(29 days)
The ADVANCE® 913 Medial Pivot Tibial Insert and the ADVANCE® 913 Medial Pivot Tibial Base are 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.
ADVANCE® 913 Medial Pivot Tibial Base and Insert Components are for use with bone cement.
Tibial Insert:
- Manufactured from UHMWPE conforming to ASTM F648 .
- Sizes: 1-5 Left & Right .
- Thickness: 10, 12, 14, 17 mm .
Tibial Base: - Manufactured from Cobalt Chrome alloy conforming to ASTM F75 .
- Sizes: 1-5 plus .
- Symmetrical .
- No screw holes .
This document is a 510(k) summary for the ADVANCE® 913 Medial Pivot Tibial Insert and Base, which are components of a knee arthroplasty system. It's a regulatory submission to the FDA demonstrating substantial equivalence to previously cleared devices, not a study describing device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not present in this document.
Here's what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not specify quantitative acceptance criteria or report specific performance metrics for the device. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against predefined acceptance criteria through clinical or standalone studies.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe a test set or any specific study that would involve a sample size of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. There is no mention of a test set, ground truth, or experts in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. This document is for a medical implant (tibial insert and base), not an AI-assisted diagnostic device. Therefore, an MRMC study involving human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is not a software/algorithm device, so a standalone algorithm performance evaluation is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. As no study creating a new ground truth is described, this information is not available.
8. The sample size for the training set
- Cannot be provided. This document does not describe a training set for an AI or algorithm.
9. How the ground truth for the training set was established
- Cannot be provided. This document does not describe a training set or its ground truth establishment.
Summary of what the document does provide:
- Device: ADVANCE® 913 Medial Pivot Tibial Insert and ADVANCE® 913 Medial Pivot Tibial Base.
- Intended Use/Indications: For use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with conditions like noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), correction of functional deformity, revision procedures, and treatment of unmanageable fractures.
- Materials: Tibial Insert: UHMWPE conforming to ASTM F648. Tibial Base: Cobalt Chrome alloy conforming to ASTM F75.
- Regulatory Context: This is a 510(k) premarket notification claiming substantial equivalence to previously cleared predicate devices. The safety and effectiveness are supported by "substantial equivalence information, materials information and the analysis data provided within this Premarket Notification," not necessarily by direct performance testing against acceptance criteria in this summary.
- Predicate Devices: The indications for use and design features are stated to be identical or substantially equivalent to previously cleared predicate devices.
§ 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.