(30 days)
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved;
- Correction of varus, valgus, or posttraumatic deformity;
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total 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 (InterlokTM) devices and all-polyethylene patellar components are indicated for cemented application only. Regenerex™ components are intended only for uncemented biologic fixation application.
The Biomet® Splined Knee Stems V2 are intended for cemented fixation to provide additional stability to femoral or tibial knee components where needed.
This submission describes modifications to compatible components of the Vanguard SSK 360 Revision Knee System. Specifically, the design and size offering was modified.
The provided text describes a 510(k) premarket notification for a medical device (Vanguard® SSK 360 Revision Knee System), focusing on modifications to compatible components, specifically the "Biomet® Splined Knee Stems V2." The document states that the changes "do not affect the intended use or alter the fundamental scientific technology of the device."
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Acceptable stability of stems after fit analysis | "All stems tested met the acceptance criteria of 'acceptable stability'." |
| No new risks of bone perforation or fracture due to design modifications | "Secondary evaluation determined that the design modifications did not introduce any new risks of bone perforation or fracture." |
| Taper connection not affected by proposed design modifications compared to predicate stems | "An engineering justification evaluated the proposed modifications and demonstrated that the proposed design modifications would not affect the taper connection of the stems as compared to the predicate stems." |
| MR Conditional status maintained within existing parameters | "The modified stems are determined to be MR Conditional within the parameters of the previously tested Vanguard 360 Revision Knee System stems." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Fit Analysis Performance Testing" and "secondary evaluation" but does not specify the sample size of stems or components used for these non-clinical tests.
The data provenance is non-clinical testing, performed by the manufacturer, Biomet Manufacturing Corp. The document does not provide details on the country of origin of the data beyond implicitly being from the manufacturer's testing. It is inherently retrospective in the sense that it's testing a design modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention any human experts used to establish ground truth for the non-clinical testing performed. The "acceptance criteria" appear to be based on engineering and design specifications.
4. Adjudication Method for the Test Set
Since human experts were not involved in establishing the ground truth for this non-clinical testing, no adjudication method was used. The assessment appears to be based on direct measurement and engineering analysis against predefined specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical Data was not required to demonstrate substantial equivalence to the predicate Vanguard® 360 Revision Knee System (K093293)."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is a physical medical device (knee stems), not an AI algorithm. Therefore, the concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study does not apply.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical tests appears to be based on engineering specifications and performance metrics for fit, stability, and absence of new risks (e.g., bone perforation, fracture, effect on taper connection) as defined by the manufacturer for the device's intended function. Additionally, the MR Conditional status implies adherence to predefined safety standards for MRI compatibility.
8. The Sample Size for the Training Set
This document describes a non-clinical evaluation of a physical device modification, not an AI algorithm. Therefore, the concept of a "training set" does not apply.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" is not applicable here.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.