themselves are non-clinical, laboratory-based.

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

• N/A. For mechanical testing, "ground truth" is typically established by engineering specifications, accepted industry standards (e.g., ASTM F-75, F-648), and internal quality control criteria, rather than expert human consensus in the way it's used for AI/diagnostic devices. The "experts" would be the engineers and technicians performing and verifying the tests against these established standards.

4. Adjudication method for the test set

• N/A. Given this is mechanical testing against defined specifications, there is no direct "adjudication method" involving multiple human readers as would be found in clinical imaging studies. The results are quantitative measurements compared against predefined pass/fail criteria.

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. This is a mechanical device, not an AI/software diagnostic device. An MRMC study is not applicable.

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

• N/A. This is a mechanical device, not an algorithm.

7. The type of ground truth used

• Engineering Specifications and Industry Standards: The ground truth for this device's performance is based on established engineering specifications, mechanical test standards (e.g., ASTM F-75, F-648), and internal acceptance criteria developed to ensure the safety and efficacy of knee prostheses. The goal is to demonstrate that the device performs within these acceptable mechanical limits.

8. The sample size for the training set

• N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

• N/A. Not applicable, as there is no training set.

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