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K Number
K193057
Device Name
ATTUNE All-Polyethylene Tibia
Manufacturer
DePuy Ireland UC
Date Cleared
2020-01-30

(90 days)

Product Code
JWH
Regulation Number
888.3560
Type
Traditional
Panel
OR
Reference & Predicate Devices
K101433,K140881,K103756,K943462,K950010,K961685,K971189
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Device Description

The subject device is an all polyethylene tibia component made from AOX Polyethylene that mates with existing ATTUNE cemented (K101433) and cementless (K140881) femoral components, and existing ATTUNE patella components (K103756).

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device, the ATTUNE All Polyethylene Tibia, and does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance data.

Here's why the requested information cannot be extracted from this document:

  • Device Type: The device is a "Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis," which is a physical implant for total knee replacement, not a software or AI/ML-driven device.
  • Study Type: The studies mentioned are "non-clinical tests" related to mechanical properties and material performance of the physical implant (e.g., Contact Area/Pressure, Wear, Constraint on tibiofemoral interface, Spine Fatigue, C2 Fixation Testing, Range of Motion, and bacterial endotoxin testing). These are not studies to evaluate AI/ML performance.
  • Lack of AI/ML Specifics: There is no mention of AI, machine learning, algorithms, or any form of software performance evaluation.
  • Clinical Testing: The document explicitly states: "No clinical testing was conducted to demonstrate substantial equivalence." This further indicates that the type of clinical performance study typically associated with AI/ML device validation (e.g., impact on human readers, standalone performance) was not performed.

Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this 510(k) submission for a knee implant.

§ 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.