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Indications:

Indications for Total Knee Replacement:

• 1. Rheumatoid arthritis,
• 2. Correction of functional deformity.
• 3. Osteoarthritis.

4. Degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result.

5. Failed osteotomies, unicompartmental replacement, or total knee replacement.

The femoral component and tibial tray are for cemented use (biological fixation).

The patellar component and metaphyseal stem (K080199) are for cemented use only.

Indications for Posterior Stabilized Knee Replacement:

Posterior stabilized knee systems with a deep articular surface are designed for use in patients in primary and revision surgery, where the anterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Total Knee indications still apply.

Indications for Constrained Knee Replacement:

Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/ or lateral collateral ligament) are absent or incompetent. Total Knee indications still apply.

The Agility Symmetric™ Total Knee System is intended for the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem previously cleared in K080199) and a potellar component (also cleared in K080199).

The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/ molybdenum (CoCrMo). The femoral component is available in five sizes (3-7) and will have two condylar pegs to aid in rotational stability. It is mesh coated with ASTM F67 titanium.

The TIBIAL TRAY is a symmetric designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti6Al4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside providing rotational stabilization and increased tray strew holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting an ultra-high polyethylene (UHMWPE) tibial insert to be snapped into place. The tibial tray has 5 sizes (3-7) and is mesh coated with ASTM F67 titanium.

Mating geometries for the previously cleared (K080199) TIBIAL INSERT, METAPHYSEAL STEM, REVISION STEM, and PATELLAR COMPONENT have not changed from the predicate devices.

The prompt asks to describe the acceptance criteria and the study proving a device meets them, but the provided text is a 510(k) clearance letter for a total knee replacement system (Agility Symmetric Total Knee System). This document does not describe acceptance criteria for an AI/ML medical device, nor does it detail a clinical study with human readers or AI assistance.

Instead, it's a premarket notification for a medical implant and focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot fulfill the request as it pertains to an AI/ML medical device's acceptance criteria and study, based on the provided text. The text outlines:

• Device Name: Agility Symmetric™ Total Knee System
• Regulation Number/Name: 21 CFR 888.3565 / Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
• Product Codes: MBH, JWH
• Indications for Use: Total Knee Replacement, Posterior Stabilized Knee Replacement, Constrained Knee Replacement (details specific conditions like rheumatoid arthritis, osteoarthritis, failed osteotomies, ligament integrity, etc.).
• Predicate Devices: K080199 (Symmetric™ Total Knee System - primary), K141635 (Arthrex iBalance® TKA System - secondary)
• Device Description: Components (femoral, tibial tray, patellar, metaphyseal stem), materials (CoCrMo, Ti6Al4V), and coating (ASTM F67 titanium mesh).
• Technological Comparison: Differences from predicates in coating material and bone interface features (e.g., removal of central post/gussets, addition of condylar pegs), but deemed to not raise new questions of safety and effectiveness.
• Non-Clinical Tests Summary & Conclusions:
  • Fatigue testing per ASTM F3210 (femoral knee) and ASTM F1800 (tibial tray, tibial tray and modular stem).
  • Wear testing per ISO 14243-1.
  • Particle characterization per ASTM F1877-16.
  • Shear-off testing for tibial locking mechanism per ASTM 1814.
  • Cleaning validation per ISO 19227.
  • Biocompatibility assessment per ISO 10993-1.
  • Sterilization assessment per ISO 11135 and AAMI TIR28.
  • Uncemented design validation per ISO 21536.
  • Morse taper modular connection assessment per ISO 21536 and ASTM F1814.
  • Constraint and contact area assessment per ASTM F1223 and ISO 21536.
• Clinical Testing: Not Applicable. This further confirms that no human-in-the-loop or standalone AI/ML performance study was conducted.

In summary, the provided document does not contain the information required to answer the prompt regarding acceptance criteria and study data for an AI/ML medical device.

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The Symmetric(TM) Total Knee System consists of single use components intended for total knee arthroplasty with the following indications:

1. Rheumatoid arthritis,
2. Post-traumatic arthritis,
3. Osteoarthritis,
4. Degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
5. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   All components are for cemented use only.

The Femoral components are cobalt chromium alloy (ASTM F75). Tibial articular inserts and patellar components are UHMWPE (ASTM F648). Tibial trays, metaphyseal and revision stems, femoral and tibial wedges and cones, and screws (K961157), are titanium (ASTM F1472). Coated cobalt chromium and titanium components feature a coating of plasma sprayed titanium (ASTM F1580).
The purpose of this 510(k) is to submit an additional sterilization method of a flexible bag system. Other descriptive details remain unchanged from the predicate.

