(30 days)
The Scorpio® CR Superflex™ Tibial Bearing Inserts are single use devices. They are intended for mating with commercially available Howmedica Osteonics tibial trays and patellas and Scorpio® Total Knee CR femoral components, which are intended for cemented fixation.
The indications for the modified Scorpio® CR Superflex™ tibial inserts will remain the same as the indications for the current Scorpio® CR inserts. These are:
- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
- Post-traumatic loss of knee joint configuration and function
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
- Revision of previous unsuccessful knee replacement or other procedure
The Scorpio® CR Superflex™ tibial inserts share critical design features as the predicate Scorpio® CR tibial inserts. They have a barb and wire locking mechanism for mating with the appropriate Howmedica Osteonics tibial trays and are compatible with the current Scorpio® patella and CR femoral components. The subject inserts will be available in the same range of sizes and thicknesses as the current Scorpio® CR inserts.
The modifications incorporated with the Scorpio® CR Superflex™ inserts address ease of manufacturability and constraint in internal rotation. These modifications include increasing the anterior radius of the sagittal curve and adding a patella recess feature.
The provided text describes a 510(k) summary for the Scorpio® CR Superflex™ Tibial Inserts. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the way a diagnostic AI device typically would.
Therefore, many of the requested fields are not applicable to this type of medical device submission.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Scorpio® CR Tibial Bearing Inserts cleared via K974556) in terms of design features, materials, manufacturing methods, and intended use. | Device Description states: "The Scorpio® CR Superflex™ tibial inserts share critical design features as the predicate Scorpio® CR tibial inserts." |
| Statement of Technological Comparison states: "The fundamental scientific technology of the current Scorpio® CR tibial inserts has not changed with regard to the modified inserts. The modified inserts employ the same basic design concepts, the same materials, and the same manufacturing methods." | |
| Intended Use states: "The intended use of the modified tibial bearing inserts is identical to that of the unmodified tibial bearing inserts." | |
| Indications state: "The indications for the modified Scorpio® CR Superflex™ tibial inserts will remain the same as the indications for the current Scorpio® CR inserts." Ratings (if available) | |
| Performance demonstrated through static testing. | Performance Data states: "Static testing has been performed to demonstrate the substantial equivalence of the subject inserts to the predicate inserts." This indicates the testing was performed, but specific performance metrics or acceptance thresholds are not provided in this summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The "static testing" would typically involve testing of physical samples of the device, not a "test set" in the context of diagnostic AI data. The sample size for the number of inserts tested is not mentioned.
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)
This is not applicable for this type of device submission. Ground truth (in the AI/diagnostic sense) is not established through expert consensus for a knee implant's substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for this type of device 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
This is not applicable. This submission is for a knee implant, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This submission is for a knee implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, the "ground truth" for substantial equivalence is derived from a comparison of design, materials, manufacturing processes, and performance (via static testing) against a legally marketed predicate device. It's not a diagnostic "ground truth." The static testing would objectively measure physical properties, but the specific metrics and how they correlate to a "ground truth" are not detailed in this summary.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of an AI algorithm for this device.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.