(108 days)
The ADVANCE® Total Knee System is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques.
The ADVANCE® Total Knee System components are for use without bone cement and are single use devices.
The ADVANCE® Total Knee System contains femoral components, tibial components, and patellas. The ADVANCE® Total Knee System components are compatible with existing ADVANCE® tibial inserts and patellas. The design features and function of the ADVANCE® Total Knee System are substantially equivalent to the design features and function of the existing ADVANCE® Total Knee System and are highlighted below.
- Manufactured from Cobalt Chrome Alloy or Titanium Alloy .
- Manufactured with porous coating .
- Accessory components available without porous coating .
- Available with or without HA coating .
- Intended for use without bone cement .
This 510(k) summary (K061223) is for the ADVANCE® Total Knee System, a knee arthroplasty device.
Based on the provided document, there is no acceptance criteria or study mentioned that proves the device meets specific performance criteria in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics typically associated with AI/software devices.
The document is a traditional 510(k) submission for a medical implant (a knee replacement system) which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting analytical or clinical performance data that would involve acceptance criteria and a study design as described in the prompt.
Therefore, I cannot populate the table or provide the requested information. The document pertains to a mechanical device, not an AI/software-based medical device.
Here's why the requested information cannot be extracted from the provided text:
- Type of Device: The "ADVANCE® Total Knee System" is a knee implant (femoral components, tibial components, patellae). It is a physical, mechanical medical device.
- Regulatory Pathway: The submission is a 510(k), which for devices like these, primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves comparing materials, design features, intended use, and sometimes mechanical testing (e.g., fatigue, wear resistance) if new materials or designs are introduced. It does not involve diagnostic accuracy studies, human reader studies, or AI algorithm performance metrics.
- Content of the Document: The document explicitly discusses "intended use, material, type of interface, and design features" and states that "The ADVANCE® Total Knee System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." This "testing results" would refer to mechanical or biocompatibility tests, not clinical performance studies in the context of AI.
- Absence of AI/Software Indicators: There is no mention of algorithms, AI, machine learning, image analysis, diagnostic capabilities, or any other terms that would suggest an AI component that would require the kind of performance metrics outlined in your prompt.
If this was an AI/Software-based device, the 510(k) summary would typically include sections detailing:
- Algorithm description
- Training data characteristics
- Test data characteristics
- Ground truth establishment
- Performance metrics (e.g., sensitivity, specificity, AUC)
- Results of standalone studies
- Results of human-in-the-loop studies (MRMC studies)
Since none of this information is present, it confirms that the device is not an AI/software device and therefore does not have the "acceptance criteria" and "study" as envisioned in your prompt.
§ 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.