This document is a 510(k) premarket notification for a medical device called the "Symmetric™ Total Knee System." It's important to note that this submission is for an additional sterilization method for an existing device, not for a new AI/software-driven device. As such, the information typically requested for AI device studies (like sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) does not apply to this specific submission.

Therefore, I cannot provide a table of acceptance criteria for AI performance or details of a study proving a device meets AI-specific criteria, as this document pertains to a physical orthopedic implant and its sterilization process, not an AI or software-based medical device.

Here's a breakdown of what the document does provide, and why the requested information isn't present:

Device: Symmetric™ Total Knee System (a knee joint prosthesis)
Purpose of 510(k): To submit an additional sterilization method (flexible bag system) for the device. The core device itself was previously cleared under K080199.

Missing Information (and why it's not applicable here):

1. Table of acceptance criteria and reported device performance: This document doesn't define acceptance criteria for AI performance. The "performance data" mentioned (Section VII) refers to "full sterilization qualification of the flexible bag sterilization vendor," not clinical or AI performance.
2. Sample size, data provenance for a test set: No test set for AI performance is discussed.
3. Number of experts and qualifications for ground truth: Not applicable, as there's no AI ground truth to establish.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. Human readers are not using AI assistance with a knee implant.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

What the document does state regarding the study (sterilization-related):

• Study: "The full sterilization qualification of the flexible bag sterilization vendor is included in the submission." (Section VII. Performance Data)
• Conclusion: "The technological characteristics/features and performance characteristics for the Symmetric Total Knee System are substantially equivalent to the legally marketed predicate device. This 510(k) is submitted for the addition of the flexible bag chamber sterilization method." (Section VIII. Conclusions)

In summary, this document is about changes to the manufacturing process (sterilization) of a physical medical implant, not the evaluation of an AI or software algorithm.

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The Symmetric™ Total Knee System consist of single use components intended for total knee arthroplasty with the following indications.

1. Osteoarthritis (for cemented use only)
2. Rheumatoid Arthritis (for cemented use only)
3. Traumatic Arthritis (for cemented use only)
4. Where the use of a more conservative procedure has failed or is unacceptable.

The Symmetric™ Total Knee System is intended for the resurfacing of the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem) and a polyethylene tibial insert and patellar component.

The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo). The femoral component will be available in eight sizes (1-8) and will have a central post (with a 5° valgus angle) and gussets to aid in rotational stability and to increase strength. It will be plasma sprayed with Commercially Pure Titanium (CPTi).

The TIBIAL TRAY is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti 6Al-4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside broviding rotational stabilization and increased tray strength. Four screw holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 8 sizes (1-8) and is plasma sprayed with Commercially Pure Titanium (CPTi).

The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semiconstrained and is captured in the tibial tray by the mating capture features. The insert is available in nine thicknesses (10, 12, 14, 16, 18, 20, 25, 30, 35mm) and 8 sizes (1-8).

The METAPHYSEAL STEM is designed to be driven onto a tibial tray further increasing the fit and fill of the component allowing for a more stable system.

The REVISION STEM is designed to be driven onto a tibial tray or femoral component further increasing the stability of a revision component.

The PATELLAR COMPONENT is dome shaped and tracks nicely against the femoral component.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "No clinical data was utilized for the basis of substantial equivalence."
Therefore, there is no clinical test set, sample size, or data provenance related to clinical data. The evaluation was based solely on non-clinical testing.

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

Not applicable, as no clinical test set or ground truth derived from expert opinion on clinical cases was used. The substantial equivalence was determined through non-clinical testing and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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

No MRMC study was performed on human readers as no clinical data was used. The evaluation was based on device performance in non-clinical tests.

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

This concept is not directly applicable in the context of this traditional medical device (knee implant). The "standalone" performance here refers to the device's physical and mechanical properties as tested in a laboratory setting, without human interaction in a 'use' scenario beyond the testing parameters. The non-clinical testing performed is essentially a standalone evaluation of the device's material and design integrity.

7. Type of Ground Truth Used

The ground truth for proving substantial equivalence was established through:

• Comparison to predicate device specifications: The physical dimensions, materials, and fixation methods were compared to those of the Beacon Cemented and Uncemented Total Knee System (K051510) and the Profix Total Knee System (K933958).
• Non-clinical testing methodologies: Performance was assessed against established engineering standards and guidance documents, specifically "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA (dated January 16, 2003)."

8. Sample Size for the Training Set

Not applicable, as this is a medical device submission based on substantial equivalence through non-clinical testing and comparison to predicate devices, not an AI/machine learning algorithm that requires a training set.

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

Not applicable, as no training set was used.

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