Search Results
Found 1 results
510(k) Data Aggregation
(71 days)
The Continuum Patellar is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, and 5) treatment of fractures that are unmanageable using other techniques. This device is intended for use with bone cement.
The Continuum Patellar is fabricated from Hedrocel® and UHMWPE. The UHMWPE is direct compression molded into the Hedrocel®, thereby creating the articulation surface. The Continuum Patellar is intended for use with bone cement when performing total knee arthroplasty or revisions with legally marketed Implex Continuum Femoral and Tibial components.
The Implex Continuum Patellar is a knee joint patellofemorotibial prosthesis. The 510(k) summary states that "Performance testing of the Continuum Patellar demonstrates its equivalence to the claimed predicate devices." This implies that the acceptance criteria for the device are met if its performance is comparable or non-inferior to the predicate devices.
However, the provided text does not explicitly define specific "acceptance criteria" in terms of quantitative metrics or performance thresholds. Instead, it relies on the concept of "substantial equivalence" to predicate devices.
Here's an analysis of the information requested, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from "Substantial Equivalence") | Reported Device Performance |
|---|---|---|
| Material Composition | Equivalent to predicate devices (Hedrocel® and UHMWPE) | Uses Hedrocel® and UHMWPE |
| Design and Geometry | Similar and/or identical to predicate devices | Two-part design and articulating surface geometry similar and/or identical to predicate devices. |
| Intended Use | Identical to predicate devices | Intended use is consistent with predicate devices for total knee arthroplasty or revisions. |
| Safety and Effectiveness | Equivalent to predicate devices | Performance testing demonstrates equivalence to claimed predicate devices. |
| Fixation Method | Intended for use with bone cement | Intended for use with bone cement. Crucially, the FDA explicitly states it "may not be labeled or promoted for non-cemented use" and "Any non-cemented fixation of this device is considered investigational." |
Study Information
The document mentions "Performance testing of the Continuum Patellar demonstrates its equivalence to the claimed predicate devices," but it does not provide details about a specific study in the format of a clinical trial or a detailed bench testing report. It's a summary statement rather than a detailed study description.
Based on the provided text, the following information is not available or implicitly handled by the substantial equivalence argument:
- Sample size used for the test set and the data provenance: Not specified. The "performance testing" is not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. This typically applies to image-based diagnostic devices. For a prosthetic device, "ground truth" would likely refer to engineering specifications, material properties, and clinical outcomes, which are not outlined in a study format here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified.
- 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: Not applicable. This is a prosthetic device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a prosthetic device, "ground truth" would generally involve meeting engineering specifications, material tests, and potentially biomechanical evaluations, comparing them to established predicate devices. The document only states "Performance testing" without detailing methodology.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided K971789 document details a 510(k) submission where "substantial equivalence" to predicate devices is the primary means of demonstrating safety and effectiveness. It does not contain detailed information about a specific quantitative study with predefined acceptance criteria, sample sizes, and expert panel ground truth verification as typically seen for diagnostic devices or more complex clinical trials. The "performance testing" mentioned is general and not elaborated upon in this summary document. The FDA's decision emphasizes the "cemented use only" limitation as a critical aspect of its substantial equivalence finding.
Ask a specific question about this device
Page 1 of 1