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K Number
K203779
Device Name
Symmetric Total Knee System
Manufacturer
Signal Medical Corporation
Date Cleared
2021-06-10

(164 days)

Product Code
MBH,JWH
Regulation Number
888.3565
Type
Traditional
Panel
OR
Reference & Predicate Devices
K961157,K080199
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.
Device Description

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.

AI/ML Overview

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.

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.