(30 days)
The ADVANCE® Double High Insert 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:
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- noninflammatory degenerative joint discase including osteoarthritis, traumatic arthritis, or avascular necrosis;
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- inflammatory degencrative joint diseasc including rheumatoid arthritis;
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- correction of functional deformity;
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- revision proccdures where other treatments or devices have failed; and
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- treatment of fractures that are unmanageable using other techniques.
The ADVANCE® Double High Insert is for single cemented use.
- treatment of fractures that are unmanageable using other techniques.
The design features of the ADVANCE® Double High Insert are summarized below:
- Manufactured from UHMWPE ●
- Offered in left and right designs, sizes 0-6, thicknesses of 10mm-25mm .
- Allows for medial-pivot rotation
- Allows for the retention of the cruciate retaining ligament .
- Allows for higher flexion .
The provided document describes a 510(k) premarket notification for a medical device, the ADVANCE® Double High Insert, which is a tibial insert for knee arthroplasty. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a de novo study with acceptance criteria and a detailed study report.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert qualifications, and ground truth establishment are not present in the provided text.
Here's an attempt to answer the questions based only on the provided information, noting where information is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: Materials of the ADVANCE® Double High Insert are identical to predicate devices. | Achieved: The ADVANCE® Double High Insert uses UHMWPE, which is identical to the ADVANCE® Medial Pivot Insert and AXIOM® Standard Tibial Insert. |
| Indications for Use Equivalence: Indications for use are identical to predicate devices. | Achieved: The ADVANCE® Double High Insert's indications for use are identical to the ADVANCE® Medial Pivot Insert and AXIOM® Standard Tibial Insert. |
| Articulating Surface Equivalence: Articulating surface is substantially equivalent to predicate devices. | Achieved: The articulating surface of the ADVANCE® Double High Insert is substantially equivalent to the ADVANCE® Medial Pivot Insert and AXIOM® Standard Tibial Insert. |
| Overall Safety and Effectiveness: Safety and effectiveness are adequately supported by substantial equivalence information, materials information, and analysis data. | Achieved: The FDA found the device substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The submission is for substantial equivalence, not a performance study requiring a test set of data in the manner typically associated with AI/diagnostic devices. The safety and effectiveness are supported by comparing design features and materials to existing devices.
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)
- Not Applicable / Not Provided: As this is a submission based on substantial equivalence for a physical medical implant, there is no "test set" requiring expert-established ground truth in the context described (e.g., for diagnostic accuracy).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No test set or expert adjudication is described for this type of submission.
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
- No: No MRMC study was performed or described. This type of study is not relevant for a knee implant based on substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: The "ground truth" for this submission revolves around demonstrating that the device's design, materials, and intended use are sufficiently similar to predicate devices that have established their safety and effectiveness. This is based on engineering analysis, material specifications, and regulatory comparison rather than clinical "ground truth" derived from patient data.
8. The sample size for the training set
- Not Applicable / Not Provided: As this is a submission for a physical medical implant based on substantial equivalence, there is no "training set" in the context of an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: There is no training set mentioned in this submission.
§ 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.